research ethics committee usa

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Regulatory Authority

Scope of assessment, regulatory fees, ethics committee, scope of review, ethics committee fees, oversight of ethics committees.

Clinical Trial Lifecycle

Submission Process

Submission Content

Timeline of Review

Initiation, Agreements & Registration

Safety Reporting

Progress Reporting

Sponsorship

Definition of Sponsor

Site/Investigator Selection

Insurance & Compensation

Risk & Quality Management

Data & Records Management

Personal Data Protection

Informed Consent

Documentation Requirements

Required Elements

Participant Rights

Emergencies

Vulnerable Populations

Children/Minors

Pregnant Women, Fetuses & Neonates

Mentally Impaired

Investigational Products

Definition of Investigational Product

Manufacturing & Import

Quality Requirements

Product Management

Definition of Specimen

Specimen Import & Export

Consent for Specimen

Requirements

Additional Resources

Information Not Yet Incorporated Into Country Profile:

New FDA Final Rule Issued for Informed Consent Exceptions for Minimal Risk Clinical Investigations The Food and Drug Administration (FDA) issued a final rule , which went into effect on January 22, 2024. The final rule allows an institutional review board (IRB) to waive or alter certain informed consent elements, or waive the informed consent requirement for certain FDA-regulated minimal risk clinical investigations.

Clinical Trials Registries

• ClinicalTrials.gov listing of studies in United States
• International Clinical Trials Registry Platform (ICTRP) consolidated listing of studies in United States

Ethics Committees

• Database of institutional review boards/ethics committees registered with the United States Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP)

Funding & Institutions

• World RePORT database of funding organizations, research organizations, and research programs in United States
• HHS OHRP database of institutions with approved Federalwide Assurances (FWAs) for the protection of human subjects

US Profile Updated

Us profile updated in clinregs, united states: ohrp issues guidance for research impacted by covid-19, united states: fda and nih issue guidance for clinical trials impacted by covid-19.

Other Regulatory Databases

• United States Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) International Compilation of Human Research Standards for United States
• Health Research Web - United States

This profile covers the role of the Department of Health & Human Services (HHS) ’s Food & Drug Administration (FDA) in reviewing and authorizing investigational new drug applications (INDs) to conduct clinical trials using investigational drug or biological products in humans in accordance with the FDCAct , 21CFR50 , and 21CFR312 . Regulatory requirements for federally funded or sponsored human subjects research, known as the Common Rule ( Pre2018-ComRule and RevComRule ), which the HHS and its Office for Human Research Protections (OHRP) implements in subpart A of 45CFR46, are also examined. Lastly, additional HHS requirements included in subparts B through E of 45CFR46 are described in this profile, where applicable, using the acronym 45CFR46-B-E . (Please note: ClinRegs does not provide information on state level requirements pertaining to clinical trials.)

Food & Drug Administration

As per the FDCAct , 21CFR50 , and 21CFR312 , the FDA is the regulatory authority that regulates clinical investigations of medical products in the United States (US). According to USA-92 , the FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

An overview of the FDA structure is available in USA-33 . Several centers are responsible for pharmaceutical and biological product regulation, including the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) . Additionally, per USA-88 , the Office of Clinical Policy (OCLiP) develops good clinical practice and human subject protection policies, regulation, and guidance.

See USA-47 for a list of FDA clinical trials related guidance documents.

Office for Human Research Protections and Common Rule Agencies

Per USA-93 , the OHRP provides leadership in the protection of the rights, welfare, and well-being of human research subjects for studies conducted or supported by the HHS. The OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.

USA-65 states that the Common Rule ( Pre2018-ComRule and RevComRule ) outlines the basic provisions for institutional ethics committees (ECs) (referred to as institutional review boards (IRBs) in the US), informed consent, and Assurances of Compliance. See USA-65 for a list of US departments and agencies that follow the Common Rule, which are referred to as Common Rule departments/agencies throughout the profile.

The RevComRule applies to all human subjects research that is federally funded or sponsored by a Common Rule department/agency (as identified in USA-65 ), and: 1) was initially approved by an EC on or after January 21, 2019; 2) had EC review waived on or after January 21, 2019; or 3) was determined to be exempt on or after January 21, 2019. (Per USA-55 and USA-74 , the RevComRule is also known as the “2018 Requirements.”) For 2018 Requirements decision charts consistent with the RevComRule , including how to determine if research is exempt, see USA-74 . For more information about the RevComRule , see USA-66 .

Per the RevComRule , the Pre2018-ComRule requirements apply to research funded by a Common Rule department/agency (as identified in USA-65 ) that, prior to January 21, 2019, was either approved by an EC, had EC review waived, or was determined to be exempt from the Pre2018-ComRule . Institutions conducting research approved prior to January 21, 2019 may choose to transition to the RevComRule requirements. The institution or EC must document and date the institution's determination to transition a study on the date the determination to transition was made. The research must comply with the RevComRule beginning on that date. For pre-2018 Requirements decision charts consistent with the Pre2018-ComRule , including how to determine if research is exempt, see USA-74 .

See USA-54 for additional information regarding compliance with the Pre2018-ComRule and the RevComRule .

USA-65 indicates that the FDA, despite being a part of the HHS, is not a Common Rule agency. Rather, the FDA is governed by its own regulations, including the FDCAct and 21CFR50 . However, the FDA is required to harmonize with the Pre2018-ComRule and the RevComRule whenever permitted by law.

If a study is funded or sponsored by HHS, and involves an FDA-regulated product, then both sets of regulations will apply. See G-RevComRule-FDA for additional information.

Other Considerations

Per USA-16 , the US is a founding regulatory member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The US has adopted several ICH guidance documents, including the E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population ( US-ICH-E11 ), E17 General Principles for Planning and Design of Multiregional Clinical Trials ( US-ICH-E17 ), and E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) ( US-ICH-GCPs ), which are cited throughout this profile.

Contact Information

As per USA-81 , USA-91 , and USA-90 , the contact information for the FDA is as follows:

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Telephone (general inquiries): (888) 463-6332

CDER Telephone (drug information): (301) 796-3400 CDER Email: [email protected]

CBER Telephone: (800) 835-4709 or (240) 402-8010 CBER Email (manufacturers assistance): [email protected] CBER Email (imports): [email protected] CBER Email (exports): [email protected]

Office for Human Research Protections

Per USA-82 , the contact information for the OHRP is as follows:

Office for Human Research Protections 1101 Wootton Parkway, Suite 200 Rockville, MD 20852 Telephone: (866) 447-4777 or (240) 453-6900 Email (general inquiries): [email protected]

Department of Health & Human Services

According to USA-83 , the contact information for the HHS is as follows:

US Department of Health & Human Services Hubert H. Humphrey Building 200 Independence Avenue, S.W. Washington, D.C. 20201 Call Center: (877) 696-6775

In accordance with the FDCAct , 21CFR50 , and 21CFR312 , the Food & Drug Administration (FDA) has authority over clinical investigations for drug and biological products regulated by the agency. 21CFR312 specifies that the scope of the FDA’s assessment for investigational new drug applications (INDs) includes all clinical trials (Phases 1-4). Based on 21CFR56 and 21CFR312 , institutional ethics committee (EC) review of the proposed clinical investigation may be conducted in parallel with the FDA review of the IND. However, EC approval must be obtained prior to the sponsor being permitted to initiate the clinical trial. (Note: Institutional ECs are referred to as institutional review boards (IRBs) in the United States (US)).

As delineated in 21CFR312 and USA-42 , sponsors are required to submit an IND to the FDA to obtain an agency exemption to ship investigational drug(s) across state lines to conduct drug or biologic clinical trial(s). An IND specifically exempts an investigational drug or biologic from FDA premarketing approval requirements that would otherwise be applicable. 21CFR312 states that “‘IND’ is synonymous with ‘Notice of Claimed Investigational Exemption for a New Drug.’"

According to USA-42 , the FDA categorizes INDs as either commercial or non-commercial (research) and classifies them into the following types:

• Investigator INDs - Submitted by physicians who both initiate and conduct the investigation, and who are directly responsible for administering or dispensing the investigational drug.
• Emergency Use INDs - Enable the FDA to authorize experimental drugs in an emergency situation where normal IND submission timelines cannot be met. Also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.
• Treatment INDs - Submitted for experimental drugs showing potential to address serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.

Per the G-PharmeCTD , non-commercial products refer to products not intended to be distributed commercially and include the above listed IND types.

As indicated in the G-IND-Determination , in general, human research studies must be conducted under an IND if all of the following research conditions apply:

• A drug is involved as defined in the FDCAct
• A clinical investigation is being conducted as defined in 21CFR312
• The clinical investigation is not otherwise exempt from 21CFR312

The G-IND-Determination states that biological products may also be considered drugs within the meaning of the FDCAct .

Further, per 21CFR312 and the G-IND-Determination , whether an IND is required to conduct an investigation of a marketed drug primarily depends on the intent of the investigation and the degree of risk associated with the use of the drug in the investigation. See 21CFR312 and the G-IND-Determination for detailed exemption conditions for marketed drugs.

Clinical Trial Review Process

As delineated in 21CFR312 , the FDA's primary objectives in reviewing an IND are to ensure human participant safety and rights in all phases of the investigation. Phase 1 submission reviews focus on assessing investigation safety, and Phase 2 and 3 submission reviews also include an assessment of the investigation’s scientific quality and ability to yield data capable of meeting marketing approval statutory requirements. An IND may be submitted for one (1) or more phases of an investigation.

As per USA-41 and USA-94 , the FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) receive IND submissions for drugs, therapeutic biological products, and other biologicals. Per the FDCAct and 21CFR312 , an IND automatically goes into effect 30 calendar days from receipt, unless the FDA notifies the sponsor that the IND is subject to a clinical hold, or the FDA has notified the sponsor earlier that the trial may begin. A clinical hold is an order the FDA issues to delay or suspend a clinical investigation. If the FDA determines there may be grounds for imposing a clinical hold, an attempt will be made to discuss and resolve any issues with the sponsor prior to issuing the clinical hold order. See 21CFR312 for more information on clinical holds.

According to USA-41 , with respect to sponsor-investigators, once the FDA receives the IND, an IND number will be assigned and the application will be forwarded to the appropriate reviewing division. A letter will be sent to the sponsor-investigator providing notification of the assigned IND number, date of receipt of the original application, address where future submissions to the IND should be sent, and the name and telephone number of the FDA person to whom questions about the application should be directed.

As indicated in 21CFR312 , the FDA may at any time during the course of the investigation communicate with the sponsor orally or in writing about deficiencies in the IND or about the FDA's need for more data or information. Furthermore, on the sponsor's request, the FDA will provide advice on specific matters relating to an IND.

21CFR312 indicates that once an IND is in effect, a sponsor must submit a protocol amendment if intending to conduct a study that is not covered by a protocol already contained in the IND, there is any change to the protocol that significantly affects the safety of subjects, or a new investigator is added to carry out a previously submitted protocol. A sponsor must submit a protocol amendment for a new protocol or a change in protocol before its implementation, while protocol amendments to add a new investigator or to provide additional information about investigators may be grouped and submitted at 30-day intervals. See 21CFR312 for more information on protocol amendments.

As per 21CFR312 , if no subjects are entered into a clinical study two (2) years or more under an IND, or if all investigations under an IND remain on clinical hold for one (1) year or more, the IND may be placed by the FDA on inactive status. An IND that remains on inactive status for five (5) years or more may be terminated. See 21CFR312 for more information on inactive status.

21CFR312 indicates that the FDA may propose to terminate an IND based on deficiencies in the IND or in the conduct of an investigation under an IND. If the FDA proposes to terminate an IND, the agency will notify the sponsor in writing, and invite correction or explanation within a period of 30 days. If at any time the FDA concludes that continuation of the investigation presents an immediate and substantial danger to the health of individuals, the FDA will immediately, by written notice to the sponsor, terminate the IND. See 21CFR312 for more information on FDA termination.

For more information on CDER and CBER internal policies and procedures for accepting and reviewing applications, see USA-96 and USA-95 , respectively.

Expedited Processes

USA-84 further indicates that the FDA has several approaches to making drugs available as rapidly as possible:

• Breakthrough Therapy – expedites the development and review of drugs which may demonstrate substantial improvement over available therapy
• Accelerated Approval – allow drugs for serious conditions that fill an unmet medical need to be approved based on a surrogate endpoint
• Priority Review – a process by which the FDA’s goal is to take action on an application within six (6) months
• Fast Track – facilitates the development and expedites the review of drugs to treat serious conditions and fill an unmet medical need

See USA-84 and USA-85 for more information on each process. Additionally, see the FDCAct , as amended by the FDORA , for changes to the accelerated approval process.

The G-RWDRWE-Reg , issued as part of the FDA’s Real-World Evidence (RWE) Program (see USA-17 ), discusses the applicability of the 21CFR312 IND regulations to various clinical study designs that utilize real-world data (RWD). See the G-RWDRWE-Reg for more information.

For information on the appropriate use of adaptive designs for clinical trials and additional information to provide the FDA to support its review, see G-AdaptiveTrials .

For research involving cellular and gene therapy, see the guidance documents at USA-80 .

The Food & Drug Administration (FDA) does not levy a fee to review investigational new drug submissions.

However, per the FDCAct , FDARA , and USA-45 , the FDA has the authority to assess and collect user fees from companies that produce certain human drug and biological products as part of the New Drug Application (NDA). Per USA-43 , the NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States. The data gathered during the animal studies and human clinical trials of an investigational new drug become part of the NDA.

As indicated in 21CFR50 , 21CFR56 , and 21CFR312 , the United States (US) has a decentralized process for the ethics review of clinical investigations. The sponsor must obtain institutional level ethics committee (EC) approval for each study. (Note: Institutional ECs are referred to as institutional review boards (IRBs) in the US.)

As set forth in 21CFR50 , 21CFR56 , and 21CFR312 , all clinical investigations for drug and biological products regulated by the Food & Drug Administration (FDA) require institutional EC approval.

The Pre2018-ComRule and the RevComRule also require that human subjects research receive institutional EC approval. However, note that these regulations’ definition of “human subject” does not include the use of non-identifiable biospecimens. Therefore, the use of non-identifiable biospecimens in research does not, on its own, mandate the application of the Pre2018-ComRule to such research. However, the RevComRule does require federal departments or agencies implementing the policy to work with data experts to reexamine the meaning of “identifiable private information” and “identifiable specimen” within one (1) year of the effective date and at least every four (4) years thereafter. In particular, these agencies will collaboratively assess whether there are analytic technologies or techniques that could be used to generate identifiable private information or identifiable specimens.

(See USA-65 for a list of Common Rule departments/agencies, and the Regulatory Authority section for more information on when the Pre2018-ComRule and the RevComRule apply to research.)

Per the RevComRule , for non-exempt research (or exempt research that requires limited EC review) reviewed by an EC not operated by the institution doing the research, the institution and the EC must document the institution's reliance on the EC for research oversight and the responsibilities that each entity will undertake to ensure compliance with the RevComRule . Compliance can be achieved in a variety of ways, such as a written agreement between the institution and a specific EC, through the research protocol, or by implementing an institution-wide policy directive that allocates responsibilities between the institution and all ECs not operated by the institution. Such documentation must be part of the EC’s records. The G-HHS-Inst-Engagemt can help an institution to determine if a research study can be classified as non-exempt.

Ethics Committee Composition

As stated in 21CFR56 , the Pre2018-ComRule , and the RevComRule , an EC must be composed of at least five (5) members with varying backgrounds to promote complete and adequate research proposal review. The EC must be sufficiently qualified through member experience, expertise, and diversity, in terms of race, gender, cultural backgrounds, and sensitivity to issues such as community attitudes, to promote respect for its advice and counsel in safeguarding human participants’ rights and welfare. EC members must possess the professional competence to review research activities and be able to ascertain the acceptability of proposed research based on institutional commitments and regulations, applicable laws, and standards. In addition, if an EC regularly reviews research involving vulnerable populations, the committee must consider including one (1) or more individuals knowledgeable about and experienced in working with those participants. See the Vulnerable Populations section for details on vulnerable populations.

At a minimum, each EC must also include the following members:

• One (1) primarily focused on scientific issues
• One (1) focused on nonscientific issues
• One (1) unaffiliated with the institution, and not part of the immediate family of a person affiliated with the institution

No EC member may participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide EC requested information.

Terms of Reference, Review Procedures, and Meeting Schedule

As delineated in 21CFR56 , ECs must follow written procedures for the following:

• Conducting initial and continuing reviews, and reporting findings and actions
• Determining which projects require review more often than annually, and which projects need verification from sources other than the investigator that no material changes have occurred since the previous EC review
• Ensuring that changes in approved research are not initiated without EC review and approval except where necessary to eliminate apparent immediate hazards to participants
• Ensuring prompt reporting to the EC, institution, and FDA of changes in research activity; unanticipated problems involving risks to participants or others; any instance of serious or continuing noncompliance with these regulations or EC requirements or determinations; or EC approval suspension/termination

Per the Pre2018-ComRule , the RevComRule , and the US-ICH-GCPs , ECs must establish and follow written procedures for the following:

• Conducting initial and continuing reviews, and reporting findings and actions to the investigator and the institution
• Ensuring prompt reporting to the EC of proposed changes in research and ensuring that investigators conduct the research in accordance with the terms of the EC approval until any proposed changes have received EC review and approval, except where necessary to eliminate apparent immediate hazards to participants
• Ensuring prompt reporting to the EC, the institution, the FDA, and the Department of Health & Human Services (HHS) ’ Office for Human Research Protections (OHRP) of any unanticipated problems involving risks to participants or others; any instance of serious or continuing noncompliance with these regulations or EC requirements or determinations; or EC approval suspension/termination.

21CFR56 , the Pre2018-ComRule , and the RevComRule further require that an institution, or where appropriate an EC, prepare and maintain adequate documentation of EC activities, including copies of all research proposals reviewed. The applicable records must be retained for at least three (3) years after completion of the research. For more details on the EC records included in this requirement, see the Pre2018-ComRule , the RevComRule , and 21CFR56 .

See G-IRBProcs for detailed FDA guidance on EC written procedures to enhance human participant protection and reduce regulatory burden. The guidance includes a Written Procedures Checklist that incorporates regulatory requirements as well as recommendations on operational details to support the requirements.

Per 21CFR56 , the Pre2018-ComRule , and the RevComRule , proposed research must be reviewed during convened meetings at which a majority of the EC members are present, including at least one (1) member whose primary concerns are nonscientific, except when an expedited review procedure is used. Research is only considered approved if it receives the majority approval of attending members.

Refer to the Pre2018-ComRule , the RevComRule , 21CFR56 , the G-IRBProcs , and the G-IRBFAQs for detailed EC procedural requirements.

In addition, per the Pre2018-ComRule , the RevComRule , and the G-HHS-Inst-Engagemt , any institution engaged in non-exempt human subjects research conducted or supported by a Common Rule department/agency (as identified in USA-65 ) must also submit a written assurance of compliance to OHRP. According to USA-59 , the Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP for HHS-funded research. See USA-57 for more information on FWAs.

21CFR56 , 21CFR312 , the Pre2018-ComRule , the RevComRule , and the US-ICH-GCPs state that the primary scope of information assessed by the institutional ethics committee (EC) (referred to as an institutional review board (IRB) in the United States (US)) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. As delineated in 21CFR56 , the Pre2018-ComRule , and the RevComRule , the EC must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. (See the Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses, & Neonates; Prisoners; and Mentally Impaired sections for additional information about these populations). The EC is also responsible for ensuring a competent review of the research protocol, evaluating the possible risks and expected benefits to participants, and verifying the adequacy of confidentiality safeguards.

See USA-65 for a list of Common Rule departments/agencies, and the Regulatory Authority section for more information on when the Pre2018-ComRule and the RevComRule apply to research.

Role in Clinical Trial Approval Process

In accordance with 21CFR56 and 21CFR312 , the Food & Drug Administration (FDA) must review an investigational new drug application (IND) and an EC must review and approve the proposed study prior to a sponsor initiating a clinical trial. The institutional EC review of the clinical investigation may be conducted in parallel with the FDA review of the IND. However, EC approval must be obtained prior to the sponsor being permitted to initiate the clinical trial. According to 21CFR56 , the Pre2018-ComRule , and the RevComRule , the EC may approve, require modifications in (to secure approval), or disapprove the research.

Refer to the G-RevComRule-FDA for information on the impact of the RevComRule on studies conducted or supported by the Department of Health & Human Services (HHS) that must also comply with FDA regulations.

Per 21CFR56 , the Pre2018-ComRule , the RevComRule , and the G-IRBContRev , an EC has the authority to suspend or terminate approval of research that is not being conducted in accordance with the EC’s requirements or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval will include a statement of the reasons for the EC’s action and will be reported promptly to the investigator, appropriate institutional officials, and the department or agency head (e.g., the FDA). See the G-IRBContRev for additional information and FDA recommendations on suspension or termination of EC approval.

Expedited Review

21CFR56 , the Pre2018-ComRule , and the RevComRule indicate that the FDA and HHS maintain a list of research categories that may be reviewed by an EC through an expedited review procedure (see the G-IRBExpdtdRev for the list). An EC may use the expedited review procedure to review the following:

• Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk
• Minor changes in previously approved research during the period (of one (1) year or less) for which approval is authorized
• Under the RevComRule , research for which limited EC review is a condition of exemption

21CFR56 , the Pre2018-ComRule , and the RevComRule specify that under an expedited review procedure, the review may be carried out by the EC chairperson or by one (1) or more experienced reviewers designated by the chairperson from among the EC’s members. In reviewing the research, the reviewers may exercise all of the authorities of the EC except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the EC’s non-expedited review procedure.

Continuing Review and Re-approval

21CFR56 and the G-IRBContRev state that any clinical investigation must not be initiated unless the reviewed and approved study remains subject to continuing review at intervals appropriate to the degree of risk, but not less than once a year. The G-IRBContRev notes that when continuing review of the research does not occur prior to the end of the approval period specified by the EC, EC approval expires automatically. A lapse in EC approval of research occurs whenever an investigator has failed to provide continuing review information to the EC, or the EC has not conducted continuing review and re-approved the research by the expiration date of the EC approval. In such circumstances, all research activities involving human participants must stop. Enrollment of new participants cannot occur after the expiration of EC approval.

In addition, per the G-IRBContRev , research that qualified for expedited review at the time of initial review will generally continue to qualify for expedited continuing review. For additional information and FDA recommendations regarding continuing review, see the G-IRBContRev .

The Pre2018-ComRule similarly indicates that the EC must conduct reviews at intervals appropriate to the degree of risk, but not less than once per year. However, the RevComRule provides the following exceptions to the continuing review requirement, unless an EC determines otherwise:

• Research eligible for expedited review
• Research reviewed by the EC in accordance with the limited EC review described in Section 46.104 of the RevComRule
• Research that has progressed to the point that it involves data analysis and/or accessing follow-up clinical data from procedures that are part of clinical care

Exemptions under the Revised Common Rule

Per the RevComRule , certain categories of research are exempt from EC review, and some “exempt” activities require limited EC review or broad consent. Users should refer to Section 46.104 of the RevComRule for detailed information on research categories specifically exempt from EC review, or exempt activities requiring limited EC review or broad consent.

Per USA-54 , for secondary research that does not qualify for an exemption under the RevComRule , the applicant must either apply for a waiver of the informed consent requirement from the EC, obtain study-specific informed consent, or obtain broad consent.

Further, the RevComRule modifies what constitutes research to specifically exclude the following types of research:

• Scholarly and journalistic activities
• Public health surveillance activities authorized by a public health authority to assess onsets of disease outbreaks or conditions of public health importance
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for criminal investigative activities
• Authorized operational activities in support of intelligence, homeland security, defense, or other national security missions

See the G-IRBFAQs , the G-OHRP-IRBApprvl , and USA-54 for frequently asked questions regarding EC procedures, approval with conditions, example research, expedited review, limited review, and continuing review.

Per the FDA’s G-IRBReview , an EC may review studies that are not performed on-site. When an institution has a local EC, the written procedures of that EC or of the institution should define the scope of studies subject to review by that EC. A non-local EC may not become the EC of record for studies within that defined scope unless the local EC or the administration of the institution agree. Any agreement to allow review by a non-local EC should be in writing. For more information, see G-IRBReview .

Cooperative Research Studies

In the event of multicenter clinical studies, also known as cooperative research studies, taking place at US institutions that are subject to the RevComRule , the institutions must rely on a single EC to review that study for the portion of the study conducted in the US. The reviewing EC will be identified by the Common Rule department/agency (as identified in USA-65 ) supporting or conducting the research or proposed by the lead institution subject to the acceptance of the department/agency. The exceptions to this requirement include: when multicenter review is required by law (including tribal law) or for research where any federal department or agency supporting or conducting the research determines that the use of a single EC is not appropriate.

Designed to complement the RevComRule , per the NIHNotice16-094 and the NIHNotice17-076 , the National Institutes of Health (NIH) issued a final policy requiring all institute-funded multicenter clinical trials conducted in the US to be overseen by a single EC, unless prohibited by any federal, tribal, or state law, regulation, or policy.

For more information on multicenter research, see the FDA’s G-CoopRes . For more information on how new sites added to ongoing cooperative research can follow the same version of the Common Rule, see the HHS Office for Human Research Protections (OHRP) ’s G-ComRuleCnsstncy .

Many institutional ethics committees (ECs) (referred to as institutional review boards (IRBs) in the United States (US)) charge fees to review research proposals submitted by industry-sponsored research or other for-profit entities. However, this varies widely by institution. Neither the Department of Health & Human Services (HHS) nor the Food & Drug Administration (FDA) regulate institutional EC review fees. Because each EC has its own requirements, individual ECs should be contacted to confirm their specific fees.

As delineated in 21CFR56 and 45CFR46-B-E , the Department of Health & Human Services (HHS) and the HHS’ Food & Drug Administration (FDA) have mandatory registration programs for institutional ethics committee (ECs), referred to as institutional review boards (IRBs) in the United States (US). A single electronic registration system ( USA-28 ) for both agencies is maintained by HHS’ Office for Human Research Protections (OHRP) .

Registration, Auditing, and Accreditation

In accordance with the G-IRBReg-FAQs and USA-61 , EC registration with the HHS OHRP system ( USA-28 ) is not a form of accreditation or certification by either the FDA that the EC is in full compliance with 21CFR56 , or by the HHS that the EC is in full compliance with 45CFR46-B-E . Neither EC competence nor expertise is assessed during the registration review process by either agency.

According to 21CFR56 and the G-IRBReg-FAQs , the FDA requires each EC in the US, that either reviews clinical investigations regulated by the agency under the FDCAct or reviews investigations intended to support research or marketing permits for agency-regulated products, to register electronically in the HHS OHRP system ( USA-28 ). Only individuals authorized to act on the EC’s behalf are permitted to submit registration information. Non-US ECs may register voluntarily. The G-IRBReg-FAQs also indicates that while registration of non-US ECs is voluntary, the information the FDA receives from them is very helpful.

As stated in 21CFR56 and the G-IRBReg-FAQs , any EC not already registered in the HHS OHRP system ( USA-28 ) must submit an initial registration prior to reviewing a clinical investigation in support of an investigational new drug application (IND). The HHS OHRP system ( USA-28 ) provides instructions to assist users, depending on whether the EC is subject to regulation by only the OHRP, only the FDA, or both the OHRP and the FDA.

21CFR56 and the G-IRBReg-FAQs indicate that FDA EC registration must be renewed every three (3) years. EC registration becomes effective after review and acceptance by the HHS.

See 21CFR56 and the G-IRBReg-FAQs for detailed EC registration submission requirements. See the G-IRBInspect for FDA inspection procedures of ECs.

Per the Pre2018-ComRule and RevComRule , institutions engaging in research conducted or supported by a Common Rule department/agency (as identified in USA-65 ) must obtain an approved assurance that it will comply with the Pre2018-ComRule or RevComRule requirements and certify to the department/agency heads that the research has been reviewed and approved by an EC provided for in the assurance.

Per USA-59 , a Federalwide Assurance (FWA) of compliance is a document submitted by an institution (not an EC) engaged in non-exempt human subjects research conducted or supported by HHS that commits the institution to complying with Pre2018-ComRule or RevComRule requirements. FWAs also are approved by the OHRP for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects ( Pre2018-ComRule or RevComRule ) may rely on the FWA for the research that they conduct or support. Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question.

Per USA-54 , institutions do not need to change an existing FWA because of the RevComRule . See USA-57 for more information on FWAs.

Per 45CFR46-B-E and USA-61 , all ECs that review human subjects research conducted or supported by HHS and are to be designated under an OHRP FWA must register electronically with the HHS OHRP system ( USA-28 ). An individual authorized to act on behalf of the institution operating the EC must submit the registration information. EC registration becomes effective for three (3) years when reviewed and approved by OHRP.

Per USA-59 , an institution must either register its own EC (an “internal” EC) or designate an already registered EC operated by another organization (“external” EC) after establishing a written agreement with that other organization. Additionally, each FWA must designate at least one (1) EC registered with the OHRP. The FWA is the only type of assurance of compliance accepted and approved by the OHRP.

See 45CFR46-B-E , USA-58 , and USA-61 for detailed registration requirements and instructions.

As delineated in 21CFR312 , USA-42 , and USA-52 , the United States (US) requires the sponsor to submit an investigational new drug application (IND) for the Food & Drug Administration (FDA) 's review and authorization to obtain an exemption to ship investigational drug or biological products across state lines and to administer these investigational products in humans. Per 21CFR312 and the G-IND-Determination , whether an IND is required to conduct an investigation of a drug to be marketed (this includes biological products under the FDCAct ) primarily depends on the intent of the investigation, and the degree of risk associated with the use of the drug in the investigation. See the Scope of Assessment section for more information.

In addition, per 21CFR56 and 21CFR312 , institutional ethics committee (EC) (institutional review board (IRB) in the US) review of the clinical investigation may be conducted in parallel with the FDA review of the IND. However, EC approval must be obtained prior to the sponsor being permitted to initiate the clinical trial.

Regulatory Submission

According to 21CFR312 , meetings between a sponsor and the FDA may be useful in resolving questions and issues raised during the course of a clinical investigation. The FDA encourages such meetings to the extent that they aid in the evaluation of the drug and in the solution of scientific problems concerning the drug, to the degree the FDA's resources permit. See 21CFR312 for more information on meetings with the FDA.

A sponsor who is conducting a clinical trial to support a future marketing application may ask to meet with the FDA for a special protocol assessment (SPA) to help ensure the clinical trial can support the application. For more information, see G-SPA .

Additionally, the G-FDAComm describes the FDA’s philosophy regarding timely interactive communication with IND sponsors, the scope of appropriate interactions between review teams and sponsors, the types of advice appropriate for sponsors to seek from the FDA in pursuing their drug development programs, and general expectations for the timing of FDA response to sponsor inquiries. See the G-FDAComm for more information.

According to the G-PharmeCTD , which implements FDCAct requirements, and as described in USA-34 and USA-53 , commercial IND submissions must be submitted in the Electronic Common Technical Document (eCTD) format. Noncommercial INDs are exempt from this eCTD format submission requirement. “Noncommercial products” refer to products not intended to be distributed commercially, including investigator-sponsored INDs and expanded access INDs (e.g., emergency use and treatment INDs). However, the G-AltrntElecSubs indicates that sponsors and applicants who receive an exemption or a waiver from filing in eCTD format should still provide those exempted or waived submissions electronically, in an alternate format.

The G-AltrntElecSubs and USA-35 indicate that for both eCTD and alternate electronic formats, submissions should include only FDA fillable forms and electronic signatures. Scanned images of FDA fillable forms should not be submitted. In addition, before making an electronic submission, a pre-assigned application number should be obtained by contacting the FDA’s Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) . See USA-35 for more information on requesting an application number.

For more information and detailed requirements on eCTD submissions, see the G-PharmeCTD , the G-eCTDTech , USA-35 , and USA-36 . Additionally, the G-CBER-ElecINDs provides instructions on how to submit an IND using an electronic folder structure on a CD-ROM.

According to the G-eCTDspecs and USA-7 , eCTD submissions sized 10 GB and under for most applications must be submitted via the FDA Electronic Submissions Gateway (ESG) ( USA-44 ). However, the G-eCTDspecs adds that the FDA also recommends the use of USA-44 for submissions greater than 10 GB when possible. See USA-8 for information on how to create an account.

As indicated in the G-eCTDspecs , physical media greater than 10 GB should be submitted using a USB drive. For specific instructions on how to submit physical media, email CDER at [email protected] or CBER at [email protected] . See the G-eCTDspecs for additional physical media information.

The IND must be submitted in English. As indicated in 21CFR312 , the sponsor must submit an accurate and complete English translation of each part of the IND that is not in English. The sponsor must also submit a copy of each original literature publication for which an English translation is submitted.

According to USA-41 and USA-94 , paper submissions of INDs should be sent to CDER or CBER at the following locations, as appropriate:

Drugs (submitted by Sponsor-Investigators):

Food and Drug Administration Center for Drug Evaluation and Research (CDER) Central Document Room 5901-B Ammendale Rd. Beltsville, MD 20705-1266

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Bioethics Resources for Investigators & Research Ethics Committees

A collection of resources for scientific investigators conducting research in the developing world, and ethics committees reviewing it.

• Guidelines (non-regulatory)

Regulations

Practical aids, research ethics committees, guidelines and regulations.

Guidelines (non-regulatory) Human Subjects Research in General These are the key non-regulatory documents that are likely to be cited by ethicists and research ethics committees. The Nuremberg Code The World Medical Association Declaration of Helsinki Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects . The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (USA) PREVENT Project: Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research, and Response , September 2018 HIV/AIDS UNAIDS 2012. Ethical considerations in biomedical HIV prevention trials National Institutes of Health, USA. NIH Guidance for Addressing the Provision of Antiretroviral Treatment for Trial Participants Following their Completion of NIH-Funded HIV Antiretroviral Treatment Trials in Developing Countries Research in Developing Countries The Nuffield Council. The Ethics of Research Related to Healthcare in Developing Countries . 2002. The Nuffield Council is a UK-based independent body that researches and reports on topical issues in bioethics. They published a follow-up discussion paper on this same topic in 2005. National Bioethics Advisory Commission, USA. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries . Research in Humanitarian Crises Post-Research Ethics Analysis (PREA) - A research project investigating ethical issues in health research in humanitarian crises. PREA tool - Provides researchers and other stakeholders with a pragmatic tool that assists learning lessons about the actual ethical challenges that develop during health research in humanitarian crises. R2HC Research Ethics Tool Elrha, September 2017         Disasters: Core Concepts and Ethical Theories [Open access] Springer Nature, supported by Disaster Bioethics/COST Action, 2018 Genetics and Genomics Human Genome Organisation (HUGO) - HUGO Ethics Committee . Statements on several issues, including genetics research and benefit sharing. UNESCO. Universal Declaration on the Human Genome and Human Rights . The Office for Human Research Protections (OHRP) in the US has guidance on the application of US regulations to genetic research and research on biological samples . See "Coded Private Information," "Biological Specimens," and "Tissue Storage/Repositories." The US National Institutes of Health also have guidance documents relating to Genome-Wide Association Studies (GWAS). National Bioethics Advisory Commission, USA. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance .

US Regulations Code of Federal Regulations Title 45 Part 46 . Food and Drug Administration (FDA). Title 21 Part 50 Protection Of Human Subjects . A helpful FDA and HHS comparison chart showing the similarities and differences between FDA and HHS regulations. Compilations of National Regulations ClinRegs from the National Institute of Allergy and Infectious Diseases (NIAID). A central resource for exploring and comparing international clinical research regulations. Global Research Ethics Map . Harvard School of Public Health. As of March 2009, provides guides to the human subjects protections in 11 countries: Botswana, Ghana, Kenya, Kuwait, Malawi, Nepal, Pakistan, Philippines, Senegal, South Africa, Tanzania. From the Office for Human Research Protections (OHRP) at HHS: International Compilation of Human Research Protections - Lists the approximately 1,100 laws, regulations, and guidelines that govern human subjects research in over 100 countries, as well as standards from a number of international and regional organizations. Compilation of European GDPR guidances as of July 24, 2018 UNESCO Global Ethics Observatory includes a database containing ethics related legislation and guidelines from 34 countries.

• Research Ethics in Epidemics and Pandemics: A Casebook published by PAHO in 2024, free through Springer Open Access.
• WHO's Special Programme for Research and Training in Tropical Diseases (TDR). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants . Provides guidance for setting up and developing standard operating procedures for research ethics committees and ethical review systems.
• Foreign Grants Information . NIH Office of Extramural Research (OER) has a website for foreign applicants and grantees. It goes through the grants process and includes a section on human subjects protections.
• OER also have a page providing HHS and NIH requirements and resources for all members of the extramural community involved in human subjects research
• The Elements of a Successful Informed Consent [Video] created by the Human Subjects Protection Team of the National Institute of Mental Health (NIMH) Office of the Clinical Director. This video is intended for use by novice clinical investigators and clinical research staff.
• Global Health Reviewers A "resource for all those involved in the ethical and regulatory review of research, particularly in resource-limited settings. A variety of materials and forums are provided to assist committee members from Ethics Review Committees, Institutional Review Boards, and Food and Drug Administration regulatory committees."
• Iberoamerican Bioethics Network The network, with headquarters at FLACSO-Argentina, has subcoordinator centers in Brazil, Mexico and Spain. The Iberoamerican Bioethics Network is a dependent of the IAB (International Association of Bioethics).
• Inventory of research ethics committees in Africa and for Latin America and the Caribbean From Health Research Web, the inventory includes contact information for each REC.
• IRB Primer: Incidental and Secondary Findings [Archive] From the from the archive of the U.S. Presidential Commission for the Study of Bioethical Issues , the IRB Primer is designed to help institutional review boards (IRBs) understand and implement the Bioethics Commission's recommendations regarding how to manage incidental and secondary findings ethically in the research setting.

The PAHO Regional Program on Bioethics strengthens the development of bioethics. The program builds capacity in bioethics in the region and support PAHO and Member States in the integration of bioethics in all health-related activities.

• Research Ethics in Africa , by Mariana Kruger, Paul Ndebele, Lyn Horn This free e-book for research ethics committee members focuses on research ethics issues in Africa.
• Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) A network of independently established regional fora for ethical review committees, health researchers and invited partner organizations with an interest in the development of ethical review. The regional fora are composed of Asia and Western Pacific (FERCAP), former Russian states (FECCIS), Latin America (FLACEIS), Africa (PABIN) and North America (FOCUS).
• Africa - The Pan-African Bioethics Initiative (PABIN) aims to strengthen ethical awareness and discussion across the African continent. They are currently surveying research ethics committees in Africa.
• Asia - The Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP) is a regional organization of researchers and members of ethics review committees.
• Latin America - The Latin American Forum of Research Ethics Committees in Health (FLACEIS) is located at FLACSO-Argentina. From its creation in 2002 there have been three or four lectures each year about issues relevant for research ethics committees.

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Updated April 29, 2024

• Department of Health and Human Services
• National Institutes of Health

We are excited to welcome Dr. Yukiko Asada, PhD and Dr. Robert Steel, PhD as the newest members of our department's faculty.

The NIH Bioethics offers several courses, training and lecture opportunities related to bioethical issues. Learn more.

Our interdisciplinary research is published in a range of high impact medical, legal, scientific, philosophical, social science and bioethics journals.

The Department of Bioethics hosts Ethics Grand Rounds four times per year. Ethics Grand Rounds is designed to provide a venue to learn about and discuss important issues in bioethics.

Christine Grady , RN, PhD

Chief, Department of Bioethics

Welcome to the NIH Department of Bioethics

Phone: 301.496.2429 Fax: 301.496.0760 Email: [email protected] Twitter: @NIHBioethics

Featured Training

Fellowship Opportunities

The NIH Department of Bioethics welcomes applications for fully funded two-year postbaccalaureate and postdoctoral research fellowships. Fellows will:

• Be centrally involved in the daily activities and intellectual life of our interdisciplinary department.
• Participate in weekly bioethics seminars, case conferences, ethics consultations, IRB deliberations, and other educational opportunities at NIH.
• Study ethical issues related to biomedical research, clinical practice, genetics, biotechnology, public health, health policy, and other important issues in bioethics.
• Conduct mentored theoretical and empirical research. For a typical fellow, this research yields multiple first-authored publications in academic journals.

We do not require or expect bioethics experience and encourage anyone with a strong interest to apply.

Multinational Capacity Building

We have several initiatives designed to build capacity in low- and middle-income countries, including:

• Mentored research program for early career bioethics scholars from low- and middle-income countries
• International workshops in health policy and research ethics for researchers, governmental officials, and IRB and Ethics Committee members
• International workshops to support a network of young scholars in bioethics from low- and middle-income countries
• Three month IRB training program that brings participants from resource poor settings to the NIH for training in ethics and IRB review
• Joint NIH-University of Bergen Ph.D. program for candidates from low- and middle-income countries. Please contact the Department or Reidar Lie for more information [ disclaimer ] about this program
• Of the fellowships that we offer , the two-year postdoctoral training program is open to both international and domestic participants. The post-baccalaureate training program is open only to domestic participants.
• Short-term appointments for visiting scholars and researchers from around the world

Featured Projects

Continuing trial responsibilities for implantable neural devices Saskia Hendriks, Christine Grady et al., Neuron Read more

Building a "We" With Deliberative Dialogue in Pursuit of Health for All Yukiko Asada et al., AJPHn Read more

Research Faculty and Head of the Bioethics Consultation Service

We invite scholars with outstanding credentials and experience to apply for the position of Research Faculty and Head of the Bioethics Consultation Service in the Department of Bioethics at the NIH Clinical Center.

The selected candidate will also lead important empirical and/or conceptual research on theoretical and applied issues in bioethics and will oversee and guide the planning, management, and implementation of the Bioethics Consultation Service. They should be an independent scholar with an established (or potential) career as a recognized leader in their respective field, with a strong record of publication.

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institutional review board

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• National Center for Biotechnology Information - PubMed Central - Institutional Review Boards

institutional review board (IRB) , in the United States , ethics committee that reviews proposed and ongoing research involving human subjects. The institutional review board (IRB) exists to protect the rights and safety of human subjects who participate in research studies. The need for an IRB became apparent in the 1960s and 1970s, largely as a result of the Tuskegee Syphilis Study , in which human subjects received substandard medical care without their consent . The IRB system subsequently was established with the passage of the National Research Act of 1974. The Office of Human Research Protections, within the U.S. Department of Health and Human Services , is responsible for the registration of IRBs and their oversight.

Initially focused on biomedical research, IRBs later were also developed for research in the social sciences and liberal arts (e.g., for research involving living history interviews). Institutions seeking federal funding must have an IRB, and the IRB must review and approve federally funded research studies. Most institutions require IRB approval for all research that involves human subjects, not only that funded by the federal government.

The IRB process begins before participants are recruited for a study. The study protocol must satisfy the three basic principles of the Belmont Report (a summary of ethical principles and guidelines for the conduct of research involving human subjects): 1) respect for persons, 2) beneficence (avoiding harm to subjects and maximizing the benefits compared with the risks of participation), and 3) justice . Once the study is approved, the IRB is charged with overseeing the research from an ethics perspective. This oversight usually is exercised through two mechanisms. First, participants are provided with a means of contacting the IRB directly if they have concerns, and, second, the IRB conducts periodic reviews of the study to monitor the research progress and address any ethical issues. The review process usually occurs annually. Although rarely used, the IRB can carry out additional reviews and actively conduct surprise inspections of research records.

IRBs for institutions receiving U.S. federal funds are required to have at least five members, though most institutions have more. The IRB must include members who represent diverse bodies of knowledge relevant to the conduct of ethical research. For example, at least one member must be from the scientific community and knowledgeable about scientific research, and there must be at least one member from outside the scientific community; this person should advocate for the nonscientific issues relevant to ethical conduct of research, such as legal issues and standards for professional conduct. In addition, at least one person must be from outside the institution; this person (who may also serve as the nonscientific member) usually is a community member and represents the community standard for assessing the ethics of a study.

When the research proposed is outside the expertise of the IRB members, the IRB can invite experts in the research area to provide additional information in the review; however, these consultants are not allowed to vote. Most IRBs use a consensus approach (i.e., votes must be unanimous) to reach a decision, although some IRBs allow a majority vote. When a majority vote is used, the community member typically still has substantial power because most IRBs will not override the perspective of the community member. The administration of an institution (e.g., president of a university or director of a hospital ) must allow the IRB to function independently, without undue influence related to funding pressures or other administration priorities.

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Federal Policy for the Protection of Human Subjects ('Common Rule')

The current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report , written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, HHS and the Food and Drug Administration revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations.

The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies, as listed below. The HHS regulations, 45 CFR part 46 , include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children. Each agency includes in its chapter of the Code of Federal Regulations [CFR] section numbers and language that are identical to those of the HHS codification at 45 CFR part 46, subpart A. For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency. The head of that department/agency retains final judgment as to whether a particular activity it conducts or supports is covered by the Common Rule. If an institution seeks guidance on implementation of the Common Rule and other applicable federal regulations, the institution should contact the department/agency conducting or supporting the research.

The list below displays the agencies and departments that have signed onto the Common Rule and their CFR numbers. Hyperlinks are to areas of a department or agency Web site that have been suggested to HHS as entry points for those interested in human subject protection activities of the department or agency.

General information:

• Of these, 15 agencies are official signatories with the rule codified in their own Code of Federal Regulations (CFR) sections
• 4 departments and agencies follow the Pre-2018 Common Rule because of executive order or statutory mandate (Department of Homeland Security, Social Security Administration, Office of the Director of National Intelligence, and Central Intelligence Agency)
• There is 1 new signatory to the revised Common Rule (Department of Labor)
• 2 agencies that followed the pre-2018 Common Rule because of executive order or statutory mandate have become official signatories to the revised Common Rule (Department of Homeland Security and Social Security Administration)
• 1 original signatory (Department of Justice) intends to become an official signatory to the revised Common Rule
• You can find more information about the FDA regulations here

Common Rule Departments and Agencies:

For additional details about the agencies and departments that have signed onto the Common Rule, including contact information and links to relevant webpages/resources, please visit https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/common-rule-departments-agencies/index.html .

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Nih clinical research trials and you, guiding principles for ethical research.

Pursuing Potential Research Participants Protections

“When people are invited to participate in research, there is a strong belief that it should be their choice based on their understanding of what the study is about, and what the risks and benefits of the study are,” said Dr. Christine Grady, chief of the NIH Clinical Center Department of Bioethics, to Clinical Center Radio in a podcast.

Clinical research advances the understanding of science and promotes human health. However, it is important to remember the individuals who volunteer to participate in research. There are precautions researchers can take – in the planning, implementation and follow-up of studies – to protect these participants in research. Ethical guidelines are established for clinical research to protect patient volunteers and to preserve the integrity of the science.

NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research:

Social and clinical value

Scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent.

• Respect for potential and enrolled subjects

Every research study is designed to answer a specific question. The answer should be important enough to justify asking people to accept some risk or inconvenience for others. In other words, answers to the research question should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease to justify exposing participants to the risk and burden of research.

A study should be designed in a way that will get an understandable answer to the important research question. This includes considering whether the question asked is answerable, whether the research methods are valid and feasible, and whether the study is designed with accepted principles, clear methods, and reliable practices. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose

The primary basis for recruiting participants should be the scientific goals of the study — not vulnerability, privilege, or other unrelated factors. Participants who accept the risks of research should be in a position to enjoy its benefits. Specific groups of participants  (for example, women or children) should not be excluded from the research opportunities without a good scientific reason or a particular susceptibility to risk.

Uncertainty about the degree of risks and benefits associated with a clinical research study is inherent. Research risks may be trivial or serious, transient or long-term. Risks can be physical, psychological, economic, or social. Everything should be done to minimize the risks and inconvenience to research participants to maximize the potential benefits, and to determine that the potential benefits are proportionate to, or outweigh, the risks.

To minimize potential conflicts of interest and make sure a study is ethically acceptable before it starts, an independent review panel should review the proposal and ask important questions, including: Are those conducting the trial sufficiently free of bias? Is the study doing all it can to protect research participants? Has the trial been ethically designed and is the risk–benefit ratio favorable? The panel also monitors a study while it is ongoing.

Potential participants should make their own decision about whether they want to participate or continue participating in research. This is done through a process of informed consent in which individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to participate.

Respect for potential and enrolled participants

Individuals should be treated with respect from the time they are approached for possible participation — even if they refuse enrollment in a study — throughout their participation and after their participation ends. This includes:

• respecting their privacy and keeping their private information confidential
• respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without a penalty
• informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating
• monitoring their welfare and, if they experience adverse reactions, unexpected effects, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study
• informing them about what was learned from the research

More information on these seven guiding principles and on bioethics in general

This page last reviewed on March 16, 2016

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The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents

Affiliations.

• 1 Center for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway.
• 2 Faculty of Health and Social Sciences, University of South-Eastern Norway, Kongsberg, Norway.
• PMID: 33734933
• DOI: 10.1080/03007995.2021.1905621

Aim: To conduct a descriptive content analysis of normative documents on the role of research ethics committees (RECs) after the approval of clinical trial protocols. The question to be addressed is whether and to what extent normative documents support a monitoring role for RECs in the United States and the European Union.

Design: A qualitative content analysis of 19 normative documents on clinical research as outlined by the International Compilation of Human Research Standards 2020 edition and other related documents for the EU and USA.

Results: After the approval of research protocols, RECs' general role is to receive reports from researchers on the trials' progress. Additionally, RECs receive notifications of protocol amendments, deviations and, to a lesser extent, violations, which is the remit of the regulatory/competent authorities. RECs are expected to issue opinions on clinical trials' progress and give supplemental opinions/approval or withdraw/suspend/terminate previous favorable opinions on adverse events or safety concerns that may arise. RECs are to receive an end of the trial report.

Conclusion: The role of RECs post approval of protocols is to protect human participants through activities such as continuing review of: (a) progress reports, (b) notifications of significant protocol amendments, (c) adverse events, (d) protocol deviations, and (e) protocol violations. Although some international guidelines such as the Declaration of Helsinki emphasize the right to monitor, RECs' predominant activity is document review. In the USA, RECs are authorized to issue approvals and terminate/suspend previously issued approvals. However, in the EU, the approach is to relegate to member states to decide the extent of legislative power they wish to give to the RECs. The REC's opinion on the end of trial report is identified as an area for further exploration.

Keywords: Ethics committees; Institutional review board; clinical trials; post approval; post-trial; role.

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• Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees. Benfatto G; Regulatory Group; Ethics Committee Catania 1 (Group); Drago F. Benfatto G, et al. BMC Med Ethics. 2021 Apr 7;22(1):40. doi: 10.1186/s12910-021-00605-7. BMC Med Ethics. 2021. PMID: 33827541 Free PMC article.
• Navigating the maze of requirements for obtaining approval of non-interventional studies (NIS) in the European Union. Ramirez I. Ramirez I. Ger Med Sci. 2015 Nov 17;13:Doc21. doi: 10.3205/000225. eCollection 2015. Ger Med Sci. 2015. PMID: 26633964 Free PMC article. Review.
• The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study. Homedes N, Ugalde A. Homedes N, et al. J Med Ethics. 2015 Jun;41(6):464-9. doi: 10.1136/medethics-2013-101381. Epub 2014 Oct 23. J Med Ethics. 2015. PMID: 25341735
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Committees: Research Ethics Committees

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• Ana Borovecki 2  

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Research ethics committees have become a permanent fixture when it comes to ethics of research. They are essential part of quality control of research protocol, and their existence and work are thoroughly described in all important international documents dealing with research ethics issues. In this contribution history, development and different types of research ethics committees are discussed. The functions, structure, and locale of research ethics committees are also addressed. The global dimension of the work of research ethics committees is also discussed.

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Research: Human Subjects

Committees, Research Ethics Committees (See Research Ethics; Research Ethics Committees)

Borovecki, A., ten Have, H., & Oreskovic, S. (2009). Ethics committees in Croatia: Studies in bioethics . Saarbrücken: VDM Verlag Dr. Müller.

Google Scholar  

Bouëssau, M. S., et al. (2009). Research ethics committees: Basic concepts for capacity building . Geneva: WHO.

Glasa, J. (Ed.). (2000). Ethics committees in central and Eastern Europe . Bratislava: Institute of Medical Ethics and Bioethics.

Huriet, C. (2009). Article 19: ethics committees. In H. A. M. J. ten Have & S. J. Michele (Eds.), The UNESCO universal declaration on bioethics and human rights background principles and application (pp. 265–270). Paris: UNESCO.

Jonsen, A. R., Veatch, R. M., & le Roy, W. (1998). Source book in bioethics. A documentary history . Washington, DC: Georgetown University Press.

Levine, R. J. (2004). Research ethics committees. In W. T. Reich (Ed.), Encyclopaedia of bioethics (Vol. IV, pp. 2311–2316). New York, NY: Macmillan Simon and Schuster.

ten Have, H. (2005). Establishing bioethics committees guide No. 1 (pp. 40–52). Paris: UNESCO.

Further Readings

Amdur, R., & Bankert, E. A. (2011). Institutional review board: Member handbook (3rd ed.). Sudbury, MA: Jones and Bartlett Publishers.

Emanuel, E. J., et al. (Eds.). (2008). The Oxford textbook of clinical research ethics (pp. 541–588). Oxford/New York: Oxford University Press.

Schrag, Z. M. (2010). Ethical imperialism. Institutional Review Boards and the Social Sciences, 1965–2009 . Baltimore: The Johns Hopkins University Press.

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Andrija Stampar School of Public Health, School of Medicine, University of Zagreb, Zagreb, Croatia

Ana Borovecki

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Borovecki, A. (2016). Committees: Research Ethics Committees. In: ten Have, H. (eds) Encyclopedia of Global Bioethics. Springer, Cham. https://doi.org/10.1007/978-3-319-09483-0_104

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Committee on animal research and ethics (care).

The charge of the Committee on Animal Research and Ethics is:

To safeguard responsible research with animals, other than humans, and to establish and maintain cooperative relations with organizations sharing common interests.

To disseminate in cooperation with other organizations accurate information about such research.

To review the ethics of such research and recommend guidelines for its ethical conduct.

To disseminate in cooperation with other organizations, guidelines for the protecting the welfare of animals, other than humans, that are used in research, teaching and practical applications and to consult on the implementation of these guidelines.

The committee consists of six members, two of whom are elected each year for a term of 3 years.

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The Research Ethics Committee Assessment Toolkit (RECAT) is designed to facilitate evaluation of the operational needs of Research Ethics Committees (RECs) globally to inform local quality assurance and quality improvement efforts. The toolkit is published open-access for non-commercial use.

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The RECAT was developed by the African Bioethics Consortium (ABC) whose members include the Johns Hopkins University-Fogarty African Bioethics Training Program, the University of Zambia School of Medicine, the University of Botswana Office of Research & Development, and the Makerere University College of Health Sciences.

Financial support to develop the RECAT was provided to Johns Hopkins University Bloomberg School of Public Health and Berman Institute of Bioethics though a US National Institutes of Health, Fogarty International Center and National Institute of Allergy and Infectious Diseases supplemental grant under Award No. R25TW001604. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: World Health Organization; 2011.

Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants.

Ii standards and guidance for entities that establish research ethics committees, standard 2. composition of research ethics committees.

The research ethics committee (REC) is constituted according to a charter or other document that establishes the manner in which members and the Chair will be appointed. The appointing entity ensures that the REC has a multidisciplinary and multisectoral membership, that its composition is gender balanced, that it reflects the social and cultural diversity of the communities from which research participants are most likely to be drawn, and that it includes individuals with backgrounds relevant to the areas of research the committee is most likely to review.

The entity establishing the REC takes the following factors into consideration when appointing members.

• Members include individuals with scientific expertise, including expertise in behavioural or social sciences; health care providers; members who have expertise in legal matters and/or ethics; and lay people whose primary role is to share their insights about the communities from which participants are likely to be drawn.
• Lay people and other members, whose primary background is not in health research with human participants, are appointed in sufficient numbers to ensure that they feel comfortable voicing their views.
• In order to enhance independence, committee membership includes members who are not affiliated with organizations that sponsor , fund, or conduct research reviewed by the REC (see also Standard 4 ).
• Committees are large enough to ensure that multiple perspectives are brought into the discussion. To this end, quorum requirements provide that at least five people, including at least one lay member and one non-affiliated member, are present to make decisions about the proposed research.

Standard 3. Research ethics committee resources

The entity establishing the REC supports it with adequate resources, including staffing, facilities, and financial resources to allow the REC to effectively carry out its responsibilities.

As an integral part of a health research institution or health system, an REC receives:

• support staff, adequate in number and training to enable the REC to carry out its technical and administrative responsibilities;
• adequate resources for the staff to fulfil its assigned functions, including office space and equipment and supplies (e.g. computers, stationery, telephones, photocopying machines, shredding machine) to conduct administrative business, to store committee files, and to keep documents secure and confidential;
• access to appropriate space for the committee to meet and adequate means for members to communicate as needed between meetings;
• adequate financial resources to permit the committee to produce high-quality work;
• if considered necessary by the entity establishing the REC , resources necessary to compensate REC members, unless they are already being compensated for their time and effort on the REC through other means.

Standard 4. Independence of research ethics committees

Policies governing the REC include mechanisms to ensure independence of the REC's operations, in order to protect decision-making from influence by any individual or entity that sponsors, conducts, or hosts the research it reviews. Such policies provide at a minimum that REC members (including the Chair) remove themselves from the review of any research in which they or close family members have a conflicting interest.

To ensure that the REC cannot be pressured to approve or disapprove particular protocols, the charter, by-laws, policies and/or procedural rules of the REC provide that:

• the REC 's membership includes at least one person with no connection to the organization that sponsors or conducts the research under review;
• researchers, sponsors, and funders may attend an REC meeting to answer questions about their research protocols and associated documents, but they are not present when the REC reaches decisions about their proposed research;
• senior decision-makers of the entity creating the REC , or of any organization that sponsors or conducts the research reviewed by the REC (such as the director of an institution, or his or her agent), do not serve as members of the REC or its Chair;
• the entity that establishes the REC ensures that REC members are protected from retaliation based on positions taken with respect to REC-related matters or review of research projects.

Standard 5. Training the research ethics committee

Training on the ethical aspects of health-related research with human participants, how ethical considerations apply to different types of research, and how the REC conducts its review of research, is provided to REC members when they join the committee and periodically during their committee service.

The training provided to REC members, either directly by the appointing entity or through cooperative arrangements with other RECs and/or organizations that provide education on research ethics, focuses on:

• the role and responsibilities of the REC , and its role vis-à-vis other relevant entities, according to relevant international guidelines (e.g. the Council for International Organizations of Medical Societies [CIOMS] International Ethical Guidelines for Biomedical Research, CIOMS International Ethical Guidelines for Epidemiological Research, International Council on Harmonization [ICH] Good Clinical Practice [GCP] guidelines in the case of clinical trials), national laws, and institutional policies;
• the full range of ethical considerations relevant to research with human participants;
• the application of such ethical considerations to different types of research;
• basic aspects of research methodology and design (for members who lack such background);
• the impact of different scientific designs and objectives on the ethics of a research study;
• the various approaches for recognizing and resolving the tensions that can arise among different ethical considerations and modes of ethical reasoning.

When training is supported by research sponsors, mechanisms are in place to ensure that the sponsor has no control, direct or indirect, over the content of the training.

Standard 6. Transparency, accountability, and quality of the research ethics committee

Mechanisms exist to make REC operations transparent, accountable, consistent, and of high quality.

The entity establishing the REC employs reliable means to evaluate whether the staff and members of the REC routinely follow the REC's policies, rules, and written procedures (see Standard 9 ), with special attention to whether the ethical considerations articulated in international guidelines and national standards are being considered and applied consistently and coherently.

• Such evaluations are conducted by knowledgeable and unbiased people at regular, pre-defined intervals using a pre-defined format; internal assessments are supplemented periodically by independent external evaluations.
• The entity establishing the REC is committed to consider and, when appropriate, follow up on the findings and recommendations of the internal and external evaluations.
• The results of the evaluation are of a type that can aid the REC in reviewing its practice and appraising performance (rather than apportioning blame), while also assuring the public that research is being reviewed according to established standards.
• Researchers, research participants, and other interested parties have a means of lodging complaints about the REC ; such complaints should be reviewed by an entity other than the REC itself, and appropriate follow-up actions should be taken.
• Researchers have a means of discussing concerns with REC members, both on general matters and in response to REC decisions on particular research studies.
• REC decisions, excluding confidential information, are made publicly available, through mechanisms such as clinical trial registries, web sites, newsletters, and bulletin boards.

All rights reserved. Publications of the World Health Organization are available on the WHO web site ( www.who.int ) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: tni.ohw@sredrokoob ).

Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press through the WHO web site ( http://www.who.int/about/licensing/copyright_form/en/index.html ).

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Training and resources in research ethics evaluation (trree), type of training/training methods.

TRREE is a free and open access online training program on research ethics and regulation. TRREE's learning material is currently available in English, French, German, Polish and Portuguese. It also provides access to the national regulation in the participating countries. The training is modular. It includes an introduction to research ethics (module 1), a module on the role and responsibilities of Research Ethics Committees (module 2.1), several modules on the national regulation in given countries from the North and the South (module 3) and a detailed module on informed consent (module 4). TRREE has been recognized as continuing program by the Swiss Medical Association (FMH) and the Swiss Pharmacists Association (FPH).

Target audience and charges

While some modules may focus on more specific training needs of research ethics committee members, or research teams including investigators, nurses, or study coordinators, the training is open to all and may be of interest to health authorities, funding agencies and universities, as well as to political authorities, patients and the media. Free of charges.

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English and Portuguese Research Ethics Training Programs

On-line training (lectures, case studies, self-test multiple choice questions). Each module has its own case studies.

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All the interested parties, the target groups are not specified. Free of charge.

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The Vienna School of Clinical Research (Austria)

Training courses (lectures, workshops) on different topics related to clinical research. ("The course modules have been designed to offer as broad a range of subjects within clinical research to as many different disciplines working within this field as possible").

Investigative Staff - Physicians, Nurses and Support Staff ; Industry Personnel - Clinical Research Associates, Industry Physicians; Ethics Committee Members Healthcare Decision Makers. Free access to the contents and description of the courses; paid participation.

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On-line GCP training (5-7 hours)

Investigative Staff - Physicians, Nurses and Support Staff ; Industry Personnel - Clinical Research Associates, Industry Physicians; Ethics Committee Members Healthcare Decision Makers. Paid participation.

http://www.vscr.at/educational_programme/e-learning/bgcp_ecourse

Educational and Training materials in Polish

(Training materials in Polish for Polish members of ethics committees and researchers):

A free and open access online training program on research ethics and regulation in Polish is available at: elearning.trree.org

Guidelines:

• Deklaracja Helsińska wersja 2013
• Europejska Konwencja Bioetyczna (Oviedo Convention)
• Protok�ł Dodatkowy do Europejskiej Konwencji Bioetycznej w sprawie zakazu klonowania istot ludzkich
• Zasady Prawidłowego Prowadzenia Badań Klinicznych (Good Clinical Practice)
• Raport z Belmont (Belmont Report)
• Kodeks Etyki Lekarskiej, 2003
• Kodeks Etyki Pracownika Naukowego
• Dobra Praktyka badań naukowych � Rekomendacje, 2004

Handbooks and manuals:

• Poradnik dla członk�w komisji etycznych do spraw badań naukowych
• Galewicz W. (red.) Badania z udziałem ludzi, Universitas, 2011, Krak�w
• R�żyńska J, Walig�ra M.(red): Badania naukowe z udziałem ludzi w biomedycynie. Standardy międzynarodowe. Lex, 2012, Warszawa
• Galewicz W. Status ludzkiego zarodka a etyka badań biomedycznych. Wydawnictwo Uniwersytetu Jagiellońskiego, Krak�w 2013
• Galewicz W. (red.) Etyczne i prawne granice badań naukowych, Universitas, 2009, Krak�w
• Wnukiewicz-Kozłowska A. Eksperyment medyczny na organizmie ludzkim w prawie międzynarodowym i europejskim. Dom Wydawniczy ABC, 2004, Warszawa
• Grzymkowska M Standardy bioetyczna w prawie europejskim, Oficyna, 2009, Warszawa
• Walter M.(red) Badania kliniczne. Organizacja, nadz�r, monitorowanie. Oinpharma, 2004, Warszawa
• Śliwka M. (red) Prawo badań klinicznych w zarysie. TNOiK Dom Organizatora, Toruń, 2013
• Czarkowski M, R�żyńska J: Poradnik dla badacza: Świadoma zgoda na udział w eksperymencie medycznym, Ośrodek Bioetyki NIL 2008 Warszawa
• Łagocka I, Maciejczyk A.(red.): Nadz�r nad bezpieczeństwem farmakoterapii. Pharmacovigilance. Oinpharma, 2008, Warszawa
• Czarkowski M. Zasady prowadzenia badań na ludzkim materiale biologicznym Polski Merkuriusz Lekarski 2009, 160: 349-352
• Encyklopedia bioetyki. Polwen, 2009, Radom.
• Czarkowski M. Analiza działalności polskich komisji bioetycznych opiniujących projekty eksperyment�w medycznych, Warszawski Uniwersytet Medyczny, 2010, Warszawa

Family Health International, USA

On-line tutorial. 4 hours. Covers cases on:

• Respect for Persons
• Beneficence and Justice
• Informed Consent
• Ethics Committee Considerations
• Research with Minors
• Principles of Research Ethics
• Community participation
• Inducement / Compensation
• Social risks
• Individual versus Community Consent (All cases are available on the web)

Researchers and all other interested parties. Free of charge.

http://www.fhi.org/training/en/RETC2/RETCTraditional/intro.html

University of Maryland School of Medicine MERETI program

On-site training (lectures, workshops, practical assignments) 2 months of on-site studies (4 hours a day) and 10 months performance of a project in research ethics in trainee's home country. Covers cases on practical experiences in the ethical review of research protocols.

Physicians, nurses, scientists, members of research ethics committees, social scientists, philosophers, and other individuals with appropriate backgrounds and interests in health research or ethics, Research investigators, IRB/Ethics Committee members and research staff. Free access to the contents and description of the course. Scholarships are available to fund travel, living expenses, and course fees, but are limited.

http://medschool.umaryland.edu/mereti/cert.asp

CITI program

On-line course (more than 20 thematic modules; includes self-test quiz). ~1 hour to read one module and answer the quiz questions. Each module includes cases.

Investigators and all other interested parties. Paid participation.

https://www.citiprogram.org/default.asp?language=english

HRETIE Initiative in Egypt

Health Research Ethics Training

On-site training (lectures, practical assignments).

Physicians, nurses, scientists, members of research ethics committees, social scientists, philosophers, and other individuals with appropriate backgrounds and interests in health research or ethics. Research investigators, IRB/Ethics Committee members and research staff. Paid participation.

http://medschool.umaryland.edu/hretie

National Institute of Health (NIH) Department of Bioethics

On-site training (Lectures, discussions, readings, CD) 7 sessions of 3 hours. Several presentations include case analysis.

The course is offered to anyone interested or involved in clinical research involving human subjects. Free access to the contents and description of the course and to the presentation slides, free participation.

http://www.bioethics.nih.gov/hsrc/index.shtml

Practical Ethics Center at the University of Montana

On-line training (readings, case histories, self-assessment). 3-4,5 hours in total. At least one case study for each section.

Institutions that are working to promote Responsible Conduct of Research. Free participation.

http://ori.dhhs.gov/education/products/montana_round1/research_ethics.html

Qu�bec health and social services network, Canada

On-line tutorial (lectures, case studies, normative texts, tools for decision making). Each module takes approx. 20 minutes. Each course module includes cases adapted to the topic.

Research ethics board (REB) members and support staff who work in the institutions of the Qu�bec health and social services network as well as the institutions, administrators, government who are involved research ethics review for the purpose of ensuring the protection of research participants and promoting ethical conduct that demonstrates respect for individuals. Free participation.

http://ethique.msss.gouv.qc.ca/didacticiel/index.php?lang=en

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• Published: 01 July 2024

Ethics committees promote responsible research in China

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Guoyu Wang leads and serves on Chinese ethics committees. She explains how research ethics have developed in China, and why ethics review promotes responsible innovation.

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Acknowledgements

This work was supported by the National Natural Science Foundation of China (grant no. L2224015).

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DOI : https://doi.org/10.1038/s41562-024-01917-5

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Ethics probe into Matt Gaetz now reviewing allegations of sexual misconduct and illicit drug use

FILE - Rep. Matt Gaetz, R-Fla., questions Attorney General Merrick Garland during a House Judiciary Committee hearing on the Department of Justice, June 4, 2024, on Capitol Hill in Washington. The House Ethics Committee in an unusual public statement Tuesday confirmed it is reviewing several allegations against the congressman. The committee said it is investigating whether Gaetz engaged in sexual misconduct and illicit drug use, whether he accepted improper gifts and whether he sought to obstruct government investigations of his conduct. Four other allegations are no longer being investigated. (AP Photo/Jacquelyn Martin, File)

FILE - Rep. Matt Gaetz, R-Fla., speaks on Capitol Hill in Washington, Tuesday, March 12, 2024. The House Ethics Committee in an unusual public statement Tuesday confirmed it is reviewing several allegations against the congressman. The committee said it is investigating whether Gaetz engaged in sexual misconduct and illicit drug use, whether he accepted improper gifts and whether he sought to obstruct government investigations of his conduct. Four other allegations are no longer being investigated. (AP Photo/Nathan Howard, File)

FILE - Rep. Matt Gaetz, R-Fla., departs the House as lawmakers depart for the holiday recess, at the Capitol in Washington, Thursday, Dec. 14, 2023. The House Ethics Committee in an unusual public statement Tuesday confirmed it is reviewing several allegations against the congressman. The committee said it is investigating whether Gaetz engaged in sexual misconduct and illicit drug use, whether he accepted improper gifts and whether he sought to obstruct government investigations of his conduct. Four other allegations are no longer being investigated. (AP Photo/J. Scott Applewhite, File)

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WASHINGTON (AP) — The House Ethics Committee on Tuesday gave an unusual public update into its long-running investigation of Rep. Matt Gaetz , R-Fla., saying its review now includes whether Gaetz engaged in sexual misconduct and illicit drug use, accepted improper gifts and sought to obstruct government investigations of his conduct.

The committee also announced that it was no longer reviewing four other allegations involving the congressman, including that he shared inappropriate images or videos with colleagues on the House floor or that he accepted a bribe or converted campaign funds to personal use.

Gaetz has categorically denied all the allegations before the committee.

In a tweet Monday pre-empting the committee’s announcement, Gaetz noted that the ethics panel closed four probes and said those investigations had “emerged from lies intended solely to smear me.”

“Instead of working with me to ban Congressional stock trading, the Ethics Committee is now opening new frivolous investigations. They are doing this to avoid the obvious fact that every investigation into me ends the same way: my exoneration,” Gaetz said on the social platform X.

Gaetz led the effort to oust then-Speaker Kevin McCarthy from office last fall. Seven Republicans joined him in deposing McCarthy, along with 208 Democrats. Many House Republicans remain angry with Gaetz, arguing that McCarthy’s ouster was a selfish and destructive act that hurt the party.

Gaetz blamed McCarthy for the Ethics Committee’s review, even though the investigation began before Republicans took the majority in the House.

“This is Soviet. Kevin McCarthy showed them the man, and they are now trying to find the crime,” Gaetz wrote on X. “I work for Northwest Floridians who won’t be swayed by this nonsense and McCarthy and his goons know it.”

The committee began its review of Gaetz in April 2021, deferred its work in response to a Justice Department request, and renewed its work in May of last year after the DOJ dropped its request that lawmaker hold off an investigating. That was shortly after Gaetz announced that the Justice Department had ended a sex trafficking investigation without bringing charges against him.

The ethics committee said that despite the difficulty of obtaining relevant information from Gaetz and others, it has spoken with more than a dozen witnesses, issued 25 subpoenas and reviewed thousands of pages of documents.

One thing under investigation is whether Gaetz “dispensed special privileges and favors to individuals with whom he had a personal relationship,” the committee said.

The ethics committee cautioned that the existence of an investigation does not itself indicate that any violation of law or House rules occurred. The statement said that no other public comment will be made on the matter.

Ethics Committee expands Matt Gaetz investigation as it looks into sexual misconduct, drug use allegations

WASHINGTON – The House Ethics Committee said Tuesday that it's expanding its investigation into Rep. Matt Gaetz , R.-Fla., to include “additional allegations” that the Florida lawmaker sought to obstruct the probe as the panel looks into accusations of sexual misconduct, illicit drug use and more.

In a statement, the Committee said it had difficulty obtaining information from Gaetz during the course of its 3-year investigation. It added that the officials reviewing the case have issued “25 subpoenas and reviewed thousands of pages of documents,” related to misconduct accusations .

The probe into the Florida lawmaker has been ongoing since April 2021. The ethics committee is looking into a variety of claims that Gaetz engaged in sexual misconduct and illegal drug use, accepted “improper gifts” and gave out special favors.  

Gaetz was also under investigation by the U.S. Justice Department for allegations that he had sex with a 17-year-old girl and paid for her to travel with him. The DOJ ended the investigation in February 2023 and did not bring charges against Gaetz.  

The House Ethics Committee said on Tuesday that it is also dropping its investigation into a series of other allegations against Gaetz. It said it “will take no further action at this time on the allegations that he may have shared inappropriate images or videos on the House floor, misused state identification records, converted campaign funds to personal use, and/or accepted a bribe or improper gratuity.” 

When reached for comment, Gaetz’s office directed USA TODAY to a post on X, formerly known as Twitter, from the congressman on Monday blaming former Republican House Speaker Kevin McCarthy, R-Calif., for the investigation.

Gaetz and led an effort to oust McCarthy from the speakership last fall. McCarthy resigned from Congress months later. 

“This is Soviet,” Gaetz said in the post. “Kevin McCarthy showed them the man, and they are now trying to find the crime.” 

Gaetz also said in the post that the investigation would end in his “exoneration.” He has maintained his innocence since it began.  

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• Americans’ Views of Government’s Role: Persistent Divisions and Areas of Agreement

1. Government’s scope, efficiency and role in regulating business

Table of contents.

• Views on the efficiency of government
• Views on the government’s regulation of business
• Confidence in the nation’s ability to solve problems
• Views on the effect of government aid to the poor
• Views on government’s role in health care
• Views on the future of Social Security
• Trust in government
• Feelings toward the federal government
• Acknowledgments
• The American Trends Panel survey methodology

American s are evenly divided in their preferences for the size of government. Yet a somewhat greater share wants the government to do more to solve problems than say it is doing too much better left to others.

There is a persistent belief that government is wasteful: 56% say it is “almost always wasteful and inefficient.”

However, a majority of Americans (58%) say government regulation of business is necessary to protect the public good.

Divisions on government’s size, scope

Overall, 49% say they would prefer a smaller government providing fewer services, while 48% say they would rather have a bigger government providing more services.

Most Democrats prefer a larger government. For nearly half a century, Democrats and Republicans have differed in their preferences for the size of government. Today, those differences are as wide as they have ever been:

• Nearly three-quarters of Democrats and Democratic-leaning independents (74%) favor a bigger government, providing more services. By comparison, in 2015, a smaller majority of Democrats (59%) said they preferred a bigger government.
• Just 20% of Republicans and Republican leaners prefer a bigger government; nearly four times as many want smaller government with fewer services. Republicans’ views of the size of government have changed less than Democrats’. Still, when George W. Bush was running for reelection in 2004, roughly a third of Republicans favored a bigger government.

When asked about the proper role of government, about half of Americans (53%) say the government should do more to solve problems, while 46% say the government is doing too many things better left to businesses and individuals.

An overwhelming share of Democrats (76%) say government should do more to solve problems, while about a quarter (23%) say it is doing too many things better left to individuals and businesses.

By contrast, Republicans prefer a more limited role for government: 71% say government is doing too many things better left to businesses and individuals, while 28% say government should do more to solve problems.

There are also sizable demographic differences in these views:

• White adults (54%) are the most likely to say government is doing too many things better left to businesses and individuals, while smaller shares of Asian (34%), Black (31%) and Hispanic (29%) adults say the same.
• Younger adults are more likely than older adults to favor a larger role for government, with adults ages 18 to 29 (66%) being the most likely to say government should do more to solve problems.
• Among income groups, a majority of lower-income adults (61%) say government should do more to solve problems, while smaller shares of upper- and middle-income adults (53% and 48%, respectively) say the same.

Views among partisans by race, ethnicity and income

Among partisans, there are wide demographic differences on the preferred role of government – especially among Republicans.

Hispanic Republicans (58%) are much more likely than White Republicans (21%) to favor a larger role for government.

Views among Democrats are much less divided, with at least seven-in-ten Democrats in each racial and ethnic group saying government should do more to solve problems.

Nearly half of lower-income Republicans (46%) say that the government should do more to solve problems, while smaller shares of middle- (22%) and upper-income (19%) Republicans say the same.

Wide majorities of Democrats across income groups say government should do more to solve problems.

In assessments of the efficiency of the government, a majority of Americans (56%) find it to be “almost always wasteful and inefficient.” A smaller share (42%) say government “often does a better job than people give it credit for.”

Overall, views on the efficiency of government have remained somewhat steady since 2019, with views today mirroring those five years ago.

Among partisans, a majority of Democrats (63%) say the government often does a better job than people give it credit for, while a large majority of Republicans (77%) say government is often wasteful and inefficient.

Views on the efficiency of government in both parties have remained steady since 2021.

While Democrats are generally more likely than Republicans to say government does not get enough credit, these views vary somewhat depending on which party holds the presidency:

• Democrats are now more likely to give credit to the government than they were during the Trump administration.
• Among Republicans, views of government efficiency were more positive during the Trump administration.

This is consistent with shifts in views during prior administrations .

On the topic of government regulation of business, about six-in-ten Americans (58%) say that government regulation of business is necessary to protect the public interest. Four-in-ten, however, say government regulation of business usually does more harm than good.

These views have remained largely unchanged since 2017.

As with other attitudes about government, Republicans and Democrats differ on the impact of government regulation of business:

• About two-thirds of Republicans (65%) say government regulation does more harm than good.
• Roughly eight-in-ten Democrats (82%) say government regulation is necessary to protect the public interest.

Among other demographic differences:

• White adults (45%) are the most likely to say government regulation does more harm than good, while smaller shares of Hispanic (32%), Asian (29%) and Black (27%) adults say the same.
• Younger adults are more likely than older adults to say government regulation of business is necessary to protect the public interest, with adults ages 18 to 29 (64%) being the most likely to say this.

Americans are divided in their views on the country’s ability to solve important problems. About half (52%) of Americans say “this country can’t solve many of its important problems,” while 47% say that “as Americans, we can always find ways to solve our problems and get what we want.”

More Americans express confidence in the country’s ability to solve problems now than a year ago (47% now, 43% then). Still, the share saying this is lower than it was from 2019 to 2022.

Unlike assessments of government, there are no partisan differences in views on the country’s ability to solve its important problems.

In both parties, about half say the U.S. can’t solve many of its important problems, while slightly narrower shares say Americans can always find ways to solve the country’s problems.

Views among age groups

Among age groups, younger adults are the most likely to express skepticism in the country’s ability to solve its important problems. About six-in-ten adults ages 18 to 29 (62%) say the U.S. can’t solve many of its important problems, while smaller shares of older adults say the same.

Overall, the shares of adults in each age group who voice skepticism on the country’s ability to solve its problems remain higher than they were in 2022.

However, older adults have grown slightly more optimistic on this issue in the past year. Views among the youngest adults are relatively unchanged from 2022.

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ABOUT PEW RESEARCH CENTER  Pew Research Center is a nonpartisan fact tank that informs the public about the issues, attitudes and trends shaping the world. It conducts public opinion polling, demographic research, media content analysis and other empirical social science research. Pew Research Center does not take policy positions. It is a subsidiary of  The Pew Charitable Trusts .

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