Research Involving Human Participants Policy

Policy Summary

The Geroge Washington University ("GW" or "university") is committed to protecting the rights and welfare of human participants, and to complying with federal and local regulations regarding human-participant research. The purpose of this policy is to articulate the responsibilities of all members of the university community engaged in research activities including but not limited to principal investigators, researchers and research scientists, research staff, and student researchers (collectively, "Investigator" or "Investigators") who conduct research involving human participants. Prior to any activity that involves human participants, the proposal must be submitted to the university’s Office of Human Research (OHR), and reviewed and approved by the university’s Institutional Review Board (IRB). This policy applies to all human research participants regardless of funding status or source. Engaging in research activity involving human participants, or analysis of data gathered from human participants without prior approval may result in disciplinary action up to and including termination of research privileges and/or academic appointment. 

Related Regulations

• 21 CFR 50, 56, 312, 812, and 814 (FDA regulations) 
• 38 CFR 16 (VA regulations) 
• 45 CFR 46  et seq. (DHHS regulations) 
• Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subject Research, DHHS, Office for Human Research Protections 
• Policy of the National Cancer Institute for Data and Safety Monitoring of Clinical Trials 

Who is Governed by this Policy

• Students
• Staff
• Faculty

Policy

The university is committed to upholding the ethical principles of the Belmont Report and complying with the Department of Health and Human Services (DHHS) regulations (45 CFR 46, including subparts A, B, C, and D) with respect to all research involving human participants, regardless of sponsorship. The ethical principles set forth in the Belmont Report are: 

1. Respect for Persons: Recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy; 
2. Beneficence: Obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risk of harm; and 
3. Justice: Fairness in the distribution of research benefits and burdens. 

The university is also committed to compliance with additional relevant regulations such as the U.S. Food and Drug Administration (FDA) regulations (21 CFR 50, 56, 312, 812, and 814), the Veterans Administration (VA) regulations (38 CFR 16, as well as any VA directives when applicable), the Health Insurance Portability and Accountability Act (HIPAA), and any federal, state and local law under review that pertains to research involving human participants. 

In situations where there is more than one applicable law or regulation, the university will apply the most stringent. 

Approval of Research 

Federal regulations require that, prior to instituting any research activity or study involving human participants, all such research must first be reviewed and approved by the university’s IRB, or determined to be exempt.  

Investigators are responsible for contacting OHR for guidance concerning whether a research activity constitutes human-participant research, and if so, whether it is exempt from the requirement for IRB review. Investigators should become familiar with the information and guidance concerning this subject from the DHHS’ Office for Human Research Protections (OHRP), which is available online.  

All Investigators seeking to engage in research involving human participants must first submit a research proposal to the university’s OHR, which is responsible for compliance with federal regulations regarding the protection of human participants in research and serves as the administrative office for the IRB.  

The university’s IRB will review and oversee all research involving human participants at the university and is authorized toaudit research facilities, obtain records, observe the consent process, suspend or terminate research, and take other actions as necessary to comply with federal and local regulations. The IRB is also responsible for providing assurance to the federal government that the university is in compliance with federal regulations. Further detailed instructions regarding IRB responsibilities, procedures, and regulations can be found on OHR's website.

Research Requirements 

When the research is subject to regulation by any federal department or agency, all additional conditions imposed by the department or agency for the protection of human participants must be followed. 

Special provisions are set forth in the federal regulations for research involving pregnant women, fetuses, fetal material and/or the placenta, neonates, children, and prisoners. All Investigators are responsible for complying with all regulations concerning these classes of research participants. 

Informed Consent 

No Investigator may involve a human being as a participant in research unless the Investigator has obtained legally effective, written, informed consent from the participant or the participant’s legally authorized representative, or unless informed consent is specifically waived by the IRB. No exculpatory language may be included in the consent that waives or appears to waive any of the participant’s legal rights, or that releases or appears to release the Investigator, sponsor, or the institution or its agents from liability for negligence.  

Responsibilities of Investigators 

1. Investigators are responsible for ensuring that the conduct of the research adheres to and complies with approved IRB protocols and other IRB requirements for the proposed research. 
2. Investigators will promptly report proposed changes in previously IRB-approved activities to OHR. The proposed changes must not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to currently enrolled participants. 
3. Investigators will promptly report to the IRB any injuries or other unanticipated problems involving risks to participants or others. 
4. Investigators are responsible for submitting reports on the progress of approved research to OHR as often as necessary and in the manner prescribed by the approving IRB on the basis of risks to participants. 
5. Investigators are responsible for acquiring the appropriate knowledge regarding human-participant protections, ethics, federal regulations, training, and monitoring to conduct their proposed research. 
6. Investigators must also ensure that study personnel are adequately trained and knowledgeable regarding human-participant protections, ethical considerations, and federal regulations applicable to the proposed research. 
7. Investigators are responsible for complying with the training, monitoring, and human-participant research guidance as outlined in university IRB policies and procedures. 
8. Detailed instructions for carrying out the responsibilities in this policy can be found on OHR's website. All research Investigators engaged in human participant research are responsible for familiarizing themselves with that information and for keeping abreast of all requirements for conducting human participant research under the auspices of the university. 

Definitions

Human Participant: A living individual about whom an Investigator conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information. 

Private Information: Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may be readily ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human participants. 

Research: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.  

Procedures

Procedures can be found on the GW Office of Human Research (OHR) website and additional details through the DHHS’ Office for Human Research Protections (OHRP) Decision Chart. 

Related Information

• Collaborative IRB Training Initiative (CITI) 
• Department of Health and Human Services (DHHS) 
• DHHS Human Subjects Decision Charts 
• Food and Drug Administration 
• Good Clinical Practice in FDA-Regulated Clinical Trials 
• NIH Education Requirements
• Privacy of Personal Information Policy

Contacts