man_faqs
What is an IRB?

An Institutional Review Board (IRB) is a committee of professionals from the medical and health care communities charged with the mission of protecting the rights and wellbeing of human subjects involved in research projects. IRBs have the authority to approve, require modification to or disapprove all research activities covered by the HHS and FDA Protection of Human Subjects Regulations. It is the job of an IRB to make sure that any proposed research project involving human participants be conducted safely and ethically.

Who authorizes an IRB?

IRBs are formally designated by an institution to review research involving human subjects once they issue an ‘assurance of compliance’ to the HHS. Hospitals, academic medical centers, government units, and others engaged in federally conducted or supported health research activities involving human subjects—and entities conducting FDA-regulated clinical investigations—can then designate IRBs. The IRBs must be registered by the Office for Human Research Projections (OHRP) of the HHS.

What constitutes an ‘assurance of compliance’?

Institutions engaged in non-exempt human subjects research conducted or supported by the HHS must issue a Federalwide Assurance (FWA) of compliance, in which the institution commits to HHS that it will comply with the requirements set for in 45 CFR part 46, which is the HHS Code of Federal Regulations on the Protection of Human Subjects. On behalf of the HHS, the Office on Human Research Protections (OHRP) approves the terms of these written institutional assurances, which constitute binding commitments.

What is the OHRP?

The Office for Protection from Research Risks (OPRR) is a unit within the Department of Health and Human Services (DHHS) that implements these regulations on behalf of HHS. It is located in the offices of the offices of the National Institutes of Health (NIH) in Bethesda, Maryland.

Who needs an IRB?

Every institution engaged in human subjects research conducted or supported by a Federal department or agency is required to designate one or more IRBs under an assurance of compliance. Research using human subjects that is conducted by independent investigators not associated with an institution must also be approved by an IRB. Additionally, when FDA-regulated products are investigated using human subjects, the protocol is subject to review and approval by an IRB.

Is there a difference between an FDA and an HHS IRB?

The HHS regulations (45 CFR 46) apply to all research involving human subjects conducted or supported by HHS. The FDA regulations (21 CFR 50 and 56) apply to all research involving products regulated by the FDA, including research and marketing permits for drugs, biological products, and medical devices for human use, regardless of federal funds. When research involves products regulated by the FDA that are funded by HHS, both HHS and FDA regulations apply. While the FDA did not adopt the “Common Rule” Federal Policy that all other federal agencies adopted (including HHS) it did adopt many of its provisions. For the specific differences in regulations, go to: http://www.hhs.gov/ohrp/archive/irb/irb_chapter2.htm#d7

Does my research need to be reviewed by an IRB?

An IRB is necessary when research involves humans as participants, and when it has as its goal the generation of universal scientific knowledge. Taking a patient’s blood sample for analysis of medical conditions would not need to be reviewed because its primary goal is educational, rather than scientific. Taking a patient’s blood sample as part of a study on elevated sugar levels in response to stress would require an IRB because its goal is to produce universal or generalized scientific knowledge.

Who are ‘investigators’?

HHS regulations define “investigator” as an individual performing various tasks related to the conduct of human subjects research activities. They may include physicians, scientists, nurses, administrative staff, teachers, and students, among others. If multiple investigators are conducting the research then one investigator is usually designated the “principal investigator” with overall responsibilities for the study. Investigators have certain responsibilities regarding the ethical treatment of human subjects.

What are the investigators’ responsibilities?

Investigators are responsible for: Obtaining prior approval from an IRB for the research; obtaining and documenting informed consent from the subjects; supplying progress reports to the IRB for continuing review and approval; providing IRB prompt reports are any unanticipated problems involving risk to the subjects; keeping certain records as required by the HHS for at least three years after completion of the study.

What constitutes informed consent?

Informed consent is a fundamental step toward making sure that medical research on human subjects is performed ethically. Human participants in a research project must have enough information to make an informed decision on whether to participate. Consent documents signed by participants should clearly explain the purpose of the study, what the procedure will entail, what parts of the procedure are experimental, what the risks are, what the benefits might be, and how long it will take. If participants cannot give informed consent due to age or cognitive incapacity then the patient’s legal guardian must give consent.

Where can I get other FAQs answered?

For other, more in depth HHS IRB FAQs that you don’t see here, go to:

http://www.hhs.gov/ohrp/archive/irb/irb_chapter2.htm#d3

For other, more in depth FDA IRB FAQs that you don’t see here, go to:

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm

Where can I learn more?

The HHS Code of Federal Regulations on the Protection of Human Subjects (45 CFR 46) can be read in its entirety at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

  • The FDA guidelines for IRBs and investigators can be accessed at:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm