EthicsGlossary Term
ICH E6(R3) Section 1.31
An independent body constituted of medical, scientific, and non-scientific members whose responsibility is to ensure protection of the rights, safety, and well-being of human subjects involved in research.
The Institutional Review Board functions as an essential safeguard in clinical research, providing independent oversight to protect human research participants. This committee reviews, approves, and monitors clinical trials to ensure that ethical standards are maintained and that participant rights and welfare are adequately protected. In the United States, IRBs are regulated by the FDA and the Office for Human Research Protections, with specific requirements for composition, procedures, and documentation.
IRB composition must include at least five members with varying backgrounds to ensure complete and adequate review of research activities. The membership must include at least one member whose primary concerns are in scientific areas, at least one member whose primary concerns are in non-scientific areas, and at least one member who is not otherwise affiliated with the institution and is not part of the immediate family of a person affiliated with the institution. This diverse composition helps ensure that reviews consider both scientific merit and broader ethical and community concerns.
The IRB review process encompasses initial review of proposed research, periodic continuing review of ongoing studies, and review of any amendments or modifications to approved protocols. The board evaluates whether risks to subjects are minimized and reasonable in relation to anticipated benefits, whether selection of subjects is equitable, whether informed consent is adequate, and whether appropriate safeguards are in place to protect the welfare of vulnerable populations. No human subjects research may commence without documented IRB approval, and any subsequent changes to the protocol require IRB review before implementation.
Initial approval
"The research team submitted the protocol, informed consent form, and recruitment materials to the IRB and received approval after addressing the committee's questions about the risk-benefit ratio for healthy volunteers."
Continuing review
"As part of the annual continuing review, the investigator submitted a progress report to the IRB summarizing enrollment status, adverse events, protocol deviations, and any new information affecting the risk-benefit assessment."
An independent body constituted of medical/scientific professionals and non-medical/non-scientific members whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial.
A process by which a subject voluntarily confirms willingness to participate in a clinical trial after being informed of all aspects relevant to the decision.
An individual whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation of benefits or fear of negative consequences, or who may have diminished capacity to provide informed consent.
ICH E6(R3) Section 1.31
An independent body constituted of medical, scientific, and non-scientific members whose responsibility is to ensure protection of the rights, safety, and well-being of human subjects involved in research.
The Institutional Review Board functions as an essential safeguard in clinical research, providing independent oversight to protect human research participants. This committee reviews, approves, and monitors clinical trials to ensure that ethical standards are maintained and that participant rights and welfare are adequately protected. In the United States, IRBs are regulated by the FDA and the Office for Human Research Protections, with specific requirements for composition, procedures, and documentation.
IRB composition must include at least five members with varying backgrounds to ensure complete and adequate review of research activities. The membership must include at least one member whose primary concerns are in scientific areas, at least one member whose primary concerns are in non-scientific areas, and at least one member who is not otherwise affiliated with the institution and is not part of the immediate family of a person affiliated with the institution. This diverse composition helps ensure that reviews consider both scientific merit and broader ethical and community concerns.
The IRB review process encompasses initial review of proposed research, periodic continuing review of ongoing studies, and review of any amendments or modifications to approved protocols. The board evaluates whether risks to subjects are minimized and reasonable in relation to anticipated benefits, whether selection of subjects is equitable, whether informed consent is adequate, and whether appropriate safeguards are in place to protect the welfare of vulnerable populations. No human subjects research may commence without documented IRB approval, and any subsequent changes to the protocol require IRB review before implementation.
Initial approval
"The research team submitted the protocol, informed consent form, and recruitment materials to the IRB and received approval after addressing the committee's questions about the risk-benefit ratio for healthy volunteers."
Continuing review
"As part of the annual continuing review, the investigator submitted a progress report to the IRB summarizing enrollment status, adverse events, protocol deviations, and any new information affecting the risk-benefit assessment."
An independent body constituted of medical/scientific professionals and non-medical/non-scientific members whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial.
A process by which a subject voluntarily confirms willingness to participate in a clinical trial after being informed of all aspects relevant to the decision.
An individual whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation of benefits or fear of negative consequences, or who may have diminished capacity to provide informed consent.