Domain II: Institutional Review Board or Ethics Committee

Tip Sheets

The following are the AAHRPP Accreditation Standards related to the IRB or EC.

Standard II-1: The structure and composition of the IRB or EC are appropriate to the amount and nature of the research reviewed and in accordance with requirements of applicable laws, regulations, codes, and guidance.

Element II.1.A. The IRB or EC membership permits appropriate representation at the meeting for the types of research under review, and this is reflected on the IRB or EC roster. The IRB or EC has one or more unaffiliated members; one or more members who represent the general perspective of participants; one or more members who do not have scientific expertise; one or more members who have scientific or scholarly expertise; and, when the IRB or EC regularly reviews research that involves vulnerable participants, one or more members who are knowledgeable about or experienced in working with such participants.

Element II.1.B. The IRB or EC has qualified leadership (e.g., chair and vice chair) and qualified members and staff. Membership and composition of the IRB or EC are periodically reviewed and adjusted as appropriate.

Element II.1.C. The Organization has and follows written policies and procedures to separate competing business interests from ethics review functions.

Element II.1.D. The IRB or EC has and follows written policies and procedures so that members and consultants do not participate in the review of research protocols or plans in which they have a conflict of interest, except to provide information requested by the IRB or EC.

Element II.1.E. The IRB or EC has and follows written policies and procedures requiring research protocols or plans to be reviewed by individuals with appropriate scientific or scholarly expertise and other expertise or knowledge as required to review the research protocol or plan.

Standard II-2: The IRB or EC evaluates each research protocol or plan to ensure the protection of participants.

Element II.2.A. The IRB or EC has and follows written policies and procedures for determining when activities are exempt from applicable laws and regulations, when permitted by law or regulation and exercised by the IRB or EC. Such policies and procedures indicate that exemption determinations are not to be made by Researchers or others who might have a conflict of interest regarding the studies.

Element II.2.B. The IRB or EC has and follows written policies and procedures for addressing protection of participants in research that is exempt from applicable laws and regulations. These functions may be delegated to an entity other than the IRB or EC.

Element II.2.C. The IRB or EC has and follows written policies and procedures for conducting meetings by the convened IRB or EC.

Element II.2.D. The IRB or EC has and follows written policies and procedures to conduct reviews by the convened IRB or EC.
 
                   Element II.2.D.1. – Initial review
                   Element II.2.D.2. – Continuing review
                   Element II.2.D.3. – Review of proposed modifications to previously approved
                   research

Element II.2.E. The IRB or EC has and follows written policies and procedures to conduct reviews by an expedited procedure, if such procedure is used.
                  
                   Element II.2.E.1. – Initial review
                   Element II.2.E.2. – Continuing review
                   Element II.2.E.3. – Review of proposed modifications to previously approved
                   research

Element II.2.F. The IRB or EC has and follows written policies and procedures for addressing unanticipated problems involving risks to participants or others, and for reporting these actions, when appropriate.

Element II.2.G. The IRB or EC has and follows written policies and procedures for suspending or terminating IRB or EC approval of research, if warranted, and for reporting these actions, when appropriate.

Element II.2.H. The IRB or EC has and follows policies and procedures for managing multi-site research by defining the responsibilities of participating sites that are relevant to the protection of research participants, such as reporting of unanticipated problems or interim results.

Standard II-3: The IRB or EC approves each research protocol or plan according to criteria based on applicable laws, regulations, codes, and guidance.

Element II.3.A. The IRB or EC has and follows written policies and procedures for identifying and analyzing risks and identifying measures to minimize such risks. The analysis of risk includes a determination that the risks to participants are reasonable in relation to the potential benefits to participants and to society.

Element II.3.B. The IRB or EC has and follows written policies and procedures for reviewing the plan for data and safety monitoring, when applicable, and determines that the data and safety monitoring plan provides adequate protection for participants.

Element II.3.C. The IRB or EC has and follows written policies and procedures to evaluate the equitable selection of participants.
 
                   Element II.3.C.1. The IRB or EC has and follows written policies and procedures
                   to review proposed participant recruitment methods, advertising materials, and
                   payment arrangements and determines whether such arrangements are fair,
                   accurate, and appropriate.

Element II.3.D. The IRB or EC has and follows written policies and procedures to evaluate the proposed arrangements for protecting the privacy interests of research participants, when appropriate, during their involvement in the research.

Element II.3.E. The IRB or EC has and follows written policies and procedures to evaluate proposed arrangements for maintaining the confidentiality of identifiable data, when appropriate, preliminary to the research, during the research, and after the conclusion of the research.

Element II.3.F. The IRB or EC has and follows written policies and procedures to evaluate the consent process and to require that the Researcher appropriately document the consent process.

Element II.3.G. The IRB or EC has and follows written policies and procedures for approving waivers or alterations of the consent process and waivers of consent documentation.

Standard II-4: The IRB or EC provides additional protections for individuals who are vulnerable to coercion or undue influence and participate in research.

Element II.4.A. The IRB or EC has and follows written policies and procedures for determining the risks to prospective participants who are vulnerable to coercion or undue influence and ensuring that additional protections are provided as required by applicable laws, regulations, codes, and guidance.

Element II.4.B. The IRB or EC has and follows written policies and procedures requiring appropriate protections for prospective participants who cannot give consent or whose decision-making capacity is in question.

Element II.4.C. The IRB or EC has and follows written policies and procedures for making exceptions to consent requirements for planned emergency research and reviews such exceptions according to applicable laws, regulations, codes, and guidance.

Standard II-5: The IRB or EC maintains documentation of its activities.

Element II.5.A. The IRB or EC maintains a complete set of materials relevant to the review of the research protocol or plan for a period of time sufficient to comply with legal and regulatory requirements, Sponsor requirements, and organizational policies and procedures.

Element II.5.B. The IRB or EC documents discussions and decisions on research studies and activities in accordance with legal and regulatory requirements, Sponsor requirements, if any, and organizational policies and procedures.