After analyzing all Step 1 application reviews completed from October 2009 to June 2011 using the revised standards, AAHRPP has developed a list of the most frequently identified deficiencies found in Step 1 Review of Application Materials, which evaluates an organization’s written policies and procedures. Here are five areas to focus on when preparing your application for accreditation:
1. Element II.2.C. The IRB or EC has and follows written policies and procedures for conducting meetings by the convened IRB or EC. Required in 85% of reviews.
Tip: AAHRPP requires the unaffiliated IRB member and the IRB member representing the perspective of participants to attend most, if not all, convened IRB meetings. Make sure that your policies and procedures pertaining to IRB meetings indicate either that the unaffiliated member and the member representing the perspective of participants are required to be present in order to meet quorum or that there is an attendance requirement that they attend meetings most of the time (for example, 80% of meetings). Alternatively, it is acceptable to use IRB minutes as documentation that these members were in attendance most of the time. The non-scientific member, the unaffiliated member, and the member representing the perspective of participants may be the same person or maybe two or three people.
2. 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. Required in 81% of reviews.
Tip: Programs often focus only on consent forms and documentation of consent, and do not focus on the process of consent. The consent process includes: 1) the person or persons who are authorized and qualified to conduct the consent interview, 2) the person who will provide consent or permission, if not the participant himself or herself, a legally authorized representative or, in the case of children, the parents, 3) any waiting period between informing the prospective participant and obtaining consent, 4) steps taken to minimize the possibility of coercion or undue influence, 5) the language used by those providing information to the prospective participant and obtaining consent, 6) the language understood by the prospective participant or the legally authorized representative, and 7) the information to be communicated to the prospective participant or the legally authorized representative in the consent interview and consent document (if applicable).
3. Element II.3.C. The IRB or EC has and follows written policies and procedures to evaluate the equitable selection of participants. Required in 76% of reviews.
Tip: A common finding is that the convened IRB or IRB reviewer does not adequately review advertising and recruitment materials; in particular, the final copy of an advertisement must be reviewed and approved. If the convened IRB or IRB members require revisions to a written advertisement, audio message (e.g. radio advertisement), or video message, the final versions of the advertisements in the media they will be presented to potential participants must be reviewed by the convened IRB or reviewer using the expedited procedure to ensure that the revisions have been made and the advertisements comply with the regulations and organizational policies and procedures.
4. Element I.5.D. The Organization has and follows written policies and procedures for addressing allegations and findings of non-compliance with Human Research Protection Program requirements. The Organization works with the Institutional Review Board or Ethics Committee, when appropriate, to ensure that participants are protected when non-compliance occurs. Such policies and procedures include reporting these actions, when appropriate. Required in 73% of reviews.
Tip: Policies and procedures often do not describe the process for determining whether a report or allegation constitutes non-compliance, and whether the non-compliance is serious or continuing. If the convened IRB is designated to make the determination of serious or continuing non-compliance, policies and procedures should make this clear. If the non-compliance is determined to be serious or continuing, policies and procedures must define the process for reporting to organizational officials, sponsors, and the appropriate regulatory agencies, including OHRP and FDA, and for international sites or for U.S. sites conducting research internationally, the relevant regulatory officials in those countries. (VA facilities must also report to the Office of Research Oversight.)
5. 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. Required in 72% of reviews.
Tip: Policies and procedures must incorporate all determinations mandated for vulnerable populations. For organizations following DHHS regulations, this includes determinations required in Subpart B (pregnant women), Subpart C (prisoners), and Subpart D (children) when the research study proposes to enroll any of these vulnerable groups.
Policies and procedures must address all the accreditation Standards and Elements, not just the five elements above. Considering these five elements, particularly the parts noted, will help to ensure that your policies and procedures will avoid the most common deficiencies that have been noted in previous Step 1 Reviews of Application Materials.
In future issues of Advance, AAHRPP will present the next five most frequent required revisions from Step 1 reviews and also the top ten areas of concern in Draft Site Visit Reports.
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