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APPENDIX B 124 As performance evaluation of HRPPs, IRBs, and investigators becomes more routine around the United States, PRIM&R will publicize innovative programs that effectively address these organizational best practices. 1.17 The organization must provide evidence of programs, policies, or procedures for ongoing communication with representatives of the geographic and/or subject communities studied in research. These communication vehicles should provide for the ongoing discussion of commonalities and/or differences in research portfolios and agendas, goals of interest to either or both parties, and for the sharing of each other's values and concerns. COMMENTARY on Standard 1.17: The organization must be aware of the customs and values in the respective research participant populations it serves, including legal requirements as appropriate. This awareness is especially important when research is being conducted or contemplated that involves individuals from that community (geographic, demographic, and cultural). For example, organizations conducting research involving Native Americans must understand and appreciate tribal concerns that influence the conduct of such research. Organizations whose IRBs are widely separated geographically from their investigators should detail the manner in which such potentially diverse communities will be engaged and involved. Section 2âInstitutional Review Boards (IRBs) GENERAL COMMENTARY on Section 2: In fulfilling their mandate to protect the rights and welfare of individuals studied in research, IRBs are intended to be impartial reviewers of research studies. Their responsibilities include the review, approval, or disapproval of protocols, and the recommendation of protocol and/or consent modifications, all of which are designed to minimize the risks to the individuals to be recruited into the study. 2.1 The IRB(s) must comply with all applicable laws, regulations, and organizational policies and procedures. COMMENTARY on Standard 2.1: See Standard 1.2 2.2 The IRB(s) must identify to the appropriate institutional officials the resources it requires.
APPENDIX B 125 COMMENTARY on Standard 2.2: The IRB staff, chair(s), and members constitute the relevant source of information concerning the needs for this component of the HRPP. 2.3 Each IRB should be constituted to promote respect for its advice and counsel in safeguarding the rights and welfare of the individuals studied in research. COMMENTARY on Standard 2.3: The size of the organization and the extent of its research will determine the number of IRBs required. The type(s) of research reviewed by the IRB(s) (e.g., behavioral research, clinical trials, epidemiological research, and research involving vulnerable populations or minority groups) will influence membership requirements. Appropriate expertise of IRB members, chair (s), and staff is required to ensure an adequate review of protocols from varied disciplines. IRBs also need to recognize when consultant expertise is required. 2.4 The IRB chair(s), members, and staff must possess sufficient respect within the organization and the leadership skills as a team sufficient to be an authority on the protection of individuals studied in research under the jurisdiction of the HRPP. COMMENTARY on Standard 2.4: The position of IRB chair is of singular importance, and requires commitment, knowledge, and the necessary leadership skills to serve as an effective steward. The responsibility of the chair should be vested in a highly credible member of the organization, as s/he will then be better able to engender respect for the authority of the IRB. Attributes which are a measure of an effective IRB team include: (1) the ability to conduct meetings in an efficient, expeditious, and fair manner; (2) attentiveness to the details of applicable federal regulations and other legal and institutional requirements; (3) skillful facilitation of contextual interpretations and application of these requirements that will foster ethically and scientifically sound research involving human beings; (4) the ability to encourage dialogue in IRB meetings and within the organization; (5) respect for the contributions of all IRB members and staff, especially the contributions of the non-scientists and community representatives; (6) the confidence and courage to uphold IRB judgments, and (7) investment of adequate time, interest, and commitment by the chair, IRB members, IRB staff, researchers, and other interested individuals in the organization.
APPENDIX B 126 2.5 Knowledge, Skills, and Abilities The IRB administrator, staff, chair(s), and Board members must possess and maintain knowledge, skills, and abilities appropriate to their role including: General ethical principles and concepts underlying the conduct of research involving humans; ⢠Applicable Federal, state, and local laws and regulations; ⢠Applicable HRPP and IRB policies and procedures; ⢠Role of the IRB(s) in the HRPP; and ⢠These Accreditation Standards COMMENTARY on Standard 2.5: Appropriate activities include education of new members, chair(s), and staff and continuing education for current staff, members, and chair(s) using performance feedback, mentoring, and monitoring techniques. These activities should be designed to ensure that IRB chairs, staff, and members know and apply the concepts and requirements in this Accreditation Standard. Continuing education for an IRB team is particularly important in light of the breadth and depth of their expected knowledge base. Organizations should support the team's attendance at and/or participation in local, regional, and/or national meetings or programs on the protection of individuals studied in research. Successful IRB administration requires a combination of a working knowledge of protection of those studied in research and skills in administration. Organizations should support appropriate training for IRB administration. This may include their attendance at and/or participation in meetings or programs on the protection of individuals studied in research, acquisition of topic-oriented journals/books, and/or professional development such as certification through the ARENA Council for Certification of IRB Professionals (CCIP). 2.6 In the review of protocols, the IRB must recognize when additional expertise is needed and must obtain that expertise (e.g., education in, or consultation on scientific, ethical, community representation, or other issues). COMMENTARY on Standard 2.6: Some protocols may present new or special considerations beyond the scientific and ethical expertise of the IRB. The IRB should have and follow policies regarding inviting individuals with competence in special areas to assist in the review of protocols that require expertise in addition to that available within the IRB. These individuals can submit comments in writing and they may attend
APPENDIX B 127 IRB meetings in a non-voting capacity to present their findings. IRB procedures must specify in writing details regarding this process. 2.7 IRBs must demonstrate systematic review of research protocols in order to assure that issues, regulations, and other applicable organizational policies and procedures relevant to the protection of individuals studied in research are consistently addressed. COMMENTARY on Standard 2.7: IRBs must determine, at a minimum, that all of the following criteria are satisfied: (1) Research risks are reasonable in relation to anticipated benefits; (2) Risks are minimized; (3) The selection of those in the population to be studied is equitable (the IRB should be particularly cognizant of the special problems of research involving vulnerable populations); (4) Informed consent is sought from research participants or their authorized representatives unless waived by the IRB; (5) Monitoring of data is appropriate to ensure safety; (6) Adequate provisions are made to protect privacy and maintain the confidentiality of research data, and (7) When vulnerability to coercion or undue influence may exist, additional safeguards are included in the study to protect the rights and welfare of individuals participating in the research. 2.8 The IRB must ensure that consent documents are legible, understandable, well organized, and remain appropriate for the research population. COMMENTARY on Standard 2.8: Technical and legal language should be defined and stated in terminology that the research population can understand. Systematic feedback from coordinators, research participants, and investigators should be one method for implementing the assessment of the adequacy of the consent documents. 2.9 The IRB must determine that the consent process is appropriate for the circumstances under which the research will be conducted. COMMENTARY on Standard 2.9: The entire process for obtaining informed consent must be considered in the IRB review including who, when, how, and any special circumstances pertinent to the process. The Principal Investigator (PI) of the study is responsible for all aspects of the consent process regardless of any special circumstances. 2.10 The IRB must receive evidence that the investigator(s) is qualified through training, experience, and commitment of time and resources, to be responsible and appropriate for the planned research.
APPENDIX B 128 COMMENTARY on Standard 2.10: The IRB should have policies that define acceptable evidence of the qualifications of the principal investigator and research team members as related to the specific protocol. These policies should also include provisions indicating how students and trainees are covered when the curriculum or training requires that research be accomplished. 2.11 The IRB must have written policies and procedures pertaining to the following and which are appropriate and relevant to the types of research reviewed within the organization, including research involving special populations (children, persons who are decisionally impaired, the elderly, etc.) or certain types of research (e.g., social and behavioral research, drug washout studies, double-blinded placebo controlled studies, or research conducted in emergency circumstances). POLICIES REQUIRED OF ALL IRBs (A) Initial IRB review of protocols COMMENTARY on Standard 2.11 (A): IRB review of protocols must be complete and substantive. IRB members must receive sufficient information to make a determination of each review criterion. (B) Substantive and meaningful continuing IRB review of protocols, including frequency of review and assuring that design and procedures continue to be appropriate and safe COMMENTARY on Standard 2.11 (B): When conducting continuing review, all IRB members must receive sufficient information to allow the Board to pass judgment. (C) Full review requirements (e.g., quorum requirements, asking IRB members who have conflicts of interest to recuse themselves, etc.) (D) Requirements for the consent process, including the consent forms and their modifications (E) Expedited review (F) Exempt research (G) If appropriate, procedures for the IRB's primary reviewer of the protocol (H) Investigators' conflicts of interest COMMENTARY on Standard 2.11 (H): In keeping with Standard 1.8, the IRB implements the organization's written conflicts of interest policies in regard to individuals studied in research. The IRB is responsible for determining whether any potential, real, or perceived conflicts of interest could affect the conduct of research under consideration or that could impact the safety of those individuals studied in research.
APPENDIX B 129 (I) Identification and reporting of adverse events (to the IRB and others as required) (J) Procedures/rules for the review of PI's response(s) to IRB stipulations and recommendations (K) Noncompliance by researchers or research personnel with protocol requirements and/or with IRB policies/procedures (L) Suspensions or terminations of approvals (M) Collaborative agreements (national and international) (N) Reporting IRB findings to investigators, appropriate institutional officials, and appropriate federal or other regulatory agencies (O) Advertisements and other recruitment-related materials (P) Remuneration to research participants (Q) Investigator record keeping and retention requirements (R) Vulnerable populations (S) Waiver of informed consent or of documentation of consent (T) Any other relevant areas POLICIES REQUIRED OF IRBs WITH SPECIAL INTERESTS (A) Determining the regulatory status of an investigational device concerning the significance of the risk of the device, if needed (B) Emergency use of IND compounds or other investigational interventions (C) Grant review for certification of approval of research (D) Any other relevant areas 2.12 The IRB protocol records/files must contain at least the below-listed information. COMMENTARY on Standard 2.12: As the study file contains the details regarding the protocol and the review of that protocol, and as the file is subject to audit, it is necessary that the study file be complete, accessible, and archived. The IRB protocol records/files must contain at least the following information: (A) A copy of the protocol, including approved consent documents and results of existing related information pertinent to the protocol (B) Scientific evaluations reviewed by the IRB, if any (C) Initial reviews (D) Advertisements and other applicable recruitment materials (E) Payments to be made to research participants (amount of payment, etc.) (F) Continuing reviews and progress reports (G) Adverse event reports with documentation of IRB review
APPENDIX B 130 (H) All correspondence (including electronic mail) with investigator(s), consultants, and others (institutional officials, sponsors, etc.) about the protocol. (I) Statements of significant new findings provided to research participants (J) Reports of non-compliance, if applicable (K) Reports of deviations from approved protocols, if applicable (L) Protocol modifications/amendments (M) Suspensions or revocation of approval, if applicable (N) Minutes relative to the protocol review and actions (O) When applicable, the investigator's plan to communicate with representatives of the community from which individuals will be recruited in order to share the protocol and learn of community concerns, values, and expectations 2.13 IRB minutes, record keeping, and retention requirements. COMMENTARY on Standard 2.13: IRB minutes are fundamental parts of its record keeping activities. The minutes, together with other IRB documents, should enable a reader who was not present at the meeting to determine how and with what justification(s) the IRB arrived at its decisions. The IRB must also have policies and procedures for retention of minutes and records. (A) The IRB meeting minutes must include at least the following information: (1) Approval of minutes from the previous meeting; (2) Attendance at meetings; (3) Actions taken; (4) Votes (including total number of members present) for, against, and abstaining, as well as names of abstainers, and reason for abstention, if appropriate; (5) Documentation indicating change or loss of quorum throughout meeting; (6) Summary of the discussion of issues and their resolution (including, when appropriate, minority reports); (7) Basis for requiring changes, deferring, or disapproving protocols; (8) Special findings (i.e., criteria for varying or altering consent requirements or risk categories for children and other vulnerable populations); (9) Discussion of the need for a DSMB or other monitoring procedure(s) when applicable;
