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Evaluations & Standards
Review by an Institutional Review Board (IRB) is the cornerstone of an institution's program for the protection of human subjects. IRBs are responsible for ensuring that the rights and welfare of the subjects are adequately protected.
- Criteria for IRB approval of research:
- risks to subjects are minimized by using procedures which are consistent with sound research design and do not unnecessarily expose subjects to risks, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research
- selection of subjects is equitable; in making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations
- informed consent will be sought from each subject or the subject's legally authorized representative; informed consent will be appropriately documented, in accordance with, and to the extent required by the HHS regulations.
- there are adequate provisions to protect the privacy of the subjects and confidentiality of data;
- when some of all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards are included to protect the rights and welfare of these subjects.
- Continuing Review
- An IRB must conduct continuing review of ongoing approved research at intervals appropriate to the degree of risk, but not less than once per year. For approved research, the IRB determines which activities require continuing review more frequently than every 12 months. Continuing IRB reviews are preceded by receipt of appropriate progress reports from the investigator, including available study-wide findings. Continuing review must be substantive and meaningful.
- Relying on Another IRB
- An institution relying on another IRB has the following responsibilities:
- To ensure that the reviewing IRB is in compliance with the IRB requirements in the Federal regulations;
- To ensure that the particular characteristics of the institution's local research context are considered, either through knowledge of its local context by the reviewing IRB; or through subsequent review by appropriate designated institutional officials.
- IRB Authority
- To approve, require modifications in to secure approval, or disapprove all research activities covered by the HHS regulations, including proposed changes in ongoing, previously approved, human subjects research. To suspend or terminate the approval of ongoing, previously approved research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected, serious harm to subjects.
- The Human Protections Administrator is named in item #6 of the Federalwide Assurance (FWA) for the Protection of Human Subjects For Domestic (U.S.) Institutions issued to Heritage Community Services by the U.S. Department of Health and Human Services (HHS) serves as the primary point of contact for the Office for Human Research Protections (OHRP). An Institutional Review Board is named in the FWA which will review research activities covered by HHS regulations.
- Human Protections Administrator administrative responsibilities
- Institutional Review Board (IRB) Communication & Education
- Promoting communication among the research administrators, educators, and human subjects to maintain a high level of awareness regarding the ethical conduct of research and safeguarding the rights and welfare of subjects.
- Maintaining access to the institution's Assurance; copies of pertinent Federal regulations, policies, and guidelines related to the involvement of human subjects in research; and institutional policies and procedures.
- Educating the members of the Heritage community in order to establish and maintain a culture of compliance with Federal regulations and institutional policies relevant to the protection of human subjects.
- Record keeping & Reporting
- Ensuring that IRB records are being maintained per HHS regulations and that the records are accessible, upon request, to authorized HHS officials. For institutions relying on another IRB, records may be retained at the IRB site.
- Ensuring certification of IRB approval of proposed research to the appropriate HHS agency for HHS-conducted or supported research.
- Ensuring that changes in approved research, during the period for which IRB approval has already been given, are not initiated without IRB review and approval, except when necessary to eliminate apparent, immediate hazards to the subject.
- Ensuring prompt reporting to the IRB all proposed changes in a research activity.
- Monitoring & Oversight
- Ensuring the prompt reporting to the IRB, appropriate institutional officials, OHRP, and any sponsoring Federal department or agency head of:
- any unanticipated problems involving risks to subjects or others;
- any serious or continuing noncompliance with the regulations or requirements of the IRB
- any suspension or termination of IRB approval for research.
- Ensuring that appropriate oversight mechanisms have been implemented to ensure compliance with the determinations of the IRB.
- Ensuring that all cooperating performance sites in HHS-conducted or supported research conducted primarily under the direction of the institution have appropriate OHRP-approved assurances and provide certifications of IRB approval to the appropriate federal authorities.
- Ensuring that cooperative IRB review arrangements are documented in writing, in accordance with OHRP guidance.
- Ensuring that all independent investigators that rely on the institution's IRB have documented, in accordance with OHRP guidance, their commitment to the institution's human subjects protections requirements and to the IRB's determinations.
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