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Washington State University
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About post-approval review

Program for research involving human subjects

Research involving human subjects may undergo post-approval review by the WSU Office of Research Assurances and the Human Research Protection Program (HRPP), according to HRPP policy.

The HRPP is still in the process of developing the Post-Approval Review (PAR) program and will make more information available here when it is finalized.

Purpose of the post-approval review program

  • Ensure adequate protection of human subjects
  • Check materials and processes (such as the approved protocol, informed consent, data security, personnel training, and adverse event reporting)
  • Help you, the investigator, prepare for your next HRPP continuing review, as well as for sponsor or regulatory audits

Post-approval review versus continuing review

  • Continuing review: Conducted routinely to renew approval for human subjects research
  • Post-approval review: Selects studies for additional scrutiny

Why studies are chosen for post-approval review

All protocols are eligible for post-approval review, whether exempt, expedited, or full-board approved. Studies may be chosen for a variety of reasons. Examples include (but are not limited to) the following:

  • Random selection
  • Levels or types of risks posed to subjects
  • Involvement of vulnerable populations
  • Complex expedited studies
  • Characteristics of funding sources
  • Request of the principal investigator
  • Allegations of non-compliance
  • Questions from research participants
  • Post-approval monitoring

Process

  • Background reading
    The reviewer will read the current approved protocol and all correspondence between the investigator and the HRPP. The reviewer will also research laws and regulations that are relevant to the research.
  • Informal meeting
    The reviewer will contact the principal investigator, inform him/her that the study has been selected for review, and arrange an informal meeting. In the meeting, the reviewer will do the following:
    • Explain the review process
    • Set expectations for when the review summary will be delivered and what authority it will carry
    • Ask and answer questions
    • Deliver documents to help you prepare for the site visit
  • Site visit
    The reviewer will do the following:
    • Visit the research site
    • Review documentation (consent and/or assent forms, research protocol, recruitment materials, instruments and surveys, amendments, adverse events)
    • Assess data security
    • Examine the training of research staff
    • Observe the informed consent process

    A representative who is knowledgeable about the study and has access to all research materials must be present for the site visit.

  • Report of deviations
    The reviewer will forward any deviations to the HRPP coordinator for follow up. Any necessary changes must be approved by the coordinator or, for more serious deviations, by the IRB.
  • Summary
    Findings of the review will be discussed with the principal investigator and/or staff at the end of the site visit.  When the review is complete, the reviewer will submit a summary to the coordinator, who will convey it to the HRPP. Variances from approved applications, adverse events, or unanticipated events—depending upon their seriousness—may be reported to the vice president for research and federal agencies as required by federal regulations. When the review is “closed” a summary will be presented to the IRB in its next scheduled monthly meeting.

Principal investigator responsibilities

  • Complete the self-evaluation tool for post-approval review.
  • Be available for a brief visit at the beginning of the review and again to ask/answer questions at the end.
  • Organize documents in a binder (supplied by the reviewer), store them securely, and have them readily accessible. Documents to be reviewed include the following:
    • Regulatory documents
    • Approved applications
    • Addendums
    • Consents and authorizations
    • Recruitment materials
    • Survey instruments, questionnaires, interview scripts
    • IRB correspondence related to the study
    • Data security methods
    • Training of staff, to verify that it has been completed as described on the application
    • Adverse event and unexpected occurrence records

    In addition, have ready specific subject records that the reviewer may request. Review of subject records will include the informed consent process, the inclusion/exclusion criteria, treatment procedures and any follow-up.

Be prepared to allow the reviewer to observe an informed consent being given to a subject or to contact a subject who has participated in order to review their understanding of the consent process, the research project, and their impressions of participation in the research process.

  • Set aside a private space, such as a conference room, where the reviewer can work and talk with research staff during the site visit.
  • Assign a staff member who is knowledgeable about the study and has full access to project resources to assist the reviewer during the site visit.
  • Address recommendations made by the reviewer and be available for a follow-up visit.

Privacy

Post-approval review does not violate subjects’ privacy rights. The reviewer is a representative of the WSU Institutional Review Board and is approved to inspect records related to the study. The reviewer will adhere to confidentiality laws and WSU policies related to human subject research.

Guiding regulations and policies

The following regulations and policies authorize the University to conduct post-approval review.

 

WSU IRB Manual for the Protection of Human Research Subjects (2010) 

Refer to the following sections:

  • 2.5. Authority and Purpose / IRB Authority and Jurisdiction
  • 900. Post Approval Review

 

Federal Policy for the Protection of Human Subjects (Common Rule) 

Title 45 CFR 46.109(e), Title 21 CFR 56.109(f), Title 32 CFR 219

“An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.”

 

Office of Research Support and Operations Policy 29: Research records: Definition, retention, ownership, access, and storage

Refer to the section entitled, “Ownership and Access to Research Records.”

Questions?

Please contact the HRPP.