HRPP Manual Section 8-10

Site Visits

The Michigan State University (MSU) Human Research Protection Program (HRPP) has the authority and responsibility to conduct site visits to ensure protection of human subjects involved in research and compliance with federal, state, and local regulations and university policies and procedures by providing oversight and if needed, education for the researchers. This includes but is not limited to requirements related to Institutional Review Boards, investigational drugs and devices, registration, good clinical practice, protected health information, and clinical research billing compliance. The Institutional Review Board (IRB) also has the responsibility and authority to directly observe or have a third party, including the MSU HRPP, observe ongoing research studies and the consent process, as well as conduct continuing review of the study, including review of research records. 45 CFR 46.109 (e), 21 CFR 56.109(f)

The HRPP will review human research projects randomly, for cause, based on the compliance records of the researchers, and using a risk based approach (e.g., reoccurring review of U.S. Food and Drug Administration (FDA) regulated research). See HRPP Manual 3-3, Evaluation and Quality Improvement, for more information. The HRPP will review all relevant records relating to the research. Site visits may include human research projects upon which MSU has relied upon another IRB as the IRB of record; however, if the reviewing institution conducts site visits, the HRPP may review those site visit records in lieu of a full site visit. Full cooperation by the department, principal investigator (PI) and other members of the research team (if necessary) is expected.

The information gathered during the site visit is used to monitor the implementation of research studies, process necessary corrections, identify areas that need improvement, target education, and to gather information for continuous improvement of the HRPP.

Site Visit Procedures

The basic site visit procedures are described below but due to the high variability in research studies, it is anticipated that modifications will be made to tailor each site visit to the specific study.

The HRPP typically does the following:

  1. Review the documentation and correspondence to identify approved elements for record review, e.g., protocol eligibility criteria, informed consent procedures, interventions, security/confidentiality procedures, billing compliance plan.

  2. Assemble site visit materials, e.g., specific site visit tool, interview forms.

  3. Notify the PI of the site visit and make site visit arrangements, e.g., scheduled time and space (for in-person site visits), names/titles of research team members, location of records, number of subjects enrolled. If MSU serves as the IRB of record for another institution, the HRPP may notify the appropriate contact at that institution of the site visit; a representative from that institution may choose to accompany the HRPP on the site visit.

  4. Visit the research site(s) or meet remotely through web or teleconferencing to conduct an interview and review procedures and records, including but not limited to:

    • Informed consent obtained

    • Signed authorization forms

    • Case histories

    • Confirmation of eligibility of subjects

    • Confirmation of interventions/treatments used

    • Unanticipated problems that may involve risks to subjects or others reported to the IRB

    • Security/confidentiality measures employed

    • Subject complaints

    • Subject calendars

    • Drug/device accountability

    • Billing claims and/or bill holds to verify proper billing

    • Medical records

    • Study research account (if applicable)

    • Study invoices (if applicable)

  5. Schedule follow-up meeting or discussion with PI to clarify any outstanding questions, discuss specific deficiencies found, and obtain input on possible corrective actions if necessary.

  6. Draft compliance report for review by others as appropriate.

  7. Finalize compliance report including requirements for corrective actions.

  8. Present the compliance report to the IRB when necessary or as requested. The IRB chair may determine what, if any, corrective actions are required or may determine that review and action by the IRB is necessary.

  9. Send the compliance report to the PI and others as appropriate (e.g., MSU IRB, other IRBs which rely on an MSU IRB); notify other offices as appropriate (e.g., covered entities, other affected University offices or individuals).

  10. The PI must respond to the report and make requested changes within a set timeframe provided to the PI by the HRPP. If the PI does not respond within a set timeframe, the IRB may discuss the site visit at a convened IRB meeting.

  11. The PI’s response may be brought to the HRPP director or the IRB chair to determine if any further action is needed.

Procedures for Immediate Action When Information is Discovered that Indicates that Subjects May be at Greater Risk

If information is discovered at the time of the site visit that indicates subjects may be at a greater risk than previously identified, the appropriate HRPP personnel will promptly notify the HRPP director and/or the IRB chair

At any time during the review process the IRB chair or IRB may determine that it is necessary to act to protect subjects by suspending, modifying, or permanently closing the research study. If this occurs, policy and procedures in HRPP Manual 9-3 “Termination or Suspension of Research” would be followed.

If compliance issues are discovered that may require other immediate action but may not involve greater risk to the subjects, the appropriate individuals will be notified (e.g., clinical research billing compliance, MSU Protocol Registration and Results System (PRS) contact for registration, Privacy Officer for the Covered Entity for Health Insurance Portability and Accountability Act (HIPAA) Compliance).

IRB Noncompliance

If possible IRB noncompliance is discovered during the site visit, the IRB noncompliance policies and procedures will be followed. See HRPP Manual 9-2 “Noncompliance” for policies and procedures.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 3-9-2008. Revision 2 approved by VP Research & Graduate Studies on 7-21-2011. Revision 3 approved by VP Research & Graduate Studies on 3-13-2013. Revision 4 approved by VP Research & Graduate Studies on 12-9-2015. Revision 5 approved by Assistant VP Regulatory Affairs on 11-15-2021.

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