Research Compliance

1. Research Compliance Audit Requirements, Findings & BASICS

2. Audit requirements • 100% of VA consents must be audited. • All VA Human Research protocols approved after January 1, 2008 must be audited triennially or at least once in the life of the study (if opened and closed within 3 years).

3. Common Audit Findings • Use of expired/outdated consent document. • Consent lacks signature and/or signature date(subject and/or person obtaining consent). • Lack of signed HIPAA authorization. • No documentation of study entry/termination, or subject interactions/intervention in CPRS. • Lack of additional consent (i.e. audio/photo or optional studies imbedded in main study consent).

4. VA Consent Documents • Unless there is IRB approved waiver of consent or documentation of consent, all VA subjects must sign and date a VA consent document (form 10-1086). • Must be the most current IRB approved version. • Must contain IRB date stamp in upper right hand corner. • Must also be signed and dated by the Person Who Obtained Consent (*PWOC). • Mail out consents may be signed and dated by the PWOC when received back from subject. • *PWOC must be designated in the protocol or application for IRB approval.

5. Additional Consent • All subjects that will be audiotaped, videotaped, and/or photographed must sign VA consent form 10-3203 “Consent for Use of Picture and/or Voice” • This is required for research participants and does not apply to audio/photo for clinical purposes.

6. Disposition of Consents • Subjects must receive a copy of signed consent. • A copy must be placed in the subject’s medical record*. • The Investigator must retain the original signed consent. • The Investigator must maintain a subject enrollment log. • *If a medical record exists or will be created.

7. Investigational drug studies • All drugs must be received, stored, and dispensed by the Research Pharmacist. • The Investigator is responsible for furnishing the Pharmacist with: • A copy of the protocol • A completed Investigation Drug Information Record (form 10-9012) • Any pertinent information about the drug • A copy of form 10-9012 must be placed in the subject’s medical record.

8. Documentation of Study Participation • *All participants in research are required to have documentation of their enrollment and informed consent process entered into their computerized electronic medical record (CPRS). • Subsequent visits/encounters must have a progress note entered in CPRS, as well as when withdrawing a subject from participation. • Consent and entry notes can be combined when both occur at the same visit. • *with exceptions

9. When documentation or Record Creation is required • Research subjects admitted as inpatients, treated as outpatients, or when research procedures or interventions are used in the medical care of the research subject. • A record must be created when the research requires use of any clinical resources such as radiology, cardiology (e.g. ECG, stress test, etc.) clinical laboratory, and pharmacy. • The research intervention may lead to physical or psychological adverse events.

10. When documentation may not be necessary • There is only one subject encounter. • Research involves only the use of a questionnaire. • Research involves the use of previously collected biological specimens. • The research is not related to the medical care of the subject.

11. Documentation content • Documentation of the informed consent process must at a minimum include: • The name of the study and Investigator • The person obtaining the subject’s consent and date consent obtained. • A statement that the subject or the subject’s legally authorized representative was capable of understanding the consent process, • A statement that the subject was given the opportunity to ask questions.

12. Additional documentation • Information on possible drug interactions and/or toxicity of the pharmaceutical agents that are being administered to the subject because of the research (i.e., investigational drugs) • A copy of any research results that are used for medical care. • A method to identify clinic visits solely for research (such as a note title) must be used to differentiate those visits from any other clinic visits.

13. Enrollment Log • The PI must maintain a master list of all subjects from whom informed consent has been obtained whether or not IRB has granted a waiver of documentation of consent. • *IRB may waive this requirement if there is waiver of documentation of informed consent and the IRB determines including subjects on a master list may pose a potential risk of breach of confidentiality. • *IRB must provide written documentation in the IRB minutes or IRB protocol file justifying the waiver.

14. Reporting to IRB • Reports from the investigator to the IRB must be submitted via HawkIRB within ten working days of the event or notification to the investigator of the event. Reporting events include: • Any unanticipated problems involving risks to subjects or others which occur at the UI/VAHCS or that impacts subjects or conduct of the study. • A serious adverse drug event (either expected or unexpected) occurring in a UI\VAHCS subject. • A serious adverse device effect (either anticipated or unanticipated) occurring in a UI\VAHCS subject. • An unanticipated serious adverse device effect occurring in a non-UI/VAHCS subject. • Receipt of new information (including risk or benefit) that may impact the willingness of subjects to participate or continue participation in the research study. • Any incidents of noncompliance with the federal regulations or the requirements or determinations of the IRB.

15. Reporting to ORO • Apparent serious or continuing noncompliance must be reported (via the RCO) within 5 business days to: the MCD, IRB, ACOS/R, and R&D Committee. The MCD has 5 additional days to report to ORO. • Examples of noncompliance: • Lack of informed consent or HIPAA authorization • Conducting research by a person without required credentialing, privileging, or scope of practice • Use of a consent document with content not approved by IRB • Failure to report SAEs or serious unanticipated problems as required • Continued subject interaction/intervention beyond IRB approval period • Failure to implement IRB required changes within the IRB specified time period

16. Miscellaneous • Language in the consent document must be consistent with that in the protocol. • The PI is responsible for overseeing ensuring the research staff under the investigator’s direction comply with all applicable requirements including, but not limited to, implementing the research study in accordance with the approved protocol.

17. Sources VHA Handbook 1200.05 (May 2, 2012) “REQUIREMENTS FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH” UI Investigators Guide (2014) “Guide for Human Subjects Research at the University of Iowa”