What is the purpose of the Compliance Program?
The purpose of the compliance program is to protect the rights and safety of all human research participants and to maintain public trust in the University and all research conducted under the jurisdiction of its Institutional Review Board.
In addition, the University maintains an agreement with the Department of Health and Human Services (DHHS) known as the FWA or Federal Wide Assurance Agreement. This agreement states that all research conducted at or affiliated with the University of Pittsburgh will comply with the applicable federal policies for the protection of human subjects as well as the ethical principles outlined in the Belmont Report. The quality assurance activities conducted as part of the compliance program serve to uphold this commitment.
Is the Education and Compliance Office for Human Subject Research (ECO-HSR) the same as the IRB?
No. The ECO-HSR is one of nine research oversight offices that comprise the Research Conduct and Compliance Office (RCCO). The ECO-HSR is a “sister” office to the IRB; the offices within the RCCO include:
- Conflict of Interest Office (COI)
- Education and Compliance Office for Human Subject Research (ECO-HSR)
- Education and Compliance Office for Animal Subject Research (ECO-ASR)
- Human Stem Cell Research Oversight Office (hSCRO)
- Institutional Animal Care and Use Committee and Office (IACUC)
- Institutional Biosafety Office (rDNA)
- Institutional Review Board (IRB)
- Office for Investigator-Sponsored IND and IDE Support (O3IS)
- Radioactive Drug Research Committee (RDRC)
- Radiation Safety
- Human Use Subcommittee (HUSC)
What should I do to prepare for an audit?
Communicate with the auditor to confirm exactly what records will be reviewed. Assemble the requested records in an organized manner by subject and in order of enrollment if possible. Arrange for a quiet workspace for the duration of the audit; if enrollment numbers are high, the audit may take several days. The following documents are likely to be requested by the auditor:
- Informed consent documents for all enrolled subjects
- Enrollment/Randomization logs
- Individual subject research records, medical records (if applicable), and shadow charts
- Source documentation, case report forms and any other data capture forms
- Regulatory binder/file including correspondence with funding agencies/sponsors
What should I do if I find a deficiency while preparing for the audit?
Deficiencies are often discovered in preparation for an audit. When an error or omission is found the best practice is to document the occurrence of the event/omission in a signed and dated “note-to-file” and place the note in the appropriate research record. A corrective plan of action should also be developed to prevent future occurrence of the identified problem. If the event is reportable to the IRB, you may complete the report prior to the audit. In cases where the safety of the research participants may be compromised by the finding, please immediately contact the IRB for advice on how to deal with the issue.
What are the most common audit findings or deficiencies?
The most common audit findings at the University of Pittsburgh are similar to those reported by the FDA, namely:
- Inadequate record-keeping
- Failure to use the most recently approved consent document
- Deviations from the IRB approved protocol
What should I do to prepare for a RISE interview?
Relax! Remember the RISE interview is an internal, collaborative, educational activity to assist investigators with protocol-specific regulatory issues. The best way to prepare for the interview is to be very familiar with your approved research protocol and the logistics associated with implementation. With your research team “walk through” the conduct of the study as described in the protocol from identification and screening of subjects, implementation of study procedures to the final study visit and closeout. Questions that may be asked during the interview include:
- What are your plans for recruiting research subjects?
- If a phone screening script is used with an IRB approved waiver to document informed consent for this purpose, who has been delegated the responsibility for this task?
- How are you going to implement and document the informed consent process?
- How do you intend to verify and document that all subjects met the inclusion and exclusion criteria?
- Are you prepared to implement all study procedures as described in the protocol?
- What mechanisms do you have in place to evaluate and report UAPs?
This list of questions is not exhaustive but is representative of the types of questions asked during a RISE interview. You may contact the ECO-HSR staff member who is the team leader of the RISE review for further guidance.