A Message from the University of Pittsburgh Institutional Review Board

IRB Announcements

Paper Submission Hours

Beginning July 23, 2007, the IRB office located at the McKee Place entrance will be accepting paper submissions (renewals, modifications, other non-electronic reports) only between 8:30 a.m. and 3 p.m.


Guidance to Investigators Regarding Audits by Regulatory Agencies

The IRB recently adopted a policy related to the process which must be followed when principal investigators are notified by regulatory agencies (e.g., FDA; OHRP; NIH) that the agency is scheduling an inspection or an audit. Highlights of the policy are as follows:

  • The IRB must be notified as soon as possible after the notification of audit/inspection is received
  • The PI must make arrangements to ensure the Authorized Institutional Official (or his designee) is available for the exit interview
  • The Education and Compliance Office will make arrangements (if time permits) to conduct a review of records related to the research study
  • The investigator must submit to the IRB any report issued as a result of the regulatory inspection
  • The IRB must be notified of any FDA correspondence indicating that a clinical hold has been placed on any human subject research
  • The PI must submit to the IRB any written response that is prepared for submission to the agency BEFORE it is sent

The full text of the policy is available on the IRB web site at www.irb.pitt.edu under the Guidance page.

Revisions to Chapter 8 of Reference Manual Related to Information Being Placed in Medical Records

The IRB recently revised Chapter 8 of the IRB Reference Manual to provide updated language with respect to results of research-related procedures being placed in medical records. The following sections were revised:

Section 8.1.1(5)(b) was revised as follows:

Potential subjects should be informed of who will have access to their research records and the purpose of such access. For example:

    i)    THIS TEXT DID NOT CHANGE
    ii)   THIS TEXT DID NOT CHANGE
    iii)   For research involving procedures performed in any UPMC facility indicate that copies of test results as well as other research-related procedures may be placed in the participant’s electronic medical record.

Parts of Section 8.2(12) were revised as follows:

Under "Will this research study involve the use or disclosure of my identifiable medical information?," the following paragraph was added:

If research test results or procedures are being conducted at UPMC facilities and are generating laboratory test results or other clinical information, the UPMC testing facility will likely generate an electronic medical record of those results – even if the research subject is not an in- or out-patient at any UPMC facility. Research subjects must be informed in the consent form of this eventuality. The following suggested language may be utilized: "This research study will result in identifiable information that will be placed into your medical records held at [specify the name of the applicable institution or physician’s office]. The nature of the identifiable information resulting from your participation in this research study will be recorded in your medical record includes [specify the type of research data which may or will be recorded in the subject’s medical record."

Under "Who will have access to identifiable information related to my participation in this research study?," the following paragraph was added:

Include the following standard statements and information if the research study (or any aspect of the research study) will involve the utilization of hospital or health care services (e.g., laboratory tests, diagnostic procedures); hospital or health care provider care of the patient-subject; or hospital or health provider billing activities: "Authorized representatives of the UPMC hospitals or other affiliated health care providers may have access to identifiable information (which may include your identifiable medical information) related to your participation in this research study for the purposes of (1) fulfilling orders, made by the investigators, for hospital and health care services (e.g., laboratory tests, diagnostic procedures) associated with research study participation; (2) addressing correct payment for tests and procedures ordered by the investigators; and/or (3) assessing internal hospital operations (i.e., quality assurance)."

Chapter 8 can be accessed through the IRB web site (www.irb.pitt.edu).