A Message from the University of Pittsburgh Institutional Review Board

IRB Announcements

Policy on Blood Draws

The University of Pittsburgh Department of Environmental Health and Safety (EH&S) has issued a new standard operating policy (SOP) designed to establish a standardized procedure for establishing a safe and appropriate location and method for obtaining human blood and human blood products for research purposes.

The policy covers the following:

  1. Appropriate blood draw locations – this would include the Central Blood Bank, the Clinical and Translational Research Center (CTRC) or other approved locations that meet established guidelines as defined by the SOP.
  2. Requirements related to safety-engineered sharps devices.
  3. Requirements for IRB approval to include an appropriate consent document.
  4. Requirements for an appropriate location for the blood draws which must meet all BSL-2 work practices.
  5. Requirements for personnel conducting blood draws including appropriate qualifications and completion of bloodborne pathogen training on an annual basis.

The full text of the SOP can be found at http://www.ehs.pitt.edu/biosafety/SOP-LabBloodDraw2006.pdf


IRB Question of the Week

We encourage investigators to send us questions that would be of general interest to the human subjects research community. Address your questions to the IRB Director, Christopher Ryan (ryancm@upmc.edu) using as the subject line ‘IRB Question of the Week.’

QUESTION:   I am an investigator with appointments at both the University of Pittsburgh and the VA Pittsburgh Healthcare System. How do I know if I need University IRB approval, VAPHS IRB approval, or both?

ANSWER:   According to the Memorandum of Understanding between the University of Pittsburgh and the VA Pittsburgh Healthcare System, the following criteria determine which IRB serves as the IRB-of-record for a particular protocol:

  • The VAPHS IRB will be the IRB-of-record for those human subjects' studies in which: (1) a VAPHS staff member or University of faculty member is the Principal Investigator or a Co-investigator of the study; (2) the research is conducted using only VAPHS records and/or research subjects recruited through the VAPHS; (3) no University or UPMC facilities are engaged in the conduct of the research; and (4) no University funds are expended in direct support of the research.
  • The University IRB will be the IRB-of-record for those human subjects' studies in which: (1) a VAPHS staff member is the Principal Investigator or co-investigator of the study; (2) the conduct of the research does not involve VAPHS records, patients, and/or other resources; (3) no VAPHS facilities are engaged in the conduct of the research; and (4) either the research is funded in whole or in part by or through the University, or the research involves the records of the University of UPMC or research subjects recruited through the University of UPMC, or University or UPMC facilities are engaged in the conduct of the research.
  • Approval of both the VAPHS IRB and University IRB is required for all other cases.

If you have specific questions about conducting research at VAPHS, please contact the VAPHS IRB Office at 412-365-4295 for additional information. You can also visit the VAPHS Research Office website at http://www.vaphs.research.med.va.gov/index.htm