Information Letter #55

ORO
Information Letter #55

ORCA Information Letter #55:

On July 12, I sent out ORCA Alert #12 to notify VA facilities that the Office of Human Research Protections (OHRP) had issued some important guidance, one of which was a document titled “Guidance on Continuing Review.” The Alert was also posted on the ORCA website. This new guidance replaced and expanded on three of OHRP’s prior guidance documents on this topic and was developed to assist IRBs, investigators, research institutions and sponsors to implement the requirement for continuing review of human subjects research by an Institutional Review Board (IRB). The OHRP “Guidance on Continuing Review,” can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/Continreview.pdf .

Dr. Jeffrey Cohen, Director, Division of Education and Development in the Office of Human Research Protections (OHRP) in the Department of Health and Human Services, and Dr. Joan P. Porter, VA Office of Research and Compliance (ORCA) (10R) have produced a 30-minute satellite broadcast to assist VA facilities in understanding this recent OHRP guidance on continuing review of research protocols involving human subjects. In the video, Drs. Porter and Cohen address what is in the guidance, give examples of how to apply it, and point out some pitfalls encountered by VA Medical Centers when interpreting the requirements for Institutional Review Board continuing review. Some of the points made in the video are illustrated by a PowerPoint presentation. This presentation will be posted on the ORCA Website Home Page at http://www.va.gov/oro/. This broadcast should provide a quick way to find out about or pick up some good tips on how to keep your research program in compliance with regulations concerning technical and substantive aspects of continuing review of research protocols involving human subjects.

Audience: All employees in the VA research community who have the authority and responsibility for managing/overseeing VA research programs or IRBs, such as Research Compliance Officers, IRB administrators, IRB members, ACOS and AO for R&D, Research Coordinators, R&D Committee staff. The VA facilities that use the IRB of an academic affiliate may want to invite them to view this broadcast as well.

VA Learning Catalogue: This video is being listed in the Employee Education Service (EES) Learning Catalogue. The Learning Catalogue lists all VA satellite broadcasts, including the one described in this ORCA Information Letter. The URL for the VA Learning Catalogue is http://vaww.sites.lrn.va.gov/vacatalog/. (NOTE: This site is on the VA computer system and is available only to those who can access the VA Intranet).

Additional information is available from Office of Research Compliance and Assurance (ORCA) (10R) Regional Offices or ORCA Central Office.

For those of you who would be interested in viewing the broadcast, or showing it to others in your institution, here are the dates and times scheduled for showing the program on the VA satellite system. IMPORTANT NOTE: This broadcast can be taped from the VA satellite system while it is being shown. Since the information given during this broadcast could be used to train IRB members, provide a resource for new IRB staff, and contribute to the education of investigators, you may wish to ask your A/V department to make a tape during one of the broadcasts to keep in your research or IRB office for future use.

OCTOBER 2002 NOVEMBER 2002

10/10: 10:30-11:00 AM 11/7: 11:00-11:30 AM

10/16: 6:30-7:00 PM 11/18: 9:30-10:00 AM

10/22: 3:00-3:30 PM 11/26: 12:30-1:00 PM

10/25: 10:00-10:30 AM

10/30: 2:00-2:30 PM

Note: All times listed are Eastern Standard Time.

THE VIDEO SCHEDULE WILL ALSO BE POSTED ON THE ORCA WEBSITE AS IT BECOMES AVAILABLE AT http://www.va.gov/orca/.

Reviewed/Updated Date: May 10, 2005