FDAnews Drug Daily Bulletin

FDA, OHRP Working on Joint IRB Database

July 17, 2008

The HHS Office for Human Research Protections (OHRP) is working with the FDA on expanding institutional review board (IRB) registration to create a joint database that would have a unified esubmission form, OHRP Director Ivor Pritchard said.
“There has been considerable pressure on the FDA to register IRBs, just to know where they are,” Pritchard said. Currently there is no master list of IRBs, and nobody knows how many there are.

There is no timeline for development of the database, and it may not be universal when complete, Pritchard said. For example, it would include IRBs of federal agencies other than HHS that sponsor human subject research, such as the Department of Education, which receive “assurance” from OHRP. However, a few agencies, such as the Department of Defense, do not participate in the OHRP assurance program, and their IRBs would not be included.

One benefit of the proposed database is that it would encourage federally funded research institutions that do not use external IRBs to do so, Pritchard said. The institutions’ reluctance stems from OHRP’s practice of contacting them if their IRBs are found to be out of compliance, Pritchard said. For example, if a board has inappropriate membership for the research it is reviewing and OHRP contacts the institution, it may make the institution appear to be noncompliant although that is not OHRP’s intention, he added.

With the database in place, OHRP could contact the external IRB directly to inform it about the problem, Pritchard said, which could be helpful in encouraging the use of a single external IRB in multi-site studies.

Separately, OHRP has solicited comments as to whether members of IRBs under its aegis should have education requirements imposed on them. The request for comments can be viewed at www.hhs.gov/ohrp/documents/fedreg20080701.htm.