2002 Archived News - Human Research Protection Program

2002 IRB News Archive

May 7, 2002

OHRP has moved! OHRP has relocated to The Tower Building 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852. All correspondence, either by direct mail or courier (Fed Ex, UPS, etc.) should be directed to the new address. OHRP staff telephone numbers and new email addresses are found at the OHRP web site.

FDA Seeks Comment on Whether to Require Sponsors and Investigators to Inform Institutional Review Boards (IRBs) of Any Prior IRB Reviews. The Food and Drug Administration (FDA) on Wednesday, March 6 published in the Federal Register an Advance Notice of Proposed Rulemaking seeking information on IRB practices to determine whether to draft a regulation to require sponsors and investigators to inform IRBs about any prior IRB review decisions. According to the Notice "These disclosures could help ensure that sponsors and clinical investigators who submit protocols to more than one IRB will not be able to ignore an unfavorable IRB review decision and that IRBs reviewing a protocol will be aware of what other IRBs reviewing similar protocols have concluded." The DHHS Office of Inspector General recommended this requirement in a 1998 report in an effort to curb "IRB shopping." Comments on the notice are due by June 4, 2002. If, after reviewing comments submitted in response to the Notice, FDA determines that it is appropriate to draft regulations, it would seek additional comment on the draft before issuing any new regulations.

The Office for Human Research Protections (OHRP) is aware of the recent questions posted on the IRBForum regarding the new version of the Federalwide Assurance (FWA) that was posted on the OHRP website on March 20, 2002. At this time, we would like to respond to some of

these questions. Information regarding the posting of the FWA is available at the OHRP web site.

The answers to some specific questions raised on the IRB Forum follow:

Why has OHRP revised the FWA?

OHRP originally placed the FWA on its website in December 2000 for public comment, and has revised the forms in accordance with those comments and to accommodate suggestions made by other Federal Departments and Agencies that support human subjects research.

Why is OHRP now taking public comment on the FWA? Does this mean that the FWA is still undergoing revisions?

Further public comment is sought in accordance with the Paperwork Reduction Act. Because the forms have been modified in accordance with public comment and to meet concerns raised by other Federal Agencies, OHRP does not anticipate further significant changes to the forms.

What is the status of FWA's issued up to today's date? Are they effective? What if they do not incorporate items in the revised FWA published today?

FWAs submitted and approved prior to March 21, 2002 will be considered effective by OHRP. Furthermore, FWAs using the December 2000 version submitted to OHRP and pending approval will be processed by OHRP. The new FWA does not change the regulatory requirements nor an institution's commitment to the federal regulations from what was provided in the original FWA.

Given that OHRP is taking public comment on the FWA, should institutions continue to apply for an FWA or wait until a final FWA is published on the website?
The FWA is posted for public comment. If institutions choose to submit an FWA while comment is being sought and OMB approval is pending, OHRP will accept that submission.

It would be helpful to those of us in the field who work with investigators on FWA applications for OHRP to post an outline of the differences and changes between the old FWA and the revised FWA. OHRP is preparing a document that will provide a comparison of the old and new FWA, as well as answers to frequently asked questions, and will providethese on its website in the near future

April 8, 2002

HHS Proposes Changes to Privacy Rule That Protect Privacy, Access to Care. HHS Secretary Tommy G. Thompson proposes changes to HHS' health privacy regulations to ensure strong privacy protections while correcting unintended consequences that threatened patients' access to quality health care. Proposed Modifications to Privacy Rule open for public comment for 30 days, through April 26, 2002.

The Office for Human Research Protections (OHRP) has posted guidance regarding written Institutional Review Board (IRB) procedures. In order to assist institutions in developing adequate written IRB procedures, OHRP has compiled a summary of the relevant

regulatory requirements and guidance issued routinely by OHRP over the past several years. This new OHRP guidance, dated April 2, 2002, can be found at the OHRP web site.

March 19, 2002

OHRP has updated its November 16, 2001 guidance entitled, "Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells, and Cell-Derived Test Articles." OHRP's March 19, 2002 guidance can be found at the OHRP web site.