October 26

OHRP Backtracks on Public Disclosure – BNA

September 5, 2002.

OHRP Backtracks on Public Disclosure – Bureau of National Affairs


In Aug. 2000, when the Office of Human Research Protections replaced the former Office of Protection from Research Risks there was much talk about openness, accessibility, transparency and public accountability. One new feature was the posting of OHRP’s letters of determination following an investigation prompted by a complaint filed alleging violations of ethical conduct in human research. Two years later, OHRP has buckled under to pressure from research institutions that have been violating federal regulatory protections and getting away with it.

It should be noted that laboratory animals are protected by the national Animal Welfare Act of 1966, ensuring that Congress is provided a detailed annual report about the welfare of laboratory animals. No such requirement protects the interest of human subjects– including children. OHRP’s letters of determination are the ONLY avenue for public access to information about the conduct of human research supported by taxpayers.

Whose interests weigh more heavily than the public’s need to know in order protect itself?” Below, the BUREAU OF NATIONAL AFFAIRS–a Washington-based subscriber service–reports that a source told BNA that OHRP was not pressured from above but that: “the Council on Governmental Relations, a university lobby group, asked OHRP to black out sensitive information on behalf of its members.” OHRP readily obliged by shielding the offending institutions.

The first OHRP blacked out letter is a follow-up to an investigation begun in May, 2000 at the University of Miami. According to the letter of determination, the deaths of six patients in two trials involving Selenium therapy in HIV-positive patients went unreported for 4 to 7 months. For unexplained reasons two years elapsed before OHRP responded. http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/aug02b.pdf


OHRP Backtracks on Public Disclosure, Open Investigation News No Longer Posted

At the request of several universities, the Department of Health and Human Services Office for Human Research Protections has stopped posting on its Web site details about ongoing investigations of alleged human research misconduct at U.S. research institutions.

Until mid-July, OHRP posted in full determination letters sent to universities detailing OHRP concerns with how studies are conducted.

But since then, the office has blacked out sections of posted letters that deal with unresolved subject safety concerns.

Federal agencies typically withhold news of ongoing investigations, an OHRP spokeswoman noted. She said her office wanted to follow the same rules as other government agencies.

However, a source close to the situation told BNA the change was made at the request of several research universities.

Unredacted determination letters still are available from OHRP but must be requested under the Freedom of Information Act by letter or fax. Requests can take up to a month to fulfill, and journalists and some others must pay for them.

Research Under Scrutiny. Universities were wary of having news of ongoing investigations freely available to the public at a time when research is under great scrutiny, the source said. The letters made schools look guilty of wrongdoing even though investigators had not reached any conclusions.

In a written request, the Council on Governmental Relations, a university lobby group, asked OHRP to black out sensitive information on behalf of its members.

Some observers are concerned the move will limit public scrutiny of human research.

Dr. Robert M. Nelson, moderator of the Web-based IRB Forum and University of Pennsylvania associate professor of anesthesia and pediatrics, said the letters helped institutions troubleshoot their own research programs.

Learning of OHRP concerns with other institutions, schools would say “here’s something we may be doing that’s similar to this so let’s make a change,” Nelson said.

He also noted there was very little speculative information in the letters OHRP posted.

Reversing the Tide. Human subject advocate Vera Sharav, head of the Alliance for Human Research Protection, accused OHRP of shielding the research industry from public scrutiny.

“OHRP has essentially shifted its oversight role from ensuring that the safety of human subjects is protected–as is its mandate–to shielding those who the agency has found to be in violation of federal safeguards,” she said.

Sharav expressed concern that the move could signal a return to the days of OHRP’s predecessor, the Office for Protection from Research Risks, which typically revealed very little information to the public.

Nelson and Sharav both noted that OHRP’s move is consistent with the Bush administration’s apparent reluctance to disclose information publicly. However, BNA’s source said OHRP was not pressured from above to redact sensitive information from posted letters.

By M. Alexander Otto

The OHRP notice is at http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm.

Copyright 2002, The Bureau of National Affairs, Inc., Washington, D.C. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

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