August 26, 2002
OHRP Retreats from Providing Public Info re: Compliance Activities
A newly posted announcement by the Office of Human Research Protection (OHRP), dated July 15, rescinds the agency’s announced policy of making public the content of its letters of determination following the agency’s investigation of compliance / noncompliance with federal human protection regulations.
This change in policy will effectively eliminate the single deterrent to research violations in the research protection system. 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.
The change in policy came in the aftermath of a complaint by the Alliance for Human Research Protection (AHRP’) about OHRP’s handling of noncompliance with informed consent by the University of California San Francisco.
The case involved a respiratory distress experiment: “Ventilation with Lower Tidal Volumes as Compared with Traditional Tidal Volumes for Acute Lung Injury and the Acute Respiratory Distress Syndrome,” New England Journal of Medicine (2000, May 4), 342 (18): 1301-1308
According to OHRP’s Feb 8, 2002 letter of determination, The ARDS experiment was conducted without legally effective informed consent on gravely ill individuals. http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/feb02l.pdf.
The Code of Federal Regulations clearly states: “no investigator may involve a human being as a subject unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally effective representative.” (45 CFR 46.116)
California law prohibits non-consensual experiments to be conducted on incapacitated individuals unless the research is likely to improve or maintain their condition–in other words, it is of therapeutic benefit to them. Following the determination by OHRP, the University of California announced a moratorium on all research involving proxy or surrogate consent. http://www.oprs.ucla.edu/human/NewsLetters/041602.htm
See also: Bernadette Tansey, “UCSF VIOLATED PATIENTS’ RIGHTS DOCTORS IMPROPERLY GOT CONSENT FOR STUDY, FEDS SAY” THE SAN FRANCISCO CHRONICLE, July 28 http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2002/07/ 28/MN119229.DTL
Putting the interests of research ahead of the protection and safety of human subjects, the University of California embarked on a campaign to amend California’s law. AB2328 is a bill sponsored by UC that would allow nonconsensual experiments on incapacitate human beings without the protection of the court.
See: CHARLES ORNSTEIN and REBECCA TROUNSON, “UC Seeks to Ease Curbs on Patient Research Health: A bill has passed Assembly. Critics say the university has failed to protect earlier subjects.” THE LOS ANGELES TIMES August 7 2002 http://www.latimes.com/features/health/medicine/la-me-uc7aug 07.story?coll=la %2Dhealth%2Dmedicine
See AHRP website for documents pertaining to the case: http://www.researchprotection.org/index.html
*Effective July 15, 2002, OHRP has implemented a policy to redact from compliance oversight determination letters posted on its website any sections that discuss unresolved concerns,questions, or allegations related to an ongoing investigation. Anyone wishing to obtain an unredacted copy of these letters should submit a request for the unredacted letter under the Freedom of Information Act (FOIA). Such requests should be directed to: Ms. Darlene Christian, PHS FOIA Office, Parklawn Building, Room 17A-46, 5600 Fishers Lane, Rockville, MD 20857; telephone 301-443-5252; fax 301-443-0925.