239) Indeed, the fact that today the OHRP
has to recommend that the 1991 Common Rule's definition of "human subject"--which as written does not clearly apply to archival material--be taken to include archival material, suggests as much.
for the Common Rule, and by the OCR for the HIPAA
has jurisdiction over research funded by or supported by the Department of Health and Human Services, for research conducted either in the US or in other countries.
Additional resources on the differences between QI and research activities are provided by DHHS on the OHRP
website (DHHS, OHRP
If FDA follows the model of OHRP
and OCR and assigns a handful of
Through the Multicultural Curriculum Change Program, interested instructional faculty and graduate teaching assistants work one-on-one, in pairs, or as small group with OHRP
staff in integrating multicultural educational approaches into their courses.
mandates that institutions and investigators know their responsibilities when conducting and overseeing research.
A Town Hall meeting on the Notice of Proposed Rulemaking, which when finalized will bring about the first changes to the Common Rule since it was published in 1991, will also be held, featuring leadership and staff from OHRP
146) See Guidance on Research Involving Coded Private Information or Biological Specimens, OHRP
12) In response to Boehringer's concerns, the OHRP
then launched its own investigation.
said it was research and did need IRB review, forcing Johns Hopkins to halt the project pending that review.
In a determination letter dated March 28, 2002, the OHRP
concluded that there were procedural lapses but did not find any harm to any participants in the studies and did not apply sanctions to the university.