Furthermore, the protocol template has attempted to incorporate guidance from CMS, CFR, FDA, HHS, ICH, ISO, NIH, OHRP
, and other influential sources.
additional information is obtained, OHRP
determines whether the
adopts this provision, compliance would include disclosing informational risks and drafting a policy designed to ensure that consumers adequately comprehend and assess the risks and benefits of permitting 23andMe and subsequent entities to use their DNA and private health information.
Policy & Guidance: Frequently Asked Questions, last reviewed January 20, 2011, http://www.
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.
should also provide more specific direction about the conditions under which Informed Consent can and should be waived.