We get a lot of questions pertaining to the “The Common Rule” that we’d like to address:
The Common Rule does not apply to AJRR activities as that rule relates to research that is “conducted, supported, or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research.” The Common Rule defines “research subject to regulation” as:
Research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department’s or agency’s broader responsibility to regulate certain types of activities whether research or non-research in nature.
Where the Common Rule applies, it covers research involving human subjects, which includes the collection of identifiable patient information. The Common Rule does not apply to privately-funded research activities such as the AJRR that are not otherwise subject to federal regulation.
The Common Rule also does not apply to participants that submit data to the AJRR. The HHS Office for Human Research Protections has clearly stated that data collected in the course of clinical care that is submitted to external researchers is not human subjects research and therefore is not subject to the Common Rule. Specifically, “Institutions whose employees or agents release to investigators at another institution identifiable private information or identifiable biological specimens pertaining to the subjects of the research” are not engaged in human subjects research. Thus, hospitals that submit PHI collected in the course of clinical care to national registries for research purposes are not engaged in human subjects research.
Nonetheless, AJRR has obtained a waiver of the Common Rule informed consent requirement from WIRB to cover the collection of patient information for research purposes. The Office for Human Rights Protections, like OCR, strongly supports the use of central IRB review for multicenter clinical research, including research conduct or facilitated by clinical data registries.
Access the AJRR HIPAA/Common Rule Compliance Strategy here.