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Human Subjects Protection

Human subject protection, also known as patient participation research, involves careful design of research objective and research methodology. Before any biomedical research with people can be initiated, universities and other entities must undertake a rigorous review process and adhere to monitoring policies for the protection of the rights, welfare, and wellbeing of humans involved in research. AAU analyzes and offers its expertise on federal oversight regulations, such as the Common Rule and NIH policies.



AAU and other organizations sent a letter to representatives Pocan, Deutch, DelBene, Speier, Raskin, Nadler, DeGette, Lee, Lofgren, and Khanna to express their support for their amendment to H.R. 2740
AAU, AAMC, APLU, and COGR sent a joint letter to the Office for Human Resources Protection (OHRP) expressing concern about the application of the cooperative research requirement under the revised Common Rule.
Four Associations, including Association of American Universities, wrote in support of the proposal to delay the general compliance date of the revised common rule.
Statement by AAU and APLU praising the Obama administration's final rule amending the “Common Rule,” the set of regulations governing federally funded research using human subjects.
University groups’ statement on National Academies report to optimize federal investments in academic research.
The analysis found that over 95% of patients and members of the research community were opposed to one or more of the major proposed changes.
We concur with OHRP’s conviction in the foundational principles of the Belmont Report, and furthermore emphasize that justice and beneficence merit equal consideration alongside autonomy.
Policies and regulations related to human subjects protection are among the most frequently cited causes of the increased burden and cost associated with research.