Table 1.

Revised Common Rule: Key Challenges and Opportunities

Change	Challenge	Opportunity
Single IRB	Ensuring adequate training and that board membership has the depth, breadth, and diversity of knowledge to perform effectively	Streamlining the review process, eliminating redundancy
Informed consent and capacity	Making the informed consent process and documentation clearer and of greater benefit to research participants Ensuring special populations, including those with diminished decision-making capacity or educationally/economically disadvantaged potential participants, are well served by the RCR	Development of “capacity assessment teams” to help ensure protocols and informed consent process/documentation are optimized for the population being studied Recognition of the effect of non-medical determinants of health (socioeconomic factors) on the potential participant’s ability/willingness to engage in clinical research. Designing studies to mitigate the negative effect of these factors
Biospecimens	Implementing the concept of “broad consent” for the future use of biospecimens	Create a nimble, secure, biorepository model equipped to address emerging research needs rapidly while respecting/protecting research participant autonomy and privacy
Evaluation of the RCR	Determining the benefits and limitations of the RCR; identifying points for future refinement	Use the delay in implementation to create a platform for anonymous prospective feedback from administrators, investigators, and research participants to assess the expected and unintended consequences of the RCR

IRB = institutional review board; RCR = Revised Common Rule.