Last year, NIH announced several key policy changes for clinical research studies, with the overall goal of building a better clinical research enterprise. These new efforts focus on streamlining some processes (such as the single IRB requirement for multicenter clinical trials) and enhancing stewardship, accountability, and transparency for the overall NIH clinical research program. Dr. Mike Lauer, NIH Deputy Director for Extramural Research, recently updated the research community about NIH’s progress in implementing these new policy reforms through his blog.
In view of the NIH reforms to enhance the clinical research enterprise, we have developed an NCCIH Policy on Study Accrual and Retention for all new human subjects research projects funded after January 1, 2017. This policy requires that a Study Accrual and Retention Plan (SARP) be developed for every clinical research project, which provides specific accrual timelines and benchmarks. The plan is submitted for approval to NCCIH prior to the initiation of clinical activity.
NCCIH recognizes that successfully attaining accrual and retention goals is essential for ethical conduct of human subjects research, and that our regular monitoring of clinical projects is also essential for proper stewardship of public funds. Since its inception, the NCCIH Office of Clinical and Regulatory Affairs (OCRA) has regularly monitored interim accrual across the Center’s clinical research portfolio. This new Policy on Subject Accrual and Retention provides greater transparency on project goals and expectations prior to study initiation, and allows NCCIH staff—including Program Officers, OCRA staff, and Grants Management Officers—to continue working closely with research teams and their institutions to address challenges that may arise in funded studies. It enhances our shared goal of maximizing the impact of NCCIH-funded clinical research.