Biophysical Society Newsletter - October 2015

4

BIOPHYSICAL SOCIETY NEWSLETTER

2015

OCTOBER

Public Affairs

BPS Weighs in on NIH Strategic Plan

Revisions to the Common Rule Proposed The US Department of Health and Human Services (HHS) has proposed revisions to the regulations that govern research on individuals who participate in research. While the rule applies most directly to those who conduct clinical trials, it may be of interest to individuals in the biophys- ics community doing basic research as well. The current regulations that protect individu- als who participate in research, which have been in place since 1991, are followed by 18 federal agencies and are often referred to as the Com- mon Rule. They were developed at a time when research was predominantly conducted at universi- ties, colleges, and medical institutions, and each study generally took place at a single site. The expansion of research into new scientific disci- plines, such as genomics, along with an increase in multisite studies and significant advances in technology, has highlighted the need to update the regulatory framework. Notably, a more participa- tory model of research has also emerged, with individuals looking for more active engagement with the research enterprise. The Notice of Proposed Rulemaking (NPRM) was issued by HHS in September; comments are being accepted until December 7. This NPRM proposes to modernize the current regulations by enhancing the ability of individuals to make informed decisions about participating in research, while reducing unnecessary burdens by streamlining the regulatory requirements for low- risk research. Changes proposed in the NPRM issued Septem- ber 8 include: • Strengthened informed consent provisions to ensure that individuals have a clearer under- standing of the study’s scope, including its risks and benefits, as well as alternatives to participating in the study.

In response to a request from Congress, the Na- tional Institutes of Health (NIH) is developing a five-year NIH-wide strategic plan to advance its mission to support research in pursuit of funda- mental knowledge about the nature and behavior of living systems, and the application of that knowledge to extend healthy life and reduce illness and disability. The goal of this larger NIH-wide strategic plan is not to outline the myriad of im- portant research opportunities for specific disease applications as that is covered in the strategic plans from each of the NIH’s Institutes, Centers, and Offices (ICOs), which will be referenced appropri- ately, but to highlight major trans-NIH themes. The strategic plan is due to the Congress in late December 2015. As part of the process, the NIH released a frame- work for the plan in late July and asked stakehold- ers throughout the community for input. The Society’s Public Affairs Committee submitted a response on behalf of the biophysical research community. In whole, the Committee is very supportive of the framework as it was presented. Specifically, the Committee liked that the frame- work highlighted the importance of basic research, the need to focus on discovery rather than spe- cific disease, the need to work across disciplinary and ICO boundaries, and the limits faced by the biomedical research enterprise because of financial constraints. The Committee also commended the NIH for recognizing the need to promote a diverse workforce and asked that the NIH be cog- nizant of the community’s need for infrastructure support. The NIH is now reviewing the comments submit- ted about the framework, meeting with the ICO councils, and preparing a full plan. The final plan is due to Congress at the end of December. The Society’s comments on the strategic frame- work can be found on the Society’s website under “press room.”