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Recently published federal rules and requirements for clinical trials
- NIH DIrector's Statement: Update on NIH’s efforts to address sexual harassment in science
In this statement released February 28, 2019, the NIH senior leadership announced the actions they were taking as they await the Working Group of the Advisory Council to the Director (ACD) on Changing the Culture to End Sexual Harassment recommendations and other input to strengthen thier efforts. These thems include: demonstrating accountability and transparency; clarifying expectations for institutions and investigators to ensure a safe workplace and inform the agency; providing clear channels of communication to NIH; and listening to victims and survivors of sexual harassment and incorporating their perspectives into future actions.
- Statement on Article Publication Resulting from NIH Funded Research
To help protect the credibility of papers arising from its research investment, NIH encourages its stakeholders, including grantees, contractors, intramural researchers, and librarians, to help authors: 1) adhere to the principles of research integrity and publication ethics; 2) identify journals that follow best practices promoted by professional scholarly publishing organizations; and 3) avoid publishing in journals that do not have a clearly stated and rigorous peer review process.
- Clinical Trial Requirements for Grants and Contracts
NIH is launching a series of initiatives that are rolling out in 2017-2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the whole clinical trial lifecycle from concept to results reporting. Learn more about these changes and how they will affect your research.
- Clinical Trials: Special Considerations for Career Development, Fellowship, Training, and Research Education Programs (NOT-OD-18-001) (Published November 6, 2017)
The purpose of this notice is to provide prospective applicants for career development, NRSA fellowships or training grants, and research education grants advanced information about the upcoming funding opportunity announcements (FOA), expected dates of FOA issuance, and application due dates. As indicated in NOT-OD-17-043, effective January 25, 2018, all grant applications with plans to conduct independent clinical trials must be submitted in response to an FOA which specifically states that independent clinical trials are allowed.
- Policy Supporting the Next Generation Researchers Initiative (NOT-OD-17-101) (Published August 31, 2017)
This policy amends the definitions of, and policies supporting, early stage investigators (ESIs). In addition, it creates a new policy for early established investigators (EEIs), previously referred to as mid-career investigators, and describes how NIH will monitor the implementation of the policy to determine the impact on ESI and EEI diversity in the NIH portfolio.
- Federal Policy for the Protection of Human Subjects (Published January 19, 2017)
The Department of Health and Human Services has updated the Common Rule for Protection of Human Subjects. This will impact specific policies and programs in NIH and implementation as of January 21, 2019, including review of the grant application by the IRB, posting of consent document, and categories of exempt research.
- Inclusion Across the Lifespan - Policy Implementation (Published December 19, 2017)
The purpose of this policy is to ensure individuals are included in clinical research in a manner appropriate to the scientific question under study so that the knowledge gained from NIH-funded research is applicable to all those affected by the researched diseases/conditions. The policy expands the Inclusion of Children as Participants in Clinical Research Policy to include individuals of all ages. The policy also clarifies potential justifications for age-based exclusion criteria, and requires participant age at enrollment to be provided in progress reports The policy applies to all grant applications submitted on or after January 25, 2019. Until then, ongoing research and grant applications/proposals are subject to the Inclusion of Children in Clinical Research Policy.
- Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020 (Published July 10, 2019)
In response to recommendations from the Advisory Committee to the NIH Director and the National Science and Technology Council's Working Group on Research Business Models that federal agencies adopt tools and approaches to simplify applicant reporting and improve the tracking of career outcomes, NIH introduced the option for PD/PIs and other users to associate an ORCID identifier with their eRA Commons Personal Profile in 2017. Since that time, more than 30,000 eRA Commons Profiles have been linked to ORCID iDs. ORCID iDs are unique, persistent digital identifiers that distinguish individual investigators and can be used to connect researchers with their contributions to science over time and across changes of name, location, and institutional affiliation. These free identifiers are assigned and maintained by the non-profit organization ORCID.
In addition, more than 7,000 journals now use ORCID iDs and, with the permission of users, can automatically populate ORCID user accounts with their citations when they publish. Federal grant applicants can also link their ORCID accounts with SciENcv (Science Expert Network Curriculum Vitae), to simplify the creation of biosketches for grant applications.
NIH Medical Research Initiatives
- NIH HEAL Initiative - a transagency effort to speed scientific solutions to stem the national opioid crisis.
- The Brain Initiative - an audacious initiative aimed as revolutionizing understanding of the human brain.
Bamman MM, Cutter GR, Brienza DM, Chae J, Corcos DM, et al. Medical Rehabilitation: Guidelines to Advance the Field with High-Impact Clinical Trials Arch Phys Med Rehabil. 2018 Aug 24. pii: S0003-9993(18)31113-4. doi: 10.1016/j.apmr.2018.08.173. [Epub ahead of print] PMID: 30148997.
Ronald L. Wasserstein, Allen L. Schirm & Nicole A. Lazar (2019) Moving to a World Beyond “p < 0.05” The American Statistician, 73:sup1, 1-19, DOI:10.1080/00031305.2019.1583913/
NIA Clinical Research Study Investigator's Toolbox
This tool box provides researchers and their study teams with a central source of materials to plan studies, incorporate consistent processes, collect accurate data, and maintain appropriate safety oversight.
Learn about active NIH funded medical rehabilitation research projects.
Access the list on the NIH RePORT website.