National Institutes of Health (NIH) and Research Involving Clinical Trials

During the past year, the National Institutes of Health (NIH) has instituted new requirements for studies that it funds involving clinical trials, as well as new requirements will go into effect for NIH application dates on or after January 25, 2018.  


Conducting Clinical Trials Funded by NIH?   Read about new requirements taking effect in January 2017

The National Institutes of Health (NIH) recently issued two policies that impact the conduct of clinical trials that the NIH funds, either partially or in full.  They are as follows:

NIH New Podcast on Certificates of Confidentiality

The National Institutes of Health (NIH) has released a new podcast entitled “Obtaining Certificates of Confidentiality for Your Research” as part of its All About Grants podcast series.

NIH Changes Definition of a Child for Clinical Research

On October 13, 2015 the National Institutes of Health (NIH) announced that it has changed the definition of a child for purposes of inclusion in clinical research.  The change was made to reduce confusion among stakeholder groups (applicants, peer reviewers, grantees, subjects).

The change is that for the purpose of NIH’s inclusion policy, the age of a child will be defined as individuals under 18 years of age, instead of 21.

NIH Simplifies Vertebrate Animals Section of Funding Applications/Proposals

On October 13, 2015 the National Institutes of Health (NIH) announced that it has changed the requirements of the Vertebrate Animals Section (VAS) of grant applications, cooperative agreements, and contract proposals.  The change was made to simplify the application/proposal, and to remove redundancy with Institutional Animal Care and Use Committee (IACUC) review.

The changes consist of:

OLAW to Oversee Vertebrate Animal Welfare in NSF-Funded Studies

The National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) oversees the welfare of vertebrate animals in NIH-funded studies.  NIH announced on August 10, 2015 that OLAW will extend its oversight of vertebrate animal welfare to studies funded by the National Science Foundation (NSF).  The memorandum of understanding (MOU) between the two agencies is posted at

NIH Systematic Application Compliance Checking – What It Is and What It’s Not

Automated enforcement of business rules by NIH eRA systems plays an important role in the application submission process – it helps you and it helps NIH. Understanding what that role covers can be the difference between your application moving forward to review and not.


System-enforced application validations are what they are – nothing more, nothing less.

They ARE

NIH Wants Your Input on Sex as a Biological Variable in Research

In her September 11, 2014 issue of Rock Talk , Sally Rockey, National Institutes of Health’s (NIH) Deputy Director for Extramural Research, reported on NIH’s efforts to develop policies requiring applicants for NIH biomedical research funds involving animals and cells to address sex as a variable.

NIH Updates Web-based Resources on Research Integrity

The National Institutes of Health (NIH) has updated its Web-based resources on research integrity.  New resources include a videoclip, “Protecting Confidentiality in Peer Review”, and links to NIH training on the responsible conduct of research.  Other information includes related policies and regulations, research integrity professional codes, norms, and ethics training, and NIH bioethics resources.

NIH Works to Maximize Fairness in its Peer Review Process

The National Institutes of Health (NIH) announced late last month efforts underway at the agency to address problems in its peer review process.  Dr. Richard Nakamura, Director of the NIH Center for Scientific Review, explained the initiative in a recent blog post.


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