NIH Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule)

NIH has issued initial guidance on the implementation of the Revised Common Rule NOT-OD-19-050. The effective date for the amended regulation is January 21, 2019.  It applies to studies initiated on or after this date, and ongoing studies that voluntarily transitioned to the Revised Common Rule, including those that implemented the three burden-reducing provisions during the delay period (July 19, 2018 through January 20, 2019). Continue reading

New Application Requirements for Institutional Training Grants: Letter of Institutional Commitment to Harassment and Discrimination Protections

NIH takes the issue of sexual harassment and discrimination very seriously. As such, beginning with applications submitted for due dates on or after January 25, 2019, institutional training grant applications (T15, T32, T34, T35, T36, T37, T90/R90, TL1, TL4) must include a letter that describes the institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices. Continue reading

End-of-fiscal-year Reminder to Review Accuracy of Grant Information

We make data on all funded NIH grants available to the public on the RePORT website. One of the ways we provide information is by school/department, which you can explore using the Awards by Location feature. Because of inconsistencies in the way information on department and school names are provided in grant applications, grantee officials may want to make changes in how that information is reflected in NIH systems. Continue reading

Protecting Human Research Participants (PHRP) Online Tutorial No Longer Available as of September 26, 2018

We recently released a policy notice announcing that as of September 26, 2018, the NIH will no longer be offering the Protecting Human Research Participants (PHRP) course. It is important to note that investigators are still required to comply with all aspects of the NIH policy Required Education in the Protection of Human Research Participants, and can do so through a different training program or course.
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OHRP Announces Availability of Three Draft Guidance Documents Related to Revised Common Rule

As you may recall, NIH issued guidance for implementing the burden-reducing provisions of the 2018 Common Rule (NOT-OD-18-211). Subsequently on July 20, 2018, the HHS Office for Human Research Protections (OHRP) has announced the availability of three draft guidance documents that relate to three burden-reducing provisions Continue reading

NIH Application Resubmission Policy

NIH’s resubmission policy has not changed, but the policy notice highlights some important points: only a single resubmission (A1) of an original application (A0) will be accepted, an A0 application may be submitted following an unsuccessful A0 or A1 application (with a few exceptions), what happens when switching FOAs between the A0 and A1 applications, and generally a change of activity code (e.g., R01) between the A0 and A1 is not allowed, with one exception. Continue reading