New NIH Clinical Trial Requirements for Grants & Contracts

2017-2018 At A Glance

Why NIH Changes?

NIH is strengthening requirements to enhance stewardship of public resources and ensure scientific rigor, transparency, ethical oversight, & accountability. 

For more information, see  https://grants.nih.gov/policy/clinical-trials/why-changes.htm

NIH Definition of a Clinical Trial

Revised October 23, 2014

Emory contact:  Jennifer Prozonic at jprozon@emory.edu

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

  • If answer is yes to all of the following questions, it is considered a clinical trial by NIH:

1)    Does study involve human participant research?

2)    Are participants prospectively assigned to an intervention?

3)    Is study designed to evaluate effect of intervention on participants?

4)    Is the effect being evaluated a health-related biomedical or behavioral outcome?

  • Not considered a clinical trial if limited to the following:  surveys, questionnaires, user preferences, focus groups, secondary research with biospecimens or health information, or educational studies with outcomes focusing on memorization or retention and recall of information to assess teaching methods.

 

IMPORTANT NOTE:  Investigators are strongly encouraged to verify whether their proposal meets the NIH definition of a clinical trial with the NIH program officer and document it accordingly.  The proper processing of the proposal is contingent on this determination.

For more information, see https://grants.nih.gov/policy/clinical-trials/definition.htm

NIH Funding Opportunities

Effective January 25, 2018

Emory contact:  Holly Sommers at hsomme2@emory.edu/Kerry Peluso at kerry.peluso@emory.edu

For due dates on or after January 25, 2018, all applications involving clinical trials must be submitted through a Funding Opportunity Announcement (FOA) or request for proposal (RFP) that explicitly states it will accept clinical trials.  After January 25, 2018, NIH will no longer accept clinical trial applications through existing parent announcements.

Existing FOAs will be updated in Fall 2017 as follows:

  • All FOAs will specify allowability of clinical trials in Section II. Award Information.
  • All new FOAs will specify allowability of clinical trials in FOA title.
  • FOAs accepting clinical trials will incorporate specific review criteria so clinical trial-related information is appropriately considered by reviewers.

Training (T) Awards do not support clinical trials (exception in second bullet below):

  • All Training FOAs will be designated as “Clinical Trials Not Allowed” in Section II. Award Information, but will indicate that appointment trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.
  • Some D43 and K12 FOAs will be designated as “Clinical Trials Optional” in Section II. Award Information.

Fellowship (F) Awards do not permit NIH supported fellows to conduct a clinical trial independently:

  • All Fellowship FOAs will be designated as “No Independent Clinical Trial” in the title and in Section II. Award Information, but will indicate applicants are permitted to propose research experience in a clinical trial led by a sponsor or co-sponsor.
  • Fellowship applicants proposing to gain mentored training in a clinical trial will be instructed to provide details of their contribution to the study in the Research Strategy rather than the clinical trial specific fields on the PHS Human Subjects & Clinical Trials Information form.
  • NIH expects the mentor or individual receiving support for the clinical trial to assume overall responsibility of the trial.

Career Development (K) Awards may support either independent clinical trials or a mentored research training experience, depending on the FOA:

  • FOAs indicating “Clinical Trials Required” in the title & Section II. Award Information will support independent clinical trials conducted by the applicant.
  • FOAs indicating “No Independent Clinical Trials” in the title & Section II. Award Information permit the applicant to propose research experience in a clinical trial led by a sponsor or co-sponsor.
    • Career Development applicants proposing to gain mentored training in a clinical trial will be instructed to provide details of their contribution to the study in the Research Strategy rather than the clinical trial specific fields on the PHS Human Subjects & Clinical Trials Information form.
    • NIH expects the mentor or individual receiving support for the larger trial to have the overall responsibility of the trial.
For more information, see https://grants.nih.gov/policy/clinical-trials/specific-funding-opportunities.htm or https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-043.html

New Human Subjects & Clinical Trial Information Form

Effective January 25, 2018

Emory contact:  Holly Sommers at hsomme2@emory.edu/Kerry Peluso at kerry.peluso@emory.edu

For all human subjects and/or clinical trial research applications with due dates on or after January 25, 2018, this new form will be included in the new FORMS-E Application Packages and will be required.  The form consolidates all human subjects & clinical trial related information in one place, and expands the information required for studies that meet the NIH definition of a clinical trial.

Important Dates:

  • September 25, 2017—new FORMS-E Application Instructions available.
  • October 25, 2017—FORMS-E Application Packages will start being published for FOAs with due dates on or after January 25, 2018 (published 60 days prior to first due dates).
  • January 25, 2018—first due dates for new FORMS-E Application Packages.

 

During transition, both form packages (FORMS-D to FORMS-E) may be available.  It is important to choose the announcement specific for your due date.

For more information, see https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm or https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-062.html

New Clinical Trials Protocol Template

Optional

Emory contact:  Rebecca Rousselle or rrouss2@emory.edu

The NIH and FDA collaboratively developed a template & electronic protocol-writing tool for NIH-funded phase 2 or 3 clinical trials requiring IND or IDE applications.

For more information, see https://grants.nih.gov/policy/clinical-trials/protocol-template.htm or https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-064.html or https://e-protocol.od.nih.gov/#/home

Good Clinical Practice Training

Effective January 1, 2017

Emory contact:  Rebecca Rousselle at rrouss2@emory.edu /Bridget Strong at bstrong@emory.edu

  • NIH requires all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice (GCP).
  • Must retain documentation of training & refresh every three years.

For more information, see https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm or https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html

Single IRB Policy

Effective January 25, 2018

Emory contact:  Rebecca Rousselle or rrouss2@emory.edu

For applications/proposals with due dates on or after January 25, 2018, NIH expects all domestic sites of NIH-funded multi-site studies, where each site conducts the same protocol involving non-exempt human subjects research, will use a single IRB (sIRB).  This can be either an independent IRB, or the institutional IRB of one of the participating sites.

  • Applicants will be expected to include a plan for use of a sIRB in grant applications & contract proposals submitted to NIH.
  • Scope includes all multi-site studies, not limited to clinical trials.

IMPORTANT NOTE: If Emory is designated as the single IRB on a NIH grant, the IRB review will be managed by an independent/commercial IRB with associated charges.  The NIH has confirmed that this option is acceptable, and we have heard from several peer institutions that they will be taking the same path.  Please factor single IRB review costs into the proposed budget.

For more information, see http://www.irb.emory.edu/forms/external-irbs/index.html or https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm or https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html or https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-076.html or www.irb.emory.edu/forms/external-irbs/index.html

*Please see the attached NIH Webinar Presentation regarding the process for requesting exceptions to the NIH Single IRB policy. It should be noted that NIH expects exceptions outside those required by law or regulation, or time-limited exceptions, to be extremely rare.

Certificates of Confidentiality

Effective October 1, 2017

Emory contact:  Rebecca Rousselle or rrouss2@emory.edu

Effective October 1, 2017, all NIH-funded research meeting certain criteria, that was commenced or ongoing on or after December 13, 2016, is deemed to be issued a Certificate of Confidentiality (CoC) via a new NIH policy. (Previously, researchers had to proactively apply to the NIH for a CoC.) By law, Emory must refuse to release individually-identifiable research data from studies covered by a CoC. The following research is now covered automatically by a CoC:

  • Funded by NIH; and is
    • “Human subjects research” as defined by the Common Rule, including exempt research where data is identifiable; or
    • Research involving the collection or use of biospecimens that are individually identifiable or for which there is at least a very small risk that there is some way to deduce the identity of an individual; or
    • Research that generates individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is “identifiable” per the Common Rule; or
    • Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that the subject’s identity could be deduced.

Moreover, for studies that obtain informed consent, the human subjects must be informed that their information is protected by a CoC. The IRB provides language in its consent form template to be used in all new submissions meeting the above criteria. The IRB will also provide an addendum to be used in consenting prospective subjects in ongoing research studies, until the study team updates the consent form to include the CoC language.  Once in place, the CoC applies to all data collected in the study, including before the CoC was issued.

ClinicalTrials.gov Registration & Reporting

Effective January 18, 2017

Emory contact:  Jennifer Prozonic at jprozon@emory.edu

The revised FDA Final Rule and NIH Policy on Clinical Trials Registration and Results Information Submission issued new requirements effective January 18, 2017 for clinical trials that meet the: 

  • FDA definition of an “applicable clinical trial” and/or 
  • NIH definition of a clinical trial and funded by the NIH.  

For PI-initiated clinical trials, the PI is required to register the project in ClinicalTrials.gov within 21 days of enrollment of the first subject, complete periodic updates as required, and report summary results information within one year of the primary completion date.  The NIH also issued a companion policy requiring that language on the dissemination of clinical trial information be included in new or competing applications submitted on or after January 18, 2017 (template language available on the OCR website).  The FDA and NIH have established strict timelines for updating ClinicalTrials.gov and have incorporated heavy penalties for failing to meet these timelines.

The additional workload for these requirements is significant and places new responsibilities on PIs.  To ensure that PI-initiated studies are in compliance, Emory has established a ClinicalTrials.gov Service Center.  For all awards issued on or after September 1, 2017, the service center in OCR will manage all PI-initiated studies where Emory is considered the sponsor.  The NIH allows direct charging of the costs of complying with the new clinical trial reporting requirements and at Emory such studies will be charged a fee of $3,500.  This amount reflects the work necessary to comply throughout the life of the study and is not the full cost since the service center is being subsidized by the institution.  This service center fee needs to be incorporated in the budget as a direct charge covering the support needed to facilitate the registration, periodic updates, and results reporting within ClinicalTrials.gov for the duration of the study.  The PI will continue to review the accuracy of the information entered by the service center and document their approval in ClinicalTrials.gov.

For applications/proposals:  Template language for the dissemination of clinical trial information and the ClinicalTrials.gov Service Center fee are now available on the OCR’s website at http://www.ocr.emory.edu/ct.gov/language.html.  If you have any questions, please contact OCR@emory.edu.

For informed consent documents:  Template language for a required statement on the posting of clinical trial information at ClinicalTrials.gov in the informed consent document is available on the IRB’s website at http://irb.emory.edu/forms/consent_toolkit/index.html.  If you have any questions, please contact IRB@emory.edu.

For more information, see http://www.ocr.emory.edu/ct.gov/index.html or https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm or https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html or https://grants.nih.gov/policy/clinical-trials/reporting/understanding.htm

Emory Internal Training Materials

The following materials are being presented across campus in preparation for the NIH policy changes. These slides will be updated as more information is posted. Please visit this site for the most up-to-date training materials.

Presentation: New NIH Clinical Trial Requirements for Grants & Contracts 2017-2018

Preview of FORMS-E Grant Application Form Changes