Historically, in many multi-site studies, each site has its own IRB which conducts an independent ethics review of studies involving human research participants.

To help streamline this process and eliminate the unnecessary repetition of IRB reviews across sites, the NIH expects the use of a single IRB (sIRB) of record to conduct the ethics review for certain multi-site studies.

This policy applies to:

• Applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018

• Domestic sites of NIH-funded, multi-site human subjects research in which each site will conduct the same non-exempt protocol

This policy does NOT apply to:

• Career development, research training or fellowship awards

More information on the Single IRB policy for Multi-Site Research may be found here.

If your NIH-funded research includes identifiable, sensitive information, then a Certificate of Confidentiality (CoC) will be issued as part of the Terms and Conditions of your award.

How is "identifiable, sensitive information" defined?

Information about an individual that is gathered or used during the course of biomedical, behavioral, clinical, or other research, where the following may occur:

• An individual is identified; or

• There is at least a very small risk that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual

NIH considers research in which identifiable, sensitive information is collected or used, to include:

• Human subjects research as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46), including exempt research except for human subjects research that is determined to be exempt from all or some of the requirements of 45 CFR 46 if the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; 

• Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual; 

• Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46); 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 some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual, as defined in subsection 301(d) of the Public Health Service Act.

Facts about Certificates of Confidentiality!

Effective October 1, 2017 all NIH-funded research that includes identifiable, sensitive information commenced or on-going as of December 13, 2016, were issued a CoC as a term and condition of the NIH award. The researcher does not have to apply to the NIH for the CoC nor does the NIH issue a separate CoC document, however, action may be required on the researcher's part - see Action Items below.

A CoC protects the privacy of research subjects by prohibiting forced disclosure of their individually identifiable, sensitive research information, records, or data to anyone not associated with the research, except when the subject consents to such disclosures or in other limited specific situations.

CoCs are issued by different federal agencies, most typically by the National Institutes of Health (NIH).

• For NIH-funded research, the CoC is automatically included as a term and condition of the NIH award.

• For other HHS agencies (that do not have a CoC application process) or for research without federal funding, researchers may apply for an NIH CoC if a primary focus of the research is within the NIH mission (i.e., health/mental health-related).

• For research funded by other HHS agencies such as the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), or funded by or operating under the authority of the Food and Drug Administration (FDA), researchers should apply for a CoC to the applicable funding agency.

If you are still enrolling subjects, you may have to notify current subjects about the CoC and/or update your IRB application to revise your informed consent document(s), as the CoC boilerplate text has been modified as part of the new policy. You should:

• carefully review the new NIH CoC policy and FAQs found at the NIH CoC Kiosk to learn about the expanded protections and limitations around disclosures.

• ensure that any collaborators (e.g., sub-awardees, sub-contractors, or others) that will receive or access identifiable, sensitive data are made aware of the presence of the CoC, its protections, and limitations on disclosure, as part of your planning or on-going communications. Communication of the CoC information may also be covered by the sub-award/contract and/or by obtaining signed CoC Assurances from these institutions.

More resources for Certificates of Confidentiality may be found below:

For detailed instructions on the CoC IRB submission process, please see SOP: Certificates of Confidentiality (HRP-027).

Harvard’s policy on CoCs may be found here.

All NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials are required to be trained in Good Clinical Practice (GCP).

GCP training is separate and distinct from the standard training in ethical conduct of human subjects research.

The principles of GCP help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials. GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials.

See the Training section of the IRB website for various GCP training options that are available.

More information on Good Clinical Practice training may be found here.

What is ClinicalTrials.gov?

ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. ClinicalTrials.gov also provides transparency to the public about research outcomes.
 

What studies must be registered on ClinicalTrials.gov?

Any research project that:

1. Intends to seek publication in a journal that adheres to ICMJE policy, AND
2. Prospectively assigns people (or groups of people) to an intervention with or without concurrent comparison or control), AND
3. studies the relationship/impact of the health-related intervention on health outcomes

See http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html

OR

Any research project that:

1. Applied for NIH support on or after January 18, 2017, AND
2. Is funded or supported by NIH, AND
3. Involves human participants prospectively assigned to an intervention, AND
4. Is designed to evaluate the effect of the intervention on the participants’ health-related, biomedical or behavioral outcome.

See https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

OR

Any research project that meets the FDAAA definition of “Applicable Clinical Trial.” See https://clinicaltrials.gov/ct2/manage-recs/fdaaa

OR

Any study meeting the definition of “Qualifying Clinical Trial” seeking Medicare payment for routine costs in a Clinical Trial under NCD 301.1
 

Who is the Responsible Party?

At Harvard University Area, the Principal Investigator is the Responsible Party for ClinicalTrials.gov.
 

What studies must be actively maintained, and reviewed at least annually on ClinicalTrials.gov?

All studies registered on clinicaltrials.gov must be reviewed at least annually and updated within 30 days of certain changes to the study.
 

What studies must report results on ClinicalTrials.gov?

Any research project that:

1. Applied for NIH support on or after January 18, 2017, AND
2. Is funded or supported by NIH, AND
3. Involves human participants prospectively assigned to an intervention, AND
4. Is designed to evaluate the effect of the intervention on the participants’ health-related, biomedical or behavioral outcome.
    

See https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

OR

Any research project that meets the FDAAA definition of “Applicable Clinical Trial.” See https://clinicaltrials.gov/ct2/manage-recs/fdaaa

Get Started

Quick link for access to PRS system: https://register.clinicaltrials.gov/
 

Get Help

Harvard Catalyst Clinical Trial Registration and Results Reporting Resources:
https://catalyst.harvard.edu/regulatory/clinical-trial/
ClinicalTrials.gov Guided Tutorials:
https://prsinfo.clinicaltrials.gov/tutorial/content/index.html#/
ClinicalTrials.gov PRS Administrator for Harvard University Area:
Jonathan Girard
Email: jonathan_girard@harvard.edu