Resources and Guidance

Revised Common Rule

Changes to the human subjects regulations known as the Common Rule took effect in January 2019.  The new rule (often referred to as the 2018 rule) includes:

  • New and expanded exemption categories,
  • Updated Approval Criteria including changes to criteria for:
    • waiving or altering informed consent
    • waiving documentation of consent
  • Additional Required Elements of consent for non-exempt research (see our Consent Resources page),
  • Changes to the continuing review requirements for research qualifying for expedited review under the Common Rule.
  • A requirement to post consent forms for any federally-funded Clinical Trial.
    •  Instructions for uploading Consents to Regulations.gov can be found here.

 

Research Participation Listserv Guidelines
  • Messages are sent out Monday through Friday during regular business hours
  • Recruitment emails should contain:
    • Subject line with brief description of the study
    • Body of email include:
      • General description of research
      • Principal Investigator and department conducting the research
      • Description of inclusion/exclusion criteria (as applicable)
      • Total amount of time required
      • Compensation offered (if applicable)
      • Contact information or link to more information
      • IRB Approval #
  • Attachments and Survey questions cannot be distributed via the listserv.
  • Send the Recruitment message as it is to be distributed to NDSU-RES-PART@LISTSERV.NODAK.EDU.

NIH Policy on Single IRB (sIRB) Review of Multi-Site Research

The National Institutes of Health (NIH) policy on the use of single Institutional Review Board (IRB) for multi-site research went into effect January 25, 2018.  This policy establishes the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research funded by the NIH that is carried out at more than one U.S. site. 

This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.  Applicants are expected to include a plan for the use of a sIRB in grant applications/proposals submitted to the NIH.  The NIH’s acceptance of the submitted plan will be incorporated as a term and condition in the Notice of Award or in the Contract Award.


NIH Policy for Issuing Certificates of Confidentiality

Effective October 1, 2017, NIH has modified its policy for issuing Certificates of Confidentiality to research supported in whole or in part by NIH. 

All NIH-funded research that was ongoing as of October 1, 2017 and is within the scope of this policy is deemed to be issued a Certificate and is therefore required to protect the privacy of individual who are subjects in accordance with subsection 301(d) of the Public Health Service Act.

To what does this policy apply?

This policy applies to all biomedical, behavioral, clinical, or other research funded wholly or in part by the NIH that collects or uses identifiable, sensitive information.

What is identifiable, sensitive information?

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
  • For which 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.

What are my responsibilities for protecting identifiable, sensitive information?

The recipient of a Certificate of confidentiality SHALL NOT:

  • Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document, or biospecimen pertains; or
  • Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

Disclosure is only permitted when:

  • Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding;
  • Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;
  • Made with the consent of the individual to whom the information, document, or biospecimen pertains; or
  • Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

Consent documents must reference the privacy protections offered by the Certificate of Confidentiality.  Example language can be found in the Consent Template.


NIH expands definition of clinical trial

NIH Definition of Clinical Trial - A research study in which one more 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.

To determine if NIH would consider the research study to be a clinical trial, ask the following questions:

  • Does the study involve human participants?
  • Are the participants prospectively assigned to an intervention?
  • Is the study designed to evaluate the effect of the intervention on the participants?
  • Is the effect being evaluated a health-related biomedical or behavioral outcomes?

NIH has provided several case studies to assist in determining whether a study would be considered a clinical trial by NIH.

Requirements for NIH-funded Clinical Trials:

  • All NIH-funded clinical trials are expected to register and submit results information to ClinicalTrials.gov.
  • All NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials must receive training in Good Clinical Practice (GCP).  See our Main page for more information on training  through the CITI Website.
  • Clinical Trial-Specific Funding Opportunities - Since January 25, 2018, NIH requires that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. 
  • Also effective January 25, 2018New FORMS-E Application packages are in effect.  Responses to requests for proposals issued as of this date must use the PHS Human Subject and Clinical Trial Information form for all proposals involving human subjects.

Guidance - Benign Behavioral Interventions

The Secretary's Advisory Committee on Human Research Protections (SACHRP) has drafted and the Office for Human Research Protections (OHRP) has published, "A Guidance and Educational Tool for Benign Behavioral Interventions."  The document outlines questions to ask to determine if the benign behavioral intervention proposed in a research study will meet the criteria for exemption under the new Exemption Category 3 in the Revised Common Rule (effective 1/21/2019).  The document describes several examples of behavioral interventions and whether or not they would be considered exempt or non-exempt under the new common rule.


Regulations, Policies and Guidance

Common Rule (45 CFR 46)

Food and Drug Administration (21 CFR 50)

NDSU Policy 345 Research Involving Human Participants

The Belmont Report

Office of Human Research Protections (OHRP)

  • OHRP FAQs:  Investigator Responsibilities, Research with Children, Informed Consent and more

NIH Guidance:Protecting sensitive data and information in research

NIMH Guidance:  Conducting Research with Participants at Elevated Risk for Suicide:  Considerations for Researchers

Clinical Trial Registration

International Committee of Medical Journal Editors FAQs about clinical trials registration

Clinical Trial Registration requirement Fact Sheet


International Research

The 2018 edition of "The International Compilation of Human Subject Protections"

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