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Resources and Guidance

NIH Issues Guidance related to new NIH Data Management and Sharing Policy (DMS Policy)

NIH recently released guidance and sample consent language for protecting the privacy and respecting the autonomy of participants when sharing data or biospecimens for future research. The document provides modifiable sample language that investigators and IRBs can use to clearly communicate potential risks and benefits associated with data/biospecimen storage and sharing for future research.

NEW - Guidelines for preventing infectious illness in face-to-face research

As we all find ways to regain normalcy in a world with COVID-19, the NDSU IRB has transitioned its guidelines for preventing the transmission of COVID-19 in face-to-face research to "Risk Mitigation Strategies for Infectious Illness." This one-page document outlines basic strategies to decrease the risk of transmitting infectious illnesses (e.g. influenza, COVID, and even the common cold) while still actively pursuing face-to-face research opportunities.

If you have questions or concerns regarding these recommendations, please contact Kristy Shirley, 701-231-8995, kristy.shirley@ndsu.edu or Ben Balas, IRB chair, benjamin.balas@ndsu.edu.

Research with Tribal Nations

The NDSU recognizes and respects the sovereignty of tribal nations to determine what research may occur with their people and on their land. When proposing research within tribal communities, researchers must obtain permission and/or approval from tribal governments (or those designated by tribal authorities) to conduct research on reservations. This may involve permission from the tribal chairperson, a tribal resolution approved by the tribal council and/or approval by a tribal IRB or Research Review Board (RRB).

North Dakota Tribal Governments

North Dakota Tribal Colleges

Cankdeska Cikana Community College - no IRB - Spirit Lake Nation
Turtle Mountain Community College - Turtle Mountain Band of Chippewa Indians Research Review Board
Nueta Hidatsa Sahnish College - no IRB - Mandan, Hidatsa, Arika Nation
Sisseton Wahpeton College
Sitting Bull College IRB - Standing Rock Sioux Tribe
United Tribes Technical College IRB

Equal Opportunity and Title IX Compliance

The Equal Opportunity and Title IX Compliance office recently updated guidance related to Mandated Reporting responsibilities for academic research approved by the Institutional Review Board (IRB). More details on the scope of this exemption can be found here.

Research Participation Listserv Guidelines

The research participation listserv may be used for:

recruitment emails for NDSU research studies, or collaborative studies between NDSU and partnering institutions.
recruitment emails for surveys conducted by NDSU students for classroom assignments.

Messages are sent out Monday through Friday during regular business hours.

Research studies approved by the NDSU or partnering IRB should contain:

Subject line with brief description of the study
Body of email include:
- General description of research
- Principal Investigator name 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 Protocol #

Student surveys not subject to IRB review and approval:

Subject line with a brief description of the survey
Body of email to include:
- Name of the student(s) conducting the survey
- Name of the faculty member and class for which the survey is being conducted.
- Contact information for questions
- Link to survey
- Statement that, "This survey is being conducted solely for educational purposes and has not been approved by the NDSU IRB."

Emails may NOT contain attachments, please provide all text within the email and provide a link to the online survey (if applicable).

Send the message exactly as you would like it to be distributed to NDSU-RES-PART@LISTSERV.NODAK.EDU.

Links to NDSU Resources

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, 2018, New 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.