Hot Topics in Human Subjects Research
Changes to Human Subjects Regulations known as Common Rule took effect January 21, 2019
Changes to the human subjects regulations known as the Common Rule have now taken effect after a yearlong delay. The revised rule includes:
- new and expanded exemption categories,
- updated Approval Criteria including changes to criteria for waiving or altering informed consent and waiving documentation of consent,
- additional required elements of consent for non-exempt research (see our Consent Resources page),
- and changes to the continuing review requirements for research qualifying for expedited review under the Common Rule.
To comply with the revised requirements, Protocol Applications have been updated and are available on the IRB Forms page. Current protocol application materials must be utilized for any new protocol submissions.
NIH Policy on Single IRB (sIRB) Review of Multi-Site Research now in effect
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.
Changes to 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 Training page for more information on completing this training through the CITI Website.
- Clinical Trial-Specific Funding Opportunities - For due dates on or after January 25, 2018, NIH will require 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 go into 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.
Revised Common Rule - Benign Behavioral Intervention Resources
- The Secretary's Advisory Committee on Human Research Protections (SACHRP) has drafted and the Office for Human Research Protections (OHRP) has published a document titled, "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.
- An 'Information Sheet' template is available for projects involving benign behavioral interventions which will fall under the new Exemption Category 3.
- Requirements for Informed Consent for non-exempt research have been updated in the new common rule. Find the Basic and Additional elements of consent on our Consent Resources page.
- Guidelines for submitting to the NDSU Student Research Participant Listserv
- Confidentiality and Data Security Guidelines for Electronic Research Data
- Encryption at NDSU - Presentation by Jeff Gimbel, Senior Security Analyst, NDSU Information Technology Services
- Group Decision Center (including NDSU Qualtrics)
- NDSU Data Storage and Sharing Options
- Guidelines for Records Management
- NDSU Secure File Transfer services - allows you to send and receive large files quickly and securely.
Example Consent, Permission and Assent Documents:
- Exempt Status Survey conducted by Graduate Student
- Exempt survey bulleted format
- Information Sheet for Employee Survey
- Oral script for phone interview
- Parental Permission form where child is <7 yrs of age
- Parental Permission form (to be used with assent form)
- Youth Assent form (13–17 yrs of age)
- Child Assent form (7–12 yrs of age)
- REVISED COMMON RULE: Elements of Informed Consent
- Increasing Return Rates of Parental Permission Forms
- Agency for Healthcare Research and Quality (AHRQ) Informed Consent and Authorization Toolkit for Minimal Risk Research
- NIH Consent Form Examples and Model Consent Language for genetic studies
Regulations, Policies and Guidance:
- Final Revisions to Common Rule - Implementation Date January 21, 2019
- Research Compensation Options
- NDSU Policy: Research on Human Subjects
- The Belmont Report
- Office of Human Research Protections (OHRP)
- OHRP FAQs: Investigator Responsibilities, Research with Children, Informed Consent, and more
- Food and Drug Administration
NIH Policies and Guidance
- Protecting sensitive data and information in research (NIH)
- Data sharing policy for genome-wide association studies funded by NIH
Clinical Trials Registration
Other Related Organizations:
Federal Sponsors’ Human Research Protections Policies:
The 2018 edition of "The International Compilation of Human Subject Protections"