Hot Topics in Human Subjects Research
Revisions to Common Rule
In January 2017, the US Dept. of Health and Human Services and fifteen (15) other Federal Departments and Agencies issued final revisions to the Federal Policy for the Protection of Human Subjects, otherwise referred to as the 'Common Rule.' In response to these changes, the NDSU IRB has conducted a comprehensive review of its procedures, forms, templates and guidance to ensure compliance by the effective date of January 19, 2018.
New Exempt Protocol applications, and Consent Templates can be found on the 'Forms' page of the website. See also the following links for more information on these changes:
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 to 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 are carried out at more than on site in the United States. This policy goes into effect for competing applications after January 25, 2018.
National Institutes of Mental Health (NIMH) updates Consideration for studies involving Risk of Suicide
The NIMH has published 'Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers.' NIMH considers the document 'informal guidance' designed to be a set of practical considerations for researchers as they design their research studies. Considerations include: Research Design, Common Data Elements and Data Sharing, Informed Consent, Monitoring and Reporting, Responding to Suicidal Crises and Clinical Worsening, and End of Study Participation.
Revised Common Rule
- A list of new and revised Exemption categories effective January 19, 2018 can be found here.
- 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 1/19/2018). 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.
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.
- Guidelines for submitting to the NDSU Student Research Participant Listserv
- Confidentiality and Data Security Guidelines for Electronic Research Data
- 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
- 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)
Additional Resources for Informed Consent:
- 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 Jan. 19, 2017
- Research Compensation Options
- NDSU Policy: Research on Human Subjects
- The Belmont Report
- Office of Human Research Protections (OHRP)
- Food and Drug Administration
- OHRP FAQs: Investigator Responsibilities, Research with Children, Informed Consent, and more
- OHRP Common Noncompliance Findings
- Protecting sensitive data and information in research (NIH)
- International Committee of Medical Journal Editors FAQs about clinical trials registration
- Clinical Trial Pre-registration requirement ClinicalTrials.gov
- Data sharing policy for genome-wide association studies funded by NIH
Other Related Organizations:
Federal Sponsors’ Human Research Protections Policies:
The 2018 edition of "The International Compilation of Human Subject Protections"