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 is conducting a comprehensive review of its procedures, forms, templates and guidance to ensure compliance by the effective date of January 19, 2018.
This section of the website will be updated frequently as more information becomes available.
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.
Revised Common Rule
- 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.
- 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
- 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
- Expedited Interview, Hard copy consent, with signatures
- 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 2016 edition of "The International Compilation of Human Subject Protections"