The SARS-CoV-2 virus and COVID-19 coronavirus disease pose unique challenges to research with human subjects. Principal investigators need to clearly address COVID-19 concerns in their application materials. Applicants should clearly indicate which research activities, if any, will require in-person interaction, which in-person interactions occur as part of non-research activities (e.g., in a classroom or as part of a routine medical/clinic visit), and which in-person interactions occur solely for research purposes (e.g., laboratory research, focus groups, in-person interviews).
The guidelines below were written under the pre-2018 Common Rule. The Office of Research Integrity is currently creating a Researcher Handbook that will replace these guidelines and reflect changes required by the Revised Common Rule. If you have any questions about the Revised Common Rule or how the guidelines below are affected by the Revised Common Rule, please contact the IRB Chair or the Office of Research Integrity.
IRB Guidelines 1.1 - Exempt Research (PDF)
IRB Guidelines 1.3 - HIPAA Research Implications (PDF)
IRB Guidelines 1.5 - Working With Existing Data Sets (PDF)
IRB Guidelines 1.7 - Oral Histories (PDF)
IRB Guidelines 1.9 - Adverse Events and Unanticipated Problems
IRB Guidelines 2.1 - Non-Compliance Issues
IRB Guidelines 2.3 - Subject Recruitment and Compensation
IRB Guidelines 1.2 - FERPA Research Implications (PDF)
IRB Guidelines 1.4 - Informed Consent Procedures (PDF)
IRB Guidelines 1.6 - International and Cross-Cultural Research (PDF)
IRB Guidelines 1.8 - Ethical Review and Local School Districts (PDF)
IRB Guidelines 2.0 - Continuing Reviews and Lapses of Approval
IRB Guidelines 2.2 - Research Termination and Suspension
IRB Guidelines 2.4 - Research with Prisoners
Below is a list of additional IRB Forms that may be attached to applications in IRB Manager. If you have any questions and/or you cannot find a particular form, contact the IRB Chair.
| Form Name | Additional Information | |
|---|---|---|
| Consent Form Template for Adults (Word) | Template for creating a form to obtain written consent from adult human participants. This template is compliant with the requirements in the Revised Common Rule. Add information as needed for your research project. Please remember to remove the comments and all elements that do not apply to your research project. | |
| Consent Form Template for Children (Word) | Template for creating a form to obtain written consent from parents/guardians when conducting research with children (under 18 years of age). This template is compliant with the requirements in the Revised Common Rule. Add information as needed for your research project. Please remember to remove the comments and all elements that do not apply to your research project. Note that you will also need to create an assent form for the children that are at a reading level appropriate for the age of the children. | |
| IRB Form 6.1 - HIPAA Data Use Agreement (Word) | The data use agreement is a requirement of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”). It applies to research that involves individually identifiable health information. While the data use agreement can be waived by the IRB under certain circumstances, the default procedure should be to include it with your application. | |
| IRB Form 6.2 - HIPAA Privacy Authorization (Word) | This form needs to be filled out in addition to a potential informed consent form (though the two can be combined) whenever the research aims to use or disclose medical information for a project. Visit the HIPPA Privacy website for more information. | |
| IRB Form 6.3 - Application for IRB Waiver of HIPAA Privacy Authorization (Word) | Please fill this form out if you think that your research project qualifies for a HIPAA Privacy Authorization Waiver (also see IRB Form 6.2). The form is used by the UNG IRB to determine whether your project involves no more than minimal risk to the privacy of individual participants and that it meets all of the criteria stipulated in the HIPAA Privacy Rule. | |
| IRB Form 7.1 - Student Consent for Release of Non-Directory Information (Word) | To comply with the Family Educational Rights and Privacy Act of 1974 (FERPA), this form may need to be filled out when a researcher seeks to use non-directory student information for research purposes. For more information, please check the UNG registrar and FERPA websites and/or contact the IRB. | |
| IRB Form 7.2 - Revocation of Access to Non-Directory Information (Word) | Researchers that have previously asked students for permission to release non-directory information for research purposes should share this form with their participants. Under FERPA rules this form gives students the right to revoke, change and/or otherwise limit the scope of their initially given permission/s. | |
| IRB Form 8.1 - Deed of Gift | This form needs to be filled out when the researcher wishes to transfer the interviewees’ rights to their interviews (e.g. in oral history research) to an individual (e.g. the researcher), and/or an institution (e.g. a library). For more information, please visit the following to links: Deed of Gift / Oral History or contact the IRB. | |