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IRB Guidelines & Additional Forms

The guidelines below were written under the pre-2018 Common Rule.  The Office of Research Integrity is currently updating the IRB guidelines and policies to fully reflect changes required by the Revised Common Rule. We expect to be able to publish the new guidelines over the summer. 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

IRB Guidelines 1.1 - Exempt Research

IRB Guidelines 1.3 - HIPAA Research Implications

IRB Guidelines 1.5 - Working With Existing Data Sets

IRB Guidelines 1.7 - Oral Histories

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

IRB Guidelines 1.4 - Informed Consent Procedures

IRB Guidelines 1.6 - International and Cross-Cultural Research

IRB Guidelines 1.8 - Ethical Review and Local School Districts

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

Additional IRB Forms

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.

Sources

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