Guidelines & Forms

Updates and Highlights

As of July 1, 2022

In accordance with Dr. Jacobs May 9 Presidential update on Changes to ��'s COVID-19 Response, the IRB has updated its previous guidance on COVID-19 to treat it as we do other infectious diseases and to consider public health concerns when assessing risks to participants. The following guidelines are effective immediately.

Online and Remote Research

Because there is no risk of transmission of infectious disease when research is performed over the internet (e.g., surveys, online experiments, interviews using teleconferencing software such as Zoom) or using other technology (e.g., mail, telephone) that allows research activities to take place without physical interaction between research personnel and research participants, the IRB does not need to consider this risk in its assessment of these activities. Researchers do not need to include any special information in their IRB protocols regarding infectious disease transmission mitigation for these activities.

In-person Research in Class and Clinics

Research activities involving in-person interactions that would take place even if the research was not being performed (e.g., classroom-based research, research that is part of routine clinic visits) generally do not increase the risk of transmission of infectious disease beyond that ordinarily encountered in daily life. Researchers do not need to include any special infectious disease related information in their IRB protocol for these activities; however, researchers are expected to follow all sanitation and public health related guidelines in place at the research location when conducting the research. The IRB will only consider infectious disease risk for these activities if the research protocol requires participants to perform activities that would increase this risk (e.g., close physical contact that would not happen as a normal part of the non-research interactions).

Researchers who have active studies in this category that include special COVID-19 protections are reminded that they must always follow the currently approved protocol. Researchers who wish to remove special COVID-19 protections from the protocol must submit a research modification request and have the request approved before implementing any changes to their procedures.

Focus Groups, In-person Interviews, and Laboratory Research

Research activities involving in-person interactions that take place solely for research purposes (e.g., laboratory research, focus groups, in-person interviews) may increase the risk of transmission of infectious diseases so that it is more than minimal. The IRB will consider the risk of transmission of infectious diseases, taking into account current public health guidelines, as a factor when determining the level of risk that these research activities may pose to participants and determining whether the study qualifies for exempt status or expedited review.

If the IRB determines that the research could increase the risk to participants, the board may require the principal investigator to clearly address infectious disease transmission concerns in their IRB protocol by including a clear description of all measures the research team will take to reduce the risk of transmission of the infectious disease(s) of concern. These measures may include screening participants for risk factors, enhanced disinfection and sanitation, social distancing, and the use of personal protective equipment by researchers and participants, as appropriate. The IRB will evaluate these measures using professional standards and guidance from public health authorities, including the Georgia Department of Public Health and the Centers for Disease Control and Prevention (CDC).

Researchers who have active studies in this category that include special COVID-19 protections are reminded that they must always follow the currently approved protocol. Researchers who wish to modify approved COVID-19 protections must submit a research modification request and have the request approved before implementing any changes to their procedures.

Guidelines

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

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 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 �� 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 .
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 �� 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: / or contact the IRB.

��������