The GGC Institutional Review Board (IRB) reviews proposals for research that involve human subjects to ensure that all research at GGC or by researchers affiliated with GGC will be conducted in an ethical manner.
Research procedures must comply with federal regulations and other published guidelines. GGC is committed to ensuring that research conducted at, by and for Georgia Gwinnett College is in compliance with the ethical principles set out in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects. The IRB is charged with oversight of research on campus and ensuring that all human subjects research adheres to the following:
- Is done with the voluntary consent of participants who are properly informed about the purpose, risks, and benefits of the study;
- Protects the privacy and dignity of participants;
- Minimizes the risk to study participants while maximizing the study’s benefits;
- Uses equitable procedures for recruitment and selection of participants so that it does not discriminate on the basis of sex, gender, race, sexual orientation, national origin or any other factor; and
- Is sensitive to the setting in which it takes place.
- The Course Exempt / Expedited Form
- Do I need to Fill Out the IRB Application?
- Ethics Certification
- Informed Consent
- IRB Application Form
CITI Program Training
CITI Program training needs to be updated every five (5) years.
We highly recommend electronic submission of IRB applications (alternative options if portal is not working). At the moment, the portal does not allow electronic submission of other types of applications, so we accept the following forms:
- IRB Submission Form (Word doc) – only use if portal is down
- Unaffiliated Investigator Form (Word doc)
- Course-related Form (Word doc)
- Renewal Form (Word doc) – submit modification memo with this form
- Modification Memo (Word doc)
- Completion of Study Report (Word doc)
- Sample IRB application (PDF)
Almost all applications require an informed consent form. We recommend the following sample consent form (Word doc).
This advisory serves to inform Georgia Gwinnett College researchers involved in human subjects research projects who may have questions regarding how limitations of on-campus activities will impact the ability to collect data.
GGC is adhering to GDPH and CDC public health guidelines, and researchers are expected to follow these guidelines. This includes research conducted face-to-face, such as interviews, or research conducted in a lab.
When conducting research off-campus, efforts should be made to avoid face-to-face human subjects research and to instead use alternative methods to collect data. In situations when face-to-face contact is required, all human subjects interactions must fully comply with all GDPH and CDC risk mitigation and safety guidelines or the risk mitigation and safety guidelines applicable in the jurisdictions where research is being conducted.
Researchers whose research projects had been previously approved by GGC’s IRB are not required to again obtain approval and may resume their previously approved research so long as they maintain the safety guidelines of GDPH and the CDC.
Researchers are encouraged to review COVID-19 guidance issued by the federal Office for Human Research Protections (OHRP). In many cases, COVID-19 related precautions will not require IRB review. More from the OHRP:
- OHRP advises that “actions taken for public health or clinical purposes, and not for research purposes, are not research procedures and therefore do not require IRB approval before being implemented. For example, if a hospital implements mandatory clinical screening procedures related to COVID-19 for all people who come to that institution, including research subjects, these screening procedures do not need to be reviewed by an IRB before they may be implemented.”
- If the precautions you take with your study subjects are mandatory COVID-19-related precautions for all individuals who come to your college, school, institute, or department’s facilities, they are not research procedures and advance IRB review and approval are not required.
- If you will implement precautions specific to your study subjects and the precautions are not mandatory COVID-19-related precautions for all individuals who come to your college, school, institute, or department’s facilities, submit an amendment for advance IRB review/approval.
- If research procedures already described in an IRB-approved application will change to accommodate COVID-19-related precautions, submit an amendment for advance IRB review and approval.
The IRB is available for consultation regarding the possible need for changes to informed consent forms or research-related procedures. Any change to an approved study must be reviewed and approved by the IRB in advance.
Guidance is subject to change, so please refer to the site regularly for the most up-to-date information. If you have questions not addressed there, please contact the IRB at email@example.com.
Thank you for your dedication to the rights, safety and welfare of research participants at GGC.
The national focus on the protection of human subjects in research settings is a result of work initiated during the Nuremberg Military Tribunal. At that time, it was necessary to establish standards by which to judge the human experimentation conducted by Nazi doctors and others. The Nuremberg Code, which resulted from that effort, established what are now taken to be the basic principles that guide and govern research efforts with human subjects. Among the most significant standards established by the Code are the expectation of voluntary consent with includes the capacity to consent, freedom from coercion and comprehension of the risks and benefits involved. The Code further provides that research with human subjects should minimize potential risk and harm, be undertaken by qualified investigators using appropriate research designs, and make provision for participants to withdraw at any time. Similar recommendations were made by the World Medical Association in a document known as the Declaration of Helsinki. This document was first adopted in 1964 and revised in 1975 and 1989.
The United States first established regulations to protect human subjects in 1974. From 1974 to 1978 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research met and developed recommendations and guidelines for human research. Their final report is titled The Belmont Report and is available online. In 1981, both the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) published revisions of their regulations consistent with the recommendations of The Belmont Report. These regulations have been reviewed and revised on multiple occasions and are codified in the Code of Federal Regulations. Additional details can be found at the website of the Federal Office for Human Research Protections (OHRP).
Why submit proposals to the IRB?
The purpose of the GGC IRB is to insure that all research conducted at GGC or by those affiliated with GGC is in compliance with the appropriate Federal regulations as laid out in the Federal Regulations and The Belmont Report. While we understand that no reputable researcher would deliberately design and conduct research that violates the rights of other human beings, it is also true that those who are most invested in a particular project are least able to identify points at which the design of an investigation may infringe on those rights. The role of the IRB is to provide an objective and impartial review of all research designs to identify any potential risks to the safety or confidentiality of research participants. In this role, the IRB serves as a collegial panel of peers providing advice to the academy.
However, the IRB also serves a pragmatic and Federally required role. An institution whose faculty seek Federal funding for research is required to verify that all research conducted by faculty or students of the institution or conducted at the institution is in compliance with all guidelines protecting human subjects. Consequently, the IRB is charged with reviewing all research affiliated with the institution regardless of setting or funding source. In fulfilling this responsibility, the IRB works to ensure the eligibility of GGC to compete for government grants to support research.
Who must submit proposals to the IRB?
All researchers who are employees or students of GGC or who wish to use employees or students of GGC as subjects or research must submit applications to and receive approval from the GGC IRB before beginning any research activities. Investigators who are unaffiliated with GGC and who wish to conduct research at GGC must obtain a GGC research sponsor who will take responsibility for the research activity. Further information about the obligations of unaffiliated investigators is provided below. Researchers who begin their work without planning to use human subjects, and who later add human subjects to their research plans, must submit applications to the IRB.
What is considered Human Subjects Research?
Research is any systematic investigation including research development, testing and evaluation that is designed to develop or contribute to generalizable knowledge. This definition includes work undertaken by students for the purposes of independent study, thesis work, or dissertations. To some extent, it also includes work done by students for class assignments under the direction and supervision of a professor. Research is considered human subjects research if the investigator obtains (1) data through intervention or interaction with a human subject or (2) identifiable private information about a human subject. A human subject is defined as any living individual as well as human embryos, fetuses, and any human tissue or fluids. The IRB is charged with reviewing all research activity involving human subjects.
Types of research affected by this requirement include, but are not limited to, studies of behavior or cognition, field observation, oral histories, focus groups, interview, surveys or questionnaires, research using confidential administrative data such as individual level welfare information or individual college data, and research involving human tissue. While some specific types of research activities are exempt from IRB review and approval requirements, only the IRB can make a determination of exempt status. Consequently, any researcher planning research activity he or she believes may be exempt from review must first submit an application to the IRB for final determination of the status of the proposed project.
Who is on the GGC IRB?
In accordance with Federal regulations, the Georgia Gwinnett College IRB shall consist of a diverse group of at least 6 faculty members and at least one unaffiliated, non-faculty participant. IRB members shall be chosen from varied backgrounds to promote complete and adequate review of research activities covered by this document, and shall have the professional competence necessary to review the specific research activities that will be assigned to it. The IRB shall be sufficiently qualified, through the expertise and experience of its members and the diversity of the members' backgrounds (including consideration of the racial and cultural backgrounds of members and sensitivity to such issues as community attitudes), to promote respect for its advice and counsel in safeguarding the rights and welfare of human participants. Additionally, the IRB includes at least one member who is not an academic and at least one member who is not affiliated with the college; the regulations permit the same individual to serve in both of these roles. Its membership shall specifically include the following:
- both male and female members;
- members representing a variety of academic disciplines;
- at least one member whose primary expertise is in a non-scientific area;
- at least one member who is not otherwise affiliated with the institution and who is not a part of the immediate family of a person affiliated with the institution; and
- at least one person with scientific research experience.
IRB members are appointed by the Senior Vice President for Academic and Student Affairs/Provost on the recommendation of the Chairperson of the IRB. Members are appointed for staggered, renewable three-year terms and include faculty with expertise in the various disciplines engaged in human subjects research on campus as well as community members. All members, whether regular or alternate, have full voting rights. There is no remuneration for individuals serving as IRB members. No IRB members participate in the review of any study on which they are a Principal researcher or Co-researcher.
The Chairperson of the IRB conducts an orientation for new members which includes review of relevant materials provided (Federal Regulations, University Policy, IRB Guidelines), and details concerning committee function and procedures. Each new member attends at least one IRB meeting for the purpose of observation, before participating in the actual review of studies.
The IRB may, at its discretion, invite individuals with competence in special areas (consultants) to assist in the review of complex issues that require expertise beyond, or in addition to that available on the committee. The consultant does not take part in voting. Similarly, researchers may request, or be invited, to attend IRB meetings to clarify issues concerning their proposed research activity. These researchers do not take part in committee deliberations or voting.