IRB Facts & QuestionsThe IRB requests that those wishing to use human research participants complete an application form for each study they intend to perform. Since the review process may require the review of the full IRB committee, you should allow two to three weeks for approval of projects that do not raise major ethical concerns. If serious ethical concerns are involved, the process may take longer. After your research is approved, it is your responsibility to report immediately to the IRB any significant changes or unanticipated problems in your project, including but not limited to the addition of other treatment groups, or the introduction of new instruments or materials into the project.
The College of Coastal Georgia Institutional Review Board meets the first Friday of each month from 2:00-3:00 p.m., in the Health Science Building, Room 303.
To have a proposal reviewed at a given meeting, your materials should be received a month prior to the meeting date for Full Board reviews and two weeks for expedited or exempt reviews. If you are unsure of which type of review your protocol will be, please submit at least 30 days prior to the Full Board meeting. You will receive written notification of the IRB's decision within a few days after approval.
Application & Instructions for Researchers" link.
- risks to participants are minimized;
- risks to participants are reasonable in relation to expected benefits, if any, to the participants;
- selection of participants is equitable, meaning that vulnerable populations are not being used unnecessarily;
- informed consent will be sought from each participant or the participant's legally authorized representative;
- informed consent will be appropriately documented, and
- when appropriate, the research plan makes adequate provision to protect the privacy of participants and to maintain confidentiality of data.
When survey research is conducted as a portion of a class where a participant is asked to disclose identifying information, IRB approval is required. Further, survey research that seeks to identify participants only within a specialized population or investigates a variety of sensitive areas generally requires IRB approval.
For all student research involving human subjects conducted as a part of a course, the protocol must be reviewed and approved by the course instructor, department head, and/or school dean and applicable by IRB.
All other research conducted with human subjects as part of a course will require normal IRB approval.
In some cases, a community partner may have their own institutional review board. In these cases, the community partner may require adherence to policies that are more protective of a participant's rights than College of Coastal Georgia policy, and College of Coastal Georgia employees would be expected to comply with those policies. If an outside review board sets policy that is less stringent than College of Coastal Georgia policy, all employees will be required to adhere to the policy of College of Coastal Georgia.
I have a sponsored project for an outside organization that must be done within a tight time constraint. Do I need approval and if so, how long will it take? Will review force me to reject the funding?Sponsored projects are treated as any other research projects. How long it takes depends on which level of review is required. Technical Reviews are conducted regularly at College of Coastal Georgia, typically on a monthly basis unless the demand for reviews grows and the frequency needs to be increased. The normal review process on a complete application should take a month or less from the time of your submission; modifications to the application will extend this process.
Yes, unless approved, funding may have to be rejected.
I submitted a protocol for review because it was part of an externally sponsored project. The external sponsor did not fund my project. What do I do now?If you decide not to conduct the research, you should inform the IRB in writing and your relevant IRB file will be closed.
Many agencies provide investigators with feedback about grant applications that are not funded. If you incorporate any of the suggested modifications into your research protocol, it will be necessary to obtain IRB approval on the new research protocol. Obviously, re-approval would be necessary with any change in the subject informed consent form.
I intend to use some standardized intelligence test, (attitudinal or aptitude tests) in class for research purposes; do I need approval?Yes. A protocol would need to be submitted to the IRB for Technical Review.
On the contrary, confidentiality suggests that the data collected will be maintained and reported without divulging any identifying information; although, the investigator may have access to the study participant's names, gender, and other identifying information, which must be stored separately.
My potential subjects do not speak English in the home; how do I ensure they understand informed consent?To obtain Informed Consent for a non-English speaker to participate in research, the subject should be asked in his or her own language for consent/assent to participate. Informed Consent form should be written in the subject's home language or consent of a guardian who speaks the subject's language and understands the subject's linguistic culture is needed for any non-English speaker because the subject is not capable of giving fully informed consent. Assent of a non-English speaker who is minor may be obtained verbally however, if assent of the subject is to be obtained verbally, the submission should include a description of how the investigator will ask for assent from the minor subject.
I am only conducting research appropriate for a exemption approval. It is a completely anonymous survey - no blood and guts involved - no risk at all. Do I still have to take the compliance education session for certification?Yes. The mandate for compliance education makes no differentiation in the [education] requirements based on the level of risk imposed by the research.
My faculty advisor wants me to change the title of my research project. No big deal - has absolutely nothing to do with the subjects or anything like that. I'm going to go ahead and make the change and let the IRB know about it later on, OK?ABSOLUTELY NOT! Once research has been approved by the IRB, no changes, modifications or revisions can be made prior to IRB approval except where necessary to eliminate apparent immediate hazards to the subject. Any requests that are minor in nature, such as this title change, can be reviewed by expedited review procedures (reviewed and approved by the IRB Chair or designee) with the written approval released usually within just a couple of days. Modifications submitted for approval that are determined to be "non-minor" in nature must be presented to the IRB. Non-minor modifications are changes that affect the risk (increase or decrease risk) or would serve to cause a potential subject to reconsider whether or not they would want to remain in the study (e.g., adding on 10 more needle sticks to your nursing experiment). Go to the submission guidelines to view the guidelines and form for submitting a modification (revision or change).
- Purpose of the Research
- What is expected of the participant
- Risks and/or Discomforts
- Potential Benefits
- Alternative Procedure or Treatment
- Confidentiality Provisions
- Liability statement
- IRB Contact for Information
- Voluntary Participation and Right to Discontinue without Penalty
- Signature of Participant and Investigator
IF the original data was NOT collected for a particular research study purpose, an approval to use archival data needs to be provided from the individual who maintains the database. Include a description of how the data is stored and will be accessed in the application.