IRB Facts & Questions

The 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.
Select a Question:

What research studies must be reviewed?

Most research involving human participants at College of Coastal Georgia will require a full IRB review, but there are two categories of exceptions: EXEMPT and EXPEDITED. The criteria for Exempt status and for Expedited status can be found in the actual application as well as in the "Definitions" link. The best strategy is to submit a complete application, noting the criteria that may justify an Exempt or Expedited review. All reviews will be carried out by either the IRB chairperson or by one or more experienced reviewers designated by the chairperson.

What do I need to report on the application?

We need to know who you are and how to reach you, what question(s) your proposed research intends to answer, what risks are possible for participants, what is being done to minimize those risks, and what benefits participants will receive. We will need for you to submit a copy of the consent form(s) you will be using in the study. Please follow the general format in the IRB sample consent form in the "Application & Instructions for Researchers" link.

What does it take to get approval?

In reviewing applications, the IRB seeks to determine that:
  1. risks to participants are minimized;
  2. risks to participants are reasonable in relation to expected benefits, if any, to the participants;
  3. selection of participants is equitable, meaning that vulnerable populations are not being used unnecessarily;
  4. informed consent will be sought from each participant or the participant's legally authorized representative;
  5. informed consent will be appropriately documented, and
  6. when appropriate, the research plan makes adequate provision to protect the privacy of participants and to maintain confidentiality of data.

Do I need "Protection of Human Subjects" training?

YES. Federal regulations and guidelines require documented evidence that key personnel (IRB members, principal investigators, co-investigators, students, etc.) involved in the design, conduct, data analysis or reporting of human subject research, including exempt research, be appropriately trained in the protection of human subjects. To meet this requirement and the College's ethical standards, College of Coastal Georgia requires that all key study personnel are certified in the protection of human research subjects prior to their involvement in human subject research. For this purpose, College of Coastal Georgia works through the CITI program and requires completion of IRB 101. Click herefor more information about the CITI program.

What types of projects must faculty submit to the IRB?

The human subjects review process applies to all research involving the use of human subjects. This applies to research that is funded or unfunded; research that is undertaken by faculty, staff or students at College of Coastal Georgia; research done on the property of or using the facilities of College of Coastal Georgia; and/or research using university personnel or students as subjects.

What types of course activities do not require IRB approval, and can I make that decision?

Course activities which use human subjects (including individuals outside the classroom setting) are exempt from review as long as the purpose is purely pedagogical and the results are intended solely for use within the university community. If the results have the potential for public dissemination, IRB approval must be obtained. Anonymous classroom assessment techniques of students for the purpose of improving classroom instruction would be considered exempt from IRB review. If the activities clearly fall within these criteria then the instructor/investigator could make this determination. If the instructor/investigator is not clear on the status of the project or would prefer that the IRB decide such status of the project, the instructor/investigator can submit the proposal to the IRB for review.

Do students undertaking a project as part of a class assignment require IRB approval?

Certain types of survey research, conducted as a portion of a specific course, do not require IRB approval. This includes research where the responses of participants are not identifiable by name or description, and where the survey is seeking opinions about various topics. In cases where the participant is not asked to reveal personal experiences or behaviors, IRB approval is not necessary.

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.

My project involves a community partner. Do I need College of Coastal Georgia IRB approval?

Partnering with a community member in no way alters the College of Coastal Georgia employee's responsibility to participate in the IRB review process. All policies regarding the review and safeguards for research participants must be maintained in accordance with standard policy.

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.

Who determines that a project is exempt?

Final determination as to whether a research project is exempt from IRB review is determined during the Technical Review process following initial submission to the IRB.

What happens if my IRB application is not approved?

You are not authorized to start your project, but you may reapply with recommended changes.

What happens if I do not agree with the committee?

You may reapply with recommended changes.

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.

How does one differentiate confidentiality and anonymity?

Anonymity refers to study participants who cannot be identified by any means. No identifying demographic data exists when collecting the data from the survey or questionnaire. De-identified archival data and mailed or online surveys are potential examples.

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).

Consent form versus informational letters: What is the difference?

A consent form is a document signed by the participant that contains specific information so that he or she may make an informed decision as to whether to participate in the study or not. The following must be included:
  • 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
An informational letter should contain all of the content from the aforementioned list so that s/he may make an informed decision as to whether to participate in the study or not; however, a signature of the participant is not required. Informational letters are often used with anonymous surveys.

What is a certificate of confidentiality?

Confidentiality Certificates are issued by the Department of Health and Human Services (HHS) to provide special privacy protection to research subjects. This Certificate helps researchers protect the privacy of subjects against forced legal demands such as court orders and subpoenas that seek the names or other identifying characteristics of a research subject. It does not, however, prevent the need for possible disclosure in circumstances necessary to protect the subject or others from serious harm, as in cases of child abuse. Also, a researcher may not rely on a Certificate to withhold data if the subject consents to the disclosure.

Do I need IRB approval to use archival data? If yes, why?

The answer is YES. When using archival data, an investigator typically submits a request for an 'exempt' status review.

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.

If a study is being done in conjunction with another facility that has an IRB committee, which committee do you submit to first?

The order of IRB submission is not a critical issue, but final approval by the College of Coastal Georgia IRB will be contingent upon a letter of confirmation from the other institution.

Who should I contact if I have any more questions?

Although Dr. Aurora Ramos Nunez and Ms. Andrea Spivey are the chairperson and administrator of the IRB committee, respectively, any member of the IRB committee is available to assist you. Contact information can be accessed on the IRB contact page.
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