University Research Services and Administration

Frequently Asked Questions

Frequently Asked Questions (FAQs) - IRB

 

 

When can I begin my research?

Research can only begin once an approval letter is received from the IRB. Therefore, subjects should not be contacted or recruited before the approval letter is obtained.

Do students undertaking class projects need to obtain IRB approval?

If the project is research, deals with human subjects, and will add to "generalizable" knowledge (for example a publication or presentation), then the student will need to apply for IRB approval. Therefore, a graduate student who is collecting original data from human subjects that might lead to his/her thesis or dissertation being published will need to seek IRB approval.

What if I am working with frozen blood samples with no identifiers (no names or other identifiers to trace back where the samples came from), do I need to seek IRB approval ?

Yes. Research involving the study of pathological specimens requires IRB review. The research may be exempt per category 4. This type of research may need additional review by the GSU BioSafety Officer and/or Occupational and Safety Officer.

I am working with qualitative data (e.g. sexual abuse experiences); do I need to seek IRB approval?

If the project is research, deals with human subjects, and will add to generalizable knowledge (for example a publication or presentation), then you will need to apply for IRB approval. There are several members of the IRB that are familiar with qualitative research.

What about secondary data with or without identifiers?

Projects that use data on human subjects gathered in earlier projects require IRB review.
If the data are gathered by someone who has legitimate access to the records and who gives the investigator only "blinded" or de-identified data (so that the investigator is unable to identify the subjects), the level of risk is lowered and the project can mostly likely be exempt per category 2.

Do oral histories need to have IRB approval?

A decision whether oral history or other activities solely consisting of open-ended qualitative type interviews are subject to the policies and regulations outlined in an institution's Federal Wide Assurance (FWA) and HHS regulations for the protection of human research subjects (45 CFR 46) is based on the prospective intent of the investigator and the definition of "research" in 45 CFR 46: "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
Specifically, for GSU researchers, the evaluation of such activities hinges upon whether the person is engaged in the creation of "generalizable knowledge" that is, whether the activity represents a systematic investigation in which the person engaged in such activities intends to develop or contribute to generalizable knowledge. Oral history activities are designed to create a record of specific historical events and, as such, are not intended to contribute to generalizable knowledge.
It is recommended that all researchers undertaking oral history projects contact the GSU IRB Office to discuss their proposed oral history activities to ascertain whether the project requires IRB approval.

What about research at a pilot or feasibility stage?

Pilot studies and feasibility studies, including those involving only one human subject require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in applications to the IRB. Ordinarily, the data collected from subjects in a pilot/feasibility study are not used for study findings.
It must be explained to subjects during the consent process that the study is a pilot.
When the pilot study becomes a full study the PI will need to apply for IRB approval again.

What is the difference between full, expedited and exempt review?

Full-Committee Review
Studies are reviewed by a fully-convened IRB. The Board discusses the study and makes a decision about the approval of the study. This type of review is carried out for studies greater than minimal risk to subjects.
Expedited Review
Studies are reviewed by a qualified member of the IRB. This member reviews the appropriate materials and consults with the PI if necessary to come to a decision about the approval of the study. This type of review is carried out for studies which involve minimal risk to subjects and fit into an expedited review category of research (see Review Categories).
Exempt Review
The Compliance Specialist screens studies for exemptions. If a study fits into an exempt category of research and is low risk to subjects, it will be forwarded to the IRB Chair for review. If the study is not found exempt, it will need to go through expedited or full-committee review.

When will I hear from the IRB about approval of my study?

The length of time a study will take to be approved and an approval letter received depends on the type or level of review required. Listed below are approximate times for approval.

Exempt Review (from application submission to granting of exemption): 7 - 10 business days
Expedited Review (from application submission to approval): 14 business days
Full-Committee Review (days after a committee meeting): 7 days

Note on approval time: These times are averages for studies that are not assigned stipulations by the IRB or require additional information. Studies that are assigned stipulations will take an additional amount of time depending on how fast these stipulations are met and when they can be reviewed, either through expedited review or full-IRB review.

Why does the IRB require signatures of department heads on the application forms?

In keeping with the initiative in sponsored projects management at Georgia State University, the roles and responsibilities of researchers, department heads, and institutional officials are being articulated to ensure that all parties understand the extent of their responsibilities for project management. The IRB holds all projects, irrespective of funding source, to the same standards. Therefore, to ensure that the required local oversight of projects is in effect, all research projects that involve human subjects require the signature of the department head.

How do I submit a change in protocol to the IRB?

In IRBWise, select "Modification/Amendment" from the Task Drop Down Menu and complete the form.

Provide to the IRB all documents revised or added as a result of the proposed change (i.e. consent/assent forms, recruitment letters or ads, revised protocols, questionnaires, etc.).

A change in protocol will be reviewed by the same method in which the study was first reviewed, either by the full-committee or through the expedited review process unless the change is minor and can be managed through expedited review. The Compliance Officer will route changes for review through the most rapid means possible.

Who should be listed on the consent form as the contact to answer questions?

21 CFR 50.25(a) (7) requires contacts for questions about the research, the research subject's rights, and in case of a research-related injury. It does not specify whom to contact. The same person may be listed for all three. However, FDA and most IRBs believe it is better to name a knowledgeable person other than the clinical investigator as the contact for study subject rights. Having the investigator as the only contact may inhibit subjects from reporting concerns and/or possible abuses.

See the Model Informed Consent Form for more information.

How do you obtain consent from someone who speaks and understands English but cannot read?

Illiterate persons may have the consent read to them and "make their mark." The 21 CFR 50.27(b)(2) requirements for signature of a witness to the consent process and signature of the person conducting the consent interview must be followed, although a special "short form" consent need not be prepared.

When do adverse events need to be submitted to the IRB?

Principal investigators are required to report serious adverse outcomes and unexpected events involving risks to human subjects or others at the time they occur; it is unacceptable to wait until the next scheduled IRB review.

The adverse event form should be submitted electronically to the IRB office. The adverse event form is located on IRBwise at https://irbwise.gsu.edu.