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?
Research activities, such as class projects, with the goal of providing research experience to the students; by definition, research practica are not intended to add to generalizable knowledge and thus do not meet the federal regulatory definition of research.
Does my teaching study require IRB approval?
The answer is yes, if:
- You will be using the data in your dissertation or thesis.
- The data will be published (including at the Georgia State library).
- The data will be used to create a presentation that will be given at a peer-reviewed or professional conference.
The answer is no, if:
- You will be collecting the data only to better your teaching skills.
- The data will be shared only on a casual basis with other teachers close to you.
- You will share the data only within the school.
- You will present the data only to the principal.
- You will be presenting the data only to your teacher, class members, and other Georgia Statestudents and faculty (not for a thesis or dissertation).
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 Georgia State 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?
Studies that involve secondary analysis of data generally are not considered human subjects research. Please complete the Application for Designation of Not Human Subjects Research. This application may be found in the iRIS Portal.
If you will be using a publicly available, de-identified data set, please see the policy for those data sets at Policy for Publicly Available Archival and Secondary Data
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 Georgia State 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 Georgia State 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 ReviewStudies are reviewed by a fully-convened IRB at a monthly meeting of the Board. 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.
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 that involve minimal risk to subjects and fit into an expedited review category of research (see Review Categories). These reviews are conducted on an ongoing basis.
The IRB compliance staff screen studies for exemptions. If a study fits into an exempt category of research and is low risk to subjects, it will reviewed as exempt. If the study is not found to be 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 primary review): 14 business days
Full-Committee Review (days after a monthly 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 endorsement of a department head or chair 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?
Any change to the approved study must be reviewed and approved by the IRB. A step-by-step guide on how to submit the amendment application is available at the iRIS Training Portal. Provide to the IRB all documents with a description of the change, a justification, and all documents revised or added as a result of the proposed change (i.e. consent/assent forms, recruitment letters or ads, revised protocols, questionnaires, permission letters from sites, 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?
45 CFR 46.116(a) (7) and 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, OHRP, 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.” 45 CFR46.117(b) (2) and 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 event should be reported to the IRB in no more than one week of the investigator becoming aware of the event. A step-by-step guide on how to submit the adverse event report is available at the iRIS Training Portal.
What if a study contains deception or concealment?
The board defines three types of deception or concealment in studies:
- Concealment of the hypothesis is done in a majority of studies and the board does not take this type of concealment into consideration when reviewing studies.
- Concealment of some portion of the purpose or procedures occurs when the consent form or researcher does not tell the participant all of the procedures or the true and whole purpose of the study up front. This method is often used in studies that involve race or other issues in which knowing the purpose would bias participants.
- Deception occurs when false information is told or given to participants.
If deception or concealment is used in research the following four requirements must be met:
- The concealment or deception must be justified.
- The participant should be told in the consent form that some information is being withheld.
- A debriefing must be completed after the research to give the participant the complete information.
- The participant must have the option of withdrawing his or her data after the study.
Can passive consent be used in a study?
Passive consent occurs when a person is included in research unless the participant actively objects to being in the research. This is most commonly seen when a letter is sent to parents and the child of the parent is included in the research unless the parent objects.Passive consent is not considered true consent. A waiver of consent must be justified and granted if this method is used.
Does “Action Research” require IRB approval?
Action research is a term used to describe research that is conducted by a teacher in his or her own classroom. It is often done for the purpose of improving one’s teaching or curriculum. If the activities are research and will be used for generalizable knowledge, it must be submitted for approval. A page, ‘Determining if a Classroom Activity Qualifies as Research,‘ has been created to help you determine whether or not your study is research as defined by the federal regulations.
Am I required to include every document in the list of Required Documents in iRIS?
Only documents that are relevant to your study must be uploaded in the application. Any materials, surveys, questionnaires, consent form, recruitment materials, interviews, etc, that are used must be uploaded. Documents containing information that is included in the application (i.e. lay summary, inclusion criteria, procedures) do not need to be uploaded as separate documents.