Summary of changes to the IRB application
New study application
You may notice that some of the questions have been enhanced or worded a little differently. Please pay special attention as you go through the application. Any substantive changes or additional requirements are described below. As always, more information about the application can be found in the application assistance document.
Section II. lay summary C
This question has been broken into several separate questions to make it easier to understand and to be sure all the required information is provided. Lay Summary C asks for a description of the procedures. Lay Summary D asks who will conduct the procedures. Questions asking about the duration of participant participation and a description of where procedures will take place have been moved to the section on ‘Interaction with Human Subjects’. Questions asking about identifiable data and audio/video recording have been added to the ‘Subjects Data section’ of the application.
Section II, questions E and F:
The questions asking about international research have been enhanced.
Section III, questions G and H
Georgia State University’s IRB will not review studies involving investigational drugs or devices. If researchers plan to use a non-FDA approved drug or any investigational devices, they should contact the IRB office. The Georgia State IRB will continue to review studies involving FDA approved drugs, such as caffeine, and will review FDA approved devices, such as MRIs, treadmills, monitor, and x-rays.
Section IV, other questions A and B
Studies that involve deception or concealment typically withhold some information from the consent form. In order to approve this, the researcher must request and justify the ‘waiver of consent or waiver/alteration of the required elements of consent’.
Section III, recruitment A and B
In addition to describing the recruitment plan and any compensation, researchers will be asked to state any inclusion or exclusion criteria.
Section III, informed consent
The ‘waiver of consent’ will now be called a ‘waiver of consent or waiver/alteration of the required elements of consent’ to better reflect how it should be used. If the conditions in the federal regulations are met, the IRB can waive the requirement of obtaining consent or the IRB can approve a consent form that does not contain all of the required elements.
Section III, informed consent, question G
If the researcher is using a non- English speaking population, a translated consent form must be used. The document should be translated by a certified translator and documentation of this should be provided. In some cases in which it is not reasonable to use a certified translator, the IRB may accept a translation and a back translation. Under no circumstances should the researcher translate his/her own document. A link will be provided on the human subjects web page where local translation services may be obtained.
Section VI. attach documents
The IRB will now require the research protocol to be uploaded to the application. The research protocol should include the study title; a summary; a description that includes a rationale, objectives, methodology, and data management and analysis; ethical consideration, and references. If you are uploading a grant proposal, thesis, or dissertation that contains a research protocol, you do not need to upload an additional research protocol. The WHO has a helpful guide for writing a research protocol available on their website at the following link:http://www.who.int/rpc/research_ethics/guide_rp/en/index.html
Continuing review application
Under Continuing Review Questions a new question will be added to ask about the researcher’s risk/benefit assessment based on the study experience/results to date – “Based on the study so far, are there any changes to the risks and benefits?”
If the research protocol changes, you will be asked to upload a new research protocol. A question will also be added so changes to any documents or attachments can be described.
Study closure form
A question will be added to ask if the study was grant funded. This will assist with the tracking of grants.
Changes to exempt studies
In order to ensure that studies are properly documented, confirm that the activities still qualify as exempt, and to keep our records up-to-date, exempt studies will now be approved for 3 years. If the study will remain active after three years, a renewal application will need to be submitted. When study activities are complete, a study closure form must be submitted.
If the study is analyzing de-identified data only, please see the Application for Designation of Not Human Subjects Research
This policy will not apply to studies that have already been approved. Any approval dates already in place will not be altered. The IRB will no longer stamp the consent forms for exempt studies.
New Policies on Compensation and Lotteries, Raffles, and Other Games of Chance
The IRB has issued a new policy describing how compensation should be used in research and the information that must be provided to the IRB and to research participants. Information can be found in section 7.8 of the IRB Manual.
The new policy on Lotteries, Raffles and Other Games of Chance describes the requirements that must be met to use lotteries in research and what information must be provided to the IRB for consideration. The entire policy can be found in section 7.9 of the IRB Manual.