FAQ

Below you will find Frequently Asked Questions (FAQs) for the GC IRB and the IRB Portal.  FAQs are grouped by related content areas:  General submission and review, Exempt status, For faculty, For students, For staff, Research with children, Research conducted online, Research conducted off-campus.  Scroll down to the appropriate section to browse available FAQs and answers. 

PLEASE NOTE THAT CONTENT IS CURRENTLY BEING UPDATED IN LINE WITH GC IRB POLICIES AND PROCEDURES AND IN LINE WITH UPCOMING CHANGES TO FEDERAL GUIDELINES (to take effect January 2019).  IF YOUR QUESTION IS NOT ANSWERED HERE (YET), PLEASE EMAIL IRB@GCSU.EDU.


General Submission and Review


A step-by-step tutorial video is available on the GC IRB Portal website.  Alternatively, you may download the “Submitting a new application” pdf guide for offline use.
First, complete or update your ethical training!  You may do so via NIH training modules (found here:  https://phrp.nihtraining.com/users/login.php) or CITI training modules (http://www.gcsu.edu/grants/citi-trainings).  At the end of the training course, a “certificate of completion” will be displayed on your computer screen (for NIH) or a completion screen with quiz scores will be displayed on your screen (for CITI).  Please save this screen as a file that can be uploaded in Portal.  Three easy ways to accomplish this (on a PC) are:

1.  Right click on the image, select “Print…”, then select “Save as PDF” in the box that says “Destination.”  You can then save the certificate as a .pdf anywhere on your computer, and then upload it into your profile on Portal. 

2.  With the certificate of completion screen showing, push “Ctrl” and “PrintScreen” at the same time.  This will copy the image that is displayed on your computer screen (aka, create a “screen  shot”).  You can then paste this image into a word document and save that document as a .doc or .pdf anywhere on your computer, and then upload it into your profile on Portal.

3.  Use a "snipping" tool to select the completion screen image, then save that image in a form uploadable to IRB Portal (e.g., pdf or various image file types).

Please note:  once uploaded to your profile, it is not required that you upload your training certificate in the “documents” tab of the submission system.

  Naturally, the actual time to approval is highly variable.  As an IRB committee, we strive to provide you with some kind of feedback on your application within one week of the Wednesday review cycle closure (see "Submission Information" page for more information about the review cycle).  From there, your approval time depends on whether revisions were requested and how quickly you complete those revisions.  With a typical application (where revisions are requested and those revisions are addressed in the first round), you should receive approval for your project within three weeks.  

(Please note that this review cycle applies to projects that qualify as expedited and exempt project; if your project requires full board review, those reviews take place in person at a convened meeting of the full IRB).

Please budget your time accordingly.  The IRB review process cannot accommodate requests to meet researchers’ own deadlines!

With a new application submission (either expedited or exempt), the most important things you can do to speed up the approval process for your research proposal are to answer all questions thoroughly and completely and to include all needed documentation relevant to your proposal.  Keep in mind that the people reviewing your proposal may not be familiar with your research area, so try to avoid acronyms and jargon that is specific to your field.  In addition, keep in mind that “Not applicable” or single sentence responses are usually not appropriate for questions on the application. 

With a revised application submission, the best way to speed up approval is to submit revisions quickly. Reviewers or IRB administrators may be able to assess that the needed changes were addressed more quickly when the application is fresh on their mind.  Also, as you might expect, addressing all requested revisions ensures that you won’t be asked to make the same change in a second round of revisions.

“Consent,” or more specifically “informed consent,” is the process through which you obtain an individual’s willingness to participate in your study.  To obtain informed consent, the participant must be an adult capable of making decisions for themselves.  Thus, any research project that plans to recruit adults 18 years of age or older must describe and document some kind of informed consent process.  For information on the Federal code of ethics guidelines on informed consent, click here:  http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116.  For a template for creating informed consent, see the “Downloadable Forms” area of the GC IRB Portal homepage. 

“Assent" is a term used to express willingness to participate in research by people who are unable to give informed consent but who are able to understand the proposed research in general, its expected risks and possible benefits, and the activities expected of them as subjects. For example, research protocols where the participants are to be children younger than 18 must describe and document an assent process.  Assent by itself is not sufficient, however. If assent is given, informed consent must still be obtained from the participant’s parents or guardian (called “parental consent”).   For information on the Federal code of ethics guidelines on assent and parental consent, click here:  http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.408.  For templates for creating parental consent and minor assent forms, see the “Downloadable Forms” area of the GC IRB Portal homepage. 

*Keep in mind that both consent and assent are not just about getting a signature for participation.  Instead, think of these processes as conversations with your potential participants.  Thus, there should be opportunity for questions and exchange.  By engaging potential participants in the research project in this way, participants are more likely to feel like “partners” in your research.

*Note that assent may also be appropriate for adults with decisional impairment and other adults unable to consent for themselves, for whom a legally authorized representative will provide informed consent.

If you are curious about the status of your project that is under IRB review, please first log in to GC IRB Portal and check the application’s status.  Sometimes applications are not fully submitted and are listed as in “draft” state; if this is the case, make sure you complete the submission process as no action can be taken when an application is in “draft” state.  If your application is listed as “with moderator” or “under review” and you are curious about the specifics of your progress, feel free to email irb @gcsu.edu and we will respond as soon as we can with details. 

Exempt Status


From an ethical standpoint, exempt status for your research project means that your research question and methods are low risk to participants and fit into one of six standardized categories of research (see the categories here: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/regulatory-t...).

From an administrative perspective, exempt status for your research project, means that your project is not subject to continuing review by the GC IRB.  Practically, this means no expiration date on the approval of your study.  You would still need to submit a modification request to IRB if you want to make any substantial changes to your study, or if you want to make any changes that change the risk to subjects or alter your exempt status.

*Please note, researchers themselves cannot determine that their research is exempt; IRB must review the project and assign exempt status.*

To determine if your research is exempt, check out these six categories of research listed below that can be exempt and see if your research fits.  *Please note, researchers themselves cannot determine that their research is exempt; IRB must review the project and assign exempt status.*
Category 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

Category 3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Category 4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Category 5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

Category 6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

see also: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/regulatory-t...   

At GCSU, many research projects qualify for exempt status under categories 1, 2, and 4.  Here are some examples of projects that would qualify under each of these categories:

--Category 1:  A professor who wants to empirically assess whether a new method of teaching is effective and enjoyed by her students, compared to her usual method.

--Category 2:  A student wants to administer an anonymous survey to assess a particular aspect of personality and how it relates to romantic relationship satisfaction. 

--Category 4:  A researcher who will be examining the Health Information National Trends Survey (HINTS) data (a publicly available dataset) for information about e-cigarette use in Georgia.

If you think your research is exempt, submit your project for review on Portal via the “exempt” function.  If your research is NOT exempt, submit your research project for review on Portal via the “expedited/full” tab.

  Begin your application in GC IRB Portal and select "yes" to the "is your research exempt?" question. This will bring up the exempt checklist for you to complete.  The exempt checklist is similar to the expedited review application, so please take care to make it complete and thorough for review, including uploading consent forms, surveys, or other documentation as neeeded in the "documents" tab.

For Faculty


It depends.  If the class assignment involves anything that fits the federal definition of “human subjects research”, then YES.   The definition of a “human subject” is:  a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.  The definition of research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” 

For example, if you assign students to survey members of the community about their opinions of local restaurants, and your students will analyze that data to make a general statement about the community’s opinions, this would be “research” and should be reviewed by IRB prior to any data being collected.  On the other hand, if you assign students this same assignment, but the intention of the assignment is as an instructional tool ONLY (you are not going to make a scientific generalization), then this is probably not considered research. 

Other examples of projects you may assign that are typically NOT considered research are:

  • Oral histories
  • Case reports
  • Journalistic investigations
  • Analyses of publicly available data
  • Sample or practice research methodologies that include fellow classmates (as long as the instructor provides ethical training in the context of the course and fellow classmates are allowed to opt out of participation).

For case-by-case questions about the work students are doing in your classes, feel free to email irb@gcsu.edu and we will discuss with you further. 

See also the definitions section of the federal code of ethics here:  https://www.hhs.gov/ohrp/regulations-and-policy/regulations/regulatory-t...

No.  Please only submit research protocols to the IRB Portal which are intended to actually collect data.  Our reviewers are strictly volunteers, so we do not want to waste their valuable time reviewing protocols that are not intended to be carried out.  If you wish to assign an IRB application as a course exercise or assignment, feel free to use blank word document version of the Portal application located in the “Forms and Templates” area of Portal.

In most cases, yes.  If you are using your students or trainees, you will need to thoroughly describe the procedures you will undertake to ensure that students DO NOT feel COERCED to participate in your research project (e.g., when you describe recruiting processes, or in the consent document that students will receive).  If the students are completing a required course assignment that you would then like to use as research data, then you must allow students to withdraw their work from research use (and how you will communicate this option must be explained to IRB and documented). 

Many kinds of data gathering in the classroom do not fit the definition of “human subjects research” (see full definition below).  For example, if a professor wishes to gather student feedback on a particular assignment to use in preparing the next course module or to inform a future semester’s course structure, this is not human subjects research, as that data is not meant to contribute to generalizable knowledge.  If you are conducting a study under the umbrella of Scholarship of Teaching and Learning, however, your data gathering with students is human subjects research and should be reviewed and approved by IRB prior to data collection. 

For case-by-case questions about the data you are gathering from students in your classes, feel free to email irb@gcsu.edu and we will discuss with you further.

Full definition of “human subjects research”:  The definition of a “human subject” is:  a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information. The definition of research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”  See also the definitions section of the federal code of ethics here:  https://www.hhs.gov/ohrp/regulations-and-policy/regulations/regulatory-t...


For Students


 


For Staff


 


Research with children


 


Research conducted online


 


Research conducted off-campus