Non-Human Subjects Research
IRB Forms
Some projects that are commonly called research are not defined as human subjects research by federal definition and do not require IRB approval. It can be challenging to determine what constitutes human subjects research. Unfortunately there is no definitive list. The definitions are intentionally broad to capture a wide range of research needs from the biomedical to social and behavioral. You will need to look at 2 federal definitions: Research and Human Subjects.
If you believe your project is does not meet one or both of these definitions you may submit a non-human subjects determination form to the IRB.
Is my project Research?
Is my research Human Subjects Research?
Is GS engaged in the Research?
Investigators conducting human subjects research must satisfy DHHS (OHRP) regulations [45 CFR Part 46] known as the Common Rule and FDA regulations [21 CFR Part 50 and 56] regarding the protection of human subjects research, as applicable. Find a comparison of FDA and DHHS regulations here
| Form Name | Additional Form Information |
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| Non-human subjects determination form | Use the form for assistance in determining if your project meets the definition of human subjects research. To minimize time and effort in review, please read the definitions on the first tab before completing this form. |
| These Items may apply to your project – even if the determination is non-human subjects | |
| Georgia Southern Survey Policy | Georgia Southern’s Policy on the distribution of surveys to faculty, staff, and students. – Not limited to Human Subjects Research |
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Sample Letter of Cooperation (LOC) Not a required format – full content required. |
If subjects are students or employees of another institution, include a written letter of cooperation from the subjects. This may be a letter or email from the institutional official’s professional address with the institutional officer and title identified in the email body. All letters of cooperation must clearly identify the investigator and project by title. (See the FAQ for additional information.) Note: If using education data obtained from school records you must include documentation of parental permission for the release of such data under the Family Educational Privacy Act (FERPA). This may be a copy of the release form, informed consent, or an assurance from the institutional official that such permission has been obtained prior to data release. |
| CITI Human Subjects Training | CITI Program training provides social/behavioral content training. Online certificate will be provided to you once the course is completed. Attach certificate or transcript to each protocol submitted. Certificates are not maintained by the IRB. Training certificates from previous submissions are not readily available. Click here for instructions. REQUIRED EACH TIME YOU APPLY. |
Non-human subjects research self determinations
Print the self determination you are claiming to maintain with your project records until data is destroyed. Use the HS number for the self determination you are claiming in recruiting information.
| Standard Determination-NEW | Scenario | ||||||||||||
| HS1000 – Quality Improvement | Use the decision logic to self assess if your project qualifies as Research, Quality Improvement or Both. – IRB approval is required for any project that is or may be research. | ||||||||||||
| Non-human subjects research
Self Determination HS1001 – Literature Review – does not constitute human subjects research or require IRB review |
Research that only collects data from published books, journals, or public facing websites that do not require a password or a data use agreement or other permission to access and where the posters have the authority to legally post the information. | ||||||||||||
| Non-human subjects research –
Self Determination HS1002 – Oral History – does not constitute human subjects research or require IRB review |
“Oral history interviews seek an in-depth account of personal experience and reflection, with sufficient time allowed for the narrators to give their story the fullness they desire. The content of oral history interviews is grounded in reflections on the past as opposed to commentary on purely contemporary events.” (Oral History Association – 2018) To claim the oral history self-determination, the interview must allow the subject (narrator) to tell their story without analysis, manipulation or content editing and be collected with fully informed consent to include consent for archiving, presentation or publication, and subsequent sharing of the collected story. Oral history projects must adhere to the principles and best practices established by the Oral History Association. Oral History Association Principles and Best Practice, https://www.oralhistory.org/about/principles-and-practices/ |
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Non-human subjects research – Self Determination HS1003 – Publicly Available Data Sets Cleared as Nonhuman Subjects Research – does not constitute human subjects research or require IRB review |
Generally researchers should submit a non-human subjects determination form or Exempt 4 IRB application for use of secondary data, however the listed data sets do not contain identifiable private information and have been granted a standing non-human subjects determination provided that the researcher does not merge any of the data sets in such a way that individuals might be identified or enhance the publicly available data set with restricted, identifiable or potentially identifiable data. Restricted data sets will require individual IRB determination or exemption and a data security plan.
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| Non-human subjects research –
Self Determination HS1004 – Market Research – does not constitute human subjects research or require IRB review |
Gathering information about customer or client needs and preferences for the purpose of improving the service provided. This information is not generalizable beyond the market. This self determination also applies to data gathered for the purposes of accreditation documentation. |
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| Non-human subjects research –
Self Determination HS1005 – De-identified pre-existing data (Does not apply to clinical data.) – does not constitute human subjects research or require IRB review (Please read full description) (Does not apply to clinical data; Waiver of Authorization may apply.) |
De-identified data: If the dataset has been stripped of all identifying information and there is no way that it could be linked back to the subjects from whom it was originally collected (through a key to a coding system or by any other means), its subsequent use by the lead researcher or another investigator would not constitute human subjects research, since it is no longer identifiable. Identifiable means the identity of the subject is known or may be readily ascertained by the investigator or associated with the information. In general, information is considered to be identifiable when it can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems, or when characteristics of the information obtained are such that by their nature a reasonably knowledgeable person could ascertain the identities of individuals. Therefore, even though a dataset may have been stripped of direct identifiers (names, addresses, student ID numbers, etc.), it may still be possible to identify an individual through a combination of other characteristics (e.g., age, gender, ethnicity, and place of employment) and may require IRB review. |
Last updated: 3/23/2022