All human subjects research requires IRB review and approval before initiation of the study. This means, for example, that you may contact a particular organization at which you would like to recruit study participants before IRB approval, but you may not make announcements about your study, post flyers or contact potential participants before obtaining approval from the IRB.
Information about review by other IRBs (deferral) (see section 5).
In order to obtain approval for your study, please follow these instructions:
- Complete training for all research team members.
- Determine what kind of IRB application to complete.
- Complete IRB application.
- Prepare recruitment materials.
- Obtain research site letters.
- Prepare informed consent documents.
- Prepare other supporting materials.
- Prepare other supporting materials in another language.
- Submit IRB application.
- Apply to IBC (Institutional Biosafety Committee), if needed.
- Consult with Export Control Officer, if needed.
Have all research team members complete required training in the protection of human subjects. (See IRB Training.
2. Determine what kind of IRB application you will need to complete. Which IRB application you complete will depend on what kind of IRB review your research study will require. The possibilities are:
(1) Exempt Review
(2) Expedited Review
(3) Full Review
(4) Developmental Approval
(5) Review by Another Organization’s IRB (Deferral Request)
Please click on any of the above links to go to the IRB Applications page, which includes more information about each of these application types.
Please ensure that you have allowed appropriate time for obtaining approval prior to beginning the human subjects research portion of your study. The following are general guidelines for the timeframes to expect from submission to approval:
- Exempt Applications - 14 days
- Expedited Applications - four weeks
- Full Review Applications - within a month after a convened meeting
- Administrative review of IRB protocols to be submitted to other IRBs - generally within three business days (must be conducted before submission to another IRB and, again, after approval by that IRB)). [Please note that collaborative work involving researchers at other organizations, especially other organizations that have their own IRBs, may require additional time due to negotiating Individual Investigator Agreements, IRB Authorization Agreements (deferral agreements), and communications with additional parties. Please contact Nalinee Patin, IRB Administrator, at (864) 656-0636 to discuss how to best manage the IRB review of collaborative research studies.]
- International research - please note that the approval of international research may require additional time due to requirements in other countries, negotiation of Individual Investigator Agreements, arranging appropriate local context reviews, and geographical and communication constraints. It is recommended you plan to submit your IRB application at least three months prior to your desired study start date. (FAQs on international research and local context review)
Factors which may delay processing/approval
- Unavailability of signatories
- Errors in applications
- Missing or incomplete documentation/training
- Delayed researcher response to requests for clarification/modification
3. Complete the appropriate IRB application. All applications are available on the Forms & Documents page to download and complete electronically. IRB forms must be typed. Researchers are encouraged not to save current forms for future use because IRB forms are updated on a regular basis. PLEASE NOTE: Protocols submitted using older (out-of-date) forms will not be accepted.
4. Prepare copies of any material you will use to recruit participants (e.g., advertisements, flyers, announcements, follow-up reminders) to submit with your application packet. See: Guidelines for advertising.
5. Begin the process of obtaining research site letters, if needed. When an investigator is conducting human subjects research at an off-campus site, the Clemson IRB requires the investigator to submit a research site letter, which provides documentation of permission to recruit subjects and/or conduct research at that location. Examples of off-campus locations include: schools, churches, civic organizations, businesses, and hospitals. More information about research site letters. Research site letters are generally not required before protocol approval, but no human subjects research at a particular site is approved until the letter for that research site is on file with the IRB.
6. Prepare informed consent documents for your potential participants/IRB review. Templates for various types of informed consent documents. Different informed consent documents are needed for different types of applications and appropriate informed consent templates are included in the sections for each type of application. What we have described below is generally true. If your research design requires other consent strategies or if you have any questions about required informed consent documents, please contact the IRB staff.
- Adult participants generally require informational letters rather than signed consent forms informational letter template.
- Studies involving minors require notification of parents that their children will be invited to participate in research. Please note that signatures on parental permission forms are generally not required for exempt studies parental permission template.
- Studies involving minors require assent of the minors, but not their signatures minor assent template.
- Studies in which individually identifiable educational records are accessed, may require signatures due to FERPA (Family Educational Rights and Privacy Act) requirements. Alternatively, it may be possible to obtain an exception from the University Registrar to the requirement for signatures more information on FERPA.
- A verbal informed consent script or abbreviated consent process may be most appropriate for your research study. If this is the case, please submit the script or text you propose to use in your study.
Expedited and Full Review Applications
- Adult participants require signed consent forms, unless this requirement is waived (see below) adult informed consent template.
- Studies involving minors require that their parents sign parental permission forms, unless this requirement is waived (see below) parental permission template.
- Minor assent forms are generally required for child participants. These forms require signatures, as age and situation appropriate minor assent template.
- A waiver of documentation is required if you will not be obtaining signatures from adult participants or parents of minor participants.
- There are certain elements of informed consent that are required by Federal regulations. These are all included in the templates given. If you wish to use an abbreviated informed consent form, the elements you wish to leave out will need to be waived.
- In very limited circumstances, informed consent may be waived altogether.
Languages other than English
- If some or all of your participants will be native speakers of a language other than English, you must ensure that informed consent is obtained in a language they are fully comfortable with.
- If this will be a language other than English, consent documents for Expedited/Full Review Applications must be submitted to the IRB with the submission packet in this other language, as well as in English.
- Additionally, the IRB will require a letter from the person who is doing the translations for this project. This letter should state that this person:
The letter should also provide contact information for the translator
- has translated (or read and edited) the materials
- believes that the materials will be understandable to the potential participants
- believes that the materials communicate the same message as is expressed in the corresponding English-language materials
- In the case of a protocol requiring full board review, it is likely that a certified translation will be required. This determination will be made by the ORC/IRB on a case-by-case basis.
7. Prepare copies of surveys, interview questions, data collection tools, and debriefing statements for submission with your application packet. All materials used for data collection or presented to participants must be reviewed by the IRB.
8. For expedited and full review protocols, all materials that will be presented to participants in languages other than English must be submitted both in English and in the other language(s). These materials must be accompanied by a letter from the person doing the translations, as described above.
9. Submit the IRB application electronically with all required supporting documents to firstname.lastname@example.org. For Expedited/Full Review Applications, submit a hardcopy with the PI and department chair signatures to IRB, Office of Research Compliance, 223 Brackett Hall. The review process can begin without signatures, but expedited/full review protocols will not be approved before receipt of these signatures.
10. If your IRB protocol involves the use of human source materials (e.g., human blood, blood components, blood products, fluids, organs, pathological specimens, diagnostic specimens, organs, tissues or cell lines of human origin), you are required to submit an IBC (Institutional Biosafety Committee) application and obtain IBC approval prior to initiation of the study. If you need assistance determining if IBC approval is necessary, please contact the IBC.
11. Faculty, students and staff should contact the Export Control Officer for assistance before:
- Agreeing to any publication restrictions or participation restrictions on research projects.
- Shipping commodities, software or technology outside of the United States.
- Sharing export controlled commodities, software or technology with a foreign person in the United States.
- Making encrypted source code or object code publically available through posting to the internet or publically available venue.
- Beginning research abroad, particularly in sanctioned or embargoed countries, such as Cuba, Iran, Syria, Sudan and North Korea.
- Providing controlled items and related technology which may require a license to a foreign person, whether you own, lease, or have borrowed these items / technology, even temporarily.
- Sharing with a foreign person any commodities, software or technology covered by an NDA (non-disclosure agreement).
For more information, please see the Export Controls website or contact the Export Control Officer.
For additional information and instructions, please contact the IRB staff.