Wright State University requires all individuals who act as investigators to complete training and credentialing requirements prior to conducting exempt or non-exempt research which involves human subjects. Investigator credentialing involves three components: completion of training in human subjects research, verification of qualifications to conduct the proposed project by providing a CV, and completion of appropriate conflicts of interest disclosures and/or training.
Training in Human Subjects Protections
This training is available through the Collaborative Institutional Training Initiative (CITI). All investigators must successfully pass the applicable courses. CITI does not have to be completed in one sitting. You may start the modules, complete some of them, and come back later. CITI knows where you stopped and will highlight the next appropriate module for you. Investigators must not let certification expire while conducting human subject research and should initiate the re-certification process at least 60 days prior to their current expiration date.
Initial certification requirements for all Wright State Biomedical investigators:
- Biomedical Research Investigators Basic Course
- IRB Vulnerable Populations - Biomedical Course (if Focusing on Vulnerable Populations Only)
- Good Clinical Practice Course (if Clinical Trial Only)
- Conflict of Interest (if Annual Disclosure Required Only)
Initial certification requirements for all Wright State Social/Behavioral investigators:
- Social/Behavioral Investigators Basic Course
- IRB Vulnerable Populations - SBE Course (if Focusing on Vulnerable Populations Only)
- Good Clinical Practice for SBE Researchers (if Clinical Trial only)
- Conflict of Interest (if Annual Disclosure Required Only)
Initial certification requirements for all Wright State HUD Clinicians:
- HUD Clinicians Course
Initial certification requirements for all investigators handling HIPAA protected data:
- Health Privacy (HIPAA) Course
**Note that if you conduct both biomedical and social/behavioral research you only need to complete the biomedical modules.**
Re-Certification Requirements - Wright State Investigators:
- Biomedical or Social/Behavioral/Educational Refresher Course - Every four years
- IRB Vulnerable Populations Course - Re-certification not required
- Biomedical or SBE Good Clinical Practice (GCP) Refresher Course - Every three years
- HUD Clinician - Re-certification not required
- Health Privacy (HIPAA) Course - Re-certification not required
- Conflict of Interest Refresher - Every four years
** Note that if you are a VA Medical Center (VAMC) or Dayton Children's Hospital (DCH) researcher, Wright State University will accept the completion of VAMC/DCH human subject training requirements in lieu of the above. **
How do I access CITI training?
For a step-by-step guide for enrolling and completing CITI training, please refer to the following:
Other Credentialing Requirements
Curriculum Vita (CV) showing your qualifications for conducting the study
In accordance with federal regulations and IRB policy, the IRB must assess whether study investigators have the necessary qualifications to conduct a proposed research study. Investigators can upload his/her CV into Cayuse in the Documents section in My Profile. Once uploaded, the CV will be accessible for all studies in which the individual is listed as an investigator and will not need to be updated for four years.
Annual COI Disclosure via Cayuse
In accordance with federal regulations and WSU policy, faculty, staff and students involved in research may be required to complete an annual conflict of interest (COI) form in Cayuse. This form is in addition to the project-specific disclosure that is embedded in the initial application for each IRB study. This form is completed once per year during the annual campaign in January and anytime an investigator becomes involved in a research project. The disclosure can be accessed in the COI Disclosures tab in My Profile in Cayuse.
For human subjects research, this form is required if any of the following apply to the project:
- Funding sponsor requires disclosure of financial conflicts of interest (e.g., federally funded or supported projects);
- Includes materials or activities regulated by the Food and Drug Administration (FDA);
- Involves collaboration with an institution outside the U.S; or
- WSU IRB determines an annual disclosure is ethically appropriate.
Scientific Merit & Resource Feasibility Review
Scientific or scholarly review is required before an Institutional Review Board (IRB) can approve a human research study, to ensure that the following regulatory criteria for approval of research are met. Regulations 45 CFR 46.111(a) and 21 CFR 56.111(a):
- Risks to participants are minimized (i) By using procedures consistent with sound research design and which do not unnecessarily expose participants to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.
All non-exempt human subjects research will require attestation for scientific merit and resource feasibility.
For studies reviewed on behalf of an external entity (e.g., Premier Health, Dayton VAMC), this attestation will be performed by the respective site research committee.
For research taking place on Wright State campus, this attestation is to be made by the appropriate department head or designee.
- Provide the appropriate department head or designee a copy of this IRB application along with all supporting materials.
- Upload a completed and signed Human Research Feasibility Attestation Form.
IRB Workshop Series
Research & Sponsored Programs (RSP) is sponsoring a series of Institutional Review Board (IRB) Training Workshops for faculty, students, and staff at Wright State University. These workshops will address relevant topics related to human subjects research and the application process. Review the IRB Workshop Series on the IRB Office SharePoint site for presentation descriptions, WebEx links, access to slides, and recordings of the presentations.
- Seeing Through the Fog: Navigating the IRB Submission Process - January 12, 2022
- Shades of Grey: Why & When is IRB Approval Required? - March 29, 2022
- Crimes of the Past: The Changing Landscape of Human Subjects Research - April 28, 2022
- Your Secret is Safe with Me: HIPAA Research Considerations – May 26th, 2022
- Informed Consent: Let me Count the Ways – June 23rd, 2022
- Seeing Through the Fog: Navigating the IRB Submission Process - Intro to Cayuse Human Ethics! - July 7, 2022
- Privacy Matters: Preserving Privacy and Data Security - TBA Fall 2023