Federal/External Regulations & Guidelines
DHHS Human Subjects Regulations (45 CFR 46)
(contains list of Exempt categories in 46.101)
List of Expedited Review Categories (via OHRP Web Site)
Informed Consent Checklist (via OHRP Web Site)
FDA IRB Regulations
NIH Guidance: Inclusion of Children in Research
NIH Guidance: Inclusion of Women/Minorities in Research
National Bioethics Advisory Commission (incl. report on Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity, December 1998)
Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the Belmont Report)
The Declaration of Helsinki
Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English
OHRP Guidance: Conflicts of Interest
OHRP and NIH Guidance on Certificates of Confidentiality
Additional OHRP guidance on numerous topics
WSU Federalwide Assurance
[as required by 45 CFR 46]. To search for WSU Federalwide Assurance, please enter the following information at the Assurance site (exactly as written):
- Institution name: Wright State U
- Assurance no. 00002427
for additional information concerning protocols reviewed by an external Institutional Review Board (IRB]).
New Petitions Available for Researchers Performing Human Subjects Research (effective January 2014):
Full Medical Petition--Use this petition when your research involves treatment or medical studies that will require full IRB approval. This petition is similar to the petition that has been used for many years by the IRB for all studies.
Chart Review Petition--Use this petition when requesting approval of medical research limited to retrospective chart/electronic medical record reviews (or when reviewing publicly available datasets). This petition is to be used when consent will NOT be obtained from the research subjects.
Blood Collection Petition--Use this petition when the human component of your research is limited to the collection of blood samples from your subjects.
Social, Educational and Behavioral Research Petition--Use this petition may be used when requesting review for nonmedical studies involving human subjects. This petition should NOT be used when protected health information is being collected as part of the research, or when genetic testing is being performed that can be linked back to the subject in any way.
Humanitarian Use Device (HUD) Petition--This petition should be used when requesting review for approval of a Humanitarian Use Device. Although use of an HUD is not considered research, the FDA requires IRB approval prior to ongoing use of the device.
for information on avoiding common mistakes. Return completed petitions to Robyn Wilks, IRB Coordinator, 201J University Hall.
Human Subject Regulations Decision Charts [Provided as a guide to decide if an activity is research involving human subjects that must be reviewed by an IRB].
Categories of Exemption
[Please attach this document to your Petition for Approval of Research Involving Human Subjects.]
Form for Requesting Modification/Amendment of an existing protocol.
Instructions for completing the Modification/Amendment form.
Checklist for Submission of Human Subjects Petition
[provided as a guide; not a required form]
New Protocol Review Checklist
[provided as a guide; not a required form]
Required Elements of Informed Consent [provided as a guide; not a required form]
Continuing review petition: full board (protocols numbered HSP___) and
Expedited Review Advisory Committee (protocols numbered SC___) versions [Use these
documents to request renewal of human subjects use approval beyond current expiration date; recommend right-clicking and
selecting "save as", then opening in Word, rather than opening directly in your browser]
Instructions for completion of Expedited Review Advisory Committee Continuing Review: Print the form, sign the last page and attach the current Informed Consent document (if applicable). If there have been changes to any surveys, questionnaires or data collection instruments that are used in conjunction with this study, include these in the submission. The original submission should be single-sided documents. Include three (3) double-sided, collated copies for the members of the Expedited Review Advisory Committee to review prior to the meeting in which the studen will be presented. Any Continuing Review paperwork submitted incorrectly, will be returned.
IRB Charter and Standard Operating Procedures [IRB Guidelines]
Informed Consent/Cover Letter Template Updates (effective January 2014):
Medical Research Informed Consent Document
Medical Research Assent Form
Social and Behavioral Research Informed Consent Document
Social and Behavioral Research Informed Consent Cover Letter
Social and Behavioral Research Assent Form
Specimen Collection Informed Consent Document
Guidance on the Genetic Information Nondiscrimination Act (GINA)
Form for Reporting Adverse or Unexpected Events
Final Study Close-out Report Form
Schedule of IRB Full Board meetings:
Recommendations on how to avoid common mistakes
when petitioning for Expedited Review
Guidelines on advertising to recruit study subjects
Guidelines on paying study subjects
Guidelines on re-consenting study subjects
Guideline on use of sponsor name in consent forms
Form for Requesting IRB Authorization Agreement
Composition of the WSU IRB
WSU is pleased to offer on-line human subjects protection training for any interested faculty, staff, or student member, including Principal Investigators,
other key personnel on projects involving human subjects, and IRB members. This training is available through the
Collaborative Institutional Training Initiative (CITI). At the log-in page, either click on "New Users - Register Here" or,
if you're already registered, enter your username and password. The succeeding forms to be filled out are fairly self-explanatory.