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
Additional resources for investigators:
|
University Documents
WSU Federalwide Assurance
[as required by 45 CFR 46] [click here
for additional information concerning protocols reviewed by an external IRB]
Petition for Approval of Research Involving Human Subjects [Use this
document to request initial approval for human subjects use in research. Note: this petition has been updated effective September 2013.] [click here
for information on avoiding common mistakes]. Return completed petitions to Robyn Wilks, IRB Coordinator, 201J University Hall.
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 9 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]
Cover Letter/Consent Form Guidelines [HIPAA-compliant with sample wording for GINA]
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.
|
