Application Procedures of the IRB
All research involving human subjects on the Fort Peck Reservation must be registered in one way or another with the Institutional Review Board. Some research in which there is essentially no risk to subjects is exempt from the requirement that they be reviewed by the Board. Examples of such research are:
- Research conducted in established or commonly accepted educational settings involving normal educational practices.
- Research involving the use of educational tests, survey procedures, interview procedures, observation of public behavior, provided that the research does not deal with sensitive material such as sexual behavior, criminal behavior, substance abuse, matters affecting subject’s employability, or matters which could lead to criminal or civil litigation.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these materials are not generated at the request of the investigator and if information concerning the materials is recorded by the investigator in such a manner that the subjects cannot be identified.
If the research is believed to be exempt, the investigator should submit the form entitled Request for Designation of Research as Exempt from the Requirement of Institutional Review Board Review. These applications must be accompanied by documentation that all investigators involved in the research have received education and instruction in the protection of the rights of human subjects and the ethical conduct of human research.
For research that is not exempt, the investigator should submit copies of the standard Application Form for full committee or expedited review. These applications must be accompanied by documentation that all investigators involved in the research have received education and instruction in the protection of the rights of human subjects and the ethical conduct of human research.
- Application Form for Full Committee or Expedited Review
- Application Form for Exemption from Institutional Review Board Review
- Instructions for Writing a Human Subjects Consent Form
- Instructions for Writing a HIPAA Compliant Human Subjects Consent Form
- Guidelines for Describing Risks - Blood
- Individual Investigator Agreement