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Human Subjects Research

Research Integrity and Security

Resources

Each of the Mines templates linked below contain instructions in purple text that can be removed as you fill in the document.

Research Design

The research design template should be filled out for each application for human subjects research.

Sample Consent Forms

  • Informed consent template – standard consent form template to be used for human subjects research. This document also contains a section related to FERPA records as part of the research; please remove if not relevant to your study.
  • Audio/video release template – this form is recommended to be used in addition to the above standard consent form when audio or video recordings will be used in research beyond for the purpose of transcription. If recordings are only for transcription purposes, often that can be included in the standard informed consent. Please consult with the Human Subjects Research committee.

Reliance agreement

If an investigator is listed as a co-PI on a study that another university’s IRB has already approved, it may be possible for Mines to enter into a written reliance agreement with the other university to cede jurisdiction to the other IRB’s review and approval. This is frequently used for multi-site studies.

Application for COMIRB

COMIRB submissions require several different forms and additional information. For assistance in determining which form you need to complete, please contact the Human Subjects Research committee.

Human Subject Regulations Decision Charts

The Office of Human Research Protections (OHRP) provides guides for institutional review boards (IRBs), investigators, and others to aid in determining if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR 46.