Human Subjects Research

Resources

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.
• Informed consent FERPA template – standard consent form template to be used for human subjects research when FERPA records are part of the research.
• Audio release template – additional consent form template when only audio recordings will be used in research. This form is recommended to be used in addition to one of the above standard consent forms. If audio is being recorded only for transcription purposes, often that can be included in the informed consent without using this form. Please consult with the Human Subjects Research committee.

Reciprocity 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 reciprocity 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.