Forms for Human Subjects Research

Before you download a form, please read the step-by-step procedure for getting started.

APPLICATION FOR EXEMPTION

Download Form: Application for Exemption for Human Subjects Research (DOC)

The application asks for contact information on each of the investigator(s), the title of the project, and the projected time frame for your study. Graduate students who are participating in a faculty project must be named. For student applicants, information must also be supplied about the faculty sponsor.

Specific information about procedures and your project’s risks and benefits are required. Please carefully address the following items:

  • Detailed research design
  • Prospective vs. retrospective studies
  • Data retention for future research projects
  • Informed consent
  • Anonymity and confidentiality
  • Precautions
  • Protections for subjects who are also students

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MINES MODIFICATION REQUEST

Download Form: Mines Modification Request Form (for previously exempted research) (DOC)

Principal investigators must submit a modification request form for previously exempted research when they propose any changes to the human subjects protocol or add new investigators. A brief summary of the proposed modification must explain any changes to the previously approved study. Potential risks and benefits of a study and the overall risk/benefit ratio must be re-assessed and described, if applicable.

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RECIPROCITY AGREEMENT

Download Form: IRB Authorization Agreement (DOC)

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 agreement with the other university to cede jurisdiction to the other IRB’s review and approval. This is frequently used for multi-site studies.

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APPLICATION FOR COMIRB

Download Form: Application for Protocol Review (Smart PDF, offsite)

COMIRB requires several different forms and additional information to be submitted. For assistance in determining which form you will need to complete, please contact the human subjects team.

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SAMPLE CONSENT FORMS

Download Form: CSM General Template (DOCX)

View Templates: CU Sample Consent Templates (offsite)

Download Form: World Health Organization – Qualitative StudiesPDF versionText only version (PDF)

Each consent form will need to be customized to an individual study. Be sure to include a non-technical description of the project and the interaction between the investigator(s) and the subject(s), any risks or benefits to the subject(s), the duration of the interaction, and who to contact if there are any questions. If there are multiple subject pools or separate interactions, it is often recommended to have separate consent forms. Subject consent can also be done electronically as part of a survey tool.