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Protocols and Informed Consent

The protocol is the working document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical research project as well as the background and rationale for the trial. Protocols and amendments must be approved by the Division of Microbiology and Infectious Diseases (DMID) and all the Institutional Review Boards or International Ethical Committees of record.

Informed consent refers to the process by which a volunteer confirms his or her willingness to participate in the research after having been informed of all aspects of the trial that are relevant to the volunteer’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form. Both the U.S. Department of Health and Human Services and the Food and Drug Administration (FDA) have regulations that address the informed consent process.

DMID also follows the International Conference on Harmonisation (ICH –E6) Good Clinical Practice guidelines for protocol and informed consent content.

DMID Policies

DMID Protocol Templates

Templates There are three types of protocol templates available:

  • eCTD Compliant Interventional (required for all interventional protocols, pre-formatted)
  • Greater Than Minimal Risk
  • Minimal Risk Sample Collection

Instructional Templates

These templates contain instructions and example text that can be included in your protocol. Use these as tools while developing your protocol. Do not use the template document to draft your specific protocol.

eCTD Compliant Interventional Greater than Minimal Risk Minimal Risk Sample Collection

DMID eCTD Compliant Interventional Protocol Template and Instructions

Version 2.0, Dated 10 August 2017

DMID Greater Than Minimal Risk Protocol Template

Version 3.0, Dated 26 July 2010

Minimal Risk Sample Collection Protocol Template

Version 1.0, Dated 29 November 2004

Working Shells

Use these shells to write your protocol. Refer to the Instructional Templates for instructions and example text. Insert text for your specific protocol as appropriate.

eCTD Compliant Interventional Greater than Minimal Risk Minimal Risk Sample Collection

Create a working shell by modifying the eCTD compliant protocol template.

Microsoft Word Quick Reference Guide for Preparation of eCTD Compliant Documents

For eCTD-related questions or issues, contact and your associated Regulatory Affairs Specialist

DMID Greater Than Minimal Risk Protocol Working Shell

Version 1.0, Dated 04 November 2005

Minimal Risk Sample Collection Protocol Working Shell

Version 1.0, Dated 28 September 2004

Guidances and Tools

Additional Information

  • Selected References page under
    • FDA heading 21CFR 50 for consents; 21 CFR 312. for INDs; and 21 CFR 812 for IDEs
    • Human Subjects Protections heading for 45CFR46 for consent requirements
    • International Conference on Harmonisation
  • Specimens page for Future Use of Specimens Guidance
Content last reviewed on September 21, 2017