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Microbiology and Infectious Diseases Clinical Research Policies, Guidance, and Tools

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Protocol 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/Boilerplate Text

Protocol Development Tools

Study

Instructional Templates

These templates contain instructions and suggested 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.

Working Shell

Use these shells to write your protocol. Refer to the Instructional Templates for instructions and suggested text and modify the suggested text for your specific protocol as appropriate.
Interventional DMID Interventional Protocol Template
(MS Word)
DMID Interventional Template: Working Shell
(MS Word)
Greater Than Minimal Risk DMID Specimen Protocol Template: Greater Than Minimal Risk
(MS Word)
DMID Specimen Protocol Template: Greater Than Minimal Risk Working Shell
(MS Word)
Minimal Risk DMID Specimen Protocol Template: Minimal Risk
(MS Word)
DMID Specimen Protocol Template: Minimal Risk Working Shell
(MS Word)

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

Last Updated November 13, 2014