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

Study Volunteers

The safety of human subjects and success of generating meaningful date from clinical research depends on selection and retention of appropriate volunteers. The Belmont Report identifies the basic ethical principles of research involving human subjects.as: Respect for Persons, Beneficence, and Justice. The following links provide DMID policies to assist DMID staff and DMID investigators address the selection of study volunteers:

DMID Policies

• Recruitment and Retention (PDF) 
• Volunteer Participation (PDF)

Related Links

• Protocol and Informed Consent page
• Good Clinical Practice and Human Subject page
• Selected References page:
  • FDA heading for
    • Race and Ethnic Data in Clinical Trials
    • 21CFRpart 50 for Human Subjects Protections
  • Ethical Codes and Standards heading
  • Human Subjects Protections heading for
    • 45CFR46 for HHS regulations
    • OHRP for Consent, Review, and Vulnerable Populations,
    • International Conference on Harmonisation
  • E6 Good Clinical Practice
  • E-5 Ethnic Factors In The Acceptability Of Foreign Clinical Data
  • NIH heading for
    • Guideline on The Inclusion of Women and Minorities as Subjects in Clinical Research
    • Policy And Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects