HSRP Resources

Forms

• Annual Status Report and Renewal Application for Investigators [Word - 38 KB]

Informed Consents

• Background Information on Consent Forms [PDF - 1.3 MB]

Sample Consent Forms

• Sample Consent Youth Behavioral Risk Survey [PDF - 620 KB]
• Sample Consent Anonymous Nonsensitive Survey [PDF - 207 KB]
• Sample Consent for Diabetes Prevalence Study [PDF - 528 KB]
• Sample consent for Phase III ID Vaccine [PDF - 749 KB]
• Sample Consent Outbreak Investigation [PDF - 606 KB]
• Sample Consent Ribavirin Rx for Hantavirus [PDF - 746 KB]
• Sample Consent Sensitive Adult Survey [PDF - 1 MB]
• Consent Form Checklist [PDF - 196 KB]
• National IRB Checklist [PDF - 31 KB]
• IHS guidelines about the collection and use of research specimens [PDF - 21 KB]
• Categories of Research that may be reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure [PDF - 12 KB]
• DHHS Policy on waivers of the HIPAA Privacy Rule for Research [PDF - 64 KB]
• Multiple Project Assurance (MPA) of Compliance: IHS [PDF - 50 KB]
• Statutory Basis for Title 45 CFR 46 [PDF - 11 KB]
• Model Tribal Research Code [PDF - 62 KB]

Other Resources

• Human Research Participant Protection and FDA Regulation of Pharmaceuticals and Devices [PPT - 308 KB]
  • A presentation on 8/23/2007 by Jean Toth-Allen, Ph.D., Good Clinical Practice Program
    Office of Science and Health Coordination
    Office of the Commissioner
    Food and Drug Administration (FDA)
• Public Health Practice vs. Research [PDF - 567 KB]
  Including Cases and Guidance for Making Distinctions
  • By James G. Hodge, Jr., J.D., LL.M., Lawrence O. Gostin, J.D. and the Council of State & Territorial Epidemiologists (CSTE) Advisory Committee
• The importance of ethically-sound health research to improvements in Aboriginal health [Word - 455 KB]
  by Doris Cook
  • Doris Cook is Project Manager at the Ethics Office of the Canadian Institutes of Health Research (CIHR) and is working on the development of the CIHR Guidelines for Health Research Involving Aboriginal Peoples. Doris Cook