CARAS HRPP and RAC Forms:


Ethics:

The Belmont Report

Research Ethics:  How to Treat People who Participate in Research (2010, Clinical Center Department of Bioethics, NIH)

U.S. Federal Regulations, Guidance, and Resources:

Office for Human Research Protections (OHRP), 45 CFR 46, Protection of Human Subjects

Office for Human Research Protections (OHRP), Guidance

International Compilation of Human Research Standards

National Institutes of Health (NIH), Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

Certificate of Confidentiality (National Institutes of Health)

Certificates of Confidentiality (CoCs) protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the subject consents or in a few other specific situations.



Research Design and Reporting Resources

CARAS recommends use of the Protocol Template for Behavioral and Social Science Research Involving Humans published by the NIH and directly linked below. As noted in the instructions, this protocol template can be adapted for use by investigators. This is a public resource.