Agreements
For agreement templates, please refer to the respective program’s webpage.
Human Subject Protection/Informed Consent
Tutorials (or Education)
- NIH Protecting Human Research Participants
- OHRP Human Subject Assurance Training
- DHHS/NIH Human Participant Protections Tutorial for Researchers
- Human Subjects Protections Training
- NIH Policy on Required Education in the Protection of Human Research Participants
Guidelines
- DHHS Office for Human Research Protections: IRB Registration and Assurances/Declaration of Exemption (Common Rule)
- NIH Certificates of Confidentiality
Conducting a Clinical Trial
- FDA Clinical Trials and Human Subject Protection - An overview of the FDA standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.
- Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1)
- FDA Certification: Financial Interests and Arrangements of Clinical Investigator, Form 3454
- FDA Disclosure: Financial Interests and Arrangements of Clinical Investigators, Form 3455
- DHHS Handling Misconduct: Introduction
Resources for Investigators
Information on NCI Adverse Events Reporting
NCI Links
- Clinical Trials Management Resource Website
- NCI Booklet: "Taking Part in Cancer Treatment Research Studies"
- NCI Data and Safety Monitoring Guidelines (PDF, 108 KB)
- NCI R&D Resources
NIH Links
- Required Education in the Protection of Human Research Participants
- NIH Policy on Inclusion of Women and Children in Clinical Trials
Other Government Links
- The Belmont Report
- FDA Investigational New Drug (IND) Requirements
- Good Clinical Practice (GCP) in FDA-Regulated Clinical Trials
- IRB Registration and Assurance Filing
- Model Informed Consent for Storage & Use of Human Tissues