- A Guide to Informed Consent
- Tufts Health Sciences Campus Institutional Review Board – Informed Consent Form (ICF) Templates
- Tufts Health Sciences Campus Institutional Review Board – HIPAA forms, including Research Authorization Form
Helpful information
Informed consent forms and process
Data safety monitoring plans and boards
- NIH Policy for Data and Safety Monitoring
- Further Guidance on Data and Safety Monitoring for Phase I and Phase II Trials
- The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors
- Series on Developing a Data and Safety Monitoring Plan: Journal of Investigative Medicine. Vol 52(7): 2004 (available at the Hirsch Health Sciences Library)
- Considerations in Developing Data and Safety Monitoring Plans: A Framework Deborah R. Zucker. (Pages 443-445)
- Monitoring Participant Safety in Phase I and II Interventional Trials: Options and Controversies Patricia L. Hibberd, Debra L. Weiner. (Pages 446-452)
- Forming Your Phase III Trial’s Data and Safety Monitoring Board: A Perspective on Safety Janet Wittes. (Pages 453-458)
- Evaluating and Implementing Data and Safety Monitoring Plans Michael L. Terrin. (Pages 459-463)
- Role of Research Subject Advocates in the Development of Data Safety and Monitoring Plans Ricardo A. (Pages 464-465)
- A Worksheet to Aid in Developing a DSMP Deborah R. Zucker, et al (Pages 466-469).
Participant safety
- Codes and Documents regarding Research Involving Human Subjects and their Protection:
- The Nuremberg Code
- Declaration of Helsinki
- Belmont Report
Regulatory statutes regarding human subjects
- Tufts Health Sciences Campus Institutional Review Board
- Research Regulations:
- Institutional
- Tufts Medical Center Research Administration
- Tufts University Research Administration
- Federal Policy for the Protection of Human Subjects ('Common Rule')
- Food and Drug Administration (FDA) Guidances
- International Conference on Harmonisation (ICH) – International
- Institutional
- Research Regulations:
Conflicts of interest
- Tufts Medical Center Clinical Research Protocol Disclosure of Financial Interests
- Tufts Medical Center Conflict of Interest Policy
- Guidelines for Avoiding Conflicts of Interest in Multi-center Clinical Trials
- Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought
Clinical and translational research
Tufts CTSI is supported the National Center for Advancing Translational Sciences, National Institutes of Health, Grant Number UL1 TR000073. The content on these pages is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Please cite this grant any time you use Tufts CTSI resources, services and facilities.