Information for Participants

Informed consent forms and process

• A Guide to Informed Consent: http://www.fda.gov/oc/ohrt/irbs/informedconsent.html
• Tufts Medical Center Elements of Informed Consent (IC)-Consent form and Research Authorization Forms
  • Tufts Medical Center SAMPLE CONSENT (ADULT): http://tnemcirb.tufts.edu/downloads/AdultICF030708.doc          
  • Tufts Medical Center SAMPLE CONSENT (MINOR): http://tnemcirb.tufts.edu/downloads/ParentGuardianPermissionForm030708.doc 
  • Tufts Medical Center SAMPLE ASSENT FORM FOR CHILDREN 7-17 YEARS OLD: http://tnemcirb.tufts.edu/downloads/MinorAssentForm030708.doc 
  • HIPAA and the Research Authorization Form (RAF): http://tnemcirb.tufts.edu/downloads/RAF031708.DOC       
• Consent Document Content: http://www.fda.gov/oc/ohrt/irbs/informedconsent.html#content     
• The IC process: http://www.fda.gov/oc/ohrt/irbs/informedconsent.html#process
• IC documentation: http://www.fda.gov/oc/ohrt/irbs/informedconsent.html#documentation      
• Special consent circumstances(ex. Non-English speaking subjects; Illiterate English speaking subjects; Assent of Children; Compensation v. waiver of subject rights): http://www.fda.gov/oc/ohrt/irbs/informedconsent.html

 

Data safety monitoring plans and boards

• NIH Policy for Data and Safety Monitoring: http://grants.nih.gov/grants/guide/notice-files/not98-084.html
• Further Guidance on Data and Safety Monitoring for Phase I and Phase II Trials  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
• On the Establishment and Operation of Clinical Trial Data Monitoring Committees  http://www.fda.gov/cber/gdlns/clindatmon.htm#2
• Series on Developing a Data and Safety Monitoring Plan: Journalof InvestigativeMedicine. Vol 52(7): 2004 (available at the HSL 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 Nuremburg Code - http://ohsr.od.nih.gov/guidelines/nuremberg.html       
• Declaration of Helsinki - http://www.wma.net/e/policy/pdf/17c.pdf
• Belmont Report-http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

 

Regulatory statutes regarding human subjects

• Tufts/Tufts Medical Center Institutional Review Board: http://tnemcirb.tufts.edu/
• Research Regulations:
  • Institutional – 
    • Tufts Medical Center: http://www.tufts-nemc.org/Research/ResearchAdministration
    • Tufts University : http://www.tufts.edu/central/research/Mission.htm    
  • Health and Human Services (NIH - The Common Rule) – United States http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
  • Food and Drug Administration (FDA) – http://www.fda.gov/opacom/morechoices/industry/guidedc.htm  http://www.fda.gov/oc/ohrt/irbs/         
  • International Conference on Harmonisation (ICH) – International http://www.ich.org/cache/compo/276-254-1.html

 

Adverse events

•  Tufts Adverse Event Reporting Form:  http://tnemcirb.tufts.edu/downloads/adrform.doc          
•  Guidance on Reporting Adverse Events to Institutional  Review Boards for NIH-Supported Multicenter Clinical Trials:      http://grants.nih.gov/grants/guide/notice-files/not99-107.html  
•  DRAFT Guidance on Reporting and Reviewing Adverse Events  and Unanticipated Problems Involving Risks to Subjects or  Others: http://www.hhs.gov/ohrp/requests/aerg.html 

 

Conflicts of interest

• Tufts Medical Center Clinical Research Protocol Disclosure of Financial Interests:       http://tnemcirb.tufts.edu/downloads/COI-IRB-protocol-disclosure-form031708.doc  
• Tufts Medical Center Conflict of Interest Disclosure Form: Objectivity in Research-Conflict of Interest form for grants
• Guidelines for Avoiding Conflicts of Interest in Multicenter Clinical Trials: http://www.nhlbi.nih.gov/funding/policies/coi-res.htm
• Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought: http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm

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