​Committee on Human Studies (CHS) Documents and Forms

​CHS Contact Information

Phone Number: 617-309-4329 or 617-309-4314

Fax Number: 617-309-2542

e-mail: CHS@joslin.harvard.edu

​CHS Policies and Procedures

I. Introduction
II. Committee on Human Studies
III. Initial Review of Research (by Full Committee & Expedited Review)
IV. Research that is Exempt from CHS Review
V. Continuing Review of Research (by Full Committee & Expedited Review)
VI. Studies Requiring Continuing Review More than Annually
VII. Modifications / Amendments to an Approved Study
VIII. Reporting & Review of Unanticipated Problems involving Risks to Subjects and Others
IX. Definitions of Adverse Events and Unanticipated Problems
X. Non-Compliance: Investigations and Determinations
XI. Reporting to Regulatory Agencies and/or Institutional Official
XII. Suspensions, Terminations, Administrative Closures, Investigator-Initiated Voluntary Suspension or Termination
XIII. Post-Approval Monitoring/Auditing of CHS Approved Studies
XIV. Study Files
XV. Cooperative Agreements/IRB Authorization Agreements (IAA)
XVI. Vulnerable Populations

​Human Subject Protection Education

The Joslin Diabetes Center is committed in assuring the protection of human subjects in research in accordance with the current federal regulations. On June 5, 2000, the National Institutes of Health (NIH) announced a new requirement for education in the protection of human subjects.

This requirement was implemented to bolster the Federal committment on the protection of human research participants. Due to this, all individuals involve in human subject research at Joslin must complete education on the protection of human subjects.

The Committee on Human Studies has established a Human Subject Research Education Program for Joslin personnel who are involved in human subject research. This program consists of the follow:

  • Completion of the Collaborative IRB Training Initiative (CITI) On-Line Program for Human Subject Research (instructions for CITI on-line training)
  • Completion of the Joslin In-House Human Subject Research Training Sessions

Continuing Education

Continuing education on the human subject research is required for all personnel involved in human subject research.

The CITI on-line training refresher course must be taken every 3 years as part of this continuing education.

If there is any questions, regarding the CHS Human Subject Research Requirement, contact the CHS at CHS@joslin.harvard.edu

CHS Forms and Templates

Protocol Application - Form that needs to be completed when submitting a new study for review by the CHS

Protocol Application for Medical Record/Discarded Tissue/Samples Studies - Form that needs to be completed when submitting a new study only involving the use of medical record information and/or discarded tissue/samples for review by the CHS

Consent & HIPAA Authorization Form Template - Current format for the consent & HIPAA authorization form that needs to be used when obtaining informed consent/authorization for the use of PHI from subjects to participate in research

Assent Form Template - Current format for the assent form that needs to be used when obtaining assent from children (<18 years old) to participate in research

Request to Add New Members to Study Team - Form that needs to be completed to add a new member to an approved study's team

Adverse Event Reporting Form - Form that needs to be completed when reporting an adverse event to the CHS

Protocol/Informed Consent Violation/Deviation Reporting Form - Form that needs to be completed when reporting a protocol and/or informed consent violation/deviation to the CHS

Partial Waiver of Authorization to Contact Potential Research Subjects - Form that needs to be completed to request a partial waiver of authorization to access PHI to contact potential research subjects

Partial Waiver of Authorization to Identify Potential Research Subjects - Form that needs to be completed to request a partial waiver of authorization to access PHI to identify potential research subjects

Progress Report/Termination Notice Form - Form that needs to be completed when submitting a progress report or termination notice to the CHS for a previously approved research study

Progress Report/Termination Notice Form for Medical Record/Discarded Tissue/Samples Studies - Form that needs to be completed when submitting a progress report or termination notice  to the CHS for a previously approved research study only involving the use of medical record information and/or discarded tissue/samples

Human Subject Research Determination Form - Form that needs to be completed and submitted to the CHS so a determination can be made if an activity constitutes human subject research

PI Qualifications Form - For that should be used by an Investigator to determine if it is acceptable for them to be the Principal Investigator on a human subject research study at Joslin