Forms, Templates, and Policies

Study Roster & CITI Training Memo

Please note that as of June 1, 2022, Click is no longer available. Until further notice, please submit hardcopy fCOI disclosure forms that may be found on the website Conflict of Interest (COI) | CHA.

We are excited to announce that the new electronic IRB submission and tracking system, Cayuse IRB/Human Ethics is now available for use by the entire CHA Research Community.

• Cayuse IRB/Human Ethics should be used for all NEW IRB submissions, including exempt determinations, expedited and full committee reviews, as well as QA/QI/Not Research determinations.
• To gain access to this new system, please submit a new user request by completing this Google Form.
• Once you have an account, you may log in with your CHA credentials: https://challiance.app.cayuse.com
• Guest Users (without CHA credentials) may log in with their Cayuse username and password: https://challiance.app.cayuse.com/guest
• Please visit the Cayuse Help Center for step by step instructions regarding how to complete a number of different tasks within the system.

We will also arrange for regular virtual office hours where you may stop by to ask any questions you may have.

IRB Application Guidance

These guides help researchers understand human research responsibilities and give insight on the application process:

• IRB Responsibilities
• PI Responsibilities
• Revised Protocol Development Guidance

IRB Policies and Guidance Documents

• IRB Operations Manual - policies and procedures of the IRB
• Informed Consent Process
• Policy Memo About Case Reports
• OHRP 2019 Edition of the International Compilation of Human Research Standards - international research reference of laws, regulations, and guidelines for 133 countries as well as standards issued by a number of international and regional organizations.
• Reporting to the IRB of Adverse Events and Unanticipated Problems Involving Risks to Study Participants or Others
• Is an activity human research and does it require IRB review?
  
  • Research vs. Quality Improvement - policy; also see QI vs. Research webpage for guidance and interpretation
  • OHRP Guidance on Engagement of Institutions in Human Subjects Research
  • OHRP Guidance on Research Involving Coded Private Information or Biological Specimens
  • CHA decision chart on whether an activity is human subject research
  • Use of Publicly Available, De-identified Data Sets for Research
  • OHRP Human subject Regulations Decision Charts

Section I below lists the most common documents related to new study submissions. If you currently have an active protocol refer to section II. All other forms and templates are in the last section.

I. New Protocol Applications Forms and Resources

• Harvard Catalyst: An Investigator's Guide to Research Data Management Practices
• IRB Conflict of Interest Form - to be completed by study team members who are not HMS faculty, and are not study team members of a PHS-funded human research study.
• Department Review Form - required for all new expedited and greater than minimal risk studies
• Revised Protocol Template for Researchers - a general guide/template to help researchers ensure that the minimum required information is present for IRB review. The document is only a guide; please use in conjunction with the Protocol Development Guidance document above.

II. Previously Approved Applications

Forms to be used to request approval for a change to a previously approved study.

• Revised Amendment/modification to an IRB-approved study
• Revised Continuing Review Application
  
  • Harvard Catalyst Reliance Agreement Continuing Review Supplement - required when CHA is the IRB of record for an institution that is a member of the Harvard Catalyst
  • NON-Harvard IRB Authorization Agreement Continuing Review Supplement - required when CHA is the IRB of record for an institution that is NOT a member of the Harvard Catlyst
• Revised Termination Form

III. Consent and Assent Forms

• Revised Informed Consent Template - English (adults)
• Assent Form Template - English (5 to 7 years old)
• Assent Form Template - English (8 to 10 years old)
• Assent Form Template - English (11 to 13 years old)
• Assent Form Template - English (14 to 17 years old)
• English Short Form
• Haitian Creole Short Form
• Portuguese Short Form
• Spanish Short Form
• Nepali Short Form
• Vietnamese Short Form

Other Forms

• HIPAA Data Use Agreement -- for HIPAA Limited Data Set
• HIPAA waiver tracking/accounting (Staffnet access required)
• Serious Adverse Event (SAE) Report Form
• Business Associate Agreement

• Research Participant Brochures (Harvard Catalyst) - a variety of brochures (available in more than 15 languages) that provide useful information to prospective participants on a range of research topics, including:
  
  • Should I be a research subject?
  • Research Subject Bill of Rights
  • Social and Behavioral Research
  • CT Scans for Research
  • MRI Scans for Research
  • PET Scans for Research
  • Surrogate Decision-Making in Health Research

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