Yale University
Human Investigation Committee
Request for Approval of Amendment to Add or Remove
Co-Investigator(s) and Study Personnel
100 FR 11 (2014-1)
Instructions: This form should be used only to submit to the HIC requests to add or remove co- investigators
or other study personnel* from active protocols. The updated HIC application and any other study documents
incorporating requested changes should be submitted as usual to the HIC at time of reapproval unless the
personnel are individually named on the consent form (e.g., consenting personnel; medical back-up; etc.) If so,
the updated consent form must be submitted with this request.
* A separate form is available and must be used for a change in principal investigator.
HIC Protocol Number:_______________________
Date: __________________________
Title of Research Project:________________________________________________________________
Name of Principal Investigator:_____________________________________________
PI Signature:____________________________________________________________
PI Campus Address:
Email:
Phone Number:
Correspondent Name:
E-mail:
Yale Cancer Center CTO Correspondent (If
applicable) Name:
E-mail:
Please complete a new line for each addition or removal of study personnel (to extend the grid, press TAB from the last cell
in the last row of the grid, and a new row will automatically be created):
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Name – Enter the full name and degree of the person to be added to or removed from the study.
Add or Remove – Enter ‘Add’ or ‘Remove’ as appropriate for each person being added or removed from the
protocol.
Role of Personnel – Please identify the study role of the added or removed personnel: Co-Investigator, Study
Personnel, Correspondent or Consultant (see definitions in the HIC Application Instructions, p. 10, at
http://www.yale.edu/hrpp/forms-templates/biomedical.html)
HSPT Training – Has this person completed required Human Subjects Protection Training? If not completed
through Yale University, please submit copies of any certificate of completion.
HIPAA Training – Has this person completed the required HIPAA Training? If not completed through Yale
University, please submit copies of any certificate of completion.
Yale Affiliation – Please identify whether this person is a faculty member, an employee, trainee or student of
Yale University. If Yale-affiliated, please identify their position with Yale. If non-Yale-affiliated, please identify
the organization with which they are affiliated.
NetID – Please indicate the Yale researcher’s NetID. This will provide accurate information for training
completion information.
In Investigator Interests:
Do any new research personnel who are responsible for the design, conduct or reporting of this project, or any
of their family members (spouse or dependent child) have an incentive or interest, financial or otherwise, that
may affect the protection of the human subjects involved in this project, the scientific objectivity of the
research or its integrity? Note: The Principal Investigator (Project Director), upon consideration of the
individual’s role and degree of independence in carrying out the work, will determine who is responsible for
1 of 2
the design, conduct, or reporting of the research.
See Disclosures and Management of Personal Interests in Human Research
http://www.yale.edu/hrpp/policies/index.html#COI
Yes
No
Does a newly added member on the research team who is determined by you to be responsible for the design,
conduct or reporting of this research have any patent (sole right to make, use or sell an invention) or copyright
(exclusive rights to an original work) interests related to this research protocol?
Yes
No
If yes to either question above, list names of the investigator or responsible person:
The Yale University Principal Investigator, all Yale University co-investigators, and all Yale University
individuals who are responsible for the design, conduct or reporting of research must have a current financial
disclosure form on file with the University’s Conflict of Interest Office. Yale New Haven Hospital personnel
who are listed as con-investigators on a protocol with a Yale University Principal Investigator must also have
a current financial disclosure form on file with the University’s Conflict of Interest Office. If this has not been
done, the individual(s) should follow this link to the COI Office Website to complete the form:
http://www.yale.edu/coi/
NOTE: The requirement for maintaining a current disclosure form on file with the University’s Conflict of
Interest Office extends primarily to Yale University and Yale-New Haven Hospital personnel. Whether or not
they are required to maintain a disclosure form with the University’s Conflict of Interest Office, all
investigators and individuals deemed otherwise responsible by the PI who are listed on the protocol are
required to disclose to the PI any interests that are specific to this protocol.
Add or
Remove
Name
Ability to Co-Investigator, HSPT &
consent
Study Personnel, HIPAA
(check box Correspondent Training?
if Yes)
or Consultant?
Y/N/
N/A
Does this amendment add any new study locations?
If yes, list location:
2 of 2
Yes
Yale
Affiliation/nonYale Affiliation
(identify
institution)
No
NetID