Amendment Request Form
For changes to an already approved study. Not for use when requesting changes in study personnel. To add personnel, please submit a revised Personnel Roster (above) for review.
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Center or Program Grant Form
For initial and continuing review of center or program grants.
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CHS Application
For all new studies. Before completing this form, please review the CHS Application Instructions.
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Continuing Review Application
For all studies that require yearly review (those previously approved by the Full Committee or by expedited procedure). The IRB must review studies at least annually, or more frequently if warranted. Before completing this form, please review the Continuing Review Application Instructions.
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Determination of
Human Subjects Research
This form is to assist with determining if proposals meet the definition of Human Subjects Research as defined by DHHS and the FDA.
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Exemption Determination Form
This form is to assist with determining if proposals meet Exemption Criteria as defined by DHHS, OHRP and the FDA.
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File Closure Form
For when all study activities are complete (including data analysis),when the study will no longer be conducted, or when jurisdiction has transfered to another IRB.
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Form A
Information required when research participants are exposed to ionizing agents (for example; x-ray or radiopharmaceuticals).
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Form B
Information required when research participants are exposed to non-ionizing radiation (for example; MRI or ultrasound).
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Form C
Information required for studies involving Drugs or Biologics in research.
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Form D
Information required for studies involving Devices in research.
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Form E
Information required for studies involving genetic analysis.
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Form F
To request a waiver of the requirement to obtain informed consent, a required element of consent, or to document informed consent.
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IRB Review Designation Request Form
For requests to cede initial or to cede continuing review of the study to another institution's IRB. Please read about designated review before completing this form.
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Non-Compliance Report Form
For reporting non-compliance or protocol deviations.
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Personnel Roster
This is a list of all study personnel that should be on record with the CHS Office. Include with the initial or continuing application, or for changes in study personnel listed on an already approved study.
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Request for HIPAA Waiver
If unsure of HIPAA applicability, please review the federal guidelines or, view Harvard's HIPAA information.
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Sample Consent Form for Adults
To assist with creating the consent document. Please reference the Consent Inforamtion page for more inforamtion. Please note, Consent Forms must contain the required elements of informed consent.
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Translation Attestation Form
Information required for when study documents will be administered in languages other than English.
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Unanticipated Problem/Adverse Event Form
Required when reporting an adverse or unanticipated event or problem to the IRB.
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Use of
Coded Private
Information
or Biological
Specimens
For new human studies when an Investigator will use specimens or data where personally identifying information of participants is not readily ascertainable. Please view the Research Involving Private Information or Biological Specimens Decision Chart for more information. |
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