Form 1 (New Study)
Required for all new studies submitted for full IRB review or expedited review.
Form 2 (Drug)
Required for a new study or continuing review application that involves a drug, substance, biologic, or nutrient administered for research purposes. Ancillary or supportive drugs administered in a study require a Form 2 if the drug and dose are specified in the protocol.
Form 3 (Device)
Required for a new study and continuing review that involves a device in as part of the research study. A separate Form 3 is required for every device employed in a research study. A user manual, operations manual, etc., must be submitted for each device.
Form 4 (Research Radiation)
Required for a new study and continuing review if a research study involves radiation exposure solely for research purposes. The form must be reviewed and signed by the Radiation Safety Officer (RSO) prior to submission to the IRB office. At the time of continuing review, if the amount of radiation exposure has not changed since the Form 4 was last reviewed and signed by the RSO, a copy of the most recent RSO-signed Form 4 and a letter signed by the PI stating that there has been no change in radiation exposure may be submitted to the IRB office in place of a newly signed Form 4.
Typical Exposure Document This document lists typical effective whole body radiation doses from common medical imaging procedures, including their related increase in lifetime cancer risk and the period of natural background radiation that delivers the equivalent radiation dose.
Form 6 (Tissue Banking) Required for a new study and continuing review if a research study involves sample banking. A separate optional sample banking informed consent form (ICF) must also be submitted with Form 6.
Form 7 (Medical Record / Chart Review) Required for medical record/chart reviews only. If completed thoroughly, Form 7 is designed to eliminate the need for a separate protocol, ICF, and HIPAA documentation.
Site-Specific Appendix Required for all new and continuing review submissions if the protocol does not already detail aspects of the study as they will occur specifically at this site (e.g., consent process including who conducts the consent interview, specific location of document storage, operational details of recruitment methods). This form will typically be used for those studies that are multi-center or industry sponsored and the protocol document cannot be tailored to this site.
Request for Waiver of Research Authorization:
Databases where PHI is placed, processed and stored that are used as resources for future research require a HIPAA Research Authorization or a HIPAA Waiver. Since the definition of Research is the same under HIPAA and the Common Rule, these databases also require IRB approval. Complete a Form 7 when requesting a HIPAA Authorization or a HIPAA Waiver.
Waiver of Research Authorization Tracking Form:
This form is used to help you fulfill HIPAA accounting requirements when you are granted a research authorization waiver. If you access 50 or fewer records, you must record the names of the records you have accessed. If you access 51 or more records, you may create a profile of the study population (e.g., men over age 70 with glaucoma and a history of hypertension). In either case, it is the responsibility of the PI to report the names or profile to his/her institution’s HIPAA Privacy Officer for Research.
Data Use Agreement Form:
The Tufts Medical Center/TUHS IRB/Privacy Board may permit the use and disclosure of PHI as a Limited Data Set under a Data Use Agreement between a Data User and Tufts Medical Center/TUHS. The PI should complete the Data Use Agreement Form to ensure that the request for Limited Data Set under a Data Use Agreement includes all of the necessary information regarding the uses and disclosures. The following elements should be included in the agreement:
Establish the permitted uses and disclosures of the limited data set by the recipient, consistent with the purposes of the research.
Limits on who can use or receive the data
Requires appropriate safeguards to prevent the use or disclosure of the information other than as provided for in the data use agreement
Requires reporting of unauthorized uses or disclosures to the HIPAA Privacy Officer. This information should also be reported to the IRB.
Prohibits contacting subjects or identifying information of subjects
Review Preparatory to Research Form:
This form is required when you plan to access PHI for purposes preparatory to research (such as preparing a research protocol, assessing feasibility of a research study, developing a hypothesis, or identifying prospective participants who would meet eligibility criteria for a proposed project). The PI will confirm the following on the Review Preparatory to Research Form:
The use of the PHI is solely for purposes preparatory to research.
The review is necessary for preparation.
No PHI is removed from the covered entity during the course of the review.
Research on Decedent Form:
This form is required if you plan to conduct research on decedents (a person who has died). The PI will confirm the following on the Research on Decedent Form:
The PHI accessed is solely for research of the PHI on the decedent.
The PHI accessed is necessary for research.
Documentation of death is available upon request.
Case Report Authorization Form: This form is for use when a case report may directly or indirectly identify a patient. An analysis of more than 3 clinical cases meets the definition of research that must receive IRB approval before starting. These cases also require HIPAA authorization from the patient. Please refer to the case report policy for more information.