Major Ethical Principles, Independent Investigational Review Board

Forms Information

Investigator/Site Application

Investigator's Responsibilities

After reviewing the study protocol and determining that the research benefit outweighs the risks involved, the IRB turns to the investigator's research context and consent process to ensure that subjects will be fully aware of the risks and the benefits and that they participate in the project voluntarily. The IRB must ensure that the Principal Investigators have the training and experience the research requires. The research site-specific information addressed in these forms is key to this review.

See our new Investigator/Site Application Form!	Investigator/Site Application Form ^* ^**
Application for Waiver of HIPAA Authorization ^* ^**	Resources: Education in Human Subject Protections Printable Version

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The Investigator / Research Site Application collects information regarding the site/principal investigator's proposed study-specific resources, documents (e.g., recruitment material and informed consent form, etc.) and process.

The signature of the primary and sub-investigators are requested on this form. Original signatures are required here. An original signature certifies that the investigator(s) will be actively involved in the research project and has made a commitment to protect the research subjects.

When submitting the application(s), investigators must:

1. Make a copy of this completed form for their own records, and

2. For the IRB, provide the following additional items:

A copy of the proposed site-specific informed consent form and any other written materials to be provided to the subjects/patients
Copies of any site-specific proposed patient recruitment materials (advertisements, patient recruitment letters, screening scripts, etc.)
A copy of the FDA Form 1572 (if applicable)
Curriculum Vitae (Principal and Sub-Investigators and Coordinators)
A copy of the Principal Investigator's current Medical License
Signed Protocol Signature Page (only if the sponsor requires that it be provided to the IRB)
Authorization letter (if site is a facility other than a private medical office)
Copies of other materials requested as appropriate in the Investigator/Study Application
Application for Waiver of HIPAA Authorization (Waiver), if necessary.

Definitions:

Authorization Letter: A signed letter from a site's institutional official, IRB chair or site director documenting the institution's or site's authorization to rely upon The Goodwyn IRB for review of a specific study(ies).

HIPAA Authorization: The HIPAA Privacy Rule requires authorization or waiver of authorization for the use or disclosure of identifiable health information for research (among other activities). The authorization form may or may not be combined with the informed consent form. [Waiver of HIPAA Authorization]

Informed consent form (site-specific): The written consent form proposed for use at each site containing site-specific information (e.g., investigator names and contact numbers, any other site-specific information or requirements).

Principal Investigator: An investigator under whose immediate direction a test drug or device is administered or dispensed to a subject.

Protocol Signature Page: Signed agreement of the investigator to conduct the trial in strict compliance with the protocol agreed to by the sponsor and , if required, by the regulatory authority(ies), and given approval by the IRB.

Sub-Investigator: Investigator-team members who may help conduct the studies but are not charged with overseeing the investigation. (Team members such as pharmacists, research coordinators, and others who do not deal directly with subjects would not be listed as sub-investigators.)

FDA Form 1572: Food and Drug Administration's Statement of Investigator agreement which documents the investigator's commitment to supervise the investigation. No standard agreement exists for device studies. Instead, the device study sponsor prepares a draft agreement and negotiates its terms with the investigator, following FDA's regulations for investigational devices.

Waiver of HIPAA Authorization: Under limited circumstances, a waiver of the requirement for HIPAA authorization for use or disclosure of private health information may be obtained from the IRB by the researcher. A waiver of authorization (or a partial waiver for patient recruitment activities) can be approved only if specific criteria have been met. [See HIPAA Authorization]

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