Guide for the submission of a new research protocol involving human subjects
The following is a guide for the creation and submission of a new research protocol involving human subjects with the Institutional Review Board (IRB) at Griffin Hospital. There are a variety of forms that principal investigators must complete accurately in order to meet the Federal, state and hospital requirements necessary to ensure that such studies are implemented properly and that human subjects participating in research studies are adequately protected. Below are links and descriptions for all the forms needed by the IRB in order to consider your protocol. Each link is underlined. Click on the link to open a PDF that you can fill out. Save each completed form so you can submit them via email, fax or mail.
In order to have your study reviewed by the IRB in time for presentation at the IRB meeting, all completed documents must be submitted to the IRB office 2-4 weeks in advance of the scheduled meeting to permit adequate review by IRB staff. We cannot promise that documents submitted less than 2 weeks prior to the meeting will be considered at the meeting.
Please send written and electronic applications to:
Griffin Hospital Institutional Review Board
130 Division Street
Derby, CT 06418
Should you have questions regarding completion of the forms, please contact Susanne Salgado in the IRB office at email@example.com or 203-732-7569.
Brian D. Karsif, MD, MPH, FACOG
Chairman, Institutional Review Board
This form asks for the basic information regarding the study including title, date of submission to the IRB, the Griffin Hospital IRB number, and information regarding all key study personnel. You may obtain a study identification number by calling the IRB office at 203-732-1447. All future correspondence regarding this study should include reference to that number. We define 'key study personnel' as the principal investigators, all co-investigators, the project manager and anyone who will have direct contact with study subjects during the course of the study. This also includes the data manager responsible for collection and analysis of study data. The Application Face Sheet provides you with space to indicate your compliance and that of all key study personnel with the conflict of interest policy as set out in the Griffin Hospital IRB Human Subjects Research-Related Conflict of Interest form (see more information below). It also provides an area to note your completion of the Human Subjects Protection Training module provided by the Office for Human Subjects Protections. The URL for this training module is noted on the Application Face Sheet. No study will be approved by the IRB without evidence that all key study personnel have completed the tutorial. The study protocol should follow immediately after this Application Face Sheet.
This form provides you with a review of the conflict of interest policy as set out in the Griffin Hospital IRB Policies and Procedures. There is also a questionnaire that you must answer. Any 'yes' answers on this questionnaire indicate you believe you have a potential or real conflict of interest regarding the study being proposed. In this instance, you must submit documentation indicating the nature and extent of such conflicts. You are also instructed to sign where indicated on the Application Face Sheet and contact the Chairman of the IRB directly to discuss the potential conflict. The IRB committee will review the Conflict of Interest information and make a determination that it does or does not constitute a significant COI and may make recommendations regarding ways to mitigate the conflicts. Failure on the part of an investigator to provide the IRB with accurate information concerning possible conflicts of interests may constitute 'Research Misconduct' which is reported to the OHRP annually.
This provides you with the structure requested by the Griffin Hospital IRB in formatting the protocol, as well as guidance in completing the application properly. If you are planning to submit a large multi-site trial that uses a protocol created by a large sponsor, please contact IRB Chairman Brian Karsif, MD at firstname.lastname@example.org prior to creating a Griffin Hospital IRB-based protocol. In the past, we have accepted the multi-site protocols rather than mandate the PI create a new protocol just to meet our formatting requirements.
This form attests to your commitment to conduct your study as submitted to and approved by the IRB. Please remember that any changes you would like to make once the original protocol has been approved must be submitted to the IRB in the form of a request for an amendment to the study. Please do not make changes to the protocol without consulting the Chairperson of the IRB. Unauthorized alterations in the research plan may constitute 'Research Misconduct' which is reported to the OHRP annually.
This document provides you with guidance regarding the formatting of the informed consent form (ICF). Please follow the order of paragraphs noted in the guidance document. Use the sample ICF document to see an example of an informed consent form that you may use as a model. Please make certain that the title of the study, the IRB identification number, and the PI's name all appear on the first page of the ICF. If you believe that it will not be feasible to obtain informed consent from the study subjects, please contact the Chairperson of the IRB prior to submitting the protocol. You can fill out a Waiver of Informed Consent and must describe how and why your study meets the four criteria in order to be granted such a waiver. The criteria are:
- The research involves no more than minimal risk to the subjects.
- The waiver or alteration will not adversely affect the rights and welfare of the subjects.
- The research could not practicably be carried out without the waiver or alteration.
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation
This form notifies the potential subject that you will be utilizing certain pieces of their Protected Health Information (PHI) as part of the implementation of the study protocol. This document informs the subject which PHI you will be using, who will have access to this data and to whom you will be disclosing this data. You must provide the subject with a complete listing of all PHI you will need in order to conduct the study as well as a full disclosure of all the entities that will have access to their PHI. This must include the data manager if this is an outside vendor, the survey company if you are engaging the services of an outside entity to conduct your telephone surveys, the FDA if you are using drugs or devices, and the IRB. If the PHI is limited to only a few pieces of data and the entities you will be disclosing this data are minimal, you may elect to incorporate the Research Authorization as a separate paragraph within the Informed Consent Form. This is seen in the sample ICF provided. It is also possible to obtain a Waiver of Research Authorization from the IRB for use and disclosure of protected health information. To obtain this waiver, you must complete a HIPAA IRB Waiver of Authorization. You must also describe to the IRB in writing how and why you believe your study meets these criteria according to the Instructions for Waiver of HIPAA Research Authorization form. You should contact IRB Chairman Brian Karsif, MD at email@example.com directly prior to submission of your protocol application to discuss your possible submission of a request for Waiver of Research Authorization. The four criteria that must be met in order to obtain such a waiver are:
- The research could not practicably be conducted without access to and use of the protected health information.
- There is an adequate plan to protect the identifiers from improper use and disclosure.
- There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law.
- There are adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart.
This document must be completed and submitted to the IRB for review along with the Application Face Sheet, the Protocol, the Informed Consent, the Conflict of Interest Form and the Research Authorization Form. It is to be used to confirm that all the elements needed in your informed consent are present.
This is to be used if you will be asking for medical records to be pulled for your review as part of either preparation for research or during the conduct of the research.
This provides you with information regarding the procedures utilized by the Medical Records Department in providing you with charts you are requesting.
This is a sample paragraph that you may use in your informed consent to notify the potential subject that you are being compensated by the study sponsor for conducting the study. This paragraph should be revised as is appropriate to your particular circumstance.
This is an example of an informed consent that includes the Research Authorization within the ICF. It also uses the Investigator Compensation paragraph as noted in #10. This should be seen as a model that must be revised according to the specifics of your study.
12. Study Budget
You will need to submit a copy of the proposed study budget including planned expenditures on personnel, contractors, laboratory or radiology testing to be done, supplies, computer equipment and the like.
A listing of all the documents required in order for you to obtain IRB approval to conduct your study.