General Instructions for Preparing a Research Proposal for IRB Review

The goal of the Husson Institutional Review Board (IRB) is to assist faculty, staff, and student researchers in meeting the highest ethical and professional standards for the use of human subjects in scientific research. All those at Husson who are conducting research involving human subjects are required to obtain approval from the IRB prior to initiating a study. The IRB at Husson consists of at least 5 people from a variety of backgrounds, who read and discuss each research proposal thoroughly before determining whether to approve the project. The objective of the board is to consider both he scientific merit and the safety of the subjects involved in the proposed study in the decision-making process.

As you begin to prepare a proposal for submission to the IRB, the following instructions should clarify the process for you. If you have any questions, please do not hesitate to contact the IRB chair by phone (941-7049) or by email (siegels@my.husson.edu).

General Information about the IRB and Research

The Policy Statement for the IRB describes the rights and responsibilities of the IRB and of all researchers whose studies are approved. All researchers who submit proposals should be aware of the responsibilities of the researchers, as described in this document. Before submitting your proposal, you should read the Responsibilities of the Researcher, on page 7 of the Policy Statement.

Does your study require review?

People are sometimes unsure of whether their projects qualify as the type of research that requires approval. According to the Policy Statement, research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge. Page 10 of the Policy Statement describes the types of questions that are considered by the IRB.

NIH Tutorial

All researchers are required to complete a tutorial produced by the National Institutes of Health that covers the history of review boards, and explains the role of the review board in the research process. This tutorial is found at http://phrp.nihtraining.com/users/login.php.  Once you complete this tutorial, you will receive a certificate, with a certificate number. Keep this certificate for your future records, and submit a copy of it with your IRB proposal.

Types of research

Once you have thought about how you will structure your own research project and who your research subjects will be, you will need to determine whether your study requires "Exempt", "Expedited", or "Full Board" review. Complete descriptions of the types of research that fall into each category are found on pages 11-13 of the Policy Statement.

These terms are somewhat misleading, as an "exempt" proposal is not truly exempt from review, but includes research that involves minimal or no risk, and does not require a discussion of the board. Exempt proposals are reviewed by just one or two members of the Board. If your research qualifies as exempt, you should fill out and Exempt Status Form.

An expedited review must be submitted for research involving no more than minimal risk. It not expedited in the sense that the process is not any faster than the process for a "full board review", however the approval process does not require a discussion of the full board; a decision can be made with a meeting of at least 3 members of the board. If your research qualifies as expedited, you should fill out the Expedited Review Form.

A full board review is required for proposals that involve more than minimal risk to the subject, or where children or other vulnerable populations are involved. If your research falls into this category, you should fill out the Full Committee Review Form.

Course Research

If you are a course instructor, and are incorporating a research project into a course assignment, you should read the section on "course-related research" on page 13 of the Policy Statement in order to determine the most appropriate action for you.

Preparing your IRB Submission

Once you decide which category of research your project falls into, select the appropriate form (Exempt Status Form, Expedited Review Form, or Full Committee Review Form). Fill out the form, and follow the detailed instructions on the form. Be sure to include page numbers and line numbers on your submission (specifically the research proposal and the informed consent form), and to send the correct number of copies of the proposal to the IRB.

Research Proposal Design

Describe your proposed research according to the format provided in the webpage entitled, "Research Proposal Design". Your proposal should include all of the categories listed in this document, in the order shown, regardless of whether your proposal is qualifies as exempt, expedited, or full. Proposals that do not follow these guidelines, or are missing certain categories will be returned to the author without being reviewed. This can cause an unnecessary delay in the initiation of the research.

Informed Consent

Informed Consent means the "process through which subjects are made aware of the purpose, risks, and benefits of a specific research investigation, as well as the voluntary nature of participation in the study." It should be written in language that is comprehensible to your projected subject population, and thus should not include abbreviations or jargon specific to your field.

Typically, informed consent forms are written at a 10th grade reading level, which is documented as a Fleisch-Kincaid score. To find the reading level of your informed consent form, highlight the document, and then use the "Spelling and Grammar" function in your word program. After the program completes reviewing the full document, you will be provided with a Fleisch-Kincaid grade level. If your form is written at too high a level, you should consider simplifying your language. If your targeted subjects are college students, then you may not need to aim for a Fleisch-Kincaid grade level of 10.

You should create an informed consent form according to the format provided in the document entitled "Instructions for Preparing a Informed Consent". As with the Research Proposal Design, the Informed Consent form should follow the format shown in the Instructions document. You should pay close attention to the language that must be included in certain sections. If changes in format are necessary, please include a written explanation for any deletions, additions, or revisions prior to IRB review.

If you are submitting an exempt proposal, you may not require an informed consent form. Some types of exempt research, such as survey research, can include a statement indicating, for example, that by completing and returning the survey, the participants are implying informed consent.

If your proposal involves children, you might consider having them sign a statement of assent, even though they are not of legal age. This states that the procedures, risks, and benefits have been explained to them, and that they are in agreement about participating.

Statement of Assurance

By signing the Statement of Assurance, you are agreeing to obtain informed consent of your participants, to provide necessary reports to the IRB, to maintain appropriate documentation of your research, and to cooperate with the IRB regarding the monitoring of this project. All investigators involved in a particular study are required to sign the Statement of Assurance. This statement must be submitted with your IRB proposal.

Research Participants Rights

All research subjects should receive a copy of the Research Participants Rights document. It should directly follow the informed consent form. This document explains to subjects that their participation in the research is voluntary, and that they may withdraw from the study at any time. These documented rights assure the subjects that they can have full information about the study, the procedures, and the risks and benefits. Even though this document is not being evaluated by the IRB, we require that you include it as part of your proposal, to demonstrate that you have not neglected this statement as you are preparing to begin your research.

Financial Disclosure

For any research that involves a significant financial interest for the investigator(s), the researchers must submit a Financial Disclosure Review Form. The IRB requires documentation of any significant financial interests that the researcher, his/her spouse, or dependent children might have that might be affected by the research. For most research currently conducted at Husson, this form is not necessary.

Approval from the Dean

Once you have completed your proposal, you should submit it to your dean, along with a letter requesting his/her support for the proposed research. When you receive the letter back from the dean indicating support, include it with your proposal submission.

Submission!

Send all of the relevant documents to the chair of the IRB electronically. Please submit them all together in a single correspondence, so that it is clear to whic h proposal they belong. Also, to assist our record-keeping, please title each of the documentsusing the principle investigator's name in the document title. The documents should be submitted to Sondra Siegel, IRB chair, at siegels@my.husson.edu.

You will be informed of the date and approximate time your proposal will be discussed by the IRB. You may be invited to attend the meeting to answer any questions the committee members might have as they deliberate the scientific merit of the proposal, and determine whether the rights of the research subjects rights have been sufficiently protected.

The protocol will be reviewed by the IRB, which will assess the scientific merit of the study and the protection of the human subjects. You will receive a letter from the IRB within approximately one week of the review, indicating the decision of the Board. The Board can decide to 1) approve the proposal as it was submitted, 2) approve the proposal with minor modifications, 3) request a resubmission due to more major modifications, or 4) reject the proposal. It is very common for proposals to require a resubmission in order to satisfy the concerns of the IRB. With this in mind, you should submit your proposal well in advance of the date on which you need to begin your study, as the review of the resubmission will not occur until the subsequent month.

Emergency Review

Emergency Review is not a common issue here at Husson. Emergency Use is defined as "the use of a test article (e.g., investigational drug or biologic) on a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval for the use. The investigator is still required to obtain informed consent under these circumstances." Under these circumstances, a researcher should complete the Emergency Review Form, and should follow the procedures described on the form.

Periodic Review

Protocols involving human subjects are typically approved for a period of one year, beginning the date the approval is granted. At the completion of your study, you are required to submit a final report to the IRB, using the Periodic Review Form. If the study has not been completed within one year, and you would like to continue the study, a request for an extension must accompany the Periodic Review Form. It is entirely the responsibility of the researchers to comply with submission of the Periodic Review Form and the final report to the IRB. By initiating your study, you are agreeing to comply with these regulations; failure to comply may jeopardize research at Husson, as well as approval of future studies for you.