IRB Submission Online Tutorial

Please click here for the FY13 submission schedule

If you are planning a research project that includes the use of human subjects, then your protocol must be approved by JMU's Institutional Review Board (IRB) before you can commence the research. The steps outlined below should guide you through the IRB application process.

The first step is to complete IRB training. Please read and follow the instructions. Screen shots have been provided for your convenience. Make sure you choose the Social/Behavioral Course, Basic Course.

There are three types of reviews: Exemption, Expedited and Full Board. For more information on each review, please see the FAQs page. If you have submitted an IRB protocol in the past, please note information in the review application form has been combined into one document instead of having to choose the appropriate form. Information asked for on the form is the same, with a few additions. We have taken feedback from both the IRB and PI's and tried to incorporate all suggestions into a simpler form.

You MUST submit an electronic* copy of the form. The form must be e-mailed as an attachment to jmu_grants@jmu.edu along with the rest of your research protocol.

*Protocols must be submitted electronically in MS Word (.doc) format

Please note that the Review Request form requires signatures and therefore MUST ALSO be submitted via hard copy to the Office of Sponsored Programs (OSP). You can send the copy through campus mail to MSC 5728 or drop it off in Suite 26, JMAC-Building 6 (located behind Buffalo Wild Wings on Harrison Street.) It MUST be signed by the researcher(s) and the research advisor (if applicable). You only need to submit one hard copy. Even if your protocol is revised at any point in the process, another hard copy is not necessary.

Organizing your Research Protocol

A complete protocol should include the following elements, each of which is explained in further detail below:

• Purpose or Objective(s)
• Research Methodology
• Data Analysis
• Reporting Procedures
• Prior Relevant Experience of researcher, advisor, and/or consultants

The above items would normally be conveyed in approximately 5-10 pages total. A full literature review is not required for IRB review. Some additional attachments that may apply to your research include:

• Cover Letter(s) / Letter(s) of Consent
• Letters of Permission
• Questionnaire/Interview Questions
• Tests
• other information you deem relevant to your research.

Purpose or Objective

Please provide a summary of your research objectives in no more than one page. Keep in mind that the reviewers will weigh the value of the research and the questions to be answered against the risk of potential harm to the human subjects involved.

Research Methodology

This section should present the timeframe of your study along with the research design and sampling method. You should provide details concerning the means of collecting the research data, with particular emphasis on the risks to, and the protection of, your research subjects. Be sure to address how your method of collecting data and administering the study will protect the confidentiality of each participant. In many cases the incorporation of human subjects in the research may take place through a survey, interview, or questionnaire process. You will need to address the issue of participant consent, usually (but not always) achieved by providing consent forms that will be signed by both the subject and the investigator.

Data Analysis

This section should incorporate the researcher's means of collating, aggregating and analyzing the research data. Where human subjects are involved, the means of protecting subject confidentiality is of particular concern. Be sure to specify how data will be gathered, assessed and stored in a way that maximizes participant confidentiality.

Reporting Procedures

Reporting concerns the dissemination of the research results to both the participants and the wider public (where applicable). Please identify the audience you intend to reach in reporting your research results, as well as your intended method of distribution. You should remember to specify how you will share the research outcomes with the subjects themselves.

If research is published or publicly disseminated, the protocol is no longer eligible for exemption. This includes public presentation of the research results (i.e. conference, poster session, etc.).

Prior relevant experience of researcher, advisor, and/or consultants

The previous research experiences of the investigator, student, or student's advisor (and consultants) can have a substantial impact on the appropriate use of human subjects. Each protocol should specify how the researcher's prior experience contributes to his/her ability to carry out the research with the minimum risk to the human subjects involved.

Obtaining Consent

Templates of the following forms can be found at:
http://www.jmu.edu/sponsprog/allforms.html

Consent Forms

As an investigator, it is your responsibility to inform research subjects as to the potential risks and benefits associated with their participation in your study. You must have some means of obtaining their agreement to participate prior to the study, and a means of informing them as the study progresses. Consent must be documented in writing. More details on JMU's Policy # 1104 concerning the use of human subjects in research can be located on the JMU web site at: http://www.jmu.edu/JMUpolicy/1104.shtml

Cover Letter(s) and other Alternatives

As an alternative to the consent form, the cover letter may be a more appropriate tool for anonymous survey research. This letter conveys the purpose of the study and requests the voluntary participation of the proposed research subject. This document is signed only by the investigator, with a copy provided to the participant for future reference.

Phone Surveys:

The opening dialogue of a telephone interview should be used to obtain consent. Verbal/Oral Informed Consent

Letter(s) of Permission

There may be occasions when an investigator conducts his/her research activities outside of the JMU campus. In this instance, you should obtain a permission letter from the facility or location where you intend to conduct the research. For example, an investigator conducting a survey of elementary school students would need the permission of the principal or school board as well as the appropriate letters of consent/assent from the participants themselves.

Surveys, Questionnaires, Tests

Your protocol must include a sample of the research instrument(s) whether is consists of a survey, questionnaire, or a tentative list of interview questions. A survey or questionnaire should be systematically developed using the academic standards of the investigator's discipline or field of study. Where possible, care should be taken not to identify individual research subjects by their responses to the survey instrument. If the investigator is not conducting the survey himself/herself, then the research protocol should specify how those conducting the survey will be trained.

Internal Review Process

Once we receive your electronic Review Request, OSP will review it to check for any errors, make edits, and/or provide suggestions. Although the OSP does not approve the protocols, we are in a position to see the types of issues that cause them to be returned for additional changes. As a service to you, we try to make sure that each protocol is submitted without any missing information in order to maximize your chances for a speedy review.

Reviewers are given five business days to review each protocol.

Please note you will not receive approval until a hard copy signed by the researcher(s) and the research advisor (if applicable) is submitted and the IRB training completed by all responsible researchers and the research advisor (if applicable). Without a signed hard copy or completed training we cannot move forward with the approval process. Please complete both as early on as possible to avoid any unnecessary delays.

Once your protocol is approved you will receive an approval email followed by the IRB Approval Memo, with copy of Action of the Board (AOB) signed by IRB chair. Please save the AOB for your records.

Please submit a Follow-up Report for Research Project within 30 days of your project end date. Multi-year projects will need to be submitted annually. Although the IRB office sends reminders, it is ultimately your responsibility to submit the continuing review report in a timely fashion to ensure there is no lapse in IRB approval.

If you have any questions or concerns about training, how to prepare your protocol, the type of form(s) to use, or the review process, please do not hesitate to call the OSP at 540-568-6872 or send an email to jmu_grants@jmu.edu.