IRB Submission Online Tutorial

Please click here for the FY09 submission schedule

1. Complete IRB training modules 1-3. Proceed to module 4 -- it will test your knowledge and allow you to submit your responses for scoring.
2. For a guide to Exemption eligibility and how to file an exemption request please see the Research Protocol Exemption Guide. If you are eligible for exemption, complete and submit the Human Research Review Request Form - Exemption Template.
3. For Full or Expedited review, complete and submit the Human Research Review Request Form. For further assistance in completing the Request Form please reference the links below and the Protocol Review Example Guide.
4. Please note that the Review Request forms contain signatures and therefore MUST be submitted via hard copy to OSPA, MSC 5728. You must also submit an electronic copy of each form without signatures. The form(s) must be E-mailed to jmu_grants@jmu.edu along with the rest of your research protocol.
5. Assemble a Research Protocol for IRB Review (more guidance below).
6. Electronically Submit Protocol and Completed IRB Checklist to the Office of Sponsored Programs Administration
7. Internal Review Process (plan for a minimum of 3 weeks)
8. IRB Evaluators Approve: Proceed to Step 10.
9. IRB Evaluators Request Changes: Make requested changes and RESUBMIT revised protocol to Office of Sponsored Programs Administration
10. Receive IRB Approval Memo, with copy of Action of the Board signed by IRB chair (save for your records)
11. Submit a Follow-up Report for Research Project within 15 days of project end date. (multi-year projects submit annually).

Organizing your Research Protocol

• 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. (example)   More about consent can be found on the OSP web site under IRB Training.

JMU students must include the approval of their faculty supervisor with their research protocol.

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

Please refer to the IRB forms located at: http://www.jmu.edu/sponsprog/allforms.html

Consent Forms (NEW: Tips for Constructing a Consent Form)

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. Sample Script

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.

You can submit proposals to the IRB in one of two ways*:

• Drop off an electronic copy of your complete proposal (checklist and protocol) to the Office of Sponsored Programs Administration in Suite 26, JMAC- Building 6 (James Madison Administration Complex), formerly Medical Arts West
• Email your combined protocol as a file attachment to jmu_grants@jmu.edu

* note: Protocol must be submitted electronically in MS Word (.doc) format