The Application Process

Please read through the following, which are the essential elements of the IRB process.

Understanding the Purpose of the Review Process

The Belmont Report explains the ethical principles and guidelines for the protection of Human Subjects during resarch. It was created on April 18, 1979 by the former United States Department of Health, Education, and Welfare-now known as Health and Human Services (HHS). It defines the following fundamental ethical principles for all human subjects:

• Respect for persons: treating all individuals with courtesy and respect and protecting their rights
• Beneficence: minimixing or avoiding risk or harm to individuals while maximizing good outcomes for humanity .
• Justice: administering all reasonable, non-exploitative, and well-considered procedures fairly.

The IRB is responsible for upholding the above three principles, which are still the basis for the HHS human subject protection regulations, by reviewing all research involving human participants before it begins. For additional details see the Purpose Page.

Required Online Training

Elms College requires Researchers/Investigators to complete the National Institute of Health's free course, entitled "Protecting Human-Research Participants". See the Training Page for details.

The NIH training is required by all Researchers/Investigators and key personnel who are engaged in human research, which includes human tissue samples or identifiable private information.

Proof of Completion
For Elms students, faculty and staff:
Upon completion of the NIH course please print out and send a copy of the completion certificate to the IRB at IRB@elms.edu. Copies of completion certificates must be handed in for all individuals engaged in the research project.

For investigators from other institutions:
Anyone who has the NIH Course, or a comparable program, at their home institution, and has a copy of their completion certificate may submit a copy to the IRB at IRB@elms.edu, in order to meet the training requirement.

Recertification
Elms College Researchers/Investigators to recertify every 3-4 years due to changes in the Federal Regulations.

Preparing a Research Proposal

When you have completed the NIH training course, please complete and submit the IRB Application Form.

The questions on the application form will provide the IRB with the needed information about your research project to ensure that all policies and regulations are being observed, in order to protect the rights of the research participants. The form consists of three parts:

1. Personnel Information: requests information about the individual(s) conducting the research
2. Project Information, part 1: requests general information about the research project
3. Project Information, part 2: request specific information regarding research methods.

Please answer every question in clear, concise, self-explanatory language so that IRB reviewers, who may not be familiar with your subject, will be able to understand the proposed research.

Informed Consent

Informed Consent is a very important component of your research project. Please include documentation of your Informed Consent plan with your application documents. The IRB has created samples of Informed Consent documents to assist you. The samples also include a debriefing form, which may or may not be necessary depending on your particular research.

For more information please see the Informed Consent pages.

Student Requirements

A Faculty members must agree to supervise and sign all student research projects prior to a proposal being submitted to the IRB. The Faculty member's signature confirms supervision of both the research proposal writing as well as the research topic as submitted to the IRB.

Submission

Upon completion of your research proposal please submit all documentaion to IRB@elms.edu for review. Please send all docuements as an email attachment. Documents to be included are:

1. The Application form
2. NIH Certification
3. Recruitment Statement/Informed Consent
4. Debriefing Statement
5. Other Materials (includes: handouts, advertisements, questionnaires, stimulus materials, measurements, etc.)

Review Procedures

Upon completion of the proposal documentation the IRB Committee Chair will conduct a preliminary review to determine the review status of your proposal, which will be determined within a few days of your submission. The time frame for each review status is listed below. For specific information about each status see the Categories of Risk Page.

• Exempt Review
• Expedited Review
• Full Review

Notification of Decision

The IRB will notify you as soon as the review process is completed. You will receive one of the following:

1. Approval: The IRB has given approval for the research project to be conducted and will assign your study number
2. Project doesn't meet ethical principles: There are a number of issues with the project proposal. The IRB will return application with recommendations for resubmitting the proposal.
3. Denied: Projects that are denied are found to have risks that will outweigh the potential benefits. The IRB does not give approval for this research. Reseachers/Investigators may appeal the decision. If denied proposal is denied again the research may not proceed. This decision may not be overridden by Administration.

Changes to Protocol

Please keep the IRB abreast of any changes in your contact information while your project remains active.