The MCN Institutional Review Board is a designated group that has the responsibility to review and monitor research involving human subjects. The purpose of the MCN Institutional Review Board is to assure, in advance and by periodic review, that appropriate safeguards are in place to protect the rights, safety and welfare of human research subjects, particularly migrant farmworkers and other mobile, marginalized and vulnerable populations. Such safeguards include the use of protocols and procedures that are consistent with sound research design, equitable selection of research participants, informed consent, and adequate protection of the privacy of research participants.

The MCN Institutional Review Board, consistent with federal legal requirements, will review, approve, and monitor research conducted by MCN affiliated investigators, as well as by unaffiliated investigators whose principal interest is the health status of vulnerable and medically underserved populations.

Created in 1999, the MCN IRB consists of members who are well versed in the elements of informed consent, institutional processes of research, compliance with relevant regulations and ethical guidelines as well as having a clear understanding of what is needed to work effectively with a culturally and linguistically diverse study population, emerging research issues and new researchers. The MCN IRB staff can advise researchers in the development of a research protocol that complies with standard research procedures.

Federal law requires that an IRB review and approve any research involving human subjects before data collection is initiated. For ongoing projects, an annual review is necessary as is a mid-course review if protocol changes occur or unanticipated participant risks are identified. Legally effective informed consent must be obtained from study participants, or the IRB must approve a request to waive or alter the requirements of informed consent. More information on federal requirements for the protection of human research subjects can be found at http://www.hhs.gov/ohrp/.

For more information about the IRB, check out the IRB Roles and Responsibilities.

Instructions to submit a protocol to the MCN IRB

All applications must be received by the IRB at least 2 months before the initiation of project or research activities. Once the application is submitted, the request will receive a rapid review by a member of the IRB for completeness. If judged to meet the technical requirements, the application will be forwarded to the IRB members. The IRB meets monthly and a response to the applicant is available within 45 days of acceptance of the application for review.

Prior to submitting a completed application, researchers are encouraged to contact the IRB Chair or support staff with any questions concerning the application process.

• MCN IRB Support.

If there are no additional requirements to be met by the applicant, a letter of response signed by the Chair of the IRB will be sent to the applicant for use in whatever capacity required. Should the IRB find the application incomplete, the IRB Staff will return the application for completion and resubmission.

In the event that the application is denied, the applicant will receive an explanation of the reasons for rejection. The IRB response will also include instructions for resubmitting the request if the IRB deems that a resubmitted request will be reviewed.

Projects submitted to the IRB may receive a set of recommendations that provide important advice and counsel on the protection of human subjects and the research design. We encourage all researchers to use this feature of the IRB to help ensure quality projects.

Submission Guidelines

As a part of the IRB Protocol Review, the applicant must attest to having read the summary of The Belmont Report, which clarifies ethical issues on human subject research.

Application

A complete application contains the following:

1. IRB Protocol Review Form This document must be submitted in English and the the subjects' primary language
2. Every applicant must submit a copy of the consent form for the project in the subjects' primary language and in English. If you need assistance in developing a consent form, please download a free copy of Guidelines for Informed Consent Form, a tool developed by MCN’s IRB.
3. Materials, data collection instruments, and forms for use in the project.
4. HIPAA Compliance Form
5. If the research involves drugs, devices or other active agents then the applicant must complete the Drugs, Devices and Other Active Agents Form
6. If the research involves children under 18 years of age, then the applicant must complete the Protocols with Minors as Participants
7. If the research award includes multiple organizations, then the applicant must complete the Authorization Agreement
8. To check the for completion of your application it is recommended to look at the IRB checklist. This checklist is used by the IRB members to evaluate your request.

NOTE: To request changes to an approved application, complete the Protocol Amendment Requestor to provide Research Project Review and Progress Report, complete the following Progress Report and submit via email to MCN IRB Contact.