Investigator's Responsibilities

The IRB reviews research to ensure that the federal regulations for protecting human research participants outlined in UMMC policy, the Department of Health and Human Services (DHHS) regulations (45 CFR 46) and the Food and Drug Administration (FDA) regulations (21 CFR Parts 50 & 56), as well as other requirements, are met. The University of Mississippi Medical Center's Federalwide Assurance (FWA), FWA# 00003630, awarded by the Office for Human Research Protections (OHRP) at DHHS, is a written pledge to follow federal guidelines for protecting human research participants in accordance with the principles of the Belmont Report.

All investigators must read both the Belmont Report and the UMMC FWA to understand their responsibilities in conducting research involving human participants. Both documents are available on the Human Research Office webpage and in hard copy by request from the Human Research Office. Some of the responsibilities investigators have when conducting research involving human participants are listed below.

Conducting the research

You are responsible for making sure that the research is conducted according to the IRB-approved research protocol. You are also responsible for the actions of the study's co-investigators and research staff.

Note: Research to be conducted at the VA must receive separate review and approval from the VA IRB.

Participant enrollment

You may not recruit or enroll participants prior to the IRB approval date or after the expiration date of IRB approval. All recruitment materials for any form of distribution or media use must be approved by the IRB prior to their use. If you need to recruit more participants than was noted in your IRB approval letter, you must submit an amendment requesting an increase in the number of participants.

Informed consent

Informed consent is a process that begins with the initial contact and ends at some point after the study is complete. You are responsible for the conduct of the consent process, ensuring that effective informed consent is obtained and documented using only the IRB-approved and stamped consent document(s), and for ensuring that no human participants are involved in research prior to obtaining their informed consent. Whoever is presenting the consent document to the potential participant and conducting the consent discussion must have all pertinent information at hand, be knowledgeable about the study and the disease or condition involved, if any, and have the ability and experience to answer questions regarding the study and any treatment involved.

Give all participants a signed copy of each consent or assent document they sign, and keep the originals in your secured research files for at least six (6) years. When appropriate, you should place a copy of the consent document in the participant's medical record.

Study Renewal

The IRB must review and approve all IRB-approved research protocols at intervals appropriate to the degree of risk, but not less than once per year. There is no grace period. Prior to the date on which IRB approval of the research expires, the HRO will send you two reminders to submit a Renewal 60 and 30 days prior to expiration. Although reminders are sent, it is ultimately your responsibility to submit the renewal in a timely fashion to ensure that a lapse in IRB approval does not occur. If IRB approval of your research lapses, you must stop new participant enrollment, and contact the HRO immediately.

Modifications and revisions

If you wish to amend, modify, or change any aspect of your research, including research design, interventions or procedures, number of participants, participant population, consent document, instruments, surveys, or recruitment and retention material, you must submit the amendment or revisions to the IRB for review with a request for change. You may not initiate any modifications or changes to your research without first obtaining IRB review and written approval.

The only exception is when the change is necessary to eliminate an apparent immediate hazard to participants. In that case the IRB should be immediately informed of this necessity, but the change may be implemented before obtaining IRB approval.

Unanticipated events

All adverse events that are unanticipated (unanticipated means that the event is serious,unexpected, related or possibly related to participation in the study and places participants at greater risk of harm than previously recognized) and serious protocol deviations, must be reported to the IRB within 10 business days of discovery. The only exception to this policy is death - the death of a UMMC research participant must be reported within 48 hours of discovery. Reportable events should be submitted to the IRB using the Unanticipated Problem form.

Events that do not meet the definition of an unanticipated problem involving risk to participants or others, including research-related injury occurring at a UMMC performance site or to a UMMC study participant, participant complaints, problems, minor protocol deviations, and non-compliance with the IRB's requirements for protecting human research participants should be reported as follows: Minor deviations and problems should be submitted at the time of continuing review, as instructed on the form. All other events should be reported in writing via letter or email to the IRB with sufficient detail to allow the reviewer to understand the problem and any actions taken to prevent it from happening again.

Research record keeping

At a minimum, you must keep the following research related records in a secure location for at least six years:

• IRB approved research protocol and all amendments;
• All versions of the investigator's brochure;
• All informed consent documents;
• All recruiting materials;
• All renewal applications;
• All adverse or unanticipated event reports;
• All correspondence to and from the IRB;
• All raw data.

Reports to FDA and sponsor

When you submit the required annual report to the FDA or you submit required reports to your sponsor, you must provide a copy of that report to the IRB. You may submit the report with your IRB continuing review application.

Provision of emergency medical care

When a physician provides emergency medical care to a participant without prior IRB review and approval, to the extent permitted by law, such activities will not be recognized as research and the data cannot be used in support of the research.

Final reports

When you have completed the study, (no further participant enrollment, interactions, interventions or data analysis) or stopped work on it, you must submit a closure submission to the IRB using the electronic submission system.

On-site evaluations, FDA inspections or audits

If you are notified that your research will be reviewed or audited by the FDA, OHRP, the sponsor, any other external agency or any internal group, you must inform the IRB immediately and submit all audit reports received as a result of the audit to the IRB.

If you have questions or need assistance, contact the Human Research Office at (601) 815-5016 or umcirb@umc.edu.