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IRB Submissions Made Simple

Institutional Review Boards (IRBs) are mandated by the federal government to oversee all human subject research, be it clinical or laboratory. There are specific rules and regulations that must be followed regarding research. The IRB reviews each aspect of your research project to ensure it complies with these rules and regulation, most of which are federally mandated, but a few are locally mandated (http://www.lsuhsc.edu/no/Administration/rs/irb/ ). The reviewers will look at the science behind your proposal as well as the safety issues. Basically, they are trying to make sure the risks involved with any research do not outweigh the potential benefits to the subjects.

One thing to keep in mind, you need the IRB to conduct research. The IRB is a regulatory body who answers to the FDA, OHRP and LSUHSC Chancellor. They follow the rules and regulations and will insist that you do as well.

Remember: any change to the any part of the study, regardless of how minor, must be approved by the IRB prior to implementation.

*You must complete the Collaborative Institutional Training Initiative (CITI) web based training program in human research subjects protections http://www.citiprogram.org/default.asp?language=english and have read the IRB website (http://www.lsuhsc.edu/no/Administration/rs/irb/ ) in order to be an investigator on a clinical trial. The courses that you must take will depend on the type of research that you are involved with. There are page by page instructions for this on the LSU IRB website, http://www.lsuhsc.edu/no/administration/rs/irb/CITI%20Instructions.pdf. This is mandatory for everyone involved in research from the investigators down to the assistants.

General Submission Information
IRB meetings are the third Wednesday of each month. The deadline for submissions is always the last working Wednesday of the month prior to the next IRB meeting. Documents may be turned in at any time and will be processed for the next available meeting.

All other submissions must include a cover letter summarizing the submission along with one (1) copy of each item.

New Study Submissions
(If you are a student, Resident or Fellow, LSUHSC administration requires that a faculty mentor serve as the Principal Investigator)

Each new study submission must include a cover letter (see sample) listing the PI, the title of the proposal, and each item included for review: two (2) copies of the application (1 original), protocol with version date or number in the header or footer, the consent form with version date, HIPAA consent form, and any recruitment materials. One (1) copy of the Investigators Brochure must be submitted (if applicable). Make sure the title on the application, the protocol and the informed consent forms match. You might consider adding the contact information for your research coordinator to the cover letter.

Informed consent forms must be written in second-person narrative. Please use the consent checklist for each part of the consent

Complete all parts of the Application Form:

• Page 1: Each box must be filled in. The PI, each investigator and the head of the department must sign (Charles Sanders, MD for Medicine).
• Page 2 and on: Make sure that you have sufficient background information to support your proposal. The literature search must be current as the IRB reviewer will be looking into it. Your study summary should clearly state the design and how the study will be conducted. You will need to list all risks and possible benefits of this proposal.

After the IRB reviews your application, the board will send you the results of the review, which is usually an itemized list of the changes or clarifications needed. It can take up to two (2) weeks to receive your letter.

For studies that are “approved with changes,” you should respond to the IRB’s concerns as soon as possible. The sooner you respond and submit the appropriate information, the sooner your final approval can be granted. Make sure you submit a cover letter outlining what the concerns were and how you corrected them. Your revised protocol and/or consent must be submitted with the updated version date in either the header or footer. You must submit one copy with the changes highlighted and another that is clean. Final approval takes about three (3) weeks after you have submitted changes that address each of the IRB’s concerns.

The IRB contact person regarding new studies is Charlene Walvoord, MLS, CIP, CIM. (CWalvo@lsuhsc.edu) at 504-568-4060.

IBC review is required of all research projects including survey or chart review studies (this will confirm that the project is exempt from further IBC review). No new IRB applications will be given final approval until IBC approval has been received. This application should be sent to Dr. James Thompson, Chair, LSUHSC-NO IBC (jthomp@lsuhsc.edu).

Amendments
Any changes, no matter how minor, to any part of your study require an amendment for that portion of the study. Make sure you submit a cover letter that includes the IRB#, the study title, and the reason for amendment (sample cover letter).

Protocol amendments:  Submit a complete summary of changes to the protocol. The IRB’s approval of the revision is based on the changes you are requesting. Make sure you change the version date on your protocol.

Informed Consent Form revisions:  Submit a cover letter describing all changes to the consent and the reason for these changes. State the reason for the revision (new risk, sponsor requested, etc.). Submit one copy of the consent with the changes highlighted and another, clean copy. Make sure you change the consent revision date in the header or footer. You must use the current approved consent.

Recruitments material/Subject material: send a cover letter summarizing the changes. Attach the revised item for review.

Investigator’s Brochures:  Attach a cover letter stating what is being submitted and why. In the cover letter you must state whether or not this revision affects the consent form. If so, see consent form revisions above.

The person to contact for any sort of amendment is Sylvia Young, MA (syoung3@lsuhsc.edu) at 504-568-3779.

Annual Re-approval Process
It is federally mandated that IRBs reapprove a study at least once every 365 days. It is your responsibility to know when your study will expire, but the IRB usually sends you an email notice reminding you to file your application about two (2) months prior to expiration.

Make certain you answer each question on the application including the IRB#, title, and PI name at the top. The form must be signed and submitted with a cover letter summarizing the study and why it should remain open (sample cover letter), supporting documents, such as publications, a list of serious adverse events that have been submitted to the IRB during the year, and a copy of your current consent form.

The IRB will re-review the entire study. They may ask you for a consent revision before your final annual re-approval is granted.

If you do not submit the re-approval application, you are out of compliance and your study records will be moved to the inactive files. If want to continue the study, you will have to re-apply to the IRB as a new study. In order to avoid this, make sure you submit the re-approval application in a timely fashion.

The person to contact for annual re-approval is Linda Bernhard Potter, MA (LBernh@lsuhsc.edu) at 504-680-9070).

Serious Adverse Effects (SAEs)
A serious adverse event (SAE) is defined as any adverse event that results in any of the following outcomes: death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or congenital anomaly/birth defect. The IRB must receive reports on all SAEs related to your protocol along with a cover letter delineating the SAEs attached (sample cover letter-non-local SAE).

For industry sponsored trials, you will receive notices regarding SAEs that happened anywhere in the world from the sponsor. You will need to transfer these to a “non-local SAE form” and send the form along with the documents sent to you from the sponsor. The PI must sign the form. This is to be an ongoing cumulative list with SAEs already reviewed at a prior submission highlighted.

For SAEs that happen to your subjects, you must complete a “local SAE form”. You must report any hospitalization and any death regardless of the relationship to your study if the subject continues on protocol. Examples of SAEs may be recurrence of illness, serious side effects of drugs, secondary cancers, out of range lab values that are clinically significant, etc. If subjects are followed only for survival data, they are still on protocol and SAEs must be reported. The PI must sign this form. Attach a cover letter summarizing the local SAE and how it affects other local subjects (sample cover letter).

All SAEs must be submitted in writing on the LSUHSC-NO SAE form within 5 working days. Fatal and life-threatening local events must be reported within 48 hours.

The person to contact for SAEs is Sylvia Young, MA (syoung3@lsuhsc.edu) at 504-568-3779.

Protocol Violations/Deviations
A protocol is “a detailed study plan which specifies how a study will be performed.” All deviations from the protocol must be reported on a protocol violation form. Some examples of protocol violations and deviations are as follows:

• Enrolling a subject that is ineligible (Non-adherence to exclusion and inclusion criteria)
• Dosing or dispensing the wrong dosage amount
• Enrolling more subjects than you are approved to enroll
• Using an out-dated informed consent form or one that has never received IRB approval to enroll a subject into a research study.

Completion of Enrollment/Closure to Accrual
When you have finished enrolling subjects but have not finished the study, you need to inform the IRB that enrollment is closed. Make sure it is clear that only enrollment is closed; not the entire study.

Completion of Study
When you have collected all of the data necessary for a conclusion to your study; it is necessary to inform the IRB that you are closing the study. Send a letter to them stating the reason for closure, the number of subjects enrolled, any results, and any major problems that occurred due to the protocol.