- Submission and Reviews
IRB meetings are scheduled each week on Wednesday evenings. All study materials must be received by our office before the end of business day on Thursday prior to the meeting date to be guaranteed review. The submission must be complete in order to meet the Thursday deadline. If BioMed receives a submission on Thursday that is not sufficiently complete to meet the deadline, you will be notified by Friday. For complete submissions that meet the deadline, standard turn around is 3-4 days for full committee review.
Administrative amendments, advertisements, additional facilities, and Sub-Investigators can often be reviewed under expedited review. Our standard review of submissions, which qualify for expedited review, will take approximately 2-3 days.
Following the meeting, necessary consent revisions will be made by our staff. Approval documents will be mailed to you promptly. If your study protocol and/or informed consent are disapproved, either the Chairman or IRB Administrator will contact you. You will be informed of the reasons for disapproval and suggestions for re-submission. Otherwise, your approval documentation will be generated and mailed in a timely manner.
The following items must be received to complete a full review of a study:
- BioMed New Study Submittal Application. Click here for forms.
- Protocol (or Protocol Signature Page for subsequent submissions)
- Investigator Drug Brochure, if applicable
- Informed Consent Document (emailed or uploaded)
- FDA FORM 1572 (or equivalent, i.e., locations where the study will be conducted, name of Principal Investigator and any Sub-Investigators)
- Signed and dated Curriculum Vitae for Principal Investigator and all Sub-Investigators
- Current Medical License (Principal Investigator only, and only if applicable)
- Research Site Questionnaire (once per calendar year). Click here to download.
- Waiver/Deference of Review Form (if necessary)
- Community Consultant Review Form (if necessary)
- Cooperative Review Form (if necessary)
Massachusetts or "High-risk" Sites Only
In addition to BioMed IRB standard requirements, the IRB must perform the following:
- Conduct an on-site review within (30) days of the study start date when the principal investigator has not previously been approved by BioMed for a research project.
- Conduct an annual on-site review of each research project approved by BioMed.
- Verify that all approved investigators have or have applied for their appropriate license(s) for research currently being conducted by each investigator.
Investigators Guidance for Reporting Adverse Events
This guidance document will assist you and your staff in reporting adverse events to BIOMED IRB. It is our policy that all adverse events be reported to the IRB in accordance with the Code of Federal Regulations. The manner and speed with which an adverse event must be reported is based on the ICH Guideline for Good Clinical Practice; definition of seriousness of the adverse event; whether the adverse event was unexpected; and whether the adverse event is related to the study drug.
- SERIOUS ADVERSE EVENTS OCCURRING AT YOUR SITE MUST BE REPORTED WITHIN TEN CALENDAR DAYS FROM DISCOVERY.
- Once you have identified an adverse event that is harmful to subject participation, increases the risks of harm in the research or has an unfavorable impact on the risk/benefit ratio, please download our Serious Adverse Event Reporting Form (300 SAERF). The completed form can be returned via e-mail:
- (Use of any other form must include the following information):
- Title of the study and protocol number.
- Name of the sponsor and site location.
- Date submitted to BioMed IRB.
- Date of the Serious Adverse Event (SAE) and the date of discovery.
- Description of the adverse event including the date of onset, history, evaluation, treatment and subject's current condition.
- Statement regarding the relationship to the study drug.
- Statement whether Serious Adverse Event (SAE) was unexpected.
- Statement whether a change needs to be made to the protocol or consent.
- Subject's assigned code number, not the subject's initials.
- Name and signature of the Principal Investigator.
- SERIOUS ADVERSE EVENTS NOT OCCURRING AT YOUR SITE (IND SAFETY REPORTS) MUST BE REPORTED NO LATER THAN 30 CALENDAR DAYS FROM DISCOVERY.
- ADVERSE EVENTS THAT ARE NOT SERIOUS ARE TO BE REPORTED AS PART OF THE CONTINUED REVIEW REPORT.
- BIOMED IRB HAS THE AUTHORITY TO:
- Request a revision or modification of the protocol or informed consent.
- Temporarily suspend the study pending additional information.
- Terminate the study and provide the reasons in writing.
Prompt reporting of these events is important and BIOMED IRB appreciates your continual efforts to comply with both our policy and 21 CFR requirements. If you have any questions regarding how to report serious adverse events, you may contact one of our study managers: (800) 643-0730.