- Consent and Recruitment
INFORMED CONSENT DEVELOPMENT AND TRANSLATIONS
For studies that are subject to the requirement of the FDA regulations, the informed consent documents should meet the requirements of 21 CFR 50.20 and contain the information required by each of the eight basic elements of 21 CFR 50.25(a), and each of the six elements of 21 CFR 50.25 (b) that is appropriate to the study. BioMed IRB has the final authority for ensuring the adequacy of the information in the informed consent document.
- All informed consent documents are entered into our computer upon receipt. A copy of the informed consent form on diskette (MS Word) or e-mail must be provided to us at
- If there are any revisions to the informed consent requested by the IRB committee for approval, they will be made by our staff the day following the meeting.
- Our office will generate customized informed consent documents for each site. In addition, since all informed consents are maintained in our computer, our office will generate revisions.
- If a sample informed consent form is not available, one can be developed for an additional fee.
- If the sample informed consent form is not provided on a diskette or sent via e-mail,
there will be an additional informed consent fee charged to your invoice.
- If you would like a copy of the BioMed IRB template informed consent, please contact the IRB office.
BioMed IRB will take additional steps towards safeguarding and protecting the well being of children participating in human research. Children are a vulnerable research population and require special ethical and regulatory consideration by the IRB.
The IRB determines what the assent process involves and how the child's assent (or dissent) will be documented. It is the investigator's responsibility to explain the assent process and obtain the permission of the parents or legal guardian.
If you would like a copy of the BioMed IRB template assent document, please contact the IRB office.
Translation Consent Documents
The informed consent document should be in a language understandable to the subject. Non-English speaking study subjects must be provided an IRB approved certified translation of the informed consent in the subject's primary language. Routine ad hoc translation of the informed consent document may not be substituted for a written translation.
- There will be an administrative review charge for the approval of informed consents submitted that are translated into a foreign language by a certified translator. A cover letter, which includes a copy of the name and certification of the translator is required.
- If a translation of the informed consent is requested, we will provide that service for the cost of the translator, plus a 10% processing fee.
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.