When the sponsor of a multi-site study does not identify a "central" IRB for the included investigators to utilize, the investigators may elect to submit to E&I for review and approval of their "single-site" participation in the project. This section will assist investigators wishing to submit to E&I for approval of study conduct as a single-site.
[G] indicates a link to more information about a requirement. Additional guidance can be obtained under the Guidance menu on the website.
Although the investigator is not the sponsor in this type of submission, in a single-site study the IRB's relationship is solely with the investigator. In single-site studies, the investigator (prior to beginning any study related activities) is responsible for obtaining IRB approval of the study in addition to gaining approval for their participation as the Principal Investigator.
In some cases, review by the full board may not be required for study conduct approval. When the proposed protocol is determined to be less than minimal risk, and qualifies under one of seven specific regulatory criteria categories, the study may be determined eligible for review by an expedited review [G] process. If you believe your study may qualify under the applicable regulatory requirements for expedited review, and would like your project reviewed utilizing this process, you will be asked to submit an E&I Request for Expedited Process (Form 22) as part of the Study Application Form. E&I is always willing to discuss the specifics of any given study to assist an Investigator in determining what their review needs are in accordance with the regulations.
There are many different types of projects that an investigator may wish to take part in. The type of information the board will need to perform their review is directly related to the type of study the investigator will be conducting. E&I specializes their application forms into two types, clinical and non-clinical research.
Items required with study submission:
The IRB has a regulatory obligation to consider the local perspective of where the study will take place. As part of this consideration the board will determine whether or not the investigator's training and experience qualifies them to perform the designated functions required by the design of the study. Before approving an investigator, the board must first obtain relevant information about the individual and their location. This information is typically requested in a PI application form (also referred to as a submission or cover form.)
Item required with PI submission:
Based on the information provided in your E&I Application Forms, additional submission items, or supplemental forms may be required.
Items required only if applicable to your site/study:
For Clinical (Drug and/or Device) Research Submissions for review of these types of studies typically include a clinical investigation of a product or device and usually fall under the regulatory requirements of the FDA. These studies are often designed to test safety or efficacy of a product.
For Non-Clinical (Social, Behavioral, Educational) Research These types of projects typically do not test safety or efficacy of a product, but may at times involve products or devices in their design. Often non-clinical research will fall under the regulatory guidance of OHRP (link to 45 part 46), which varies slightly from FDA regulatory language.
E&I Principal Investigator Application Non-Clinical / SBER (Form 30b) Available on request
Supplemental Forms (as indicated):
When indicated on the PI Application form, these forms should be completed and attached to the submission packet
To identify your request for the expedited review process and the category being claimed.
E&I Investigative Drug (Form 24a) Available on reqeust
To provide additional information needed only for investigative drug studies.
To provide additional information needed only for investigative device studies.
When the PI intends to include employees, family or friends as study participants.
When the PI intends to include pregnant women as study participants.
When the PI intends to include prisoners as study participants.
When the PI intends to include children as study participants.
When the PI intends to waive some or all of the informed consent process for any or all participants.
When the PI intends to waive documentation of the informed consent process for any or all participants.
When the PI is covered entity and intends to fully or partially waive HIPAA for any or all participants.
When the PI is covered entity and intends to fully or partially waive FERPA for any or all participants.
To identify any potential conflict of interest as well as plans to manage it.
E&I Local IRB Waiver Available upon request
To assure that your local IRB agrees to waive jurisdiction to E&I.
To identify any additional or satellite sites, which the PI intends to conduct study procedures.
|Last Updated ( Wednesday, 16 September 2015 14:26 )|