If you have an IRB-related question, others probably do too! This column is an opportunity to answer your questions. Check in each month to see the answers to some of the most common questions asked by the research community. To find more questions from previous months, click here to search the archive.
Please send your questions to firstname.lastname@example.org.
A: This becomes a question of whether or not the student is acting as an agent of her home institution. For example, if the student’s work with you is part of a course requirement at her home institution, then she is acting as an agent of her home institution. The second question is whether the student will be engaged in research (i.e., having access to BUMC subjects or their identifiable data). If this is the case, then the home institution is also “engaged” in the research and is required to provide IRB oversight and do an independent review of the research. However, another alternative--and the more efficient way--is to have the home institution cede review to the BUMC IRB for her participation in your protocol, since all the student’s research activities will be done at BUMC and the BUMC IRB has already approved the research. This is done by submitting an amendment to the protocol in INSPIR (instead of an internal study personnel change, which is only for BUMC personnel) to add the student as an “External Investigator” and to request an IRB Authorization Agreement (IAA) to have her home institution cede IRB review to the BUMC IRB. (Note: The BU Charles River Campus is also considered an “outside” institution with its own FWA Number as it applies to students engaged in research at BUMC as part of academic course requirements for the BU Charles River Campus.)
To submit the amendment, you will need to:
1. Revise the IAA-related sections of your application:
* Amendment Description: State that you are requesting to add (student’s name) as an External Investigator and to request an IAA Agreement with (name of student’s home institution). Briefly state that the student will be performing research activities as part of her (describe the specific academic/degree program of her home institution); and that you have updated the application in the IAA-related sections 4.1, 9.1, 9.2, 10.4, 11.0, and 13.4; and that you are attaching (list the associated documentation of her home institution’s academic requirements and any applicable forms which the student will need to perform the research activities, such as an updated HIPAA Waiver of Authorization Form in which she has been added.) If the amendment is time-sensitive (for example, the student will be visiting BUMC to do the research and will be leaving BUMC on a specific date), then explain the time-sensitive nature of the student’s circumstances so that the IRB will take this into consideration when scheduling the review of the amendment/IAA request.
- 11.1: Answer NO if you are not adding any BU-Charles River Campus Investigators* Section 13.4: Update your design/procedure section to include the research activities that will be done by the student.
2. Forward the student’s CITI human subjects protection training certificate and BUMC CITI HIPAA Privacy Module certificates to email@example.com. Indicate in the email your protocol number, and that the student is an External Investigator from (name of home institution) so that the student’s information is entered correctly in the Investigator Database. For more information about Research Certification requirements from other institutions, see http://www.bumc.bu.edu/ocr/certification/).
3. For assistance or questions, contact IRB Coordinator Roz Schomer (firstname.lastname@example.org; 617-414-1320), who will be working with your IRB Analyst to provide a copy of your protocol application and the IAA Agreement for signature to the student’s home institution. When the IAA is fully signed, it will be attached to the protocol, and a confirmation notice will be sent to the Principal Investigator confirming that the student can begin research activities.
A: It may be that it is the study monitor who is confused. The “expiration date” at the bottom of the consent form refers to the last day that a consent form version may be used to consent new subjects. Investigators must ensure that they are using the most currently-approved version of the consent form that is available in INSPIR on the day the new subject is ready to sign the consent. Once the subject signs the current version of the consent form, it is not necessary to re-consent the subject unless specifically required by the IRB.
Sometimes the IRB requires that currently-enrolled subjects sign a revised consent. This occurs most commonly when there is new protocol information about risks; although it can also occur if changes to the research plan have been approved. Any time new information may affect a subject’s willingness to participate, it is important to provide this information to the subject and allow the subject to make an informed decision about continued participation.
Other times there are minor changes made to the consent form which the IRB does not believe will affect the willingness of subjects to continue. In this case, the IRB approves the minor changes, but does not require that currently-enrolled subjects re-sign the revised consent. If the study monitor found that the IRB had required you to re-consent subjects and have them sign a new consent form and you had not done so, then the monitor is correct. You will need to let the IRB know of your failure to do so by submitting a protocol deviation, and to re-consent your subjects. If the IRB has not required you to have subjects sign a new consent form, then it is the monitor who has made a mistake. You can direct the monitor to the IRB Office, and we will provide him/her with additional education.