Across the Board
Capella University IRB
Respecting Research Sites and their Decisions
2009 Sep 17 Posted by Courtney Jarboe
The answer can vary, but here is one possibility. Research sites make a decision based upon communication they have had with the researcher in the form of an authorization request letter. This is an important document that provides a first impression of the researcher’s character and how they may conduct their research.
If the letter does not provide enough information about the proposed study and the researcher, the research site may become wary about granting permission for anything. In addition, if the researcher does not provide the opportunity for the site to contact them with questions, they also will be hesitant. Here are some tips on writing a request letter that may help researchers creating this letter and give researchers the mindset that the research site made a fully informed decision.
Tips on Creating an Authorization Request Letter
Provide full disclosure–Always include information about:
+Your role as a doctoral learner from Capella Univeristy,
+Who will supervise your research activities (i.e. mentor)
+The title, purpose, and benefits of your proposed study,
+What exactly you need from the research site (access to records, ability to contact members, use the facilities, etc.),
+What role if any, the research site will have in research activities (e.g. sending emails),
+What exactly the researcher will do with the information obtained from the research site if permission is granted,
+Information about privacy and confidentiality (i.e., how the researcher will protect participants, etc.),
+Identify any potential risks of harm to participants or to the research site,
+Time frame of the research activities (if members are recruited to complete a survey, how long is it expected to take?),
+If applicable, demonstrate your understanding and sensitivity to the characteristics of the potential participant population of the research site,
+Identify if they will have access to the dissertation once completed,
+You will notify the research site when you have gained IRB Approval from Capella University,
+Who to contact if the site has more questions about the study,
+Make sure the contact information is professional (i.e., use an appropriate email address and have an appropriate voice mail greeting if you don’t answer their call right away).
When providing this information, make sure that the readability of the letter is appropriate. If it is too “academic,” the research site may not be able to comprehend what you are asking for in the letter. In addition, you should also include a thank you statement. Researchers should always have the mentor and/or the dissertation committee review the request letter before it is sent to the research site.
Remember, even if you send a perfect permission letter, the research site may decide not to grant permission. It’s okay to send a thank you note in response. However, we strongly encourage researchers not to appeal or request justification from the research site. Respecting research sites and their decisions is important, not only our research community, but also to researchers outside of Capella that may request permission from that very same research site.
Additional Full IRB Committee Meetings
2009 Sep 2 Posted by Courtney Jarboe
Due to the number of studies referred to the Full IRB Committee for review, an additional meeting was scheduled. Now there are two meetings held each month. Studies that do not involve prisoners as research participants will be reviewed on the first Wednesday of every month. Prisoner-based research studies will be reviewed on the third Wednesday of every month.
Here are some common questions we receive about the Full Review.
How do I know my study will be reviewed by the Full IRB Committee?
If your study involves greater than minimal risk to research participants, deception, or involves prisoners, it will be reviewed by the Full IRB Committee. However, if the IRB reviewer, during the initial review of the study determines that he or she cannot review the study at the expedited level because of some other aspect (i.e., does not fall into an expedite or exempt category of research, involves unethical research practices), they can refer the study to the Full IRB Committee. All referrals must be ready for Full IRB review at least 2 weeks prior to the IRB Committee meeting. Otherwise, the study will not be reviewed at that particular meeting and will have to wait until the next convened meeting.
If an IRB reviewer refers a study to the Full IRB Committee, the doctoral learner and mentor will receive a letter from the IRB indicating as to why the study must be reviewed in this manner.
My study has been referred to the Full IRB Committee, what do I do?
When a study is referred to the Full IRB Committee, a member of the IRB Office staff will assist you and your mentor through the Full Review process. It is important that learners review the initial IRB reviewer’s evaluation form and any other documents posted by the IRB (i.e. referral letter, deferred documents, etc.).
A week before the meeting, an IRB Office staff member will request to hold a conference call with the learner and mentor to explain the full review process and answer any questions they may have.
The Friday before the meeting, the learner and mentor will receive a preliminary evaluation document from the IRB Committee. This document includes any preliminary concerns and questions the committee has for the learner and/or mentor. It is important that the learner go through this document with their mentor and respond to the request as soon as possible.
What happens at the Full IRB Committee meeting?
The meeting occurs via teleconference. Reviewers from each school attend in addition to, a non-scientist, prisoner representative, and external member. At this time, mentors are encouraged to attend this meeting to answer any last minute questions of the committee as well as clarify anything on behalf of the learner.
The mentor, if he/she attends the meeting, is dismissed for the deliberation of the study. The reviewers discuss the following items regarding the study.
+Risk and Benefit Assessment
+Selection of Participants
+Informed Consent
+Data Monitoring
+Privacy and Confidentiality
+Special Populations (if applicable)
+Other ethical, procedural, and/or methodological concerns
Once the deliberation has completed, a motion will be made to:
Approve,
Approve with Stipulations,
Defer for Minor Revisions,
Defer for Major Revisions,
Disapprove, or
Table
the study as it was presented to the Full IRB Committee. To learn more about each decision, check out the Research and Scholarship Center on iGuide. Within 7-10 business days, a decision letter and findings document will be posted in the study on IRBNet.
If you have any questions about the Full Review, please email researchandscholarship@capella.edu.
