Human Research Protections News Brief
SUMMER 2010 ALL ABOUT THE IRB APPROVAL LETTER
Here’s the scenario: You have just been notified that your new human subject research study Inside this issue: has been approved by the IRB. This notification comes via email with a link to the web- based IRB “Document Depot.” You access your IRB-approved, stamped Consent Form and
Protocol Narrative, along with the HIPAA Research Authorization Form you previously sub- All About mitted. Additionally, you find the IRB approval letter in the “Docs” Depot. You think to the IRB yourself, “I don’t need to read the approval letter—it’s standard jargon and besides, the Approval 1-3 study is approved! I’ll just save it to my desktop or file it away for recordkeeping purposes.” Letter While it may be common practice to simply file away the IRB approval letter without review- ing it, in reality, it’s a bad idea. The IRB approval letter lists the committee’s determinations regarding your approved human research study. It provides information about the informed consent process and HIPAA Authorization requirements and includes helpful reminders. Meet Dr. So, lets go over a few of the important sections of the IRB Approval letter: Linden, 4 Chair of First Paragraph of the Approval Letter: IRB “B” Researchers are only approved to conduct the research as described in the IRB-approved Protocol Narrative.
IRB Staff Contact The IRB’s determinations begin at the bottom of the first page. Info Level of Review, Approval Period and the FWA: & 5 The level of review: Expedited (research involving no more than minimal risk) or Full Committee (research involving greater than minimal risk), the approval date and the
expiration date is listed on the bottom of the letter. In addition, UCI’s Federalwide Assur- Education ance (FWA) number is included. The Federal Policy (Common Rule) for the protection of Items and human subjects requires that each institution "engaged" in Federally-supported human Reminders subject research file an Assurance with the Office of Human Research Protections. The assurance formalizes the institution's commitment to protect human subjects.
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IRB Determinations as Conditions of Approval:
If vulnerable populations, such as children, pregnant women, and/or prisoners are to be enrolled in the research, the approval letter will include the applicable IRB determinations. When enrolling children and pregnant women, the letter will also explain who must provide informed consent. For example, when enroll- ing children in research that involves greater than minimal risk where the research presents potential benefit to the subjects, the IRB may determine that one parent’s or legal guardian’s signature is sufficient to obtain parental permission rather than requiring permission from both parents. This information is included in the IRB approval letter.
If an investigational drug is being studied the approval letter will indicate whether an IND is on file or that an IND is not required. If an investigational medical device is involved the letter will list the IRB’s device determination—Exempt, Non-Significant Risk (NSR) or Significant Risk (SR). If the use of a placebo was approved this too would be reflected on the IRB approval letter.
Informed Consent Determinations:
The informed consent requirements as determined by the IRB are included in the above reflected section of the approval letter. Are subjects required to document their informed consent by signing a consent form or has a waiver of signed consent been granted? Is child assent required? Is HIPAA Research Authorization required from subjects or was a waiver granted? It is critical that researchers review the IRB Approval letter and understand the IRB determinations.
If you are unsure what is required, please contact the HRP Staff for assistance.
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Approval Conditions For All UCI Human Research Protocols:
In addition to the IRB determinations specific to the approved research, we highly recommend that researchers periodically review the additional conditions and required clearances section on the last page of the IRB approval letter as reflected below.
SUMMER 2010
Meet Dr. Linden– Chair of IRB “B” Page 4
Kenneth Linden, M.D., Ph.D. is an Associate Professor in the Department of Dermatology at UC Irvine Medical Center. Dr. Linden is a melanoma expert with UC Irvine Healthcare’s Melanoma Center in the Chao Family Comprehensive Cancer Center. He also practices general and surgical dermatology at Gottschalk Medical Plaza on the UC Irvine campus. He is a diplomat of the American Board of Dermatology and a fellow of the American Academy of Dermatology.
How were you appointed as the IRB B Chair?
I was serving as a member on the IRB when the Vice Chair, Bill Armstrong, left to become the interim chair of ENT. Much to my surprise, I was asked if I would become the Vice Chair – I don’t know what they were thinking. I was then happy in the role of Vice Chair under the excellent Chair, Bob Burger. When a career advancement for Dr. Burger caused him to leave UCI, I was asked to serve as the Chair. I felt it was my duty and challenge to try to lead the IRB to the high standards he had set.
What is your expertise as it relates to the protection of human research subjects? Dr. Linden currently I have conducted my own human subjects research as principal investigator and been involved as a co- serves as the Chairman investigator on numerous clinical trials. I am currently the lead researcher on a multicenter human subjects for IRB “B” clinical trial related to the treatment of melanoma. Being on the IRB as a member, and then as Vice-Chair, I learned a lot by participating in the IRB meetings and review process. By working with the highly knowledgeable Human Research Protections (HRP) staff as Chair, I have learned a great deal more about human subjects protection, particularly the regulatory aspects.
Do you have any advice for new researchers at UCI?
My advice is, if you have any comments, questions, concerns, or complaints, call HRP staff, not me ... (actually, just joking about the not me part). They are here to help you. HRP staff and the IRB are here to help facilitate research. We need your feedback, both positive and negative, to continue to improve the program as well as to ensure that researchers have the education and other resources they need to carry out human subject research projects at UCI.
As an IRB Chair, how much time is spent on IRB activities in any given month?
About 12-15 hours a month, sometimes more – actually seems like more lately.
What is the hardest part of being an IRB Chair?
Finding a balance between protecting human research subjects but at the same time being facilitative to UCI researchers.
What is the most rewarding part of being an IRB Chair?
The most rewarding part of being an IRB chair is when the actions of the IRB actually lead to an important increase in human subjects safety. In addition, it is rewarding when a particularly satisfying combination of protecting human research subjects and helping to further important biomedical research at UCI can be achieved. Working with HRP staff is also quite rewarding.
Is there anything you want the UCI Researchers to know about the IRB?
The IRB and HRP staff welcomes all communication with the UCI research community.
Come and serve on the IRB — you will have a better understanding of the charge of the IRB as well as an appreciation for all that is in- volved in the review process. My experience is that nearly all researchers have a somewhat negative view of the IRB until they serve on it, but once they serve on it, they find the reviews of the research that is going on at UCI so interesting and rewarding that they usually end up volunteering for a second term or further once their term is up.
Is there anything else you would like to add?
I am continually impressed with the professionalism, commitment, and conscientiousness, of the IRB members and the HRP staff. The HRP staff in particular are outstanding in their knowledge of human subjects protection and are all a great deal of fun to work with.
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HRP Staff Contact Information Page 5 Education & Reminders: Don’t forget to open, review and Institutional Review Board “A” IRB Team “D” Biomedical Biomedical save all of your latest, IRB- —————————————————- Expedited and Exempt Submissions approved documents which can Matt Kinder ——————————————————— Administrator Laverne Estanol be found in the IRB Document 949-824-9819 Administrator Depot @ http:// [email protected] 949-824-3831 apps.research.uci.edu/irbdocs/. [email protected] Debbie Gonzalez Analyst Kristina Grimaldi Please make sure to save your 949-824-3711 Analyst submission as well as the IRB [email protected] 949-824-5057 [email protected] approved, stamped versions as Timothy Grigsby part of your record-keeping Assistant Kin Hang responsibilities. These 949-824-6068 Assistant [email protected] 949-824-0665 documents may be stored ————————————————— [email protected] electronically or in hard copy. Institutional Review Board “B” —————————————————
Biomedical Karen Allen Valerie Sanchez Director
Administrator Human Research Protections 949-824-7109 949-824-1558 [email protected] [email protected]
Cheree DuBose Beverley Esparza Analyst Assistant Director 949-824-5622 Human Research Protections [email protected] 949-824-5746 [email protected] Remember, only the LATEST Theresa Sanchez Assistant versions will be maintained in the 949-824-2125 Document Depot. Once a Human Research [email protected] modification request or Protections —————————————————— continuing application is Institutional Review Board “C” U.S. Mail: approved, the previously IRB- Social - Behavioral Office of Research Administration University of California, Irvine approved documents are Jessica Sheldon 300 University Tower removed from the Document Administrator Irvine, CA 92697-7600 Depot. 949-824-4779 [email protected] The Office is Open: Monday—Friday
8am—5pm Use the working draft Alicia Asgari Analyst versions available on the 949-824-7114 Document Depot when
[email protected] submitting modification
Matthew Alcala requests and continuing Assistant We’re on the Web! review applications. 949-824-6662 Submission of incorrect [email protected] http://www.research.uci.edu/ora/ hrpp/index.htm versions will delay review and approval.
SUMMER 2010