summer 2010 all about the irb approval letter · all about the irb approval letter 1-3 meet dr....
TRANSCRIPT
Human Research Protections
News Brief
Inside this issue:
All About
the IRB
Approval
Letter
1-3
Meet Dr.
Linden,
Chair of
IRB “B”
4
IRB Staff
Contact
Info
&
Education
Items and Reminders
5
SUMMER 2010 ALL ABOUT THE IRB APPROVAL LETTER
Here’s the scenario: You have just been notified that your new human subject research study
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-
mitted. Additionally, you find the IRB approval letter in the “Docs” Depot. You think to
yourself, “I don’t need to read the approval letter—it’s standard jargon and besides, the
study is approved! I’ll just save it to my desktop or file it away for recordkeeping purposes.”
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.
So, lets go over a few of the important sections of the IRB Approval letter:
First Paragraph of the Approval Letter:
Researchers are only approved to conduct the research as described in the IRB-approved Protocol Narrative.
The IRB’s determinations begin at the bottom of the first page.
Level of Review, Approval Period and the FWA:
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-
ance (FWA) number is included. The Federal Policy (Common Rule) for the protection of
human subjects requires that each institution "engaged" in Federally-supported human
subject research file an Assurance with the Office of Human Research Protections. The
assurance formalizes the institution's commitment to protect human subjects.
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.
Page 2
SUMMER 2010
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.
Page 3
SUMMER 2010
Meet Dr. Linden– Chair of IRB “B”
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?
I have conducted my own human subjects research as principal investigator and been involved as a co-
investigator on numerous clinical trials. I am currently the lead researcher on a multicenter human subjects
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.
Page 4
Dr. Linden currently
serves as the Chairman
for IRB “B”
SUMMER 2010
Page 5 Education & Reminders:
Institutional Review Board “A”
Biomedical
—————————————————-
Matt Kinder
Administrator
949-824-9819
Debbie Gonzalez
Analyst
949-824-3711 [email protected]
Timothy Grigsby
Assistant
949-824-6068
————————————————— Institutional Review Board “B”
Biomedical
Valerie Sanchez
Administrator
949-824-7109
Cheree DuBose
Analyst
949-824-5622
Theresa Sanchez
Assistant
949-824-2125
—————————————————— Institutional Review Board “C”
Social - Behavioral
Jessica Sheldon
Administrator
949-824-4779
Alicia Asgari
Analyst
949-824-7114
Matthew Alcala
Assistant
949-824-6662 [email protected]
IRB Team “D”
Biomedical
Expedited and Exempt Submissions
———————————————————
Laverne Estanol
Administrator
949-824-3831
Kristina Grimaldi
Analyst
949-824-5057
Kin Hang
Assistant
949-824-0665
—————————————————
Karen Allen
Director
Human Research Protections
949-824-1558
Beverley Esparza
Assistant Director
Human Research Protections
949-824-5746
Human Research
Protections
U.S. Mail:
Office of Research Administration
University of California, Irvine
300 University Tower
Irvine, CA 92697-7600
The Office is Open: Monday—Friday
8am—5pm
We’re on the Web!
http://www.research.uci.edu/ora/
hrpp/index.htm
Don’t forget to open, review and
save all of your latest, IRB-
approved documents which can
be found in the IRB Document
Depot @ http://
apps.research.uci.edu/irbdocs/.
Please make sure to save your
submission as well as the IRB
approved, stamped versions as
part of your record-keeping
responsibilities. These
documents may be stored
electronically or in hard copy.
Remember, only the LATEST
versions will be maintained in the
Document Depot. Once a
modification request or
continuing application is
approved, the previously IRB-
approved documents are
removed from the Document
Depot.
Use the working draft
versions available on the
Document Depot when
submitting modification
requests and continuing
review applications.
Submission of incorrect
versions will delay review and
approval.
HRP Staff Contact Information
SUMMER 2010