Institutional Review Boards
On the third Thursday of each month I sit on UPenn's Institutional Review Board. I am the non-scientific, unaffiliated member of the board. My job is to be the secondary reviewer on initial protocols brought to the table. I provide the voice of the patient. I believe its a very important role, Doctors and medical professionals can review the safety data and the scientific nuances of each clinical protocol, but only a patient can understand what another patient may be thinking and understanding when clinical trial options are being discussed. The scientific members of the board allow me to speak openly and ask questions, respect my opinions and often thank me for bringing something to their attention that I as a patient would want clarified in the informed consent.
Here is a blog I wrote over a year ago describing my experiences my first day as a voting
board member.
As I was driving down the crowded highway on a rainy Thursday morning I was asking myself- “What did you get yourself into this time?” I was thinking about turning the car around and driving right back home. The traffic was horrendous since the highway was under construction and I was feeling overwhelmed. I was travelling to my first Institutional Review Board (IRB) meeting as a board member. The primary responsibility of an IRB is to protect the rights and welfare of research subjects and to function as a kind of ethics committee focusing on what is right or wrong and what is desirable or undesirable. About a week prior to the meeting I was given access to 13 clinical protocols, informed consent forms (IFC) and other important documentation related to each proposed clinical research trial/study to review. My head was spinning. I was questioning myself as to if I would be able to contribute significantly to the discussions that were about to ensue.
Here is a blog I wrote over a year ago describing my experiences my first day as a voting
board member.
As I was driving down the crowded highway on a rainy Thursday morning I was asking myself- “What did you get yourself into this time?” I was thinking about turning the car around and driving right back home. The traffic was horrendous since the highway was under construction and I was feeling overwhelmed. I was travelling to my first Institutional Review Board (IRB) meeting as a board member. The primary responsibility of an IRB is to protect the rights and welfare of research subjects and to function as a kind of ethics committee focusing on what is right or wrong and what is desirable or undesirable. About a week prior to the meeting I was given access to 13 clinical protocols, informed consent forms (IFC) and other important documentation related to each proposed clinical research trial/study to review. My head was spinning. I was questioning myself as to if I would be able to contribute significantly to the discussions that were about to ensue.
Federal Regulations requires that all proposals for research involving human subjects that receives support, directly or indirectly, from the United States federal government be submitted for prior review to an Institutional Review Board (IRB). The United States Department of Health and Human Services (HHS) requires all researchers conducting human subject’s research to provide prospective subjects with informed consent. The IRB for Human Participants has the authority to review, approve, disapprove or require changes in research or related activities involving human participants. An IRB is charged with making sure subjects in human research are participants in an informed consent process which includes the informed consent document and that the research being conducted balances the risks to subjects by potential benefits to society, and for which the selection of subjects is unbiased. But why is an IRB needed?
Review boards were developed in response to a need. Prior to the twentieth century, research ethics were primarily governed by individual conscience and professional codes of conduct. But early in the 20th century it became evident that many research subjects were being abused and left uninformed. The Tuskegee Syphilis Study the experimentation done by Nazi physicians during World War II in concentration camps, the Thalidomide Tragedy , the Milgram obedience experiment and the unauthourized use of Henrietta Lacks’ tissue samples are some of the most notorious of these abuses. These abuses resulted in the National Research Act of 1974 and the establishment of the ethical principles of the Belmont Report.
Principle 1- Respect for Persons
· Treat individuals as autonomous agents
· Protect person with diminished autonomy
Principle 2- Beneficence
· Do unto others as you would have them do unto you
Principle 3- Justice
· Distribute the risks and potential benefits of research equally among those who may benefit from the research
As I approached the parking garage on that dismal Thursday morning I gave myself a much needed pep talk. I know it is always important to hear the patient’s voice, but I was questioning myself. Will I be able to provide the patient’s prospective? Will I speak up or be intimated by the doctors and other scientific board members? Will the questions I ask and the concerns I pose be taken seriously? I was the “unaffiliated, nonscientific” member of the board. None of the protocols I reviewed had anything to do with myeloma- a subject I felt comfortable discussing.
When I entered the meeting room I was greeted warmly and invited to take a seat at the table. When I previously came to observe the IRB I sat in a chair in the back on the room. As soon as quorum was present we started our discussions. There is a primary and secondary reviewer for each new protocol on the agenda. The job of the primary reviewer is review in detail the assigned protocol along with accompanying documentation and the informed consent document, complete the primary reviewer’s form, present findings to the board and end their presentation with a vote of recommendation. The job of the secondary reviewer is to review the informed consent form and present recommendations to the entire board. I wasn’t assigned to be a reviewer during this meeting, but I was part of the discussion that followed each presentation and given the right to vote.
Sitting at the table I felt prepared. I knew the language they were speaking thanks to all the education the IMF has given me. I just didn’t know the specific drugs that were being researched. I felt comfortable participating in the meeting. The two hours flew by. As I was entering the elevator to return to my car the hematologist/oncologist that chaired this IRB pulled me aside and thanked me. He told me it’s very important to the IRB process to see things through the eyes of a patient and that the other “affiliated, scientific” members really appreciated my participation. I guess they did take me seriously. I didn’t even notice the traffic driving home.
I will be a secondary reviewer for one of the protocols soon. Once again I know I will be nervous, but I am up to the challenge. I encourage anyone who has an interest in the research process to contact your local IRB office and get involved. You will be truly appreciated.
On a different note-I have read these books and recommend them to everyone whether or not you plan on participating on an IRB
The Emperor of All Maladies- A Biography of Cancer by Siddhartha Mukherjee
The Truth in Small Doses by Clifton Leaf
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