Informed Consent at DSI

How Informed Consent is Performed at DSI

I, Dr. Saponaro, perform all the informed consents at the Drug Study Institute with the help of my CRCs.
If the research subject volunteer is my patient, I am usually the first one to talk about the study and it usually happens in the context of their regular visit. I understand that, potentially being their doctor, they might want to please me, and I bring up in a straight forward manner that this is something that I am trying to see if they perceive it to be a good deal for them, and if they do not think it is a good deal, then that is okay. They should look at this like any other suggestion that I am making to them. For example, if I tell them that I think they should get a stress test to see if they might have coronary artery disease and they refuse, I would suggest a recommendation and we can continue discussing it sometime in the future.
If the patient does not belong to my practice, sometimes they answer an ad and I discuss the study briefly with them on the telephone and invite them to come to the office to discuss the details with them in person. I tell them that I would be contacting their regular physician to obtain their medical records. We discuss the confidentiality of their medical records. Sometimes the CRC will obtain IC first and begin study related procedures like a phlebotomy. Then, I see them and I go over the ICF again with the subject to make sure they understand and agree to everything.
In general, I tell people that they would have more doctor visits and more tests if they get involved with the research, and if they look at this as negative, that maybe they should not enroll. But on the other hand, it is potentially better for them because they are getting their condition looked at more carefully. When the research subject volunteer leaves my office, whether they joined the study or not, they leave with an education on the pathophysiology of their disease process to help them make a good informed decision of whether they should get involved with this or not.
When the patient visits our office, they see our receptionist, then they wait a short time in our waiting room; they are offered something to drink. Our study coordinator or our medical assistant then sees the patient and talks with them and obtains a history and does their vital signs. The patient is then brought back to my office where I discuss the study issues with them and about potentially getting involved.
If they express interest, sometimes I get them back at another visit and actually do the informed consent form at that time. Other times, I actually get two informed consent forms, and I give one to the patient, and the other I hold in my hand and I read the whole informed consent form to them and have them initial and date each page as we are doing it. Still other times, I might discuss the study with them briefly and have the study coordinator discuss the study with them and then they come back to me to re-review the study with them and I go over all the pages of the ICF and make sure they do not have any questions and then witness them sign and date each and every page.
I make sure the patient does not feel pressured into doing this. I explain to the patients, that usually if their spouse is not with them, that they can bring the ICF home and I can talk with the spouse. Frequently I see a male patient without his wife and then I wind up calling his wife and explaining what I am going to be doing to be doing with her husband. I always invite her to come back to meet me and to discuss things in detail.
The length of time this usually takes is about one and a half hours in my office. If the patient is hesitant, I never talk them into doing this. I recognize that if I talk somebody into doing it, chances are some family member or relative will talk them out of doing the research in the middle of the study and create a load of paperwork for us to do. I volunteer to talk to the patient's doctor about the study and to anybody they want me to talk to, to help them make a good informed decision. I make sure that they know if they choose to do a drug study with me that they can rest assured that their welfare and safety is my first concern, and should I think that there is anything going bad, I am going to be the first one to tell them that I am going to take them out of the study.
The patient has an opportunity to read the ICF at home before deciding whether or not to participate. I tell them they can show it to their doctor, family, or friends, and I can talk with them if anybody they know has any concerns about the study, and to make sure they know I am available to answer any questions at any time.
The feedback I have gotten from research subject volunteers with drug studies has been very positive. Usually they tell me that I have spent much more time with them than any other doctor they have ever seen, and I have given them education on their disease process that no other doctor has ever given. This is usually what has been the most valuable gift that I have imparted to any patient, the gift of knowledge that I have shared with them to help them cope with their disease and to make informed decisions on how best to treat a disease process.
When I go through the consent form, I always point out the phone number of the IRB and I jokingly tell them should I do something bad and they want to get me in a lot of trouble, that they could call this phone number and speak with the IRB person and I will find myself answering questions to many people over a long time. Then I tell them if they are thinking of calling that number, that I would appreciate if they would call me first and give me an opportunity to do anything possible to make them happy. During the informed consent process, they leave my office knowing what an IRB is and how they could use the IRB to preserve their rights and welfare as a research subject volunteer. I usually also say that this is useful because, hopefully, they will tell their friends and family about how nice they are treated in my office and how all drug studies in America have an IRB and that, hopefully, this will get more people, nationwide, volunteering to be research subject volunteers.
I have a very hands-on approach at our research site. I see every patient every visit. I make sure that they can make a good, informed decision on whether they should get involved; if they decide not to get involved, I do everything I can to help them and treat their medical condition anyway. For example, in the past, I had a patient that had difficulty paying for their medicine. When I discussed the drug study with them, the patient was hesitant about getting involved, and felt they were being pressured into doing it because they needed the drug without charge. I did not enroll that patient in the drug study. I found free samples of the drug and I pointed the patient to our health care district free doctor to get them on a medical relief plan. It is something like Medicaid, in our neighborhood, to get their drugs paid for, along with their doctoring. That patient was very happy that I pointed him in the right direction and it pleased me to do the right thing.
I note that my site has enrolled or probably will enroll the following potentially vulnerable groups: handicapped persons, non-English speaking (Spanish), economicially disadvantaged and educationally disadvantaged research subject volunteers. This will describe how I plan to safeguard these vulnerable groups from potential harm from becoming a research subject volunteer with us.
I believe, first of all, recognizing that they are a member of a potentially vulnerable group is important, and I do think about this as I am presenting informed consent forms to research subjects. Sometimes whether a research subject volunteer belongs to a vulnerable group is a little hazy. For example, I see some very wealthy patients that live on Jupiter Island that come to me in their Rolls Royce that do not have health care insurance that covers medications and I am surprised that the length of time that sometimes we spend discussing how we could switch them to a cheaper pill. Sometimes these people get involved with a drug study. I recognize that even though they are multi-millionaires, they are, potentially, a vulnerable population because they feel extremely pressured to try and get the drug cheaper or, as in the case of a drug study, for free.
I do see handicapped people, that is, patients after they have had a stroke and that they have limitations. Usually, this type of person is not mentally handicapped, and for the purpose of a drug study, is not a problem. We do see patients with Alzheimer's disease. I do recognize that this handicap is extremely difficult to deal with in a drug study. We have not done an Alzheimer's drug study as of yet, but if we do one, I presume there will be something in place in the consent form where I would have to document that I spoke with the patient's relatives and legal guardian. I do speak Spanish, as do a few people in my office. We do enroll some Spanish-speaking people with a Spanish consent form. I usually read the consent with them just as I do as if it were in English. I do see educationally disadvantaged patients. I recognize that they could be manipulated and talked into something that they do not want to do easier than well-educated people. I think about this as I am enrolling them in a drug study and I make sure that I err on not enrolling them in a study should there be any questions. I look at recent events in research history and with the events that happened at Duke: It is clear that you could do a ton of great research, but commit one mistake and you could make national headlines and hurt all medical research worldwide for decades to come.
My routine, when I get a potential research subject volunteer, is to present to them the strong points and the weak points of the individual study. I tell them, if they choose to enroll in the drug study, they will spend more time in my office and receive more blood tests and physical exams than regular care. For example, in the cholesterol study we are doing, I tell them if they elect to get involved with it, that they will be coming back in about a month, whereas if they elect not to do it, I can give them a cholesterol drug and their next appointment would be in three months. I point out how some people might look at the extra doctor visits and tests as a negative, especially if they have more money and less time; however, many people would look at the extra doctor visits and blood tests as beneficial and if they are one of that type of person, then it is something for them to think about potentially agreeing to volunteer. I routinely point out that should they decide not to get involved with the drug study with me, that there is no problem. I am not going to think poorly of them. I am very happy that they choose me as their physician and allow me to continue to take care of their general medical needs. For a person who is not my patient, I thank them for having come here to think about doing a drug study, and if this particular study is not good for them, I tell them maybe some day in the future I will have another study that they might like. I recognize that time is a factor and some people have plans and they are going away and this is another potential negative. If I have a patient that does frequent traveling, I usually do not think about presenting a drug study to them. Dr. Sanger and myself subscribe to the IRB Advisor newsletter, and we continually strive to learn more about being good clinical researchers.
If you look over our web site at www.DrugStudy.MD, you will see that Dr. Sanger and I spent a lot of time putting together a first class research information site. Our primary concern is the safety and welfare of our patients and research subjects. We understand the difference between practicing medicine with a patient vs. doing a drug study with a research subject volunteer. We understand just being a doctor and having a patient in our practice that potentially could make someone want to please us by joining a drug study that they ordinarily would not volunteer for. We think about this as we enroll patients. In fact, we have patients that tell us all the time that they do not want to get involved with drug studies with us because they do not have the time and it does not interest them, and that is not a problem for us. We are happy that these patients still see us for their regular medical care.
If you should have any questions or concerns about how DSI protects the rights and welfare of our research subject volunteers, please do not hesitate to contact us toll free at 866-575-1212.

Sincerely,

Joseph Saponaro, MD, DABIM, FACP, CPI, CCI, CCRI, CCRC, CCRP
Board Certified Internist, JPMC
Principal Investigator, DSI
Diplomat American Board of Internal Medicine
Fellow American College of Physicians
Certified Physician Investigator by the AAPP
Certified Clinical Investigator by the DIA
Certified Clinical Research Investigator by the ACRP
Certified Clinical Research Coordinator by the ACRP
Certified Clinical Research Professional by SoCRA
Member: The American College of Preventive Medicine