Paticipation in observational studies run by the Mayo Clinic

Hi @donnyboy, great questions to ask. Taking part in a long-term observational study requires careful consideration. What will this mean for me?

Naturally, by participating in such a study, you will be contributing to the advancement of disease management. That's a huge gift. Regular testing and obligations of the study can be both a pro and a con. You will be observed closely, which might provide comfort to some people. However, the obligation of regular check-ins might be onerous too.

I agree that the consent form might make it look more onerous than necessary. Researchers are held to very high ethical standards. This, among other things, requires very detailed consent forms. I can imagine that a 17-page consent form might make you ask yourself "what am I getting into?"

I'm tagging a few members like @johnbishop @Erinmfs @da69 @teababs09 @lagrange5 @loribmt @roch @parrot53 @1942marilyne and many others who have shared their experiences in these related discussions:
- Have you ever taken part in a Mayo Clinic study?
https://connect.mayoclinic.org/discussion/mayo-study/
- I took part in a clinical trial. Have you?
https://connect.mayoclinic.org/discussion/join-a-study-at-the-nih/
- Anyone participating in the Tapestry DNA Sequencing Research?
https://connect.mayoclinic.org/discussion/anyone-participating-in-the-tapestry-dna-test/
@donnyboy, I encourage you to read the consent form and make a list of questions. The research coordinators will gladly answer your questions and address any concerns you may have about the burden of testing and participation.

@donnyboy, I've participated in a 3 or 4 studies at Rochester Mayo Clinic over the years and really enjoyed helping. The first one back in the mid 80s was a heart study and fairly involved with tests done at St. Mary's Hospital one or more times a week along with a couple of overnight stays all paid for by Mayo. The result for me was a change of my high blood pressure medications due to learning more about the cause of my high blood pressure which was primary aldosteronism. The only really bothersome period for me during that study was a week that I had to wear a blood pressure cuff 24x7 and it took my blood pressure multiple times a day and I had to stop what I was doing at work and stay still.

I also participated in a Flu vaccine study and an RSV vaccine study which only required one trip to clinic downtown for baseline evaluation and instructions for the study and follow up. If I remember correctly both of the studies for the winter season and I had to report to them if I thought I had a case of the flu or was feeling sick so they could make a determination if I need to come in. The study coordinators and the whole team were really helpful. I agree with @colleenyoung that it would be helpful if you make a list of questions and contact one of the coordinators. They will be more than happy to answer any of your questions.

donnyboy @donnyboy

I have participated in many clinical trails at Mayo, though none that required weekly tests indefinity. Some were studies that lasted many years with yearly check-ins to see if anything had changed. In a few studies that I am currently enrolled in, they establish a baseline and collect data to be used in future to better predict who may or may not develop a disease.

If concerned about amount of testing, you may want to contact the study coordinator to verify the amount of actual testing they expect. Some time the consent form covers situations that might not apply to all participants.

@colleenyoung

Colleen, thanks for your detailed reply to my question about observational studies! I'll follow up on the Connect links you provided. I am going to telephone the study's coordinator to see if I have it right, that I can skip the skin biopsy consent and the lumber tap consent and still participate in the study with the possibility/likelihood that I will be asked to cooperative with some testing.

On a side note that I do not intend to purpose, I have to add that the 17-page consent form would probably not stand up to judicial scrutiny because of the vagueness of what one is being asked to consent to (i.e., occasional testing vs. testing every week indefinitely). One can only truly consent to something if one understands what one is consenting to. Just a side note, because in this actual study I can always refuse to cooperate in testing and they are not going to somehow hold it to me because I provided consent back at the beginning.

Thanks again,

Don

@johnbishop @colleenyoung

John, This is very helpful, to hear from someone like yourself who has actually gone through some studies by the Mayo Clinic. Could I ask when you participated in those studies, besides the one in the 80s? I'ld like to determine if its likely they are still continuing as you describe. Also, were there some requests for testing or procedures that you turned down while still being able to continue with the study? I do intend to speak with the study coordinator, as soon as I have gathered as much understanding from Mayo Clinic Connect participants as I can. Thanks so much!

Don

Hi Don, I never turned down any requests for testing or procedures mostly because they were all related to the study and the coordinators kept me in the loop to make sure I understood what was expected or needed for my participation in the studies. They always left the decision up to me and they did a great job to inform me what the purpose of the study was and how my data could be helpful. I'm hoping you get the answers you need when you talk to the study coordinator. Medical research is a hot topic for a lot of us with chronic or rare conditions and we are all wishing there was more being done but the silver lining that makes it work is us as patients with the conditions. As long as it's not painful or costly to me and I can fit it into my life schedule, I'm game to help but I know it's easier to say than do so I'm just hoping it works out for you.

Don, I whole-heartedly agree. Consent needs to be in plain language, clear and concise. Please provide that feedback when you speak with the study coordinator. In trying to cover all bases, the language can get unnecessarily over-complicated and omit the obvious.