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.
@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