Concern

[dot_and_line]

I've seen fliers around campus for months now calling for volunteers for clinical research for an HIV vaccine. I called the medical research office today and found out that they need volunteers who are HIV-negative as well as those who are positive, so I inquired about the the qualifications necessary for HIV-negative volunteers.

The study is only

Comments

[anytree]

The worst part of a spinal tap is the spinal headache that could follow if you aren't cared for properly afterwards. The best way to care for someone who's just had a spinal tap? Do not let them put their body in any sort of upright position. Lay down and stay down.

I know some doctors who rock at spinal taps, and some who do not. Since this is a drug study, I bet you'll get a doctor who is good at it. Pharmaceuticals are fucking picky about who does every little thing in a study. They don't want you to have any adverse effects.

Hmm, I'm guessing they want a spinal tap to see if proteins from vaccine cross the blood brain barrier. Cerebral spinal fluid is one of the best ways to check for that.

Do you know what trail phase the drug is in? I'd be less hesitant if it's in phase 3.

They're going to have to sit you down and walk you though a consent form. They're supposed to be written so that nearly anyone can understand them, but damn, they can get technical. Be sure that you're feeling empowered to ask every damn question you can think of.

also

[anytree]

are you going to be compensated somehow? grocery gift card, cash, gas money, health exams? they ought to be compensating you. it would be unethical for them not to.

the name of the study drug should be on the consent form. if you sign (or if you're just interested in the study and ask for a consent form), they have to give you a copy. i would google the drug name and read about phase 1 and 2 studies (assuming this is phase 3...it sounds like it is).

do you know how many people are in the study? how many study sites there are? which pharmaceutical is investigating? they should also tell you who the principal investigator is at the site you're thinking about going to. i would google that doctor, too...just to see what kind of research ze's up to.

if you find out that this is a phase 1 or 2 trail, i wouldn't say don't do it, but i would say be fucking careful and detailed about that consent form.

hopefully all of this doesn't feel condescending. i'm just trying to think about all the things i know from being part of the healthcare groups that run studies like these. sometimes dangerous side effects are definitely put in language that doesn't sound as terrifying. it's a balance between informing people of everything that could happen, but not freaking them out so much that they don't participate.

Re: also

[dot_and_line]

Oh my goodness, thank you so much! I can't tell you how relieved I am to know first that spinal taps are not as terrifying as I feared and second that I now have a better inkling about what kinds of questions to be asking.

The woman on the phone was speaking so quickly I didn't have time to write down the name of the drug that is being tested, but I recall it started with an "r" (lots of help, right?). Also, she was unsure about the compensation, but she mentioned $500 and $700, she just couldn't remember the exact amount. I'm not sure if she mentioned which phase the drug was in, but I would feel more at ease knowing that the drug has gone through other testing phases before this one.

I wanted to know more about the research, but I was also unfortunately rushed on my side as well: I was covering the front desk at work, with a phone to which over 70 lines are forwarded throughout the day. I was assured that I would have ample time to review any consent form if it so happened that I decided to take part in the study. She also assured me that the doctor responsible for the spinal tap is "excellent" and that I should not be worried.

Thank you again for all the help. It may not feel like it when you wrote them, but the questions you have raised make me feel that there is information to be had that will put my own mind more at ease. It also makes me feel that I can ask the questions now, which places me in such a better place than were I was this afternoon.

Thank you.

I have some follow up questions for you... as in, what do I do with the information I get? Are more study sites better than fewer? Are there pharmaceutical companies that are more responsible with their drug testing than others? What side effects, and what percentage of participants who experience those side effects, constitute an uncalled-for risk to my participating in the study? Also, unrelated to "follow up" questions, but do you know of any weight limits for safely undergoing 13 hours of continuous blood work?

Wow, thank you! I really can't thank you enough!!