Post by rapunzel on Jan 21, 2018 14:30:38 GMT -5
This is not “risk-free easy money.” There has been considerable ethical and other controversy about clinical trial/medical study transparency, common required guidelines for safety, consistent oversight, prescreening transparency, thorough informed consent, compensation, and what actually happens, in the US, abroad, and in our state and county locations.
While there are written guidelines that are supposed to be followed by the study sponsors and administrators and enforced by IRB, FDA, NIH, WHO etc., to protect our health and safety, there is also press about when things go wrong in a highly financially motivated business...keeping in mind that most don’t make it to the press.
Ultimately, it’s up to us to perform due diligence and use common sense. We know our bodies, and have the right to choose what happens to us. We also have the right to refuse procedures and leave/withdraw at any point in a study without concern for lost funding the admins prefer to keep us there to maintain.
With that in mind, I offer the following educational links, invite others to share others you’ve found helpful. Please consider the source of any information provided, understand that any “guidelines” are general, our individual biology and constitution can differ. We need to be aware and make informed choices.
It’s also important to understand what the market value of our participation is appropriate, keeping in mind that those who implement any study are also receiving far more compensation for each of us who participate.
In a perfect world, all of the needed info would be provided during recruitment (pre-screening), and it could be, without compromising confidentiality. In reality, it’s not, and many of us spend hundreds on travel to show up to screen and still not get the info, much of which isn't offered until we are handed the informed consent papers to sign if we are accepted into the study or as an alternate.
For those travelling from afar, its even more important that we get enough info before booking travel, because we could lose hundreds on a gamble that might not result in any payment.
So, if you can't get basic questions answered like the following by the recruiters, ask to speak with a study coordinator. If they stonewall, call back and try again. If you still get nowhere, consider it a red flag. There are lots of options.
In addition to the dates and times, you have a right/need to know:
1- the phase
2- the drug(s) involved
3- if they are FDA approved
4- any known side effects
5- what the purpose of the study is
6- in what form the drug(s) are being dosed, how, and where
7- any known side effects
8- blood draws- how many, how much, the maximum in one day, whether they're all straight sticks or if they will allow catheters on days there will be multiple draws
9- the facility/inpatient health/ER support, food, amenities, privacy protection, ability for contact with others outside (such as family)
10- compensation- how much, when, and specifics about the form of payment. Are screens compensated? Referrals? What (if any) payments to expect if you're chosen as an alternate. How you would be compensated if you had to leave the study early for any reason (ex: family emergency, personal or study admin choice...)
Here are some links I’ve found helpful:
Trending industry news:
www.ncbi.nlm.nih.gov/books/NBK50886/
www.who.int/reproductivehealth/topics/ethics/human_tissue_use.pdf
On study protocol:
partnershealthcare-public.sharepoint.com/Pages/Policy_and_Guidance.aspx#12
On Compensation:
partnershealthcare-public.sharepoint.com/ClinicalResearch/Remuneration_for_Research_Subjects.pdf
On Blood Draws:
www.feinsteininstitute.org/wp-content/uploads/2013/02/Maximum-Blood-Draw-Limits.pdf
www.euro.who.int/__data/assets/pdf_file/0005/268790/WHO-guidelines-on-drawing-blood-best-practices-in-phlebotomy-Eng.pdf?ua=1
Many CRO’s (study administrators) train plebotamists on us. This is good to know before they even touch you:
www.aimvein.com/venipuncture-tips/
hadawayassociates.com/blog/attempts-with-peripheral-venipuncture
www.mlo-online.com/how-many-times-should-a-phlebotomist-try-to-draw-blood.php
While there are written guidelines that are supposed to be followed by the study sponsors and administrators and enforced by IRB, FDA, NIH, WHO etc., to protect our health and safety, there is also press about when things go wrong in a highly financially motivated business...keeping in mind that most don’t make it to the press.
Ultimately, it’s up to us to perform due diligence and use common sense. We know our bodies, and have the right to choose what happens to us. We also have the right to refuse procedures and leave/withdraw at any point in a study without concern for lost funding the admins prefer to keep us there to maintain.
With that in mind, I offer the following educational links, invite others to share others you’ve found helpful. Please consider the source of any information provided, understand that any “guidelines” are general, our individual biology and constitution can differ. We need to be aware and make informed choices.
It’s also important to understand what the market value of our participation is appropriate, keeping in mind that those who implement any study are also receiving far more compensation for each of us who participate.
In a perfect world, all of the needed info would be provided during recruitment (pre-screening), and it could be, without compromising confidentiality. In reality, it’s not, and many of us spend hundreds on travel to show up to screen and still not get the info, much of which isn't offered until we are handed the informed consent papers to sign if we are accepted into the study or as an alternate.
For those travelling from afar, its even more important that we get enough info before booking travel, because we could lose hundreds on a gamble that might not result in any payment.
So, if you can't get basic questions answered like the following by the recruiters, ask to speak with a study coordinator. If they stonewall, call back and try again. If you still get nowhere, consider it a red flag. There are lots of options.
In addition to the dates and times, you have a right/need to know:
1- the phase
2- the drug(s) involved
3- if they are FDA approved
4- any known side effects
5- what the purpose of the study is
6- in what form the drug(s) are being dosed, how, and where
7- any known side effects
8- blood draws- how many, how much, the maximum in one day, whether they're all straight sticks or if they will allow catheters on days there will be multiple draws
9- the facility/inpatient health/ER support, food, amenities, privacy protection, ability for contact with others outside (such as family)
10- compensation- how much, when, and specifics about the form of payment. Are screens compensated? Referrals? What (if any) payments to expect if you're chosen as an alternate. How you would be compensated if you had to leave the study early for any reason (ex: family emergency, personal or study admin choice...)
Here are some links I’ve found helpful:
Trending industry news:
www.ncbi.nlm.nih.gov/books/NBK50886/
www.who.int/reproductivehealth/topics/ethics/human_tissue_use.pdf
On study protocol:
partnershealthcare-public.sharepoint.com/Pages/Policy_and_Guidance.aspx#12
On Compensation:
partnershealthcare-public.sharepoint.com/ClinicalResearch/Remuneration_for_Research_Subjects.pdf
On Blood Draws:
www.feinsteininstitute.org/wp-content/uploads/2013/02/Maximum-Blood-Draw-Limits.pdf
www.euro.who.int/__data/assets/pdf_file/0005/268790/WHO-guidelines-on-drawing-blood-best-practices-in-phlebotomy-Eng.pdf?ua=1
Many CRO’s (study administrators) train plebotamists on us. This is good to know before they even touch you:
www.aimvein.com/venipuncture-tips/
hadawayassociates.com/blog/attempts-with-peripheral-venipuncture
www.mlo-online.com/how-many-times-should-a-phlebotomist-try-to-draw-blood.php
