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Post by antecubital on May 15, 2012 17:51:23 GMT -5
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Post by Bulldog on May 16, 2012 7:22:47 GMT -5
Soon all CRO'S will be required to have a program such as Verified Clinical Trials. PAREXEL will also be particpating shorthly.
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Post by trialsurfer on Jul 12, 2012 12:51:22 GMT -5
I heard that Verified captures full name and drivers license, but clinicalrsvp uses just initials and a fingerprint check. In my opinion, I prefer the way clinicalrsvp does it. Seems more private.
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Post by antecubital on Jul 12, 2012 17:20:27 GMT -5
Interesting. Have you had any experience with either of these companies yourself? I haven't. I do studies, and there is one clinic that uses Verified that I'm thinking of screening at, but they haven't had any decent studies lately.
I'm not so much concerned about privacy as accuracy. What happens when you complete a study and its washout period, but the unit "forgets" to update your info in the database, thus leaving you ineligible to screen for another study someplace else, even though you're eligible under the protocols of both studies?
And, if you're in the database yourself, how much access do you have to your data? It would seem that under HIIPA, you would have an absolute right to see all the data they have on you.
Another lingering question I have is whether any research units are using these databases to weed out people who in the past might have dual enrolled or done consecutive studies too close together? I mean, are they looking to BAN people for past behavior, or just to prevent people from dual enrolling or doing "back to back" studies from here on out?
So, do you do studies yourself? Do you work for a research unit or ...?
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Post by respect on Dec 6, 2012 23:06:55 GMT -5
HIPAA rules were designed to protect you. Any entity or individual that think otherwise should be beware. Clinical Verification like anything must stand the test of the law. We should have full access to how and the content of our info are being shared. And we would should not be by any means coerced to forfeit our rights via threat or inducement. For a start make sure to keep a copy of all forms that you sign that may evidences infringement of such rights and that includes the consent form that may say if you do not allow the verification process you can not do the study under PI(doctors) care. Present these copies to organizations and lawyer(s) who have an interest in protecting your rights. Many lawyers give free first consultation and may be interested in offering their services pro bono especially if allowed to represent a group. Lawyers helps you focus on the parties that may be in violation of HIPAA rules. Is it the CRU and/or Sponsor and/or IRB and/or verification company or simply all of the above. They may even through the legal process make all potential parties that are subject to such processes made aware of potential violations of rights. Dont be scared HIPAA prevents organization from retaliating against individual(s) who complain about their rights being violated. If its makes you more comfortable approach lawyers or organizations with a friend or group its adds an urgency and will make others comfortable making the move. I took the time to provide a link to pursue complaints not excluding the above suggestions. www.hhs.gov/ocr/privacy/hipaa/complaints/index.html
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Post by respect on Dec 7, 2012 21:47:03 GMT -5
What are the penalties if an organization fails to comply with the HIPAA Privacy Rule? Failure to comply with the HIPAA Privacy Rule may result in civil or criminal penalties. HIPAA’s civil penalties were increased by the HITECH Act but may not apply if the violation is corrected within 30 days. For violations in which the individual is not aware that the violation has occurred, the minimum penalty remains $100 per violation, up to $25,000 per calendar year for identical violations. If the violation is due to reasonable cause, the minimum penalty is $1,000 per violation, up to $100,000 per calendar year. For corrected violations that are caused by willful neglect, the minimum penalty is $10,000 per violation, up to $250,000 per calendar year. The maximum civil penalty for any type of violation and the minimum penalty for uncorrected violations caused by willful neglect is $50,000 per violation, up to $1.5 million per calendar year for identical violations. The criminal penalties are: •$100 per violation, up to $25,000 per year, per standard, for disclosures made in error. •$50,000 and/or one year in prison for knowingly obtaining or disclosing PHI. •$100,000 and/or up to five years in prison for obtaining information under false pretenses, and $250,000 and up to 10 years in prison for obtaining PHI with an intent to sell, transfer, or use it for commercial advantage, personal gain or malicious harm. Taking the time to understand the rules will ensure that your organization is complying as it should under the law. Jessica Galardini is president and COO of JRG Advisors, the management arm of ChamberChoice. Reach her at (412) 456-7231 or jessica.galardini@jrgadvisors.net.
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Post by respect on Dec 8, 2012 9:35:47 GMT -5
How to get your voice heard! Let the medical staff know you think that your HIPAA rights are being violated! If every participant who walks into the exam room tells the doctor of his concern it moves the obligation away from the larger organization to individuals. Most doctors and certainly nurses are uncomfortable in any infringement in this area and particularly privacy is their concern. They also may care more than the profit sharks in corporate. They also have to answer to Medical Boards.
Their actions or in actions here may offer guidance in how they approach HIPAA sensitive situations in their private practice, hospitals and board they sit on.
The medical board in the state where that is a part of the CRO needs to be made aware of the verification HIPAA umbrella under which that doctor practices and explore violations of the HIPAA rules.
That brings up another point if you think your HIPAA rights are being violated bring the issue up with your personal doctor. Your doctor has your interest at heart much more so than a for profit CRO. They are much more likely to tell you how to proceed to protect your HIPAA rights.
When you get help share with your associates(they call us subjects) so that get they can get the assistance they deserve. Remember the Obama theme song. We take care of our OWN.
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Post by cherylphoto on Dec 19, 2012 13:19:20 GMT -5
Hi all! Just started a Facebook page: Labratus
Check it out...thought it would be faster to check out tips and travel and ride sharing.
Cheryl
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Post by travelingrat on Mar 13, 2013 12:43:11 GMT -5
i can't seem to find the thread that lists the clinics known to use VCT. the ones i know for sure are snbl, parexel, celerion.
as of december 2012, ocrc FL was NOT using VCT, nor was the unmentionable clinic as of february 2013. also when i screened for clinilabs (NYC) in fall 2012, they did not seem to be using it either.
a friend screened in Avail (FL) recently and said that they did not seem to be using anything but i seem to remember seeing somewhere that they and Accelovance DID use VCT ... does anyone know?
i follow the rules but i am very wary of VCT. somehow i just can't shake the feeling that the potential for invasion of our privacy is high. anyone who knows any other clinics who definitely use VCT, please post, thanks!
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Post by labrat1 on Mar 18, 2013 11:03:40 GMT -5
Some of the information provided in this thread is interesting. It seems some of you are saying that us lab rats have rights. However my experience is that lab rats hardly have any rights. You only have the right to quit a study. If you start asking about the legal ramifications of VCT certain clinics would only tell you not to participate if you think that any of the risks, whether medical or administrative or psychological, are too great for you individually. They would say ( true or not) that for their purposes they have reviewed all aspects of the study and are satisfied that the study meets all safety criteria and the screening procedures meet all criteria for privacy and furthermore, it already says in the consent form in some significant way that you privacy cannot be guaranteed 100% because different people and departments will look at your information such as laboratory workers, medical staff, etc. None is supposed to disclose or use your information for any purpose except for the study and it's results but mistakes can happen. Anyone who signs the consent form and participates in the study does so knowing that soing that is not supposed to happen with his/her personal information might happen. You would probably have to prove outright intent to disclose your information on the part of the research site. You would also have to prove negligence which would be hard because the research site has done everything possible such as code your medical samples or keep your file that has your name and address, under lock and key. If soing gets disclosed in spite of that, (maybe someone breaks and enters the facility, maybe someone you know , but whom you don't want to see your information, finds work in a laboratory in which your information will be sent, etc ) it could be said to be an unfortunate accident or incident that the research site is not responsible for and has already warned the volunteer that every possible precaution will be taken against it, but if the volunteer is peculiarly worried about other people seeing his/her information, s/he ought to not participate in studies.
I have yet to hear about a research site being sued by a volunteer for some "violation" of the volunteer's right. The fact is that research volunteers fall into no specific legal criterion. They are not employees of the research facility in which they do studies . They are not like government volunteers whom have rights and also certain responsibilities. In fact for research volunteers to have rights they would also have to be held to certain responsibilities. Volunteers freely disobey rules; that is what I have observed of the majority of volunteers whom I have spent time among. If they were to be considered more like employees, then they would have to really be held to do the study the right way and not disobey in-house rules such as stay up past curfew, trade food, misbehave and socially degrade the facility ( after all employees are not allowed to do that).
"antecubital" VCT is essentially a new system and they are not supposed to consider your past history regarding whether you had done studies "too close" together before, or had dual-ly-enrolled before.
I had done 2 studies at SNBL recently and underwent the VCT verification process for those two studies ( these were the first times I ever dealt with the VCT system). In fact one of the studies was in December 2012 and after I did that one another study came up at SNBL a bit more than 30 days later but when I called and spoke with a recruiter she told me that the study I am inquiring about has a special requirement that the volunteer had not participated in a study in the past 60 days, not 30 days; but since the December 2012 study did not require medications and was a "device study" it turned out that I could participate in the study that required that the volunteer not have participated in a "medicated" study in the past 60 days. So somehow they arranged for me to be accepted in the study. The VCT system is only meant to make sure that a person not done a study in the past 30 days. If the particular study requires a washout of longer than 30 days , I guess the VCT system does not apply and it is up to the particular sponsor to agree or not agree to use the volunteer according to whether the previous study was medicated or not, as in this case.
However, "antecubital" even though research sites and the staff are supposed to do things according to letter of law and according to ethical guidelines, it is possible that they could use the VCT system to ban a volunteer whom they do not to accept in their facility. You would have to prove that they are doing it unethically or illegally but a research site only needs to say that they are doing it for the volunteer's "own good" or because the volunteer is not a good candidate for any of their studies and the volunteer cannot legally contest it or overthrow . There is no law saying that a research site has to accept a volunteer whom they don't want. The volunteer is not entitled to be chosen for studies.
A research site could look at the volunteer's history or behavior and then use the excuse that the volunteer does not benefit by participating in studies at the facility. Of course if the volunteer actually misbehaved or disobeyed rules, the facility has the right to say that they are barring him or her for inappropriate behavior. But it can get more complicated than that. I actually applaud any attempt to weed out bad volunteers. I really hate the way that certain research sites scrape the bottom of the barrel and are like badly-run homeless shelters, but sometimes a research site would try to bar a volunteer who asks about the safety of studies or about his or her rights. MY personal experience (and according to what I had found out of other volunteers) is that in some sites the staff are more likely to try to ban you if you ask about your rights, or complain about bad conditions in the facility, or about being mistreated or sometimes if you complain that a medication is getting you very sick, than if you disobey rules.
So. The VCT system could be used by the research site in an unethical way but it is hard to prove.
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Post by brandon on Apr 2, 2013 16:01:48 GMT -5
Interesting. Im sure we will be hearing more about this in the future. Save up some money, kids.
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Post by parklife854 on Jun 27, 2013 10:44:47 GMT -5
Can anyone confirm whether or not Parexel Baltimore uses VCT? The posters above mentioned it but I can't find anywhere else that says they do..
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Post by sparky on Jul 1, 2013 10:17:48 GMT -5
baltimore doesnt use vct, doing a study here now
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Post by antecubital on Jul 1, 2013 18:57:07 GMT -5
baltimore doesnt use vct, doing a study here now SNBL uses VCT. You must mean that PAREXEL doesn't. Right?
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Post by travelingrat on Jul 3, 2013 10:11:39 GMT -5
snbl defintely uses vct. i thought parexel did too but i can't find anythign on the internet about it ...usually there is some sort of press release.
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