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A Clinical Trial and Suicide Leave Many Questions: Part 6: The Run-Around, or Why I Now Call for an Independent Investigation of University of Minnesota

The views expressed are those of the author and are not necessarily those of Scientific American.


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Drink me!

 

This series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotic drugs at the University of Minnesota, his suicide 2004 while participating on the study, and subsequent events as a case study in which to explore various aspects of clinical trial conduct. In previous posts, I’ve looked at issues of “good clinical practices” and ethics: consent, investigator responsibilities and conflicts of interest. Then I examined the university’s response. In the most recent post, I turned to the importance of careful documentation of consent.

I’ve experienced research in a variety of settings, from the bench in my fellowship, where I was filtering spit and nasal washings for influenza antibodies detected via laborious cell cultures, to sleeker clinical trials. I’ve conducted extensive literature reviews for my basic science research and subsequent articles, in writing my text on clinical trials, and as part of my regular patient care practice. I’m good at digging for data. But my experience digging for the truth on this series about the CAFE study at the University of Minnesota (UMN) has led me to unanticipated new frustrations and an impasse.

In this episode of my series, I share in greater detail the evolution in my thinking about the UMN’s handling of the Markingson case.

Getting to the truth

As I noted in my last post, when I started reading about this case, it was as an academic endeavor, seeking a case study for my blog. I like reading and writing about ethical stories, using a person and story to illustrate research conduct. The Markingson case, like some others, was peripherally on my radar. As I read, I became engrossed in the sleuthing as well as the tragic story, in figuring out the puzzle of “he-said-she-said.” I dove into depositions and started a timeline and spreadsheet to keep details straight. I never spoke to the principals…until March 8.

Wanting to put a more human face on my writing, that day I attempted to call several faculty members at the UMN to ask for their perspective. Only one person returned my call, politely telling me that all calls would have to be directed to Mark Rotenberg, the university’s general counsel. He didn’t return my calls either. So I e-mailed him with my questions for my most recent post. That evening, I received a call from Justin Paquette, PR Manager for the Academic Health Center and the spokesperson  for this case. I asked Paquette essentially the same things I had attempted to ask Rotenberg, and received disconcerting and evasive answers.

HIPAA

For example, as noted in my last post, there are questions raised about discrepancies in HIPAA (Health Insurance Portability and Accountability Act) forms. In a 2007 deposition of Dr. Stephen Olson, Dan Markingson’s attending physician and study investigator, Mary Weiss’ attorney notes (p. 144-5) that they (neither Weiss nor her legal team) had never been given a signed copy of the HIPAA form. In the deposition, Olson indicated that he didn’t know if there was a signed copy or, surprisingly, what the consequences were if they had not obtained a HIPAA consent. (Understanding the legal requirement to obtain a permission to access medical records, or HIPAA consent, and that failure to do so might be considered a felony is a basic concept I thought researchers were uniformly familiar with).

Yet, in response to a complaint by Mike Howard (close family friend of Dan’s mother, Mary Weiss) alleging misconduct by Dr. Olson, a signed form unexpectedly appeared in 2011—although the Fairview Hospital (the UMN campus where Dan had been admitted) medical records department certified that it didn’t have a copy of this on Dan’s chart.

Furthermore, Rotenberg’s own letter in response to Mike Howard’s complaint to the Board of Regents about Dr. Olson, states at one point that the HIPAA consent was signed November 24, yet later notes that Dan consented to participation in the trial on November 21. A date discrepancy. Rotenberg’s letter acknowledges that the HIPAA consent occurred days after Dan’s enrollment, suggesting a significant breach and possible felony.

Even if we accept that the signed HIPAA form was perhaps misfiled, I have yet to receive a response to my question about how Dan was enrolled on a trial three days before he gave consent for his records to be reviewed.

I asked Rotenberg and Paquette about the discrepancy in the evaluation to consent forms, one with a Bates number (used to identify medical and legal documents), one without. Again, they provided no explanation.

Down the garden path…

There was one response from Paquette that was particularly disturbing, given that he should be very familiar with this trial. Regarding Dan Markingson’s competency, Paquette tried to assure me that “the Court” had declared Dan competent to consent to this trial and had agreed to Dan’s participation. I countered that David Pettit, the case manager, didn’t even see Dan until 10/26/03, five days after he was enrolled on the trial. Surprisingly, Paquette reiterated it wasn’t Pettit, that “the Court had agreed to Dan’s participation.”

Perhaps this was an innocent slip of the tongue or memory. I would have expected the University’s spokesperson for this trial for several years to be more familiar with major details that are recurrently raised, and to be able to provide documents to refute specific concerns. But Paquette and Rotenberg have received multiple e-mails and calls from me since March 8 asking about this point, and have yet to provide any documentation of this claim.

I wonder if that is because there is none. In fact, Dr. Olson (deposition pages 78-79) makes the statement that he never informed the court about Dan going into the study…only that Dan’s county case manager approved it…who was never appointed until days after Dan was signed and enrolled on the trial.

That brings us to the next episode…

After reviewing the deposition again, I wondered if Paquette had deliberately misled me.

Study coordinator filling out forms

So I wrote a letter to Ben Garbe, an assistant attorney general who had represented the Minnesota Board of Social Work in their mild rebuke of the study coordinator. I raised my concerns about the puzzling responses from the university and the lack of transparency, including failure to provide documents to verify their claims.

I expressed my concern about the thinly veiled threats toward faculty. It’s not just Dr. Elliott, the University of Minnesota Professor of Bioethics and most persistent critic of the University’s handling of this case.  After all, if you ask questions, you are likely to be accused of making allegations—rather than trying to understand all sides, as General Counsel Rotenberg described Elliott’s media outreach efforts. (Mr. Rotenberg notably asked the university’s Academic Freedom and Tenure Committee to address “What is the faculty’s collective role in addressing factually incorrect attacks on particular University faculty research activities?”)
This question was widely interpreted as targeting Dr. Elliott and challenging academic freedom.

Additionally, if, as the UMN asserts there is nothing to hide, why instruct faculty not to speak with me? Or why are faculty not returning calls? Of course, typically, lawyers advise those involved in an ongoing lawsuit to refrain from speaking to the media. Such proceedings could be behind any evasiveness.

Even some other people who have expressed concern about the UMN’s behavior toward their family members have been reluctant to share more details with me, referring to admonitions from their attorneys.

And Garbe’s response? Astonishingly, he referred me back to the General Counsel’s (Rotenberg’s) office to investigate my concerns about that very office!

Fun house mirror

Some days I feel like I’m lost in a fun house with mirrors distorting everything beyond belief.

And that, dear readers, is why I have signed on to the petition to ask Minnesota Governor Dayton to launch an independent investigation of possible research misconduct in the psychiatry department of the University of Minnesota. I personally feel that multiple trials conducted by Drs. Olson and Schulz’ team should be examined, including the CATIE trial, which involved NIH. So far, 1,200+ people have signed on, from all over the world, including prominent ethicists and historians, Susan Reverby (the historian who brought unethical syphilis experiments in Guatemala to light), and three former editors of the New England Journal of Medicine. As Dr. Reverby noted, “It is imperative that when injustice happens it be acknowledged and investigated. This is not something we must do only for the past.”

see also: Petition to Gov. Mark Dayton of Minnesota to investigate psychiatric research misconduct at the University of Minnesota – started by Mike Howard (Dan Markingson family friend).

Credits:

“Molecules to Medicine” banner © Michelle Banks

Pills – ephotography

Getting to the Truth – Zoe Craft/Flickr

Coordinator filling out form – wistechcollege/Flickr

Fun house mirror – kthypryn/Flickr

Judy Stone About the Author: Judy Stone, MD is an infectious disease specialist, experienced in conducting clinical research. She is the author of Conducting Clinical Research, the essential guide to the topic. She survived 25 years in solo practice in rural Cumberland, Maryland, and is now broadening her horizons. She particularly loves writing about ethical issues, and tilting at windmills in her advocacy for social justice. As part of her overall desire to save the world when she grows up, she has become especially interested in neglected tropical diseases. When not slaving over hot patients, she can be found playing with photography, friends’ dogs, or in her garden. Follow on Twitter @drjudystone or on her website. Follow on Twitter @drjudystone.

The views expressed are those of the author and are not necessarily those of Scientific American.





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  1. 1. meegwich 7:38 pm 03/26/2013

    Thank you Dr. Stone for an excellent evaluation of the circumstances surrounding the death of Dan Markingson and the involvement of the UMN in covering up the misconduct of the psychiatry department researchers and the University itself. Your take on Mr. Paquette is right on…he has no clue what he’s even commenting on, and continues to make an ass of himself and the University. There is absolutely no document that gives any credence to the University’s claim that the court ever knew anything about Dan Markingson’s involvement with the CAFE’ study over standard accepted treatment which the court had ordered. Dr. Stephen C Olson has lied repeatedly over the years as has the University regarding the circumstances surrounding Dan’s death, and the old saying of tell a lie long enough and you’ll start to believe it as truth…and that’s exactly what the UMN has accomplished.

    Link to this
  2. 2. CurrentOutlook 9:42 pm 03/26/2013

    “Additionally, if, as the UMN asserts there is nothing to hide, why instruct faculty not to speak with me?”

    Well, one reason is that if there is a discrepancy between accounts, you make a big deal of it. Ref here the dramatic “A date discrepancy.” in paragraph 2 under ‘HIPPA’

    Link to this
  3. 3. Judy Stone in reply to Judy Stone 11:07 pm 03/26/2013

    It appears that you miss the point here. The documents–and confirmed by the General Counsel, Mark Rotenberg–indicate that the HIPAA consent was signed 3 days AFTER Dan was enrolled on the trial. That is not a trivial discrepancy. That suggests a major research ethics violation and possible large HIPAA penalty–that personal, private, psychiatric records were released without the patient’s permission. That is, in fact, a big deal.

    Link to this
  4. 4. centromere 6:43 pm 03/27/2013

    CurrentOutlook,

    I think if you examine the various outcomes from UMN’s POV, you’ll agree that it will be prejudiced towards a “single source” for official discussion.

    Consider the case where the university is actually as pure as wind driven snow. By managing the narrative through a single source, it reduces to a minimum the probability of a false positive, where a discrepancy between different accounts leads to an erroneous conclusion.

    In the instance where the university has something to hide (as clearly the author believes), by managing the narrative through a single source, it reduces the chances of any additional awkward details coming to light.

    Link to this
  5. 5. CurrentOutlook 5:41 am 03/28/2013

    “I think if you examine the various outcomes from UMN’s POV, you’ll agree that it will be prejudiced towards a “single source” for official discussion.”

    Good point: it is to the organization’s benefit to manage a debate critical of its performance, and the “single source” is a reasonable technique to achieve that end.

    It does, however, leave the organization vulnerable to the accusation that it is like Caesar’s wife, not above suspicion.

    Link to this
  6. 6. Bremsstrahlung 5:21 pm 03/28/2013

    @5. CurrentOutlook

    How many powerful organizations are above suspicion?

    Link to this
  7. 7. centromere 8:27 am 03/29/2013

    That’s one of the reasons they have a legal department. As the Federal Bureaucracy revises the rules and regs and associated fines, what was once OK is now deemed otherwise. Cignet Health, an HMO in Maryland, was assessed a $4.3 million civil monetary penalty for violating HIPAA. Although DHHS had entered into financial settlements before, that was the first time it had issued a civil money penalty under HIPAA.

    The original version of HIPAA had rather weak penalties (mx $100pd, NTE $25,000 for the same violation in any one year). From 2003 through 2007, HHS never sought financial penalties from violators.

    HIPAA has increased the COD(health)B.

    Link to this
  8. 8. jpaquette 10:54 am 03/29/2013

    Judy, since there wasn’t much context to my attribution here other than the sentence “Paquette tried to assure me that “the Court” had declared Dan competent to consent to this trial and had agreed to Dan’s participation,” I thought you, your readers and commenters would want clarification around that statement. This is especially important given your suggestion and implication that you were purposefully misled by my office.

    The information below was outlined by our Office of the General Counsel in 2011 to select faculty members who had sought an internal examination of this case (which I should add, was completed).

    “It must be understood that Mr. Markingson was determined to be competent to consent to treatment at the time he consented to participate in the study in the judgement of two courts and independent evaluators. The District Court judge that ordered Mr. Markingson’s stay of commitment and participation in the treatment plan specifically found that “the rights of Respondent [Markingson] have been protected throughout these proceedings,” and that “the Dakota County Social Services Department has developed a plan for services to treat the Respondent’s mental illness which is agreeable to the Respondent [Markingson].”

    It should further be noted to your readers that during that court proceeding, Mr. Markingson appeared in person, was represented by counsel and, as noted by the court, a Dakota County case manager recommended and endorsed Mr. Markingson’s treatment program.

    Further – in a second and separate judicial proceeding, the Hennepin County District Court specifically addressed the allegation that Mr. Markingson had not provided his informed consent to participate in the Cafe study and dismissed that allegation.

    Perhaps I should have been more specific or detailed in my statement to you, but hopefully now you understand that my original comments were justified and accurate. If you have any other concerns or allegations you wish to discuss, please don’t hesitate to contact me again.

    -Justin Paquette, assistant director of public relations for the Academic Health Center

    Link to this
  9. 9. centromere 6:28 pm 03/29/2013

    “From 2003 through 2007, HHS never sought financial penalties from violators.”

    Since the date discrepancy that the author feels is important occurred back in 2004, is it likely that the Health & Human Services HIPAA enforcement organization would have treated the study’s purported violation differently THEN than they would likely do NOW?

    Link to this
  10. 10. Judy Stone in reply to Judy Stone 8:52 pm 03/29/2013

    I don’t know the answer to your question. I do know that such HIPAA concerns were taken extraordinarily seriously at my hospital–and in fact, the fear of HIPAA penalties lead to drastic restrictions on my ability to screen potential study patients.

    Link to this
  11. 11. CurrentOutlook 6:59 am 03/30/2013

    “the fear of HIPAA penalties lead to drastic restrictions on my ability to screen potential study patients.”

    Is this another of the benefits of HIPAA?

    Link to this
  12. 12. Judy Stone in reply to Judy Stone 8:56 am 03/30/2013

    Dear Mr. Paquette,
    I don’t have time at the moment for a complete response as I have patient care obligations…more to follow. The key immediate point is that I have asked Mr. Rotenberg and you/your office for documentation of things you have asserted as being in Court depositions or publicly available documents as specific answers to specific questions.
    I have yet to receive those and would still welcome them.

    Dr. Judy Stone

    Link to this
  13. 13. Judy Stone in reply to Judy Stone 9:23 am 03/30/2013

    Yes. See Pharma Trumps HIPAA post

    Link to this
  14. 14. meegwich 11:47 am 03/30/2013

    In response to Mr. Paquette’s lengthy defense of his previous in-accurate statements…here are of a couple of cut’s from the sworn Deposition of Dr. Stephen Olson regarding whether the Dakota County Court was aware that Dan Markingson was being enrolled into a drug study…and these cut’s from Olson’s depo just prove once again that Mr. Paquette needs to put his big boy’s pants on if he wants to go out and play University mouthpiece…

    Q. Did you inform the court that you were going to
    23 put Dan into your personally profitable drug
    24 study?
    25 MR. ALSOP: Repetitious and form.
    3 A. No.

    ******************************************************************************************************

    13 Q. And it says under Paragraph 5 that the Dakota
    14 County Social Services Department has developed
    15 a plan for services to treat the respondent’s
    16 mental illness, right?
    17 A. Yes
    18 Q. Now, in the findings of fact section which is
    19 Pages one and first part of 2, do you see any
    20 indication or can you find me any wording that
    21 the court understood that Dan was going to be
    22 entered into a research study?
    23 A. No.

    20 Q. (BY DR. BARDEN) The court says that the
    21 commitment shall be stayed for a period of six
    22 months under the following terms and
    23 conditions: A, that the respondent remain
    24 hospitalized and cooperate with the treatment
    25 plan at Fairview University Medical Center

    VERBATIM COURT REPORTING 763-493-4535
    135
    1 until medically discharged and follow all of
    2 the aftercare recommendations of the treatment
    3 team. Do you see that?
    4 A. Yes.
    5 Q. Do you see any indication there that Dan is
    6 going to end up in a research study?
    7 A. No.

    1 Q. You were the keeper of the gate?
    12 MR. ALSOP: That’s vague and ambiguous.
    13 Q. For Dan by court order, you control his
    14 freedom, isn’t that right?
    15 MR. ALSOP: Vague and ambiguous and
    16 argumentative. Go ahead, Doctor.
    17 A. Yes.

    Link to this
  15. 15. centromere 11:49 am 03/30/2013

    It’s always entertaining to read how our Federal Government is looking out for us. It is, however, not obvious how HIPAA and HITECH involvement helps keep the cost of health care down by facilitating clinical research, as they would appear to place barriers in the way of securing data used for that end. Ref here the overhead costs and opportunities for potential participants to fall through the cracks involved in the University of South Carolina’s study.

    Link to this
  16. 16. bailiff 6:46 am 03/31/2013

    @14 meegwich,

    Is that your way of saying that the internal investigation did not occur or was not completed, or that the judicial review of two courts did not happen, or that Mr. Markingson did not appear in person, or was not represented by counsel?

    There are at least two sides in most disputes, correct?

    Link to this
  17. 17. meegwich 5:42 pm 03/31/2013

    bailiff@ I have no idea where you’re coming from with your comment. But, to be clear, Mr. Markingson made one court appearance in his life, the appearance on November 20, 2003 at which time the court granted stay of a full civil commitment for 6 months using the information provided the court by his treating physician that he lacked the capacity to make decisions regarding the use of neuroleptic drugs and the fact that he deemed a danger to himself or others. Mr. Markingson appeared in person having been brought to the court by a Sheriff’s Deputy and proceeded to meet his court appointed attorney for less than 5 minutes before making his appearance. Mr. Markingson’s attorney never was informed of the treating psychiatrist plan to enroll Dan in his drug study, nor was the attorney ever informed before the next scheduled court appearance that was cancelled due to Dan’s suicide. Dan Markingson signed a consent form, that’s never been questioned, he just signed it the day after the court ordered him to follow the directions of his psychiatrist, whom by the way, never informed the court of his drug study. Mr. Markingson signed his consent form still lacking the capacity to make decisions, and never had signed a HIPAA release prior to be enrolling in the study. This isn’t anything new, the court documents and study documents verify all of this. Mr. Markingson’s court appointed case manager, didn’t arrive on the scene until 5 days after Dan had been enrolled into study. And to make matters just a little more complicated the case manager’s licensed had been expired for two years before being assigned Dan’s case and is still expired. He informed Mary Weiss that he had never even heard of a drug study. The Minnesota Board of Social Work would have received and investigated a full complaint against the case manager….but they had no jurisdiction because he had no license.Hope this clears up your confusion.

    David M Pettit
    License Level: LSW
    License Number: 4705
    License Status: Expired
    Original Issue Date: 01-19-1990
    Expiration Date: 11-30-2001

    Link to this
  18. 18. bailiff 10:25 pm 03/31/2013

    @17 meegwich,

    “…Hope this clears up your confusion.”

    Actually, I think I’m not confused. You appear to be one of those who believe there is only one side to this issue.

    I think you are mistaken about that.

    Link to this
  19. 19. Judy Stone in reply to Judy Stone 8:47 am 04/1/2013

    @bailiff. I agree there are different perspectives on stories. One of the things I find quite troubling, I will repeat here (from my note to Mr. Paquette, the UMN PR representative:

    The key immediate point is that I have asked Mr. Rotenberg and you/your office for documentation of things you have asserted as being in Court depositions or publicly available documents as specific answers to specific questions.
    I have yet to receive those and would still welcome them.

    For every assertion made by Dr. Elliott or the Markingson family, I am provided referenced statements or documents, with a link to depositions or these documents, available on Scribd for anyone to examine, along with many other voluminous depositions.

    The UMN representatives have replied to my questions with letters and “we conclude that…” types of statements, but no concrete documentation.
    That they have not provided this kind of original source documentation is disturbing.

    I hope that clarifies and helps explain the evolution of my thinking on this case…and why I now support the call for an independent, outside investigation.

    Link to this
  20. 20. bailiff 10:47 pm 04/1/2013

    @19. Judy Stone,

    I had not critiqued your position, which appears to be reasonable and based upon dissatisfaction with the details of the UNM’s explanation, but rather that of one who uses expressions of the form “…Mr. Paquette needs to put his big boy’s pants on if he wants to go out and play University mouthpiece…”, which does not.

    I will now comment however, that the magnitude of failure you place now on the 2004 date discrepancy in your response to CurrentOutlook’s post @2, “a major research ethics violation and possible large HIPAA penalty”, does seem to be greater than what was commonly assigned by the DHHS then ($100/day * 3 days). As noted by centromere @7, 2007 was the first time it issued a civil money penalty under HIPAA.

    Link to this
  21. 21. meegwich 6:46 am 04/3/2013

    The American Medical Association is pretty clear about what penalty is incurred from violating someone’s HIPAA rights. Seems to be pretty self explanatory and I’d have to say somewhat expensive if the violations were done over a period of time and with multiple parties involved. Course, there’s always two sides to everything…..

    HIPAA Violation Minimum Penalty Maximum Penalty
    Individual did not know (and by exercising reasonable diligence would not have known) that he/she violated HIPAA $100 per violation, with an annual maximum of $25,000 for repeat violations (Note: maximum that can be imposed by State Attorneys General regardless of the type of violation) $50,000 per violation, with an annual maximum of $1.5 million
    HIPAA violation due to reasonable cause and not due to willful neglect $1,000 per violation, with an annual maximum of $100,000 for repeat violations $50,000 per violation, with an annual maximum of $1.5 million
    HIPAA violation due to willful neglect but violation is corrected within the required time period $10,000 per violation, with an annual maximum of $250,000 for repeat violations $50,000 per violation, with an annual maximum of $1.5 million
    HIPAA violation is due to willful neglect and is not corrected $50,000 per violation, with an annual maximum of $1.5 million $50,000 per violation, with an annual maximum of $1.5 million
    Criminal Penalties
    In June 2005, the U.S. Department of Justice (DOJ) clarified who can be held criminally liable under HIPAA. Covered entities and specified individuals, as explained below, whom “knowingly” obtain or disclose individually identifiable health information in violation of the Administrative Simplification Regulations face a fine of up to $50,000, as well as imprisonment up to one year. Offenses committed under false pretenses allow penalties to be increased to a $100,000 fine, with up to five years in prison. Finally, offenses committed with the intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain or malicious harm permit fines of $250,000, and imprisonment for up to ten years.
    Covered Entity and Specified Individuals
    The DOJ concluded that the criminal penalties for a violation of HIPAA are directly applicable to covered entities—including health plans, health care clearinghouses, health care providers who transmit claims in electronic form, and Medicare prescription drug card sponsors. Individuals such as directors, employees, or officers of the covered entity, where the covered entity is not an individual, may also be directly criminally liable under HIPAA in accordance with principles of “corporate criminal liability.” Where an individual of a covered entity is not directly liable under HIPAA, they can still be charged with conspiracy or aiding and abetting.
    Knowingly
    The DOJ interpreted the “knowingly” element of the HIPAA statute for criminal liability as requiring only knowledge of the actions that constitute an offense. Specific knowledge of an action being in violation of the HIPAA statute is not required.

    Link to this
  22. 22. Bremsstrahlung 7:28 pm 04/3/2013

    @21. meegwich,

    Emotional investment in this issue should not prevent anyone from noticing some facts. Consider: “In June 2005, the U.S. Department of Justice (DOJ) clarified who can be held criminally liable under HIPAA.” This would be about a year after the date discrepancy being discussed, so it (the date discrepancy) is more reasonably discussed in the previous, prevailing context.

    The larger economic and criminal penalties identified in your post were implemented with HITECH, which was enacted in 2009, about five years after the date discrepancy being discussed, and should not be confused with the earlier ones in place at the time in question.

    Link to this
  23. 23. meegwich 6:12 am 04/4/2013

    Com’n people, it’s not that complicated. If the speed limit says 30 MPH and you’re caught going 35 MPH…did you break the law? The fine will be more if you were going 40 MPH I’m sure…but the fact is, you broke the law, disregarded the law, ignored the law, had contempt for the law, or in the case of the study staff in the CAFE’ trial at the University of Minnesota…we didn’t even know if HIPAA existed while running the study. So I guess ignorance does apply here. If you failed to adhere to a federal law out of ignorance or whatever, you still broke the law.

    Link to this
  24. 24. meegwich 7:04 am 04/4/2013

    From a response a few years ago.

    Thank you for contacting the Department of Health and Human Services.
    HIPAA Enforcement
    HHS’ Office for Civil Rights is responsible for enforcing the Privacy and Security Rules. Enforcement of the Privacy Rule began April 14, 2003. Since 2003, OCR’s enforcement activities have obtained significant results that have improved the privacy practices of covered entities. The corrective actions obtained by OCR from covered entities have resulted in systemic change that has improved the privacy protection of health information for all individuals they serve.

    In reply to your quire, the penalties in effect for the year 2003 for violating the HIPAA Act regarding clinical trial participation in research were as follows:

    There are civil penalties of $100 per violation, but the penalties can be “stacked” if there are multiple violations with respect to a single individual. The maximum civil penalties are $25,000 per year, per person, per standard. Thus, if two standards were violated with respect to one person, the potential penalties could amount to as much as $50,000. Criminal penalties (up to a $250,000 fine and ten years in prison) may be imposed for “knowingly and improperly” disclosing information or obtaining information under “false pretenses”, with higher penalties reserved for violations designed for financial gain or “malicious harm”. In addition, of course, state laws may impose additional penalties for the same offenses, and most states would also allow common-law suits for torts such as invasion of privacy and infliction of emotional distress, among other causes of action.

    Link to this
  25. 25. centromere 4:52 pm 04/4/2013

    @20 bailiff & @22 Bremsstrahlung

    I do believe you’ve hit a nerve!

    Link to this
  26. 26. bailiff 8:35 pm 04/4/2013

    centromere,

    Indeed it does seem that way! For those who confuse the present and the past, for the record:

    HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996

    Public Law 104-191
    104th Congress

    SEC. 2722. <> ENFORCEMENT.
    “(b) Secretarial Enforcement Authority.–
    “(2) Imposition of penalties.
    “(C) Amount of penalty.–
    “(i) In general.–The maximum amount of penalty imposed under this paragraph is $100 for each day for each individual with respect to which such a failure occurs.

    http://www.gpo.gov/fdsys/pkg/PLAW-104publ191/html/PLAW-104publ191.htm

    Link to this
  27. 27. CurrentOutlook 5:41 am 04/5/2013

    bailiff, Bremsstrahlung, cetromere

    I suspect this is an occasion when mere facts will have little influence on a powerful emotional commitment. The point has been made that the rules of the game have changed – quite considerably it seems, and for the worse from some perspectives – from what they were then to what they are now.

    Link to this
  28. 28. advocate997 7:15 am 04/5/2013

    Dr. Stone, I’ve followed your series of articles from the very beginning and each one has gotten more and more interesting. First, I wanted to compliment you for your fine work on this series, and secondly, I could not agree more with meegwich@ with his comment relating to the fact if you broke the law, you broke the law. I just don’t understand what a few other commentators are trying to insinuate, it really doesn’t make any difference whether the penalty phase was $1.00 or $5.00, or $100. If the researcher or his staff violated a human subjects civil rights then they are guilty of committing a crime. I look forward to more postings on this sad case and hopefully all involved will have learned some valuable lessons.

    Link to this
  29. 29. Judy Stone in reply to Judy Stone 8:31 am 04/5/2013

    @bailiff, @centromere, @Bremsstrahlung
    Two reminders: 1st, let’s keep this civilized and on topic. You are beginning to sound like a picador jabbing for sport rather than understanding or discussion.
    2nd, I conducted clinical trials. At our institution, at that time, HIPAA was taken very seriously. I would never have known about a potential study patient if they had not signed a consent. Penalties from our hospital would have been severe had I had a patient consent signed 3 days after enrollment.
    It is not just the magnitude of the fine. It is that the PI admitted (see his deposition, previously cited) to being oblivious to basic research principles and requirements…and that the UMN, thus far, has not provided documentation that refutes these charges nor adequately answered other questions.

    Link to this
  30. 30. Judy Stone in reply to Judy Stone 8:52 am 04/5/2013

    Thank you so much. There is still a lot that needs to be addressed and more questions keep coming up. The UMN’s intransigence alone raises concern that the apparent research misconduct might well extend to other studies as well. Given the Board of Social Work’s findings of shoddy record keeping by the study coordinator, for example, there is good reason to examine all studies done by that team.
    The Principal Investigator is ultimately responsible for supervision and the work submitted…so the seeming lack of any repercussions towards the PI raises other questions.

    That 1800+ people have signed the petition to Governor Dayton requesting an independent investigation of the UMN psychiatry research is also telling. This includes prominent researchers and ethicists as well as (former) medical editors of prestigious journals.

    This case is not just about two aggrieved family members looking for answers. It is about research ethics and the need for assurance that conduct of research at the UMN is carried out responsibly. Readers who think otherwise have missed the point.

    Link to this
  31. 31. MultiWoman 6:09 pm 04/5/2013

    “… fine work on this series, and secondly …”

    Indeed, managing debate about ethical issues can be tricky. This was a good choice.

    “… I could not agree more with meegwich@ with his comment relating to the fact if you broke the law, you broke the law. …”

    What you may not have noticed is that at no point was that in question. What may be reasonably questioned is why some commentators are using post HITEC values to assess pre HITEC events?

    “… I just don’t understand what a few other commentators are trying to insinuate, it really doesn’t make any difference whether the penalty phase was $1.00 or $5.00, or $100. …”

    Actually, yes, it does. In both ethics and law, (both pertinent in this context) the proposition “Let the punishment fit the crime” means that the severity of penalty for wrongdoing should be proportionate to the severity of the infraction. If you follow the reasoning you will understand that a modest penalty (a maximum of $100 per day) reflected the then sense Congress had of the gravity of that misdeed. As its perception changed, so did the associated penalties.

    Ethics is not a Boolean system.

    “… If the researcher or his staff violated a human subjects civil rights then they are guilty of committing a crime.

    This one is easy; you are wrong. Unethical behavior =/= criminal behavior. You have confused Ethics with Law.

    “… I look forward to more postings on this sad case and hopefully all involved will have learned some valuable lessons.”

    I couldn’t agree with you more!

    Link to this
  32. 32. abolitionist 7:43 pm 04/5/2013

    SugarTax,

    That was probably posted by one of the two aggrieved family members looking for answers. Such inelegant expressions are not uncommon from the recently bereaved. Why this would still continue nine years after the fact is more unusual.

    Link to this
  33. 33. bailiff 7:57 pm 04/5/2013

    @29. Judy Stone,

    “let’s keep this civilized and on topic.”

    I have posted from the U.S. Government Printing Office a reference to the law in question as it existed at the time in question, which seems very much on topic. I have criticized, giving clear, specific reasoning, your assessment of the 3 day discrepancy.

    I would like to be able to assume that disagreeing with you in this blog does not constitute discourtesy or uncivilized behavior.

    Link to this
  34. 34. SilverTusk 9:07 pm 04/5/2013

    advocate997,

    Justice is an abstraction of moral behavior based on ethics. Justice is an ideal the world fails to live up to, despite good intentions. Where people interact but disagree, Law is required to realize more or less closely the ideals of Justice. Further, while Law tracks Ethics, it often trails it. The change in the HIPAA law is a case in point; it was revised so that its penalties more closely approximated the moral deficiency currently associated in the United States with unauthorized use of an individual’s medical information.

    You need to understand that there are many legal unethical behaviors, for although ethics cannot be completely described, laws must be reduced to printed language. The converse is also true; there are unjust laws.

    So, while your heart may be in the right place, you’re mistaken if you believe those who violate civil rights are therefore guilty of committing a crime, for it does not necessarily follow. Those who share your opinion share your mistake.

    Link to this
  35. 35. PassingFancy 11:45 am 04/6/2013

    meegwich
    “The American Medical Association is pretty clear about what penalty is incurred from violating someone’s HIPAA rights. Seems to be pretty self explanatory and I’d have to say somewhat expensive if the violations were done over a period of time and with multiple parties involved. “

    It is, is it? I was, until now, unaware that the American Medical Association was in the business of assessing penalties from violating someone’s HIPAA rights. How expensive are these penalties of the American Medical Association?

    Link to this
  36. 36. Bremsstrahlung 12:23 pm 04/6/2013

    @31. MultiWoman & 33. SilverTusk,

    Two good arguments about the Law and Ethics, and how they’re alike and different. Does anyone have a sense of why they’re so often conflated, as they were here?

    Incidentally, the acronym is HITECH.

    Link to this
  37. 37. MultiWoman 12:33 pm 04/6/2013

    @35 Bremsstrahlung,

    While it shows my prejudice, I like to think it is due to the success of Law. While it does often lag behind the more rapidly changing portions of society, in this case the changing nature of personal privacy, it is usually “close enough”.

    You’re quite right. Sorry about the spelling.

    Link to this
  38. 38. centromere 12:53 pm 04/6/2013

    @29. Judy Stone,

    “ the UMN, thus far, has not provided documentation that refutes these charges nor adequately answered other questions.”

    While I do not share all your opinions, I will agree with you that when participants in a conversation are unresponsive to criticisms, it does raise concerns about their positions.

    Link to this
  39. 39. meegwich 6:53 am 04/7/2013

    passing fancy@ Perhaps you misread the statement concerning the AMA. Nowhere does the comment reference that the AMA enforces or penalizes anyone…it simply states what information is on their website cautioning physicians to be aware of the HIPAA act and what the penalties are for violating the act.

    Link to this
  40. 40. MultiWoman 9:51 pm 04/8/2013

    @39. meegwich,

    Is this yet another example of using post HITEC values to reference pre HITEC HIPAA events?

    Link to this
  41. 41. Bremsstrahlung 4:54 am 04/10/2013

    @39. meegwich,
    More to the point, what did the AMA website have to say about HIPAA at the time of the date discrepancy mentioned by the author?

    Link to this

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