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Oh boy, yes! And the best part of it was, all of this was completely unnecessary, let me go back to the very beginning shall we?(If you don’t want the back story and know perfectly well what a cochlear is, and what Mondini Dysplasia is and you just want to get to the story, scroll down until you see a duck, then that’s when the original question gets answered! You’re welcome!)*teleports back to the very beginning!**whoosh*Alright, so I was born profoundly Deaf, and my parents tried so hard to find a ‘cure’ seeing as I was the only Deaf person in the family. We tried doctors/audiologists but a cochlear implant was not recommended but we couldn’t figure out why.I think I attempted to get a cochlear implant roughly four separate times but I was still not being approved, it was always full of excuses, either the hearing I had on my left ear was still too good to justify a cochlear implant (even though my right ear was practically deaf), or that there was just too many risks that outweight the benefits. Obviously after hearing that over and over, I just accepted it. I was going to be completely deaf on my right ear.Then I moved to England (from Scotland) and at the age of 22, I enquired about the cochlear implant yet again to a new doctor. He never heard of what a cochlear implant was, (so I kind of used it to my own advantage ^_^) and the doctor referred me over to a specialist in one of the leading hospitals in the UK.A few weeks later I got an appointment and it was discovered why I was rejected all of this time. Apparently (and I only say apparently because this was a condition I had all my life and at the ripe age of 22, I just discovered this!), I had a condition called…Mondini dysplasia (it does look like I randomly punched letters on my keyboard but that’s what I have). Basically, you know how the cochlear looks a bit like a snail?A bit like this (if I can figure out how to paste a picture onto this)(ignore the wire part, that’s what a cochlear implant does) but yes, that’s what a cochlear looks like, and it’s responsible for converting sounds into electrical stimulation so your brain can understand it. Notice how it seems to have 2 and a bit turnsWell apparently mine looks a bit like this (I am sorry for the incredibly complex image you are about to see, it is done with my wonderfully amazing art skills since google cannot find a decent picture of what my cochlear actually looks like.Yes, so my cochlear has one and a half turns…I figure by now since the population of Quora be like “WE NEED TO SEE PROPER TERMS AND PROPER EXPLANATION OF WHAT THE CONDITION IS TO FILL OUR KNOWLEDGE OF PROPER INFORMATION RATHER THAN A PICTURE THAT CLEARLY LOOKS LIKE YOU DID IT THROUGH PAINT!!!!” - pfft, fine, be right back then!“The Mondini dysplasia describes a cochlea with incomplete partitioning and a reduced number of turns, an enlarged vestibular aqueduct and a dilated vestibule. A normal cochlea has two and a half turns, a cochlea with Mondini dysplasia has one and a half turns; the basal turns being normally formed with a dilated or cystic apical turn to the cochlear. The hearing loss can deteriorate over time either gradually or in a step-wise fashion, or may be profound from birth” - Quote from Wikipedia, you’re welcome!Right, so…..let us get back to our story time. Where was I? ….*scrolls up* ah yes, so the doctor explained that this was the condition I had, which means that the operation would be very difficult and it would have more risks associated with it than the normal cochlear implant operation. Obviously I was disheartened but I was so happy when they said they can still operate.Right, so let’s actually answer the question now, what exactly was the doctors unable to explain…..So, for the actual operation, it went fine, there was a lot of leakage, but that was to be expected with the condition I had, turns out, it was a day operation so I was sent home that day. I was told to be put on bed rest and I was to expect a little blood coming through my nose. Hmm…Okay.I was fine for the first three days post op. But then I found I was bleeding through my nose, my ear, and I just felt quite off…..so an ambulance was called and we were teleported to the hospital (not the original hospital, which is part of the story….)We arrived at the hospital and I was rushed to A&E. I had all my usual checks, my heart rate, my pupil dilation, and all that fun tests that nurses like to do at 4 in the morning….What I found though was, I was getting more and more tired. I couldn’t sleep yet couldn’t stay awake. But every four hours, I had to take a drug called ‘Codeine’. After taking it, I’d be back to sleep, and I believe we were there for 8 hours and nobody came over to tell me what was wrong with me. A doctor finally came over to explain that nobody in their department has seen someone with a cochlear implant and so they wanted to transport me back to the original hospital seeing as they are the ones who are specialists in cochlear implants…..so off we went. I do remember falling asleep a few times on the way to the other hospital.We arrive at the hospital and they did their checks, and soon enough (well when I say soon enough, it was about another 8 hours) before I was checked in as a patient and had my own bed. Things seemed to be okay, I just felt a bit sickly every now and again. And they kept giving me Codeine, every four hours……(the codeine was meant to help reduce the pain and swelling from my operation)….I did let the nurses know that my head did feel like it was going to explode…there is something that is quite unexplainable, it was like my head was full of pressure and I did feel really worried about that.So here is the fun ,fun, fun, fun….part of it all. As I am Deaf, when people talk to me, my first instinct is to smile and nod and hope they go away, and turns out I did the wrong thing…..it was about 11:45pm that night, with two people coming into the room. One was a doctor, and the other was a nurse. They mentioned something called a ‘lumbar puncture’, which I had no idea what it was, and the next thing I know is…..I need to grab my knees, while they cleaned my back (why were they cleaning my back….it’s my head that really hurts!) …….they injected a long narrow needle into my spine, and let’s just say it’s not something I’m desperate to do for fun in the future…..and they left me to it. It wasn’t until I googled it (as I was in a lot of pain, I’m pretty sure my google search was initially “WHAT THE F@CK IS A LUMBAR F@CKING PUNCTURE?!” but once I calmed myself down, I googled it, and I found out that they were trying to extract the spinal fluid to see if that was what was causing the pressure in my head.What I did notice over the next couple of days…..along with being woken up every four hours for codine….was, if I was to move my head ever so slightly, I’d vomit. If I was to try bending my legs, more vomit. If I was to look upwards without moving my head, again…more vomit.See, I can handle vomit, usually I feel great after vomiting, but no, it felt a lot worse. and I’m sure anyone who has vomitted non stop for at least 3 days, can understand that being in a hospital full of people you don’t know, constantly vomiting, and not being able to smoke…..with a needle in your back……it’s not the most fun thing to go through. But after five days, they removed the needle in my back, and I was told that the vomit was normal for someone going through with the lumbar puncture, and after a few hours, I should be feeling a lot better!Great!Except I wasn’t feeling better, I was still vomiting.I even had a physiotherapist come into the room warning me that I’ll need to learn how to move without being sick, and that it’s probably just because my body was used to lying in the one position and my balance was going off the charts. She also said that if it’s not done soon, chances are, this will be chronic. So she sat me up, and we practiced standing. Pft, let’s just say I stood….for a second, before vomiting again.It wasn’t until that night when my partner and I were talking away through Skype. And she managed to figure out what was going on.(oh boy, don’t we all just love backstories?! I swear I’ll make this short)It was the previous year, when I was in pain, and my partner gave me one of her meds (I know, spare me the lecture!) but I ended up having an ambulance called and they put it down as constipation….and left.Anyway, she compared the ingredients in both and found that Codeine was the same ingredient and told me to stop taking the codeine.I spoke to the nurses and after being sleep deprived, I pretty much ordered them about. They were NOT to wake me up every four hours, they were to stop giving me codeine, I was going to get a nice shower, get a decent sleep, and all will be well with the world.Safe to say, I slept wonderfully that night, woke up, had my breakfast, even tidied up the room. I packed my stuff up and told the nurses I was going home. Obviously the world doesn’t work that way but they did discharge me that day.So yes, I’m allergic to codeine, so if I need a trip to the hospital with a needle sticking into my spine and being sleep deprived, I’ll be “surely” taking that drug again!Edit - 10/09/2017Okay, so now that I’ve actually finished work, I think I should add to this lovely answer, about what happened afterwards….safe to say I made a few complaints. While the cochlear implant is doing wonders for me, I am noticing sounds as more…3D rather than relying on my one ear.Email One: (To the complaints department of the hospital)Hi there,I feel this email address should really be saved as a contact with a number of times I've contacted you.Well, the journey I've had with having a cochlear implant has not been a straightforward journey even before I've even had the bloody surgery! Even after the surgery, I ended up being hospitalised a couple of days later for the weekend, during that time I had to have a lumbar puncture procedure which was not that great to have a needle stuck in your spine for 4 days straight!Urgh, so anyway as you can imagine I was more than happy to escape from that hospital when I got the first chance! But anyway, this is not what I'm going to be talking about, but instead, I'm going to be talking about what happened today (28th of November 2016)As you can imagine, this was meant to be one of the most exciting parts of the whole journey so I booked today as annual leave at my work to attend the hospital, I've spent money on transportation (taxi to get to the train station, the train tickets and a plus bus). All of these costs were not going out of my money, but my carers money as I only just started working 2 weeks ago and wouldn't have been paid in time.The original idea was that because I was getting my cochlear implant 'switched on' today, the costs would work out in our favour because this was meant to be the real beginning of being able to hear out of my right ear.So, we arrived at the hospital slightly late due to our train being delayed and we were told to wait in the waiting room but since the waiting room is not very accommodating (have you seen just how tiny that room actually is?!) so we ended up waiting in the lobby. I recognised the audiologist I saw in the first appointment I had and I saw he was scrambling around in the cochlear filing cabinet. Somehow this rang alarms in my head....(surely nothing is going to go wrong, surely everything will be smooth from now on) .....we get called into the room and I'm sitting down feeling really exciting that I'm going to be getting my cochlear implant and it'll be really exci- oh wait....suddenly I'm being told that the cochlear implant hasn't even been ordered yet.....so the appointment went from a life-changing moment to.....a complete waste of time.I wasn't able to get my cochlear implant mapped, I wasn't even able to attend the next appointment I had today which was meant to be equipment briefing. So the appointment was simply a check up on how my scar was looking.This didn't just cost money through transportation, but instead lost wages, of both myself and my carer, lost hours I could have been spending on my own university studies as that is getting seriously behind now as I've had to spend some time recovering from the operation itself.What they managed to do was refund the train tickets, but I still lost a days wage which was…frustrating.Email Two: To the complaints departmentThis was before the operation, I should have moved this to the first email, but what happened was, in the pre-operation appointment, the nurse kept blethering away while filling out the consent form and she failed to ask me if I wanted students to be present in the operation….and with me having a very rare conditon, I was having none of it, yet I wasn’t asked this and she still ticked the box which I couldn’t do anything about as by the time I read through the consent form, I was on the train heading homeSo, I sent them a lovely email.Me - “I'd also like to notify that (Nurse) never asked me if I was okay with students being involved with the procedure, I would like to decline this although on the content form she already ticked yes, would you have any suggestions on what to do in that situation? I'm sure it wasn't intentional or anything it was only after I was reading through the content form and I noticed this was on the sheet when I was never specifically asked. I just don't want to be turning up to the hospital and having to tell people that I didn't want students to reduce my anxiety. If you could let her know that I don't want students there, that would be fabulous xx”Complaints department - “That’s absolutely fine, don’t worry about it. I will talk to (nurse) myself”Me - “Hello (complaints department),Thank you so much for everything you've done, but I thought you'd appreciate an update on the situation with (Nurse)My girlfriend, phone just rung shortly after our conversation (She is my also my carer so takes phone calls on my behalf). It was (Nurse) herself who aggressively tried to advocate to have students in the room, completely disregarding or even acknowledging the fact that having students in the room would make me feel extremely anxious and scared, even more so since this is the first kind of operation I have ever had. She kept interrupting (girlfriend) saying that we have to appreciate that (Hospital) is a teaching hospital and that I should let them observe as I have a condition not often seen and that if I didn't allow it she would have to discuss this with the consultants giving me the impression that if I refused, my operation might not go ahead.I completely appreciate that (Hospital) is a teaching hospital but I just feel in this case she didn't appreciate my rights to say no. As I hung up, I felt guilty for using my own rights as a patient instead of letting (Nurse) intimidate me. She phoned shortly afterwards without a simple hello, to say that was fine and I was to tick no in the consent form before she hung up.And this was why I wasn't too keen on forwarding this to (Nurse) in the first place.Jake”Complaints department - “In terms of the other concern you raised relating to consent for medical students to be present and your experience with (Nurse) , I have now escalated these concerns to Deputy Operations Manager, Surgery. I have asked (Deputy Operations Manager, Surgery) to provide feedback regarding your experience and to confirm that students will not be present during your procedure and that you do not feel comfortable with (Nurse) being involved with your care in the future. Once again, I must apologise for your experience, once I have more information I will be in touch.”Complaints department - ““Thank-you for forwarding this onto me, it has allowed me the opportunity to feedback to (nurse) a patients experience of their interactions with her which we both used to understand our behaviours and communication seen from our patients eyes.Firstly we would like to thank Jake for raising the concern, it cannot have been an easy decision to make but we are grateful as it has allowed us both the opportunity to understand and improve the standard of care we deliver and without such feedback we risk failing our patients expectations and needs.I have spent some time with (Nurse) discussing this complaint and (Nurse) was concerned to hear that Jake was left feeling anything other than fully prepared, informed and supported throughout their treatment by her. She is particularly sorry that Jake and his partner felt under any pressure to agree to students being present. In her experience she has not come across any patients who have refused students and whilst this does not lessen the validity of the request but perhaps it was glossed over and the details not laboured on the consent form and so undoubtedly it was discussed insufficiently on this occasion. (Nurse) and I have reflected on how we can ensure that all patients wishes are actively sought, listened to and understood and then of course complied with, in particular with regard to the presence of students. I think this process serves as a reminder that we need to address this question more clearly to ensure that each patient is fully aware of their rights and that these are fully respected. In future she will ensure that patients clearly understand they are in full control of whether they have students present as part of their consent process.Additionally: there have been some factors which (Nurse) feels might help us to prevent such circumstances occurring again which perhaps were not picked up in the complaint but I felt were useful issues to be raised.-There was no interpreter available for this appointment which was deemed desirable. (just going to add here that there was actually a sign language interpreter present….never mind, apparently the person in the room flapping her hands was not my interpreter…..never mind….anyway, back to the lovely response….) (Nurse) made the decision to proceed with the appointment to avoid disappointment or delays and today we feel that the hindsight that this feedback has offered the appointment should have been rearranged with an interpreter and so helping with effective communication. The outcome may allowed extra confidence in the process and the opportunity to ask questions and so all parties were clear about what was discussed. I can see the benefits of both options for (Nurse) on that day and unfortunately proceeding without an interpreter has contributed to this patients experience and the quality and the completeness of their dialogue, and I do think (nurse) made a considered decision on that day but perhaps unaware of the consequences. This complaint forms useful feedback to help future decisions.-(Nurse) has reflected on the flow of patients she sees during her clinics and the pressure she can feel under to see the next patient. This may limit the time available to discuss the consent form properly and she will consider whether patients taking it home to read thoroughly and digest and then offer a method to answer queries prior to signing the consent form. This time away from Clinic with the consent form may have helped Jake’s involvement and absolute understanding of what he was signing , rather than what appears to have been a unsatisfactory consent process.(Nurse) and I discussed the follow up call with Jake’s partner and in particular the terms: abrupt, aggressively and intimidate. (Nurse) was alarmed to hear these words and her concern was solely for how she had made Jake feel like this at such a stressful time. (Nurse) reflected that her manner could have been seen as abrupt and that this feedback has allowed us to discuss styles that we can adopt to try and avoid this . (Nurse) will aim to be mindful of her patient’s needs and feelings, their response to her during consultations and to obtain feedback at the end of consultations to ensure both parties are clear about what has been discussed and that all questions have been covered satisfactorily. I am sorry that you were under any pressure or feeling that your surgery was not going to go ahead, this would absolutely not be the case at all and you are perfectly within your rights to refuse students being present, your right to refuse anything will not affect your access to other services available. I am sorry you were left feeling like this. I hope that I can reassure you that your request for no students present has been communicated clearly with the team ahead of your surgery.I do hope that this helps illuminate the way forward with our own thoughts on the interactions referred to. (Nurse) and I wish Jake well with his surgery next week. It must be both an extremely exciting yet anxious time and (Nurse) and I are profoundly sorry if this time has been made harder by (Nurse) actions or words. We look forward to seeing you here at Addenbrooke’s in the future and we hope that your future experiences are entirely positive”With best wishes”Safe to say that my journey hasn’t been easy, but I’m glad I managed to get through it. Barely though! :DI now have a full time job, 39 hours and I am coping a lot better than I did in my previous job which was only 18 hours. It’s much less lip-reading, and more being in the moment! :D

There are a number of common complaints about HIPAA provisions. I'll summarize some of the main ones:Parental access to their adult children's informationOnce children reach the age of 18, parents are no longer eligible to access their medical information. This is true even if the children are still on the parents' insurance policies, making the parents guarantors for payment of their children's procedures. That is, a parent could easily be in the position of being asked to pay for an adult child's procedure, but not able to ask the doctor's office for any details of what was done.Difficulty of doing medical researchHIPAA compliance makes it much harder to do retrospective studies. My wife actually helped design and perform a retrospective study while getting her Pharm.D., and a substantial chunk of the budget went to having the medical records department redact records to make them HIPAA-compliant.Prospective studies suffer too. Under HIPAA, informed consent forms have to include a large privacy section filled with legalese. One study that implemented HIPAA-compliant protocols suffered "...a 72.9% decrease in patient accrual, and a threefold increase in mean personnel time spent recruiting and mean recruitment costs." (http://www.ncbi.nlm.nih.gov/pubmed/16342254 )Over-caution by providersAs with any incredibly complicated law, most of the people affected by it don't fully understand all of the provisions. This leads to all sorts of knee-jerk overprotective policies. E.g., during a hospital stay the hospital placed all sorts of barriers in the way of my wife seeing my chart, blaming "privacy laws" that had no basis in HIPAA. The atmosphere of fear can impede communications, especially in situations where the patients ability to communicate or monitor their own care is impeded.Cost, waste, and bureaucracyHIPAA generates a lot of paperwork that few people ever read. Notices of privacy practices get printed in bulk. Fortunately, the costs are much less than they were back when HIPAA was introduced; all medical information systems now include HIPAA features out of the box. However, the cost to train personnel on HIPAA requirements remains a major expense, and additional personnel (or, for a small practice, a portion of a person) is necessary to perform compliance duties.IneffectivenessWhile I agree with the general privacy intent of HIPAA, the implementation isn't particularly effective. Individuals cannot sue under HIPAA for privacy breaches (although they can often sue under state privacy laws or common law principles such as negligence). All an individual can do is file a complaint with the Department of Health and Human Services, which will either be ignored or be added onto a backlog so long that it might as well be. Just last year, University of California at Los Angeles Health System settled charges that employees were browsing through patient records (http://www.hhs.gov/news/press/2011pres/07/20110707a.html). Actually doing as DHHS recommends, and having someone review all audit trails to catch unauthorized viewing, would dramatically increase the cost of HIPAA compliance.ConclusionI need to point out that most of these problems could be addressed with amendments to HIPAA. In many ways, a repeal would be a big step backwards - I think most Americans agree that they should have privacy protections, especially as their medical information migrates from paper charts to networked databases. But compliance could be made much easier, and allowing private lawsuits against employees such as those at UCLAHS that deliberately violate confidentiality would give the law more teeth. I don't think that most politicians would find a repeal of HIPAA, as opposed to a reform, politically palatable.

Clinical trials as we understand them today are a fairly recent invention, starting with the 1947 UK Medical Research Council's study of streptomycin for tuberculosis treatment, the 1st randomized clinical trial (1).Informed consent is of even more recent vintage. Dwelling at the intersection of law and medicine, birthed by the former, imposed on the latter, informed consent and clinical medicine have had an uneasy relationship from the beginning. While landmark cases started shaping its legal doctrine already in the 19th and early 20th century, informed consent's post-WWII legal lineage in the US is easy to track, with milestone rulings starting in the 1950s through to the 1970s (2, 3, 4),The 1957 Salgo v. Leland Stanford Jr. University Board of Trustees (2) established the precedent of patient self-determination with the judge coining the phrase, informed consent, in his jury instruction, the 1st known instance of its explicit use.The 1960 Natanson v. Kline (3) established the negligence standard, as in the physician having an inherent duty to make a reasonable disclosure of risks and hazards of treatment or face possible malpractice liability.The 1972 Canterbury v. Spence (4) established the reasonable person standard, i.e., the need to disclose what any reasonable person would consider necessary and sufficient to know.According to Ruth R. Faden, Tom L. Beauchamp and Nancy M.P. King, who published the definitive text-book on it in 1986 (5), how informed consent was planted in clinical medicine, how it grew, in other words its clinical medicine lineage, that's largely lost to time. This is perhaps an unavoidable difference because medicine already walks an uneasy tightrope between patient autonomy and welfare. Absence of early peer-reviewed medical studies only emphasizes the initial reluctance with which clinical medicine incorporated informed consent, and is also emblematic of the unease with which the two co-exist. Part of the reason for this unease is the perennial existence of grey areas.Why perennially grey areas? Because the young, the elderly, the frail, the poor, the poorly educated, the intellectually impaired, and the seriously ill are a part of us, a part of us that's much more dependent and thus much more vulnerable to manipulation. As Robert Q. Marston, the then-Director of the US NIH noted in an influential speech on the subject of informed consent, 'Whether or not consent is in fact informed is admittedly difficult to assess. We often are in an uncertain situation in which inadequate information, communication problems, and the inability of the subject to comprehend-or to read-or to listen-can be misleading' (6).Pre-informed consent Clinical Medicine helps understand why it's Important, nay Critical, in Clinical TrialsAs recently as 1964-1966, a study in the US found that >50% of physicians, 53% to be exact, thought it was 'ethically appropriate for a physician not to tell a cancer patient that she had been enrolled in a double blind clinical trial of an experimental anticancer drug and was currently receiving a placebo' (5, page 89).Two of the most prominent egregious abuses in human medical research, namely, Nazi human experimentation during the Holocaust and the Tuskegee Syphilis Study* certainly cast a long shadow, necessitating clear, formal, legally binding guidelines for human experimentation. While case law verdicts helped shape the legal framework for informed consent, the cultural framework, at least in the US, arose from several other cases that drove public debate, illuminated gaps in physician understanding of informed consent, and highlighted the roles and responsibilities of research committees and funders. Careful examination of the details and circumstances of some of these prominent cases helps drive home why informed consent is not only important but indeed critical. Two of several prominent US examples that were crucial in fleshing out informed consent as it exists today are elaborated here.The Jewish Chronic Disease Hospital CaseConducted at the Jewish Chronic Disease Hospital (JCDH) in Brooklyn, New York, and funded by Sloan-Kettering Institute for Cancer Research, the American Public Health Service and the American Cancer Society. With 10 years of research on anti-cancer immune responses under his belt, in July 1963, chief investigator Dr. Chester M. Southam convinced the hospital medical director Emmanuel E. Mandel to permit injection of a suspension of foreign, live cancer cells into 22 JCDH patients.The research question? Do cancer patients reject cancer transplants or not? Obviously comparison with response of cancer-free patients, the controls, was also required.The informed consent aspect? Some were informed orally they were involved in an experiment, but not that they would be injected with live cancer cells. No written informed consent.The final insult to injury, some patients were incompetent to give informed consent.The non-cancer patients, i.e., the controls, weren't informed either that they were getting injected with live cancer cells.The grounds? Might unnecessarily agitate the participants.The defense? That it was customary in medical research that consent 'not be documented even in far more dangerous research' (5, page 161), something that sounds utterly indefensible in the year 2015.As the New York Post reported in 2013, three young physicians, Drs. Avir Kagan, David Leichter and Perry Fersko, courageously went against the prevailing status quo and refused to participate in this study (7). They also brought it to the attention of attorney William Hyman, one of JCDH's Board of Directors, who filed a suit to access hospital records to learn more about the study (8). Hyman's concerns ranged from potential patient abuse, potential reputation damage to the hospital and its possible liability. The Hyman-driven review revealed (5, page 162),The study wasn't presented to the hospital's' research committee.Physicians directly responsible for patient care of subjects involved in the research weren't consulted about the cancer cell injections.Three physicians who had been consulted by Dr. Mandel were against the research arguing 'subjects were incapable of giving appropriate consent'.In 1966, the Board of Regents of the State University of New York censured Drs. Southam and Mandel, finding them guilty of deceit, fraud and unprofessional conduct, writing in its judgment (5, page 162, 9, see Regent' decision from 10 below),'A physician has no right to withhold from a prospective volunteer any fact which he knows may influence the decision. It is the volunteer's decision to make. . . . There is evidenced in the record in this proceeding an attitude on the part of some physicians . . . that the patient's consent is an empty formality. Deliberate nondisclosure of the material fact is no different from deliberate misrepresentation of such a fact. . . . The alleged oral consents that they obtained after deliberately withholding this information were not informed consents and were, for this reason, fraudulently obtained'.The Willowbrook State School CaseAn institution on Staten Island, New York, it was then classified in a manner unthinkable today, a mere 60 years later, namely, as a place for 'defective children'. Originally designed to house 3000, by 1963 it housed >6000. With the children's severe developmental impairments amplified by poor oversight, large numbers weren't even properly toilet trained. Unsurprisingly, such conditions not just predisposed to but also facilitated easy spread of fecal-borne infections. For example, in 1954, many children contracted hepatitis (presumably hepatitis A) within 6 to 12 months of living at Willowbrook.In 1956, Saul Krugman and colleagues started a series of experiments to develop an effective prophylactic. Funded by the US Armed Forces Epidemiological Board, the US Army Medical Research and Development Command, the Health Research Council of the City of New York, and several committees at New York University School of Medicine, including its Committee on Human Experimentation, they deliberately infected newly admitted patients with isolated hepatitis virus strains. Of the 10,000 children admitted to Willowbrook after 1956, ~ 750 to 800 were sent to Krugman's special hepatitis unit. Wards of the state never included in the studies, the children's parents had given written consent. At first, parents were informed by either letter or personal interview. Later, informed consent entailed groups discussions with parents of prospective parents.From the beginning, these studies were on the radar of Henry K. Beecher. With a decidedly murky ethical background himself, nevertheless, by the 1960s he'd emerged a pioneer of informed consent with his publication in 1959 of 'Experimentation in Man'. Beecher first listed the Willowbrook study in 1966 as one of 22 'ethically dubious' experiments. His repeat highlighting of this study in his 1970 book, Research and the Individual, brought the matter to the public's attention. Criticism gained momentum with the theologian Paul Ramsey joining in and with Stephen Goldby publishing a sharply critical letter in the Lancet in April 1971 (11), with the full support of the Lancet editors who publicly apologized for having previously overlooked the issue of informed consent.Such public scrutiny forced the researchers to defend themselves in the public arena. Their defense? Since most of the children recruited in the study would contract hepatitis anyway, they weren't placed in greater danger compared to the other institutionalized children. Optimal isolation, better attention, administered the best available anti-hepatitis therapy then available, the researchers asserted that their attempt to give the selected children sub-clinical hepatitis infections would immunize them against specific hepatitis viruses (12). That's not all. Influential editors of several prestigious medical journals, namely JAMA, NEJM, Journal of Infectious Diseases, agreed with this defense, arguing such research was valuable for understanding hepatitis, had potential value to such institutionalized children, had sufficient consent provisions, didn't expose the children to unnecessary risks and was performed by competent investigators (13).The rebuttal? The studyIncreased the children's later life risk for chronic liver disease.Unlike other Willowbrook residents, study children didn't receive protective doses of gamma globulin (14).Both process and legitimacy of consent obtained for the study were also easy to challenge. Consent forms used suggested the children would receive a vaccine against the virus, some parents were only contacted by letter. A key change happened in late 1964. Willowbrook became so overcrowded that new patient admissions ceased while Krugman's special research unit continued accepting children whose parents 'volunteered' them for the study, suggesting implicit coercion into the study as a means for parents getting their children admitted to Willowbrook (15). Study reviewers and we ourselves could easily conclude that social pressures under which such parents gave their consent, especially post-1964, undermined their ability to act in the best interests of their children.As Faden, Beauchamp and King note in their book (5, page 164), while Krugman's research unit was eventually closed, debate about the ethics of the Willowbrook study never resolved satisfactorily (16) and we see remarkable parallels regarding the ethics of informed consent issues here and in the 2009 PATH-ICMR HPV (Human Papilloma Virus) clinical trial**, ***. In both, the subjects of research were minors and parents/guardians offered informed consent on their behalf, one of the perennial grey areas I referenced earlier.The Road to Today's Informed Consent Becomes ClearerWith such recent examples of egregious medical research abuses as the backdrop, in 1973, Robert Q. Marston, the then-Director of the US NIH made an influential speech (6) that highlighted the central role of informed consent in clinical trials, 'That the committee determine that the rights and welfare of the subjects involved are adequately protected, that the risks of an individual are outweighed by the potential benefits to him or by the importance of the knowledge to be gained, and that informed consent is to be obtained by methods that are adequate and appropriate', and that 'if, in a specific case, I were forced to choose between the individual and the general welfare of society, I would choose to protect the individual'.He emphasized (6) that review committees that oversee human experimentation needed to strictly adhere to three basic criteria, namely,' Protection of the rights and welfare of the subjects.Weighing of risks against benefits.Determination that informed consent is to be obtained by methods that are adequate and appropriate.'In the US, it was in 1981 that the Judicial Council of the American Medical Association (AMA) first took an explicit stance on Informed Consent (5, page 96),'INFORMED CONSENT.The patient's right of self-decision can be effectively exercised only if the patient possesses enough information to enable an intelligent choice. The patient should make his own determination on treatment. Informed consent is a basic social policy for which exceptions are permitted (1) where the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent; or (2) when risk-disclosure poses such a serious psychological threat of detriment to the patient as to be medically contraindicated. Social policy does not accept the paternalistic view that the physician may remain silent because divulgence might prompt the patient to forego needed therapy. Rational, informed patients should not be expected to act uniformly, even under similar circumstances, in agreeing to or refusing treatment'.And this is more or less the landscape we've operated in ever since, with adequate and appropriate methods for obtaining informed consent remaining a perennially grey area, especially as clinical trials globalize and involve research subjects with vastly different cultural, linguistic and educational norms.Bibliography1. Marshall, Geoffrey, et al. "Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation." BMJ 2.4582 (1948): 769-782.2. Salgo v. Leland Stanford Jr. University Board of Trustees, 317 P.2d 170, 181 (1957).3. Natanson v. Kline, 350 P.2d 1093, 186 Kan. 393, 186 Kansas 393 (1960).4. Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).5. Faden, Ruth R., Tom L. Beauchamp, and Nancy M. King. "A history and theory of informed consent." (1986). Oxford University Press.6. Marston, Robert Q. "Medical science, the clinical trial and society." Hastings Center Report 3.2 (1973): 1-4.7. The New York Post, Allen M. Hornblum, Dec 28, 2013. NYC's forgotten cancer scandal8. MATTER OF HYMAN v. Jewish Hosp., 15 N.Y.2d 317, 206 N.E.2d 338, 258 N.Y.S.2d 397 (1965).9. Katz, Jay, Alexander Morgan Capron, and Eleanor Swift Glass. Experimentation with human beings: The authority of the investigator, subject, professions, and state in the human experimentation process. Russell Sage Foundation, 1972.10. Langer, Elinor. "Human Experimentation: New York Verdict Affirms Patient's Rights." Science 151.3711 (1966): 663-666.11. Goldby, Stephen. "Experiments at the Willowbrook state school." The Lancet 297.7702 (1971): 749.12. Krugman, Saul, Joan P. Giles, and Jack Hammond. "Infectious hepatitis: Evidence for two distinctive clinical, epidemiological, and immunological types of infection." Jama 200.5 (1967): 365-373.13. Is Serum Hepatitis Only A Special Type of Infectious Hepatitis? JAMA. 1967;200(5):406-407. doi:10.1001/jama.1967.03120180094017.14. Annas, George J., Leonard H. Glantz, and Barbara F. Katz. Informed consent to human experimentation: The subject's dilemma. Ballinger Pub. Co., 1977.15. Goldman, Louis. "The Willowbrook Debate." World Med 7 (1971): 23-25.16. Ingelfinger, F. J. "Ethics of experiments on children." New England Journal of Medicine 288.15 (1973): 791-792.More details on the journey to, the process of, and grey areas in informed consent available in these answers:* Tirumalai Kamala's answer to Do you believe placebos are morally permissible? Why or why not?** Tirumalai Kamala's answer to Should we have an international forum to resolve clinical trial mishaps?*** Tirumalai Kamala's answer to Is it true that Bill Gates faced trial in India for illegally testing tribal children with vaccines?Thanks for the A2A, Kritika Gupta.