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Why is informed consent important in clinical trials?

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.

As doctors, what steps can we take to make sure there are no incidences which can give rise to alleged negligence?

It might come as a surprise to many non-medicos that getting the patient’s health better, shortening hospital stays and making them happy with the treatment offered is in the doctors’ and hospitals’ best interests from just the financial point of view. Shorter hospital stays results in better turn over and more revenue than having the patients stay longer than absolutely necessary. So doctors and hospitals will try their best to ensure lowest possible complication rates, so they can move on to other cases. No medical negligence occurs due to apathy or bad intentions from the doctor or hospital. When some adverse event occurs, the doctor is the most worried. Not because the doctor is worried about being sued but because the doctor wants every patient to have the best possible outcome for the patient. Happy patients are the best advertisements from the doctors’ point of view.In these testing times it is important that you as a doctor do your job with complete integrity while also keeping yourself protected from the new world order of patient mistrust. The following are a few things you can incorporate into your practice to avoid being accused of medical negligence.Spend Time. If you see most malpractice suits, this invariably crops up. The number one thing people complain about their doctors is that they spend very less time with them. If you lend a sympathetic ear to their sometimes not important issues a lot of time is saved later trying to pacify an angry patient.Educate your patient about their disease/condition, treatment options, pros and cons of any treatment or surgery including not doing anything at all. I have made patient information forms for the most common surgeries I perform so that the patients have a ready reckoner which also doubles up as the starting point for the patient’s own research about the surgery online. Teach your patients to take ownership of their own health. Give them the choice and put the onus of the medical decisions on them.Documentation. Documentation. Documentation. I’m known by my colleagues and juniors of being obsessive about documentation and some probably think I'm nuts trying to ensure that in crowded OPDs in India. However I know that one day this extensive documentation is going to save me from trouble. If a patient refuses a necessary treatment, inform them of the consequences and mention that in the notes. A colleague you refer to suggests something orally for a patient, make sure you have that on record. Write detailed OT notes as well as complete treatment protocols and plans. Most importantly, document the complications and challenges in the course of treatment or surgery.Spot the distrusters & troublemakers well ahead of time. This becomes fairly obvious in the first few consultations. The tone and content of their words while conversing with you is a big clue. Those who call you by your first name (overfamiliarity as if they are your childhood friends) on the first consultation don't respect your expertise. Those who demand a particular treatment instead of listening to what you are suggesting are going cause you a lot of grief later on. Those who don't get investigations done or get only those that “they” think are important are the ones you should be wary of. These are all red flags. You need to be careful with such patients and you should do everything strictly by the book including obsessive documentation.Investigate your patients properly so that you have a reasonable idea what you are up against and you have enough objective data to arrive at the diagnosis. You have to be ahead of the disease even if it means more cost to the patient. The patient won't feel grateful that you saved him the MRI scan cost when he decides to sue you for any reason. This obviously doesn't mean you do unnecessary tests and investigations. Get only those that are absolutely necessary and explain those that are best to get it done. If the patient refuses to get the suggested investigations done, document that information-which serves as proof that due process was followed and the patient refused. Here you also need to have balance because if you suggest too many expensive investigations, the patient will not get any of it done. Thus, you will not be able to treat him or her. So order the minimum number of tests as possible for you to reach the closest diagnosis.Maintain standards and give patients options whenever you can. Strive to provide the patient the best standard of care possible within your place of work. Don't skimp on stuff and cut corners because you are under pressure from the hospital management to cut costs. Your patient is more important than what the hospital wants you to do.Informed consent. When you take photos of patients, make sure you take a photo consent. When you post someone for surgery, make sure you fill the consent form yourself and make the patient sign in front of you. Answer all questions that the patient may have and mention what you have spoken with the patient on your clinical notes. It is always advisable to create your own consent form instead of generic consent forms.Show empathy and not sympathy. Patients can easily discern the difference. Always put yourself in the patient’s shoes and treat all your patients as your own family members.Don’t be stupid and take unnecessary risks. Don’t operate on paediatric patients in facilities which don’t have adequate facilities for pediatric anaesthesia. Don’t perform a major surgery in a hospital which doesn’t have ICU care support close by. Bottomline- don’t be an idiot- if you still insist to be one, no one can help.Train your juniors and assistants all the above, so that they always have your back. Be strict and insist that none of the above are negotiable.Buy indemnity insurance. Despite everything, you can still be unlucky and get sued for malpractice. Find out the highest compensation paid for medical negligence in your specialty and make sure your indemnity insurance covers at least that much. Don't be complacent or act miserly about paying premiums. If you are, you are at risk of losing all your savings and some more.Don’t be that person who indulges in cut practice or doing unnecessary surgeries and suggesting an expensive treatment when a less expensive treatment would be sufficient. Don’t have an unholy nexus with the Pharma/Laboratory /Scanning facilities. You then have no excuse if the patient distrusts you.Take ownership of your patient’s condition and complications (if any) due to the surgery or treatment given by you. Don't avoid meeting such patients because it may be uncomfortable explaining what went wrong and try to push the patient to another doctor or hospital. The patient will by default assume whatever has gone wrong is because of your mistake even if it may not be so. It is best you spend time explaining your side of the story to the patient rather than having to explain it to the court later on.This is a difficult time to be a doctor in India. Presently there is a trust deficit between doctors and patients. Also the newspapers, news channels and social media activism has ensured the demonizing of the medical profession among the general public. I hope this doesn’t make us doctors look at every patient we treat as a potential lawsuit. Some of the blame for this mistrust lies within the medical fraternity for tolerating the black sheep among us but most of it is because the general public don’t take responsibility for their own health and don’t do healthcare planning.However for the most part I see that the really contentious doctors far outnumber the corrupt, unethical rotten ones and the happy, grateful patients far outnumber the spiteful, hateful ones. It is a fact that I get more hate from people on Quora on my answers than from my own patients.I have never been sued and I hope to keep it that way- for my sake and my patients’!

For surgical procedures where the patient is conscious, does fear of lawsuits limit what the surgical team will say in the patient's earshot?

Actually, the surgical team communicates normally, but restrains any "OMG" or similar exclamations upon findings or discussion of anything going badly so as not to make the patient anxious or nervous, not particularly because of a threat of a lawsuit. Usually voices are kept at a pretty even keel, even if something urgent is happening in the OR, particularly if the patient is awake.Clearly, one would not want to say something like, "Oops, we forgot that clamp inside the patient," but the trick is not to forget the clamp inside the patient in the first place (joke).In this litigation-happy society, doctors do have to be somewhat cautious, but when a patient gives an informed consent for the surgery, all the possible risks and complications are discussed ahead of time. If the patient has not consented or if they just sign the consent form without reading it, I will refuse to do surgery. And all their questions have to be answered ahead of time.There are guidelines of care and best practices for every procedure in medicine. There are also innovative procedures that don't yet have guidelines or best practices, but only experience and publications of physicians who researched and developed certain new protocols.From my observation of many colleagues in all branches of medicine (not statistics by any means but let's say an observation of several hundred physicians) doctors do what they do in the best interest of the patient and not because they are afraid of a lawsuit.

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