Listening Consent: Fill & Download for Free

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.

“…if I have nothing to hide, then why not let the cop search the car?”Because our legal system is adversarial. You and the police officer are on opposite sides of it. Regent Law School law professor James Duane, speaking to the website vice dot com[1][1][1][1] says this:“Any police officer will tell you, ‘We're here to get to the truth.’ But the reality is that over time police officers inevitably come to see themselves as part of the prosecutor's team. They work with the prosecutors, they testify for the prosecutors, they meet with the prosecutors.”In our legal system, the police are not your friends. They are obliged to tell you that “everything you say can and will be used against you in a court of law.” They’re required to tell you that because it is true. You are in an adversarial situation from the very first moment you have a working encounter with a police officer. Their goal is to charge you with a crime if they can. And you are NOT on a level playing field. It is generally illegal for you to lie to police, though it is perfectly legal, and commonplace, for them to lie to you. If you lie to them, even inadvertently, it’s a crime.Also critical to realize is this: While “everything you say can and will be used against you in a court of law.” NOTHING you say to the police is admissible in your defense. If you said something to a police officer that would serve to exonerate you, the officer will not be allowed to repeat it in court. It will be disallowed as hearsay. Think about that. Everything you say can and will be used against you in a court of law, yet nothing you say can legally be used to exonerate you. Frightening, but that’s the nature of our adversarial legal system.My question to you would be:“Why WOULD you let a police officer search your car without a warrant?”What do you hope to gain? Before a search, you are presumed innocent of any crime. The ONLY place to go from there is downhill. The only two possible outcomes from a search are 1) nothing changes and you’re still not charged with a crime or 2) you are charged with a crime. There is zero upside risk. Why would you willingly risk ANY possibility of being charged with a crime? Is there any upside to you for consenting to a warrantless search? No, there isn’t.People consent because they live with this misconception that the police are their friends. They grew up with “Officer Bob” visiting their school. Officer Bob was a great guy – the very face of benign authority, there to help them… to protect and serve them. But that is NOT the dynamic that occurs between a police officer and a citizen on the street.It isn’t the police officer’s fault. He’s probably still a great guy, but the dynamics of the encounter are adversarial. The officer’s role is to look for evidence of a crime. That is the ONLY reason to search a vehicle, warrant or not. The officer is not searching your car to help you find that earring you lost. The officer is searching your car to look for evidence of a crime. Period. Why would you EVER let that happen? You shouldn't. You should NEVER consent to a warrantless search. And never talk to the police.Yet you feel compelled to consent because you and Officer Bob are friends. You want to explain yourself to Officer Bob so he understands the truth of what a good, honest person you are. You know Officer Bob has the power to ruin your life, but you’re a good honest person. Surely he’ll know that. What do you have to lose? You have nothing to hide, after all.Wrong! You have EVERYTHING to lose. You have no idea if you have anything to hide or not. But I guarantee you, if you consent to a warrantless search, your friend, Officer Bob will let you know very quickly what you had to hide and what you have to lose.As you sit here reading this answer, do you believe you know, with 100% certainty, that there is nothing in your car that could cause you to be charged with a crime? You know, for fact, that one of your child’s friends didn’t leave a joint, or a dime bag of cocaine between the seats when you picked them up from school? You know, for a fact, that one of your friends didn’t accidentally leave something illegal in the back seat when you loaned him your car for an important errand when his car was in the shop? You know, for a fact, that your best friend Nancy didn’t accidentally drop a Percocet tablet in your car, legally prescribed to her for her surgery, but not legal for you to possess? You know, for a fact, that that nice young man at the car wash didn’t accidentally drop, in your back seat, the knife his cousin Vinny used to rob a liquor store? You know for a fact that none of your daughter’s friends from Girl Scout Troop 592 didn’t drop a feather from an American Crow in your back seat? If she did, you may be charged with a violation of the Migratory Bird Treaty Act of 1918. It is a crime to merely possess a single feather from more than 800 species of bird in the US. A conviction could result of a fine of $5000 and imprisonment for up to six months for each feather.Are you 100% certain you know the law where you’re driving today? Did you know it is illegal to possess a domestic pet on the Las Vegas strip between noon and 5AM? That’s right. Taking Mister Scruffles for a walk on Las Vegas Blvd at 2 in the afternoon will get you arrested. In New Hampshire it is illegal to possess seaweed that has been taken from a beach. While in Las Vegas, trying to hide Mister Scruffles the felonious poodle from Law Enforcement, you buy two small lobsters to cook for dinner. They’re short lobsters, banned as too small to take in Maine or Nova Scotia, though Nevada has no lobster laws on the books, and you bought them legally at a fish market. Still, you’re in violation of federal law. The Lacey Act (16 USC 53) makes it a federal offense to possess “any fish or wildlife taken, possessed, transported, or sold in violation of any law or regulation of any State or in violation of any foreign law.” That makes you liable for conformance, in matters of plants, fish and wildlife, to the laws of Maine, or Nova Scotia, or ANY foreign country. Still think you haven’t committed any crime? Do you have a working knowledge of the wildlife laws in Argentina, Liberia and Latvia?This may be the most important advise you ever receive about anything in your life. Ignoring it could land you in prison. I encourage you to watch James Duane’s excellent YouTube video[2][2][2][2] on the subject, where he, together with Virginia Beach police officer George Bruch, describes the myriad ways talking to the police can get innocent people into serious legal trouble. You will be stunned at the ways innocent people have talked their way behind bars. Note that his more recent advice, due to a recent Supreme Court decision, is to not even refuse on the basis of the Fifth Amendment. Just ask for an attorney.In addition to Professor Duane’s video, he has also published an excellent book called The Right to Remain Innocent[3][3][3][3]. It is well worth the small cost and the time to read (or listen to) it. The book contains some updated information about the Fifth Amendment after a recent Supreme court decision. You should also watch a very good interview with Professor Duane by Philippe Matthews[4][4][4][4]. Also useful is a YouTube video featuring Ex-FBI Agent Dale Carson[5][5][5][5].Footnotes[1] A Law Professor Explains Why You Should Never Talk to Police[1] A Law Professor Explains Why You Should Never Talk to Police[1] A Law Professor Explains Why You Should Never Talk to Police[1] A Law Professor Explains Why You Should Never Talk to Police[2] Don't Talk to the Police[2] Don't Talk to the Police[2] Don't Talk to the Police[2] Don't Talk to the Police[3] You Have the Right to Remain Innocent: James Duane: 9781503933392: Amazon.com: Books[3] You Have the Right to Remain Innocent: James Duane: 9781503933392: Amazon.com: Books[3] You Have the Right to Remain Innocent: James Duane: 9781503933392: Amazon.com: Books[3] You Have the Right to Remain Innocent: James Duane: 9781503933392: Amazon.com: Books[4] You Have the Right to Remain Innocent with Professor James Duane[4] You Have the Right to Remain Innocent with Professor James Duane[4] You Have the Right to Remain Innocent with Professor James Duane[4] You Have the Right to Remain Innocent with Professor James Duane[5] Ex-FBI Agent Reveals What to Do If The Police Get in Your Face[5] Ex-FBI Agent Reveals What to Do If The Police Get in Your Face[5] Ex-FBI Agent Reveals What to Do If The Police Get in Your Face[5] Ex-FBI Agent Reveals What to Do If The Police Get in Your Face

He certainly loved Katherine of Aragon. When she was the Dowager Princess of Wales he would go secretly meet her, and when his father later found out he was punished for it. One of the first things he did as king was marry her, when he could’ve had anyone. They were very much in love for most of their marriage, as has been documented, just google their letters to one another. It was a happy and successful marriage, having political benefits, and Katherine was a well-liked and respected queen. Unfortunately, he slowly fell out of love as she did not give him a son. She clearly loved him until the day she died, and he was said to have wept when he heard of her death. I believe he respected her until her death.I disagree when people say Anne Boleyn was the love of his life. I think he fell in love with the thrill that came with her ‘hard to get’ act. He certainly loved something about her, as he chased after her for 7 years. I reckon it was her fiery personality that he loved so much. I think he started to fall out of love after she delivered of Elizabeth, as he started to take mistresses during her second pregnancy, a son she eventually miscarried. Ultimately, I think he got tired of her personality - she had a crazy bad temper - and decided sending her to the chopping block would be best.He may well have loved Jane Seymour. She was meek and timid, the complete opposite of Anne. I think he just wanted a wife that would listen to him. He seemed genuinely saddened after her death, giving her a queen’s funeral and reportedly being in a deep state of mourning for a long while afterwards. He didn’t remarry for another 3 years, and when he did, it was a political decision. I think he did love her, and her delivery of a son made him love her even more. After all, a son was all he had wanted.Anna of Cleves, on the other hand, he thought so disgusting that he didn’t want to go through with the marriage. It was purely political and lasted only 6 months, her giving consent for the annulment he wanted. I believe he loved her as a friend, as she was given the title “The King’s Dearest Sister” and given precedence over all women in England save for the King’s wife and daughters.Kitty Howard was fifth, and I believe he loved her too. He was head over heels with his new young bride, spoiling her with gifts and the like. She made him feel young and he loved her energy and bubbliness. Unfortunately, his health began to fail, as he had just gone 50. He forbid her from seeing him when his leg ulcer began to act up, as he did not want her to see him in such a state. He shut her out for weeks at a time, and this time around, it was her interest that wandered. Though I don’t think she was ever interested in him. When Henry found out about her affair, he treated the allegations very cautiously, as he didn’t want to believe she would ever do such a thing to him. When it became clear that the allegations were true, he was absolutely devastated. He’d rather see her dead than face her again. I believe he truly loved her, he was clearly crushed by her affair, although I don’t have much sympathy for the bloke. He clearly got over it quickly as he remarried a year later.Katheryn Parr was a very clever, mature, and charming woman with wit and good looks. By this point, I think Henry had given up on having another son and simply wanted another wife for convenience. Katheryn was a good choice as she had been widowed twice before and was already known as a kind stepmother to her second husband’s children, so he could have a wife all his children could get along with (Mary was not fond of either Anne or Kathryn Howard), and she was very intelligent, so she could also be involved in politics. He clearly respected and trusted her, as he left her as regent, a title he had only ever deemed one woman worthy of before - his first wife. He was kind to her and her to him, and they had a mutual affection for one another, though I wouldn’t call it love. I believe he deeply respected her, but no, did not love her.The “love of his life”? I think the only candidates for such a title are Katherine of Aragon and Jane Seymour.