Consent Form For Participation In Research - New York Medical: 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.

This answer may contain sensitive images. Click on an image to unblur it.'Was anyone ever held accountable for the Tuskegee syphilis study?'When a reprehensible and unethical human experiment runs uncontested for 40 years, the contours of accountability seem porous and gray rather than clear-cut or black and white since responsibility falls far and wide, not just on individuals but on institutions, the government itself as well as an entire biomedical research community. After all, funded and operated by the United States Public Health Service - Wikipedia (USPHS), a US government agency, results of the Tuskegee syphilis study (TSS) researchers were even published in leading biomedical journals.Poor, rural, mostly illiterate black men in Macon county, Alabama, were recruited for a study with an inherently problematic, even indefensible goal; to examine in excessive detail the course of untreated syphilis. Promising them burial insurance, physical exams, hot meals and transportation to and from the hospital plus false promises of treatment for 'bad blood', the researchers lied to the participants to gain their credulous permission for detailed post-mortem autopsy as well as painful, unsafe and potentially dangerous spinal taps performed under the guise of treatment, even as they arranged for their military deferments to keep them in the study. Preemptively stripping them of their dignity, the researchers evidently considered their research subjects as akin to doltish brutes shorn of any capacity to knowingly consent to their participation in a medical study.Whatever reckoning was to be had could only ever be too little, too late for those directly damaged by this study. Of the original 399, only 74 were even alive in 1972, 28 having died directly of syphilis, 100 of related complications, 40 wives had been infected and 19 children born with syphilis. Survivor numbers had dwindled to a mere 6 by the time President Clinton offered an official apology for the TSS on May 16, 1997 (1).This answer briefly coversThe legal and regulatory consequences following public knowledge of the TSS.The biomedical research community knowledge of the TSS.The researcher cast of the TSS.The TSS aftermath in the form of continuing adverse health consequences for black men in the US.Legal & Regulatory Consequences following Public Knowledge of the Tuskegee Syphilis StudyMedia coverage of a whistleblower, a by now familiar drill, the TSS was first reported by Jean Heller - Wikipedia of the Associated Press in the Washington Star on July 25, 1972, after she indirectly heard the account of Peter Buxtun - Wikipedia, a former PHS (Public Health Service) VD (venereal disease) interviewer, who came forward as a whistle blower. One day later the New York Times carried the same story on its first page (2), and the rest as they say is history.In a way, even more so than the Nuremberg trials - Wikipedia, the aftermath of the TSS, ‘America's own Nuremberg’ (3), largely shaped the Informed consent - Wikipedia regimen under which human biomedical research operates today.The US CongressPassed the National Research Act - Wikipedia in 1974.Established the Office for Human Research Protections - Wikipedia through which guidelines for research involving human subjects were strengthened.This ActMandated the by-now familiar IRBs (Institutional review board - Wikipedia) to approve all human subject studies using US federal funds.Created a commission, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research - Wikipedia to study and write regulations governing human subject studies.Five years later this commission published the Belmont Report - Wikipedia enshrining respect for persons, beneficence and justice as the founding beliefs for modern American bioethics (4).Ciivil rights attorney Fred Gray (attorney) - Wikipedia and the NAACP - Wikipedia filed a class-action lawsuit in 1973 on behalf of the Tuskegee syphilis study participants. The case (Pollard v.United States, 5) settled out of court with a $10 million settlement awarded to the study's participants. In addition, free health care was provided to participants still living as well as their infected wives, widows and children (see below from 6).Biomedical Research Community Knowledge of the Tuskegee Syphilis StudyThough the public at large may have remained unaware of this study during its four decades, it was obviously well-known within the biomedical research community, with not one but several peer-reviewed studies published in various medical journals including the highly prestigious JAMA (journal) - Wikipedia.Peer-review means peers within the biomedical community analyzed the study results and deemed them worthy of publication. Contours of accountability thus expand even further to fellow researchers and the journals' editorial staff who reviewed these manuscripts and noticed nothing untoward about a study that left patients with syphilis untreated for years, especially in the years after penicillin was accepted as a treatment of choice all the way back in 1945.Vonderlehr, Raymond A., et al. "Untreated syphilis in the male Negro: a comparative study of treated and untreated cases." Journal of the American Medical Association 107.11 (1936): 856-860.Rivers, Eunice, et al. "Twenty years of followup experience in a long-range medical study." Public Health Reports 68.4 (1953): 391. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2024012/pdf/pubhealthreporig00184-0037.pdfPeters, Jesse J., et al. "Untreated syphilis in the male Negro: pathologic findings in syphilitic and nonsyphilitic patients." Journal of Clinical Epidemiology 1.2 (1955): 127-148.Olansky, Sidney, et al. "Untreated syphilis in the male Negro: X. Twenty years of clinical observation of untreated syphilitic and presumably nonsyphilitic groups." Journal of chronic diseases 4.2 (1956): 177-185.Rockwell, Donald H., ANNE ROOF YOBS, and M. Brittain Moore. "The Tuskegee study of untreated syphilis: the 30th year of observation." Archives of Internal Medicine 114.6 (1964): 792-798.Researcher Cast of the Tuskegee Syphilis StudyRunning four decades from 1932 until 1972 obviously meant a rotating cast of players. No one lost their job, their grant funding and/or professional accreditation.Fred Gray asserts the two black Tuskegee administrators, Robert Russa Moton - Wikipedia, head of the Tuskegee University - Wikipedia, who died in 1940, and Eugene Dibble - Wikipedia, who died in 1968, were misled to believe the study participants would receive treatment for participating in the study and that they were never aware of the study's atrociously unethical basis.The chief architects of the study, Hugh S. Cumming - Wikipedia, Taliaferro Clark, Raymond A. Vonderlehr, were dead by 1972, a careful analysis of their backgrounds showing ' similar cultural, intellectual, and institutional backgrounds' (7), especially one strongly steeped in the eugenics that dominated thinking within the USPHS in the early decades of the 20th century.Other study boosters were also dead, Joseph Earle Moore of the Johns Hopkins University Medical School dying in 1957 and Oliver Clarence Wenger of the USPHS dying in 1958.Some researchers who got involved later and were still alive in 1972 and beyond brazenly defended the study and their role in it.John R. Heller Jr. ran the TSS from 1933 to 1934. He died in 1989. When the story first broke, Heller evinced no indication he was even aware of his gross misconduct let alone his rank bias (see below from 8, emphasis mine).'Soon after the story broke, John R. Heller, the director of the TSS from 1933 to 1934, was questioned in an interview for the ethics of his study, but he declared that “there was nothing in the experiment that was unethical or unscientific.”48 He then claimed that the withholding of treatment was not required by the Study, and that all of the men in the study received some form of treatment. He also responded to the accusations that his study should have provided all test subjects with penicillin by saying that penicillin would not have been effective during the late stages of syphilis, and then later even admitted that the thought to provide penicillin never even 49 “‘occurred to us to ask because the demand was so great for other people who needed it much more than they did -- the armed forces and people in civilian life’ with other serious diseases.”'John Charles Cutler - Wikipedia died in 2003. He defended his involvement in the TSS when interviewed by PBS Nova in 1993 (see below from 9).'Cutler: The Tuskegee study has been grossly misunderstood and misrepresented this way. And the fact was that it was concern for the black community, trying to set the stage for the best public health approach possible and the best therapy, that led to the study being carried out….We were dealing with a very important study that was going to have the long-term results of which were actually to improve the quality of care for the black community so that these individuals were actually contributing to the work towards the improvement of the health of the black community rather than simply serving as merely guinea pigs for the study. And of course I was bitterly opposed to killing off the study for obvious reasons.'Still alive in 1992, Sidney Olansky offered a startling and entirely unrepentant accounting to ABC's PrimeTime Live of his participation in conducting this heinous medical malfeasance (see below from 10, emphasis mine)'A February 1992 story aired by ABC's PrimeTime Live offers telling -- and chilling -- insight into the thinking behind the continuation of the Tuskegee Study. Correspondent Jay Schadler interviewed Dr. Sidney Olansky, who directed the experiment from 1950 to 1957, when penicillin was the standard of care for syphilis . . . but not for the men in the Tuskegee Study. Asked if the experiment could have been conducted on a group of white men, Olansky replied, "I think it could have been if we'd had white men in the same general category. Say if we had a bunch of hillbillies up in West Virginia that had a lot of syphilis." Pressed by Schadler about the lies that the men were told, Olansky said, "The fact that they were illiterate was helpful too, because they couldn't read the newspapers. If they were not, as things moved on they might have been reading newspapers and seen what was going on." When Schadler presented statements from survivors who thought that the diagnostic spinal taps they received were treatments, the doctor replied, smiling, "I don't know what they were told. I mean, sometimes people will say things that they don't really mean or don't really believe in order to accomplish something they want." In response to a question about why, if the government doctors had done nothing wrong, they were no longer trusted by the men, Olansky replied, "Someone got them all heated up. They were easily swayed. They were like a pack of sheep." Finally, Olansky's summary of what was learned: "Syphilis isn't too bad a disease." 'Eunice Rivers Laurie - Wikipedia died in 1986 having never accounted for her unwavering support for this travesty of a study (11, 12). A black nurse who gained the trust of the study participants over the years, historical analysis suggests her role was crucial in keeping it alive at every turn that could have ended it (see below from 13).'Key to the cooperation of the men in the Tuskegee Study was the African-American PHS nurse assigned to monitor them. She quickly gained their trust. She dealt with their problems. The physicians came to respect her ability to deal with the men. She not only attempted to keep the men in the study, many times she prevented them from receiving medical care from the PHS treatment clinics offering neoarsphenamine and bismuth (the treatment for syphilis) during the late 1930s and early 1940s. She never advocated treating the men. She knew these treatment drugs had side affects. As a nurse, she had been trained to follow doctor’s orders. By the time penicillin became available for the treatment of syphilis, not treating these men had become a routine procedure, which she did not question. She truly felt that these men were better off because of the routine medical examinations, distribution of aspirin pink pills that relieved aches and pains, and personal nursing care. She never thought of the men as victims...'Tuskegee Syphilis Study Aftermath: Adverse Health Consequences for Black MenNot surprisingly, the Tuskegee Syphilis study further poisoned the hearts and minds of generations of blacks against the US biomedical research community, an effect that continues till date. Even today, researchers attribute to TSS the racial disparities in avoiding or delaying seeking medical care, much lower participation rates in clinical trials and overall worse health outcomes in black men in America (14).Congressional testimony of survivors made clear the sense of violation of trust ran deep (see below from 8, 15),'The participants in this study are firmly convinced that the United States Government in the manner in which this study was conducted violated their Constitutional rights.They feel that the Government knew they had syphilis and failed to treat them.Second, they feel that Public Health Service failed to fully disclose to them that they had syphilis, that they were participating in a study, and that treatment was available for syphilis.They further feel that Public Health Service led many participants to believe that they were being properly treated for whatever diseases they had when in fact they were not being treated at all...Last, but we think very importantly, the study was racially motivated and it discriminated against blacks in that no whites were selected to participate in the study and only those recruited were poor, uneducated, rural blacks...They have no faith, trust, nor confidence that the Public Health Service will properly examine them and give them proper treatment. 57'Bibliography1. Presidential Apology2. Syphilis Victims in U.S. Study Went Untreated for 40 Years3. Robert Levine4. Childress, James F. Belmont revisited: Ethical principles for research with human subjects. Georgetown University Press, 2005.5. https://scholar.google.com/scholar_case?case=5681775705869466920&q=Pollard+v.+United+States&hl=en&as_sdt=400066. Tuskegee Study - Timeline - CDC - NCHHSTP7. Lombardo, Paul A., and Gregory M. Dorr. "Eugenics, medical education, and the Public Health Service: Another perspective on the Tuskegee syphilis experiment." Bulletin of the History of Medicine 80.2 (2006): 291-316. http://www.antimicrobe.org/h04c.files/history/BullHxMed-Lombardo-PublicHealthServ-06.pdf8. Wong, Kristin X. "The Pivotal Role that Race Plays in Medical Research: The Tuskegee Syphilis Study." (2018). https://pdxscholar.library.pdx.edu/cgi/viewcontent.cgi?article=1158&context=younghistorians9. https://historynewsnetwork.org/article/13206110. http://www.thebody.com/content/art30946.html11. Reverby, Susan M. "Rethinking the Tuskegee Syphilis Study." Nursing History Review 7 (1999): 3-28. http://ftp.columbia.edu/itc/hs/pubhealth/p9740/readings/reverby.pdf12. Reverby, Susan M. "More than fact and fiction: Cultural memory and the Tuskegee syphilis study." Hastings Center Report 31.5 (2001): 22-28. http://thehastingscenter.org/uploadedFiles/Bioethics_Forum/Reverby.pdf13. Fourtner, Ann W., Charles R. Fourtner, and C. Freeman Herreid. "Bad blood-A case study of the Tuskegee syphilis project." Journal of College Science Teaching 23 (1994): 277-277. http://andreawise.cmswiki.wikispaces.net/file/view/Bad+Blood+Case+Study.pdf/547944124/Bad+Blood+Case+Study.pdf14. Alsan, Marcella, and Marianne Wanamaker. "Tuskegee and the Health of Black Men." The Quarterly Journal of Economics 133.1 (2017): 407-455. https://economics.stanford.edu/sites/default/files/tuskegee_22may2016-1.pdf15. https://ia800701.us.archive.org/31/items/qualityofhealthc00unit/qualityofhealthc00unit_bw.pdf

To be frank, China, if not leading the world in its research and development of the COVID-19 vaccines, it is for sure among the leading nations. You will see what I mean after reading through my answer.(A COVID-19 vaccine developed by China National Biotec Group)But before illustrating the R&D process of China’s COVID-19 vaccines, I’d like to say a few words about why you are not able to read the news on China’s vaccines, or, actually, nearly everything positive from China.I bet you have neither read too much of things like I listed here in my previous answer, Shou'en Li's answer to If Chinese technology is as good as they insist, why don't I see much hi-tech products from China but I see many hi-techs from Japan, Germany, South Korea and the USA?Why? One reason might be China is still not influential enough and China is not good at selling its own stories to the outside world.But I think there might be one more important reason:Back in 1980, in its article THIRD WORLD VS. THE MEDIA, the New York Times magazine once expressed their concern over the distorted information by the Western medias towards the third world nations.https://www.nytimes.com/1980/09/21/archives/third-world-vs-the-media-third-world-third-world.htmlIt cited an Indian editor, who discovered that about 90 percent of the international stories were by one of the four wire services, all of them are Western-owned.And another article in 1981 also echoed this observation and concern, The Big Four,Time has now fast-forwarded to the 21st century, and some four decades after that in 2020, has the situation changed tremendously?Unfortunately, NOT.As shown in Wiki, Concentration of media ownership - Wikipedia,Of the 12 globally conglomerates, 11 are owned by the Western world, including one from Germany, one from France, one from Japan, the other eight are all American ones, and the twelfth is one from Latin America.And in term of revenue rank, the four head ones are all of the USA.None from a fast developing Asian region (Japan is a developed nation classified into the West camp), even China, with its 1.4 billion people and the second largest economy in the world, India, with 1.35 billion and the largest democracy, have barely any voice in the international arena.So, can you see why you are not able to read any positve news and latest development on the Chinese COVID-19 vaccines?Does your not reading any mean there is really nothing done by China?NO, definitely not.It’s just because the media outlets owned or controlled by the Western nations are not interested in letting you know.And even if they occasionally happen to file any reports on China’s vaccine development or other positive events in China, they would definitely find some negative or dark elements to “keep the report balanced.”………………………………………………………………………………………………………………………………………Let me show you how China has worked diligently and scientifically on developing the COVID-19 vaccines and what achievement we have made till today.I have done a research, and will mainly list the important achievements reported by the Chinese media outlet CGTN, and also some from other outlets both Chinese and overseas.But, I have to clarify beforehand, the following would just be part of the coverage on Chinese COVID-19 vaccines, definitely there are more which I do not include here.Let’s check them out in a reverse chronological order.Novermber 25, 2020Sinopharm applies to bring its COVID-19 vaccine to market“Sinopharm, a leading Chinese vaccine developer, has applied for a license to bring its COVID-19 vaccines to the market, the company's vice general manager Shi Shengyi told Xinhua Wednesday.The application has been submitted to the National Medical Products Administration for review, Shi said. Once approved, it means the vaccines will be available for the general public.”Novermber 22, 2020China stands ready to help on COVID-19 vaccines“On Saturday, the G20 nations held a virtual summit in Riyadh, Saudi Arabia. Top on the agenda were a number of international issues and not surprisingly, the global COVID-19 pandemic.…….Pledging Beijing's help, Xi (Jinping) told the summit that ‘China is willing to strengthen cooperation with other countries in the research and development, production, and distribution of vaccines’ and pledged to offer ‘help and support to other developing countries, and work hard to make vaccines a public good that citizens of all countries can use and can afford.’”Novermber 20, 2020China Sinopharm's COVID-19 vaccine taken by about a million people in emergency use“Nearly one million people have taken an experimental coronavirus vaccine developed by China National Pharmaceutical Group (Sinopharm) through the country's emergency use program, the firm said on Wednesday.China launched the emergency use program in July, which so far includes three vaccine candidates for essential workers and other limited groups of people.Two vaccine candidates developed by Sinopharm's subsidiary China National Biotec Group (CNBG) and a third one developed by Sinovac Biotech have been used for the emergency program.”Novermber 15, 2020Chinese COVID-19 vaccine to enter late-stage trial in Uzbekistan“The Uzbek government has recently told media that the country will carry out a phase-three trial of a China-developed vaccine for COVID-19, which makes the vaccine China's fifth candidate to enter late-stage human tests overseas.‘The third phase of the pilot process will be conducted in Uzbekistan for 5,000 volunteers, and the process will continue for a year,’ the Ministry of Innovative Development said, adding that the volunteers were aged between 18 and 59 and would undergo eight medical examinations within a year.The trial vaccine was developed by China's Anhui Zhifei Longcom Biopharmaceutical. Several Chinese specialists will also be dispatched to Uzbekistan to monitor the participants and train Uzbek doctors.”Novermber 14, 2020Chinese logistics industry prepares for COVID-19 vaccine transport“Transportation capacityChinese logistics giant SF Express has been working with suppliers to help deliver vaccine candidates and semi-finished items at home and abroad, as China export and import them for clinical trials.While the company has already gone through the whole logistical process, its pharmaceutical VP Liu Xiaoli said when the quantity increases once the vaccines are approved, the main issue will be whether they can cope with such a large volume through this specialized channel.……Special equipmentChinese cold chain equipment manufacturers are also working on more specialized products to meet new demands.For example, China International Marine Containers (CIMC) has developed a new vaccine shelter, which features cold storage, positive pressure, and inactivation systems.”October 25, 2020Brazil institute to import 6 million doses of Chinese COVID-19 vaccine“Brazilian health regulator Anvisa on Friday authorized a biomedical center to import six million doses of the Sinovac coronavirus vaccine, one day after President Jair Bolsonaro said Brazil would not buy the Chinese vaccine.”October 21, 2020China's vaccine to be included in Brazil's immunization program“The Brazilian government will include China's Sinovac vaccine against COVID-19 in its national immunization program, state governors said on Tuesday after a meeting with the country's health minister, in addition to one developed by AstraZeneca and Oxford University.This means the experimental Chinese vaccine called Coronavac, which Brazil's largest state of Sao Paulo had hoped to provide to its residents, may also be used to vaccinate Brazilians elsewhere, a major success for Sinovac in a nation of 230 million people.”October 20, 2020Some 60,000 injected with China's COVID-19 vaccines with no ill effect“Nearly 60,000 people have been injected with China's COVID-19 vaccines so far and no one has reported severe adverse reactions, a Chinese official told a press conference on Tuesday.Tian Baoguo, an official from the Ministry of Science and Technology, told reporters that China is leading vaccine development with a total of 13 vaccines in clinical trials.Among them, four adenovirus vector and inactivated vaccine candidates have entered phase III trials with volunteers spread across ten countries.”October 18, 2020Preliminary results show Chinese COVID-19 vaccine safe: The Lancet“A Chinese COVID-19 vaccine candidate based on the inactivated whole SARS-CoV-2 virus is safe and elicits an antibody response, according to findings from a small early-phase randomized clinical trial published Thursday in The Lancet Infectious Diseases journal.The latest study included participants aged between 18 and 80 years, and found that antibody responses were induced in all recipients. Participants aged 60 and older were slower to respond, taking 42 days before antibodies were detected in all recipients compared with 28 days for participants aged 18-59.”October 17, 2020Philippine President Duterte confident about safety of China-developed COVID-19 vaccines“In a public address, Philippine President Rodrigo Duterte said he is confident about the safety of COVID-19 vaccines developed by China, the Latest Philippines Headlines, Breaking News, Media & Sports News | Inquirer.net reported on Thursday.”October 10, 2020China, Indonesia to enhance COVID-19 vaccine cooperation“China and Indonesia have vowed to strengthen cooperation on COVID-19 vaccine during talks between Chinese State Councilor and Foreign Minister Wang Yi and Luhut Binsar Pandjaitan, Indonesian President's special envoy and the country's Coordinator for Cooperation with China.”October 8, 2020China's experimental COVID-19 vaccine appears safe, says study“An experimental coronavirus vaccine being developed by the Institute of Medical Biology under the Chinese Academy of Medical Sciences was shown to be safe in an early stage clinical trial, researchers said.In a phase-1 trial involving 191 healthy participants aged between 18 and 59, the experimental shot showed no severe adverse reactions, researchers said on Tuesday in a paper on medRxiv preprint server ahead of peer review.The most common adverse reactions reported by the trial participants were mild pain, slight fatigue and redness, itching and swelling at the injection site.”October 1, 2020China to provide COVID-19 vaccines to the world at reasonable price: spokesperson“China will share COVID-19 vaccines with the world at a fair and reasonable price, Foreign Ministry spokesperson said Wednesday.‘Vaccines of various countries are still being developed. It is uncertain how they will be priced, but for China, one thing is clear. We will provide our vaccines to the world as a global public good at a fair and reasonable price,’ spokesperson Wang Wenbin told a regular press briefing.”September 28, 2020WHO backs China's emergency use of COVID-19 vaccines“The World Health Organization (WHO) supported China's decision to vaccinate high-risk people against coronavirus in July this year while clinical trials were still under way, a Chinese health official said on Friday.China launched its emergency program in July, having communicated with the WHO in late June, according to Zheng Zhongwei, a National Health Commission official.”September 25, 2020China's Sinovac expects interim final-stage trial data on coronavirus vaccine this year“China's Sinovac Biotech expects to begin analyzing final-stage human trial data on its coronavirus vaccine candidate this year to decide whether it is effective enough to seek regulatory approval before trial completion, its chairman said on Thursday.The plan puts the Chinese vaccine developer broadly on par with some of its Western rivals who are racing to evaluate efficacy of their vaccines just a few months into Phase 3 clinical trials.”September 24, 2020Trial of a Chinese COVID-19 vaccine in Russia: 'No side effects'“People who got a Chinese COVID-19 vaccine candidate in a large-scale clinical trial in Moscow in early September have reported no side effects, local media the Moscow Times reported Monday.The vaccine, called Ad5-nCoV, was developed by Chinese company CanSino Biologics in alliance with the Chinese military's research arm.Russia approved the Phase III trial of the vaccine last month, and Russian pharmaceutical company Petrovax worked with CanSino to conduct the trial. Petrovax said it has received more than 3,000 applications to get the vaccine so far.”September 22, 2020Pakistan Begins Phase 3 Trial of Chinese COVID-19 Vaccine“Pakistan began final-phase testing Tuesday of a Chinese-made vaccine against novel coronavirus, the first ever clinical trial of its kind in the South Asian nation.Officials at the National Health Institute (NIH) said that China had supplied the COVID-19 medication, developed by Chinese biotech CanSinoBio in partnership with the Beijing Institute of Biotechnology, to Islamabad as part of a trial agreement.”September 18, 2020Track on COVID-19 vaccines: China has 11 vaccines in clinical trials, four in phase III“China is conducting clinical trials of 11 COVID-19 vaccines, four of which have entered phase three trials, said Wang Zhigang, Chinese minister of Science and Technology, at the Global Science and Life Health Forum in Beijing on Friday.”September 15, 2020China's COVID-19 vaccine could be ready for public in November: expert“Wu Guizhen, the chief biosecurity expert from China's Center for Disease Control and Prevention (CDC), said on Monday that ordinary Chinese residents could start receiving COVID-19 vaccines as early as November, adding that the current Phase III clinical trials have been going smoothly.China has been leading the world in research and development of a vaccine against COVID-19. Nine vaccines have entered Phase III of clinical trials around the world, and five of them are being developed by China, according to Wu.”September 11, 2020Hundreds of thousands have been given Chinese COVID-19 vaccines without a single infection“Hundreds of thousands of people have been given two Chinese COVID-19 vaccine candidates as part of an emergency program, without a single case of infection or adverse effects, a senior official of a state-owned vaccine developer has said.The two vaccines, developed by China National Biotec Group (CNBG), are expected to enter the market as soon as this December, and two shots will cost less than 1,000 yuan (about 146 U.S. dollars), said Zhou Song, the company's general legal counsel.”September 9, 2020WHO says working with China on requirements for COVID vaccine approval“The World Health Organization (WHO) is working with China on requirements for international approval of any Chinese COVID-19 vaccine, a senior official said on Monday according to Reuters.‘WHO's office in China and WHO headquarters has been working with the regulatory authorities in China,’ assistant director-general Mariangela Simao told a briefing in Geneva. ‘We are in direct contact, we have been sharing information and the requirements for international approval of vaccines.’"September 7, 2020Chinese-made vaccine able to fight all mutations: developer“Chinese military infectious disease expert Chen Wei said a COVID-19 vaccine her team produced can be effective against all existing mutations of the novel coronavirus, noting that they are preparing for mass vaccination at a low price whenever phase three clinical trial results come out.‘We have complete IP rights of this vaccine, which means we do not have to rely on others and can carry out our own research and development (R&D),’ said Chen, an academician at the Chinese Academy of Engineering and a researcher at the Institute of Military Medicine under the Academy of Military Sciences, in an interview with Xinhua News Agency released on Monday.She noted that ‘we can also allow Chinese people to get vaccinated at a low price whenever they need it.’"August 23, 2020China approves emergency usage of COVID-19 vaccines, official says“A Chinese health official Saturday confirmed the country authorized emergency usage of COVID-19 vaccines developed by some select domestic companies on July 22.‘We've drawn up a series of plan packages, including medical consent forms, side-effects monitoring plans, rescuing plans, compensation plans, to make sure the emergency use is well regulated and monitored,’ Zheng Zhongwei, head of China's coronavirus vaccine development task force told CCTV.An emergency use authorization, which is based on Chinese vaccine management law, allows unapproved vaccine candidates to be used among people who are at high risk of getting infected on a limited period.”July 21, 2020China's phase 2 trial finds COVID-19 vaccine safe, inducing immune response -- The Lancet“A phase 2 trial of a COVID-19 vaccine candidate conducted in China has found that the vaccine is safe and induces an immune response, according to a new study published on Monday in medical journal The Lancet.”June 4, 2020COVID-19 Inactivated Vaccine: Annual mass production could exceed 100 million doses“All geared up, researchers are entering the world's largest inactivated COVID-19 vaccine production plant – built by China National Biotec Group. It was finished in just 2 months. National biosafety experts made sure the construction standards and quality levels meet biosafety level III protection requirements. Experts say with the annual capacity at Wuhan Institute of Biological Products, the two will produce more than 200 million doses of inactivated COVID-19 vaccines annually.”May 24, 2020Vaccine trial shows promising results“The first COVID-19 vaccine to undergo a clinical trial in China has been found to be safe and able to generate an immune response against the novel coronavirus in humans, based on the results of a preliminary trial, according to research published on Friday night in the medical journal The Lancet.The phase-one clinical trial of the vaccine involving 108 healthy adults, which lasted 28 days, showed promising results, although further trials are required to determine whether the immune response it elicits can effectively protect humans against SARSCoV-2 infection, according to the researchers of the vaccine.”April 28, 2020China's fourth coronavirus vaccine candidate conducts trials“China has permitted its fourth potential coronavirus vaccine to launch clinical trials as scientists around the globe race to find a cure for the disease.The testing for the new vaccine candidate has started today, a spokesperson from the China National Biotec Group told the press.Three other potential vaccines developed by Chinese researchers have entered their phase two clinical trials, according to reports.”April 26, 2020508 volunteers get coronavirus vaccine shots in phase two trial; unblinded likely in May: expert“A total of 508 volunteers, in the second phase trial of the adenovirus vector vaccine, have been administered with injections and are now under observation. If things proceed as planned, the vaccine will be unblinded in May this year, said Chinese military infectious disease expert Chen Wei, during an event on the occasion of China's 34th children's vaccination day, on Saturday.”April 24, 2020COVID-19 vaccine for emergency use may be ready by September: China CDC director“A COVID-19 vaccine could be developed by September, and could be ready for emergency use on medical workers and on a larger group of people early next year, said Chinese Center for Disease Control and Prevention (CDC) Director Gao Fu on Thursday.If the pandemic sees another massive outbreak, the vaccine, which is under Phase II or Phase III clinical trials, could be applied on particular groups, such as medical staff, Gao said in an interview with CGTN.According to Gao, China could have a vaccine for emergency use in September, and it could be administered more widely early next year.”April 15, 2020China approves three COVID-19 vaccines for clinical trials“China has approved three COVID-19 vaccine candidates for clinical trials, said an official with the Ministry of Science and Technology (MOST) on Tuesday.An adenovirus vector vaccine, developed by a research team led by Chen Wei, an academician with the Chinese Academy of Engineering and a researcher at the Institute of Military Medicine under the Academy of Military Sciences, was the first to be approved to enter clinical trials, said Wu Yuanbin, director-general of science and technology for social development with the MOST, at a press conference.”April 9, 2020China Recruits Volunteers for Phase 2 Coronavirus Vaccine Trial“Barely a week after Chinese scientists finished injecting an experimental coronavirus vaccine into their first group of volunteers, official news outlets reported Thursday that a second batch of participants was being recruited.The trial program is recruiting 500 people, age 18 or older, who reside in Hubei province, the former epicenter of the coronavirus outbreak. Researchers are also trying to establish a placebo control group, according to a statement posted on Weibo, a Twitter-like social media site by state-run newspaper People's Daily.”March 31, 2020Chinese trial vaccine may be tested abroad“China's first candidate vaccine for the novel coronavirus may be put into additional trials in other countries seriously hit by the pandemic if the ongoing initial trial proves it is safe and effective, the top researcher for the vaccine said.The first stage clinical trial for the vaccine was started in Wuhan on March 16 after authorities approved. It has been proceeding smoothly, and its results will be published in April, said Chen Wei, a member of the Chinese Academy of Engineering. Wuhan is the Chinese city that was hardest hit by COVID-19.”March 23, 2020China begins Phase I trial of Covid-19 vaccine(https://www.clinicaltrialsarena.com/news/china-covid-19-vaccine-trial-begins/)“China has commenced a Phase I clinical trial of a vaccine against Covid-19, the infection caused by the novel coronavirus that is so far responsible for 341,700 infections and 14,750 deaths globally.”March 18, 2020Covid-19: China to launch clinical trials for coronavirus vaccinehttps://www.clinicaltrialsarena.com/news/china-launches-coronavirus-vaccine-clinical-trials/“Researchers at China’s Academy of Military Medical Sciences have reportedly received approval to launch early-stage clinical trials of a potential coronavirus (Covid-19) vaccine starting this week.According to the Chinese clinical trial registration database, a Phase I test evaluating the safety of the experimental shot in humans intends to recruit 108 healthy people between 16 March and 31 December.China’s Academy of Military Medical Sciences and the Hong Kong-listed biotech firm CanSino Biologics will conduct the clinical trial, reported Reuters.”February 29, 2020With global push for COVID-19 vaccines, China aims to win friends and cut deals“On 29 February, less than 2 months after the world awakened to the threat of the new disease, virologist Chen Wei, a major general in China’s army, and six military scientists on her team stood in front of a Chinese Communist Party flag and received injections of an experimental COVID-19 vaccine.Chen, a national hero for her work on Ebola vaccines, had come to the initial center of the pandemic, Wuhan, with her group from the Academy of Medical Military Sciences, in part to help make the candidate vaccine with a commercial company, CanSino Biologics.”