INDEX

Abstract......................................................................................................................................2
Keywords...............................................................................................................................2
Introduction................................................................................................................................2
Informed Consent and Confidentiality.......................................................................................3
Explicit Orders.....................................................................................................................4
Is “Technical Consent” inevitable in some settings?........................................................5
Something to Think About..................................................................................................6
Obligation of Confidentiality..............................................................................................6
Conclusion..................................................................................................................................7
Bibliography...............................................................................................................................8
Journals and Books................................................................................................................8
Case Laws..............................................................................................................................9
Articles...................................................................................................................................9
 ABSTRACT

This paper examines the vital role of informed consent and confidentiality in medical practise
and research. It highlights the evolution of ethical and legal standards protecting patient
rights. The paper also underscores the complexities and importance of informed consent and
confidentiality through case studies. Furthermore, it dives into cultural and religious
considerations, emphasizing the necessity of sensitive patient handling to maintain trust and
integrity in the healthcare system.

Keywords- Informed Consent, Confidentiality, Medical Ethics, Legal Standards, Patient

Rights, Patient Autonomy, Trust in Healthcare

INTRODUCTION

A topic of vital importance in both ethical and legal research which involves human subjects,
is Informed Consent and Confidentiality. Not only is Informed Consent a matter of
uncertainty in concept, it is also an uncertain matter in application. A quick google search
regarding Informed Consent will immediately fill the search page with titles of articles which
frequently include words like “issues” and “challenges”.

During World War II, Nazi Germany and Imperial Japan conducted heinous crimes against
humanity. One common thing that both of them did, was conduct inhumane medical
experiments on prisoners without their consent.1 These experiments included exposure to
extreme conditions, infectious diseases and surgical procedures, that too without anaesthesia.

Unit 731, Japan’s infamous human experimentation, was able to prove that the best treatment
for frostbite was to submerge it in water warmer than 100 degrees but never more than 122
degrees. This piece of information was found out after conducting experiments on unwilling
Chinese prisoners, without anaesthesia, whose bodies when used up and exhausted, were shot
and/or killed by lethal injection.2
1
United States Holocaust Memorial Museum, Nazi Medical Experiments, Holocaust Encyclopaedia,
https://encyclopedia.ushmm.org/content/en/article/nazi-medical-experiments (last visited Aug. 7, 2024).
2
Pacific Atrocities Education, Human Experimentation, https://www.pacificatrocities.org/human-
experimentation.html. (last visited Aug 6, 2024)

1
Nothing more deeply affects modern thinking about the importance of informed consent than
the Nazi and Imperial Japan experiments.3 However, more apropos to an understanding of
the difficulties that have developed regarding consent are the emergence of the field of health
and law.4

INFORMED CONSENT AND CONFIDENTIALITY

Obtaining informed consent is an important step of both practice and research, however, the
emphasis on giving data about the risk has evolved contrarily in each setting. The law has
played a hefty part in defining how informed consent is handled in clinical practice. Consent
in clinical research however, has been arranged by international regulations and is extra
formalised.

Informed consent in courts is a concept often used in decision making after an injury. Only
derivatively is informed consent a probable opinion on what a physician should or should not
say to a patient. Courts understanding of informed consent also comprise what is a relaxing
village for physicians not to inform a patient who may be harmed by the divulged
information.5 This was because the potential harm that the information could cause was
recognized by the courts, however, it was also recognised that exclusive use of non-
disclosure would overpower the responsibility to protect a patient’s informed consent.6

Explicit Orders
Interestingly enough, if a patient made it explicitly clear not to be told about the risks that
they could face or be facing, then this request would be honoured and respected. 7 There are
cases in which the patient has a DNR (Do Not Resuscitate), which is an explicit condition put
forth by the patient, this means that if the patient’s breathing stops then the medical
3
Gray, Bradford H. “Complexities of Informed Consent.” The Annals of the American Academy of Political
and Social Science, vol. 437, 1978, pp. 37–48. JSTOR, http://www.jstor.org/stable/1042491. Accessed 7 Aug.
2024.
4
Renee C. Fox, "Advanced Medical Technology-Social and Ethical Implications," Annual Review of Sociology
2 (1976), pp. 231-68.
5
Mazur, Dennis J. “Influence Of The Law On Risk And Informed Consent.” BMJ: British Medical Journal, vol.
327, no. 7417, 2003, pp. 731–34. JSTOR, http://www.jstor.org/stable/25457336. Accessed 7 Aug. 2024.
6
id
7
id

2
professionals are not to do CPR. However, this raises a question on whether the partners or
family members of said patient should be up-to-date if the patient overtly does not want to be
told about the dangers. Cultural issues as well as religious issues often arise from this. A
particular religious sect of Christianism, known as Jehovah’s Witnesses, refuse blood
transfusion as they believe “the only use of blood that God has authorised is for the
atonement of sins”. Often, accepting blood transfusion has led to the patient getting
ostracised by the community.8

In cases like these more than often, the patient is informed regarding the risks and likely
outcomes of not receiving a blood transfusion, as well as any other treatment/surgery options
which are less risky.9

Informed consent in medicine has been primarily based on one type of medical decision,
which is when one medical intervention surfaces as medically “justifiable” and is
recommended by a general physician. Hence, a surgeon who recommends surgical removal
of gall bladder of a patient with gall stones may discuss the intrusion in context of the risks of
continued episodes of abdominal discomfort.

Each of the aforementioned risks has to be weighed against what could be the possible
benefits for the patient. Often times, doctors also adopt specific practises to accommodate
the requirements of informed consent in their particular field.

The courts make it compulsory for information to be disclosed to a patient in a discussion

with the doctor. Thus, simply handing over a consent form is not considered enough by the
courts unless the issues are conferred with patients and they have another chance to ask
more questions.

Is “Technical Consent” inevitable in some settings?

People often argue for improved informed consent for patients who are entering clinical
trials, and say that this consent is more than often obtained “technically without any real
commitment to its spirit”.10 This is a mutual issue in obtaining consent normally, whether for
treatment or research. Under some circumstances, it is believed that “technical consent” is

8
Medical Protection Society, The Challenges of Treating Jehovah's Witnesses,
https://www.medicalprotection.org/southafrica/casebook/casebook-may-2014/the-challenges-of-treating-
jehovahs-witnesses (last visited Aug. 7, 2024).
9
id
10
Baum, Michael, et al. “Informed Consent.” BMJ: British Medical Journal, vol. 317, no. 7163, 1998, pp. 947–
49. JSTOR, http://www.jstor.org/stable/25180575. Accessed 7 Aug. 2024.

3
inevitable. For example, during delivery, the mother is often frightened, exhausted and under
tremendous amounts of pain and medication. In this situation, if a medical emergency occurs,
and there is no family member to make a decision for the mother, implied or technical
consent will be taken, unless previously specified by the mother to not do the medical
procedure. Often times even if the mothers are fully conscious, a detailed explanation of the
process might be time consuming and risky. The Medical Termination of Pregnancy Act,
1971 ensures that no pregnancy is ended without the consent of women.

Ideally consent should be obtained before the onset of labour. 11 However, in the case of Devi
v. West Midlands12, the surgeon while operating discovered that her womb was split and
sterilized her without taking her consent. This doctor was held for medical negligence. In this
particular case, a few things were considered to declare it a medical negligence. The most
important part that was considered was whether the lack of sterilisation would have led to
some life ending event. Furthermore, in Jayshree Chowdhury & Anr vs. B.M. Birla Heart
Research Centre13, there was a high-risk patient, no consent was taken and yet an operation
was performed. In Section 2 of the Mental Healthcare Act, 2017, informed consent is
clearly explained.

The landmark case of Samira Kohli v. Dr. Prabha Manchanda & Anr.14, the Supreme Court
ruled on the need for informed consent and highlighted the patient’s right to be informed
about the risks and alternatives of medical procedures.

Something to Think About

There are somethings which one should think about when pondering on the topic of Informed
Consent. How far does it actually go, or rather how far does the State allow it to go? In India,
suicide is punishable by law, why? Because in a very warped way, a person, or rather a
citizen is the state’s “property”, and any damage to it is punishable. However, isn’t DNR or
assisted suicide the same thing? Why is that allowed in some countries? Do Netherlands,
Belgium or Luxembourg not think of their citizens as property? The reasoning behind it is
quite simple, if someone is suffering from grievous and irreversible conditions and their death
is reasonably predictable, they are permitted to go through euthanasia or assisted suicide.

11
id
12
Devi v. West Midlands Aha, (1980)7 C.L. 44
13
Jayshree Chowdhury & Anr vs. B.M. Birla Heart Research Centre
14
Samira Kohli v. Dr. Prabha Manchanda & Anr., (2008) 2 SCC 1 (India)

4
HOWEVER, this is consensual, the patients still choose whether to live or die, and if they
choose to refuse care and treatment, a doctor does not have any duty to treat the patient.

Obligation of Confidentiality
A long-accepted tradition and fundamental ethical practise in medical is the keeping of
patient’s mysteries or the obligation of confidentiality.

The Hippocratic Oath states,

Whatsoever things I see or hear concerning the life of men, in my attendance on the sick or
even apart therefrom, which ought not to be noised abroad, I will keep silence thereon
counting such things to be as sacred secrets

Further the Declaration of Geneva also reiterates this principle,

I will respect the secrets which are confided in me, even after the patient has died.

When patients visit their doctors, they expect confidentiality due to their belief in the system,
belief in privacy rights, the implied contract between doctor and patient and the general
principle of utility. these beliefs ensure that the personal and entrusted information remains
protected, encouraging patients to disclose the full truth without fearing stigma or
repercussions. This expectation however is not solely based on the Hippocratic Oath but
rather on these deeper assumptions about privacy, contractual obligations and the public
value of honest communication is medical settings.15 The case of Mr. X v. Hospital Z16,
addressed patient confidentiality and the limits of disclosure of patient information in the
context of public health and safety.

Confidentiality is the most important aspect of right to privacy, whether it be doctor patient
confidentiality or client lawyer confidentiality. Confidentiality needs to be maintained as the
client/patients trust in the system depends on it.

CONCLUSION

15
Mazur, Dennis J. “Influence Of The Law On Risk And Informed Consent.” BMJ: British Medical Journal,
vol. 327, no. 7417, 2003, pp. 731–34. JSTOR, http://www.jstor.org/stable/25457336. Accessed 7 Aug. 2024.
16
Mr. X v. Hospital Z, (1998) 8 SCC 296

5
The principles of informed consent and confidentiality are vital to ethical and legal
standards in medical practice and research. It is important to uphold these principles in order
to avoid recapping the bloody history of Nazi Germany and Imperial Japan. These historical
events underscore the need for stringent ethical standards to protect individuals.

Informed consent guarantees that patients are fully conscious of the risks, benefits and
substitutes associated with medical procedures. It is not only a legal requirement, but also a
fundamental ethical obligation that respects patients. Confidentiality, on the other hand,
safeguards the privacy of patient information, fostering trust in the healthcare system.

In legal context, informed consent extends way beyond merely informing patients about the
risks of procedures. Courts often consider broader implications of consent, including the
potential harm of non-disclosure and the importance of honest communication. The concept
of “technical consent” where consent is obtained in less-than-ideal circumstances, further
complicates the landscape. It underscores the necessity for pre-emptive discussions and
thorough documentation to uphold ethical standards in urgent medical situations.

In summary, informed consent and confidentiality are cornerstones of ethical medical

practice and research. They ensure that patients are respected, their autonomy upheld, and
their private information protected.

BIBLIOGRAPHY

Journals and Books

1. Nijhawan, L.P., Janodia, M.D., Muddukrishna, B.S., Bhat, K.M., Bairy, K.L., Udupa,
N. and Musmade, P.B., 2013. Informed consent: Issues and challenges. Journal of
advanced pharmaceutical technology & research, 4(3), pp.134-140.
2. Faden, R.R. and Beauchamp, T.L., 1986. A history and theory of informed consent.
Oxford University Press.

6
3. Schuck, Peter H. “Rethinking Informed Consent.” The Yale Law Journal, vol. 103,
no. 4, 1994, pp. 899–959. JSTOR, https://doi.org/10.2307/797066. Accessed 7 Aug.
2024.
4. Falagas, M.E., Korbila, I.P., Giannopoulou, K.P., Kondilis, B.K. and Peppas, G.,
2009. Informed consent: how much and what do patients understand?. The American
Journal of Surgery, 198(3), pp.420-435.
5. O’neill, O., 2017. Some limits of informed consent. In The Elderly (pp. 103-106).
Routledge.
6. Manson, N.C. and O'Neill, O., 2007. Rethinking informed consent in bioethics.
Cambridge University Press.
7. Pfeffer, Naomi, et al. “Informed Consent.” BMJ: British Medical Journal, vol. 315,
no. 7102, 1997, pp. 247–54. JSTOR, http://www.jstor.org/stable/25175274. Accessed
7 Aug. 2024.
8. Howe, David. “Confidentiality And Informed Consent.” British Medical Journal
(Clinical Research Edition), vol. 284, no. 6308, 1982, pp. 53–53. JSTOR,
http://www.jstor.org/stable/29504783. Accessed 7 Aug. 2024.
9. Lesser, Harry, and Zelda Pickup. “Law, Ethics, and Confidentiality.” Journal of Law
and Society, vol. 17, no. 1, 1990, pp. 17–28. JSTOR, https://doi.org/10.2307/1409952.
Accessed 7 Aug. 2024.
10. Baum, Michael, et al. “Informed Consent.” BMJ: British Medical Journal, vol. 317,
no. 7163, 1998, pp. 947–49. JSTOR, http://www.jstor.org/stable/25180575. Accessed
7 Aug. 2024.
11. Mazur, Dennis J. “Influence Of The Law On Risk And Informed Consent.” BMJ:
British Medical Journal, vol. 327, no. 7417, 2003, pp. 731–34. JSTOR,
http://www.jstor.org/stable/25457336. Accessed 7 Aug. 2024.
12. Shannon, Jennifer. “Informed Consent: Documenting the Intersection of Bureaucratic
Regulation and Ethnographic Practice.” Political and Legal Anthropology Review,
vol. 30, no. 2, 2007, pp. 229–48. JSTOR, http://www.jstor.org/stable/24497376.
Accessed 7 Aug. 2024.
13. Ralph J. Alfidi, "Informed Consent: A Study of Patient Reaction," Journal of the
American Medical Association 216 (24 May 1971), pp. 1325-29.
14. Use of Human Subjects in Research. Electronic Document,
http://www.osp.cornell.edu/Compliance/UCHS/homepageUCHS., accessed August 5,
2024
7
 15. Renee C. Fox, "Advanced Medical Technology-Social and Ethical Implications,"
Annual Review of Sociology 2 (1976), pp. 231-68.
16. Eugene G. Laforet, "The Fiction of In- formed Consent," Journal of the American
Medical Association 235 (12 April 1976), pp. 1579-85.

Case Laws
1. Devi v. West Midlands Aha, (1980)7 C.L. 44
2. Jayshree Chowdhury & Anr vs. B.M. Birla Heart Research Centre
3. Samira Kohli v. Dr. Prabha Manchanda & Anr., (2008) 2 SCC 1 (India)
4. Mr. X v. Hospital Z, (1998) 8 SCC 296

Articles
1. Gray, Bradford H. “Complexities of Informed Consent.” The Annals of the American
Academy of Political and Social Science, vol. 437, 1978, pp. 37–48. JSTOR,
http://www.jstor.org/stable/1042491. Accessed 7 Aug. 2024.
2. Robert M. Veatch, "Three Theories of Informed Consent: Philosophical Foundations
and Policy Implications" (Unpublished paper prepared for the National Commission
for the Protection of Human Subjects, 2 February 1976), p. 14.
3. Frederick S. Carney, "A Moral Analysis of Human Experimentation," in Human
Experimentation, ed. Robert L. Bogomolny (Dallas: Southern Methodist University
Press, 1976), pp. 132-48.
4. Robert A. Cooke, Arnold S. Tannen- baum, and Bradford H. Gray, A Survey of
Institutional Review Boards and Research Involving Human Subjects: A Report to the
National Commission for the Protection of Human Subjects of Biomedical and
Behavioural Research (Springfield, Va.: National Technical Information Service,
1977).
5. United States Holocaust Memorial Museum, Nazi Medical Experiments, Holocaust
Encyclopaedia, https://encyclopedia.ushmm.org/content/en/article/nazi-medical-
experiments (last visited Aug. 7, 2024).
6. Pacific Atrocities Education, **Human Experimentation**,
https://www.pacificatrocities.org/human-experimentation.html. (last visited Aug 6,
2024)

8
7. Bradford H. Gray et al., "Research Involving Human Subjects: An Empirical Report
on Human Subject Review Committees" (Paper presented at the Meetings of
American Sociological Association, 7 September 1977), pp. 14-17.
8. Lester L. Coleman, "Terrified Consent," Physician's World (May 1974).