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Year : 2007  |  Volume : 55  |  Issue : 1  |  Page : 1-3

The meaning and need for informed consent in research

Mayo Clinic College of Medicine, 4500 San Pablo Road, Jacksonville, Florida, 32224, USA

Correspondence Address:
Thomas J Liesegang
Mayo Clinic College of Medicine, 4500 San Pablo Road, Jacksonville, Florida, 32224
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0301-4738.29486

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How to cite this article:
Liesegang TJ. The meaning and need for informed consent in research. Indian J Ophthalmol 2007;55:1-3

How to cite this URL:
Liesegang TJ. The meaning and need for informed consent in research. Indian J Ophthalmol [serial online] 2007 [cited 2018 Jun 19];55:1-3. Available from: http://www.ijo.in/text.asp?2007/55/1/1/29486

Clinical research was largely unregulated until the revelations of the Nazi medical experiments led to the Nuremberg Code and the Declaration of Helsinki.[1],[2] Other governmental requirements concerning informed consent and the need for monitoring by local ethical review boards followed.[1],[3] The field of medical ethics continues to debate what constitutes "informed" patient consent and the requirements for ethical study enrollment. Further, the standards often differ among geographic and political regions.[4] The central tenet of the Declaration of Helsinki, now in its fifth revision, however, remains consistent in its requirement for voluntary consent of all human subjects of medical research.[5] The Helsinki declaration also specified that "reports of experimentation not in accordance with the principles laid down in this declaration should not be accepted for publication."[1] This suggested prohibition of publication is not universally accepted as absolute, however the nuances have been frequently debated.[5],[6],[7],[8]

Informed consent is the process, dialog and invitation for the fully informed patient to participate in choices about his/her healthcare and is simply memorialized in the signature or mark. It originates from the legal and ethical right of the patient to direct what happens to his/her body and from the ethical duty of the physician to involve the patient in healthcare decisions.[9],[10] Informed consent implies that a discussion has taken place about basic elements including the nature of the decision/procedure; reasonable alternatives to the proposed intervention; the relevant risks, benefits and uncertainties related to each alternative; an assessment of patient understanding; and the acceptance of the intervention by the patient.

Valid consent requires that the patient is competent to make the decision and that the consent is voluntary. Impairments and medical illnesses may prevent the patient from understanding the informed consent. The Declaration of Helsinki addresses vulnerable populations such as minors, prisoners, pregnant women, human fetuses or adults that are physically or mentally incapable of giving consent. If the patient is determined to be incapacitated/incompetent to make healthcare decisions, a surrogate decision maker is required. If no appropriate surrogate decision maker is available, the physicians are expected to act in the best interest of the patient until a surrogate is appointed.[11]

The physician is obligated to explain and share the reasoning process, in layperson's terms and the patient's comprehension is required. Exactly how much information to provide to the patient may best be determined by using the "typical" approach, i.e., how much information the "typical" physician would provide and how much information the "typical" patient would want to know in that particular setting and patient base.

What about consent for participation in research? Research implies a systematic investigation, research development, testing or evaluation that is designed to develop or contribute to generalizable knowledge.[5],[12] Research differs from conventional therapy not only in the comparative uncertainty of risks and benefits, but also the difference in objectives.[3] Patients who volunteer for medical research face some risks. The investigator has dual loyalties to both the protocol and to the patient, perhaps in that order.

For participation in research, the basic elements of informed consent are required and additionally the patient should receive an explanation of the purposes of the research, the expected duration of the subject's participation, a description of the procedures to be followed and identification of any procedures which are experimental; a description of any benefits to the subject or to others which may reasonably be expected from the research; also, the patient should receive a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.[3] For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained.[3] Participants should be aware that, in some studies, there is a 50% chance of being enrolled in a control arm of the study. The local ethical review boards should assure that the participants know that there may be no direct benefits to them personally for participating in this study, although there fortuitously might be, but that the primary benefits from the study are for the advancement of scientific understanding and improvements in the area of study. The participants should have access to the scientific outcomes of the studies if they choose and should be aware of their rights as a participant.[3] Rabb states, "If a subject enrolls solely because of hoped-for benefits, any informed consent process has failed".[3]

Does publication of a case report require subject consent? If, before an intervention is performed, an ophthalmologist considers publishing the results of a series of cases, then the local ethical review board approval and informed consent are required, unless waived by the local ethical review board, regardless of the number of patients included. However, if an ophthalmologist decides to publish a technique following an intervention performed solely for therapeutic purposes, then most authorities consider this situation lacking a "systematic investigation," and publication may occur without informed consent, unless the ophthalmologist applies the treatment to several patients, in which case it is then research. In practice, physicians are permitted to use innovative therapeutic techniques or off-label medications, but if they attempt to gain systematic knowledge from the intervention (e.g., by doing multiple cases or from researching multiple records) then informed consent and local ethical review board approval is required.[3],[4],[13]

What about retrospective research involving data derived from human subjects? The Common Rule exempts research involving the collection or study of existing data, records or specimens, if these sources are publicly available or if the subjects cannot be identified.[3],[12] However, investigators should be aware that local ethical review boards vary in their rules for "exempt research" and that additional medical research regulations may apply. In the United States, the Health Insurance Portability and Accountability Act of 1996 precludes investigators from viewing protected health information simply for research purposes without patients' express consent.[14] Therefore, in the United States, even a simple chart review now requires local ethical review board approval and a health insurance portability and accountability act waiver of consent to collect the data, even if subject identifiers are removed.[4] Yet there are some circumstances, such as epidemiologic research, where patients might benefit in the long term but that for practical reasons informed consent cannot be obtained. Ethical latitude is then given by local ethical review boards.[15]

Social structures and customs for clinical research differ in various parts of the world[5],[16],[17] and editors may tend to accept differences in political and social environments, consciously avoiding imposition of western values on other cultures.[18] Local ethical review boards, established in the communities where the research will take place, are charged with the obligation to protect human subjects involved in biomedical research. Whether or not particular nations have their own guidelines, researchers in every country are expected, at a minimum, to adhere to the ethical practices described in the Nuremberg Code and the Declaration of Helsinki. The Nuremberg Code specifically was written to avoid violations of the rights of research subjects by authoritarian and politically repressive governments and cultural differences cannot justify ignoring fundamental individual rights.[5] Many ethical bodies have debated the important nuances of the ethical considerations and many editors will not publish reports where human rights were violated even if scientifically valid and important.[5],[7],[15],[19] Others suggest that the study might be published but should be accompanied by an editorial disclaimer describing what the ethical violation was and why publication is nevertheless justified. Another opinion is that, if the functioning local ethics committee has determined that appropriate informed consent has been administered, then it seems appropriate that the journal should accept their assessment.[6]

While the individual must be actively involved in all discussion with researchers about the medical decision in the western culture, the importance of individual autonomy has been challenged in many cultures. In Japan and Eastern and Southern Europe[20] or in the Jewish[21] or Pakistani milieu as well as several other cultures, there is a paternalistic view of many human endeavors, including the practice of medicine.[20] These cultures offer challenges to the process of informed consent because crucial decision-making is often done by family members or is left entirely up to the attending physician. There has been an increasing trend over the past several decades towards more disclosure, even in cultures where physician paternalism is traditionally well accepted.[20]

In the prevailing circumstances, in countries such as India, often it may not be possible to obtain signed informed consent of the participants in social science research on health. It is however essential that the participants are furnished with written information giving adequate details of the research and researchers have a duty to ensure that the participants comprehend the information given.

Investigators are required to seek the guidance, approval and oversight of their local ethical review board for all research involving human subjects, retrospective or prospective and should not take it upon themselves to make decisions of such ethical consequence.[4] The researcher should never make the decision that local ethical review board approval is not needed; it is the purview of the local ethical review board to make that decision.

The research community should resolve that the indignity inflicted on vulnerable patients during the Nazi regime must not be tolerated. While the local research ethics committees have the final authority for ensuring informed consent, professional and academic journals have the obligation to confirm this voluntary informed consent[15] and they should insist that this information appear in the methods section of each manuscript. At present this informed consent is still inconsistently reported, even by major journals.[22],[23]

  References Top

World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. [cited 2006 Dec 05]. Available from: http://www.wma.net/e/policy/b3.htm.  Back to cited text no. 1
Trials of war criminals before the nuremberg military tribunals under control council law. Government printing office: Washington, US; 1949 p. 181-2. [cited 2006 Dec 05]. Available from: http://ohsr.od.nih.gov/guidelines/nuremberg.html.  Back to cited text no. 2
Raab EL. The parameters of informed consent. Trans Am Ophthalmol Soc 2004;102:225-32.  Back to cited text no. 3
Ilfeld BM. An Ethical Imperative. Reg Anesth Pain Med 2006;31:353-7.  Back to cited text no. 4
Sade RM. Publication of unethical research studies: The importance of informed consent. Ann Thorac Surg 2003;75:325-8.  Back to cited text no. 5
Smith R. Publishing research from developing countries. Stat Med 2002;21:2869-77.  Back to cited text no. 6
Smith R. Informed consent: Edging forwards (and backwards). BMJ 1998;316:949-51.  Back to cited text no. 7
Clever LH. Obtain informed consent before publishing information about patients. JAMA 1997;278:628-9.  Back to cited text no. 8
Edwards KA. Informed consent. University of Washington: 1998. [cited 2006 Dec 05]. Available from: http://depts.washington.edu/bioethx/topics/consent.html.  Back to cited text no. 9
Jester MM. A history of informed consent. Risk Review [newsletter on the Internet]. [cited 2006 Dec 05]. Available from: http://www.cnahealthpro.com/amt/consent_history.html.  Back to cited text no. 10
American Medical Association. Informed Consent. American Medical Association website [cited 2006 Dec 05]. Available from http://www.ama-assn.org/ama/pub/category/4608.html.  Back to cited text no. 11
The Common Rule, Title 45, Code of Federal Regulations, Part 46. U.S. Department of Health and Human Services, National Institutes of Health and Office for Human Research Protections 2001.  Back to cited text no. 12
Truog RD, Robinson W, Randolph A, Morris A. Is informed consent always necessary for randomized, controlled trials? N Engl J Med 1999;340:804-7.  Back to cited text no. 13
United states department of health and human services. Medical privacy - National standards to protect the privacy of personal health information. Office for Civil Rights - HIPAA [cited 2006 Dec 05]. Available from: http://www.hhs.gov/ocr/hipaa/.  Back to cited text no. 14
Doyal L. Informed consent in medical research: Journals should not publish research to which patients have not given fully informed consent-with three exceptions. BMJ 1997;314:1107-11.  Back to cited text no. 15
Yusuf S. Clinical research and trials in developing countries. Stat Med 2002;21:2859-67.   Back to cited text no. 16
Brody BA. Ethical issues in clinical trials in developing countries. Stat Med 2002;21:2853-8.  Back to cited text no. 17
Angell M. Editorial responsibility: Protecting human rights by restricting publication of unethical research. In : Annas GJ, Grodin MA, editors. The Nazi doctors and the Nuremberg Code: Human rights in human experimentation. Oxford University Press: New York; 1992. p. 276-84.  Back to cited text no. 18
Editorial policy committee. Council of biology editors. Lack of informed consent and institutional review board approval. In : Ethics and policy in scientific publication. Council of Biology Editors: Bethesda, MD; 1990. p. 97-100.  Back to cited text no. 19
Jafarey AM, Farooqui A. Informed consent in the Pakistani milieu: The physician's perspective. J Med Ethics 2005;31:93-6.  Back to cited text no. 20
Eisenberg D. Medical Informed Consent in Jewish Law- from the Patient's Side. Jewish Law Website. 1999. [cited 2006 Dec 05]. Available from: http://www.jlaw.com/Articles/MedConsent.html.  Back to cited text no. 21
Yank V, Rennie D. Reporting of informed consent and ethics committee approval in clinical trials. JAMA 2002;287:2835-8.   Back to cited text no. 22
Myles PS, Tan N. Reporting of ethical approval and informed consent in clinical research published in leading anesthesia journals. Anesthesiology 2003;99:1209-13.  Back to cited text no. 23

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