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Wednesday, March 21, 2012


Informed Consent is a dynamic process to inform the subjects of the risks, causes, profits and benefits of participation in a clinical research trial. Informed consent is a legal and ethical and essential principle and should be in writing. It has been an integral part of the ethical research. Before any research, the scientists and researchers should take the informed consent from the participants and volunteers in writing way.

According to Prof. SC Malik, Informed consent is a legal process to ensure the patient known the risks, causes, profit and benefit of proposed the treatment and intervention should be included informing the client of the nature of treatment in possible art of native and potential risks and benefit of the treatment. Informed consent must be valid and voluntary.

Informed Consent is a dynamic process not just a piece of paper on which we get signature. This is a process by which the subject voluntarily confirmed his or her willingness to participate and he or she has been informed of all aspect of trials and data are relevant to the subject who is participant. There should be written document, sign and dated on Informed Consent form. When the written informed consent is not possible with the signature and thumb impression then it is necessary to take verbal consent and two witnesses should be documented.

In the case of drugs study, when we find the patient in the state of unconscious and not in the state of the signature then in such condition, we are supposed to get only thumb impression and the legal relative’s thumb impression will not be accepted at all.

There are some cases in which we need to get the fresh informed consent re-consent when we find that the patient is unconscious, new information has come up, the change of the essence of studies, change in treatment, modality, size and procedure.

In some circumstances, the third party should be informed and involve ensuring and total accountability of the process. Similarly the Institutional Review Board where there does not exist any trial section then it is compulsory to tie up with other existing Institutional Review Board to set their studies and trials.

 It has been seen that the language of participant has been a barrier in the way of the communication between the patient and an investigator or scholar during getting informed consent; so in such situation, we must need some translators to translate the speech of the investigator into the language of the participant and vice-versa because informants should know everything about the research or experiment that is going to be conducted on them.  

It is very important for the investigators to answer and reply to all queries asked by the patient and the participant clearly step by step. It is also important to disclose all the information going to discuss and experiment. The investigators are not assumed and supposed to hide anything regarding the research and experiments from the participants and patients.

There are three main principles involved in the research and experiment of the Bioethics.

1.  Information: The investigators and scholars must give all information about the research and studies to the subjects. They are also supposed to tell them about the procedure, purpose, goal, profit, benefit, cause, risks and alternative procedure. The participants have the authority and full rights to withdraw themselves from the research and experiments in the middle or at the beginning and final without any logical reasons.
2. Comprehension: The investigators and scholars must first comprehend the psychological, mental and physical conditions of the participants and their voluntarily willingness. The investigators are supposed to test first them before they start doing experiment and research on them and ensure that the participants are not mental retardation, severely disability, any language disorder and psychological disorder.
3. Voluntariness: It is nothing but informed consent. The investigators and scholars should get voluntarily informed consent from the participants. The investigators and scholars do not have the right and authority to force them to involve in the research and experiments. The investigators also are not supposed to threaten the participants by saying that they will lose their jobs for getting informed consent.    

It is very important to keep in mind is that the investigators are supposed to reduces the risks and causes as much as they can do according to their capacity and capability. They (scholars) first try to find out the alternative procedure and method to conduct the research which can reduce risks and causes and give more benefits and profits. They need to be very careful when they conduct the experiments and research on human subject. They have to determine that it is necessary to take human subject for conducting the research or there is an alternative way where research and experiment can be conducted on animals that has seen earlier research in old time.

There is other important thing which is necessary to be kept in mind is that the investigators should be very careful about the social class, race, cast, community and of course religion of the participants especially in India. There should not be any bias at all with respect to class, cast and religion and minor community when we choose the participants for conducting research on them.

Dr. SC Malik has also emphasized the guiding principles of the research that was published in the Belmont Report by US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

1. Respect for person: This is the first guiding principle of the research that requires the choice of autonomous individuals should be respected and protected. From the principle of respect for persons, the individual is seen and viewed as an autonomous agent and we can give the opportunity to the participants to choose whether they will participate in clinical research or not, it is completely depend on them. We can involve them in clinical research forcefully. The Belmont Report also discusses about the voluntary nature of informed consent and explains that the information must be complete, understandable, and presented in an unhurried fashion.
In this category, it is very necessary and obligatory to take informed consent from the participant and volunteers before conducting any research study and also compulsory to maintain the confidentiality between patient and doctors. Ethically the investigator is responsible for determining whether the subject really understands this information properly.
2. Beneficence: This is the second guiding principle which requires that participant in research should be associated with the balance of potential benefits and harms. The harm and cause of the participant should be reduced as much as the researchers can do.
3. Justice: This is the third guiding principle that requires an equitable distribution of the burdens and benefits of research. Research must not exploit vulnerable people or exclude without any good reason that may benefit from participation in a study.

The Belmont Repot    

The Belmont Report was issued in the United States in 1979. This report talks about the basic principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was established as a result of the National Research Act in 1974. There are three major principles came out from the Belmont Report that is, Beneficence, Justice and Respect for persons.

In the United States, there are two sets of regulations regarding informed consent: Regulations found in the Code of Federal Regulations Titles 21 and 45:21 CFR 50 and 56, the Food and Drug Administration (FDA) regulations, and 45 CFR Part 46, where applicable, the Department of Health and Human Services (DHHS) Regulations.

Informed Consent: Confidentiality

If a person gives information to another in confidence and there is an obligation on the person receiving the information not to disclose it to someone. In most research studies, the participants provide information they may consider confidential or personal. In the informed consent process, they must be informed about the degree of confidentiality throughout the study and once the study is over.

The obligation of confidentiality is that the information must not be shared with others and the information should be remaining in between the provider and the receiver. Consequently, there is both an individual and a public expectation that information given to a health professional or public health authority in the context of the clinical relationship will not be disclosed to third parties. The obligation of confidentiality provides the foundation for trust in the therapeutic relationship.

There is also an understanding that confidentiality cannot be absolute and sometimes it may be permissible or even legally required to break or breach confidentiality. Various Medical Association and healthcare teams raise questions of how much information can be shared within the team and who is recognized as a team member for this purpose.

The Importance of Confidentiality

There are a number of moral foundations for the importance of confidentiality in healthcare. The expectation that information disclosed to a health professional will remain confidential and encourage patients to be open with their clinicians.  If the patient thought that this was not the case then they may withhold important information that is necessary for effective treatment or for the protection of others.

It is duty of clinician to respect patient autonomy in medical decision making. Competent patients have a right to control the use of information pertaining to themselves. A clinician, who shares that information with others without the patient’s consent, does not respect the patient’s autonomy and will have behaved in a morally questionable way- because patient is an unaware of the breach of confidentiality. Breaking the duty of confidentiality and trust is a betrayal of trust.

Breaking of Confidentiality

As J.S. Mill observed in 1859 that personal freedom may legitimately be constrained when the exercise of such freedom place others at risks of harms,(Mill 1962).
In the context of confidentiality, this suggests that a patient’s right to control how personal information is shared with others is constrained by an obligation not to harm others.

Some US legislation permits disclose of health information for epidemiological and research purpose. UK Common Law recognizes that the breach of confidentiality is lawful in some circumstances, mainly when there is a risk of serious harm to others. Professional Codes of Ethics such as American Medical Association, Australia Medical Association, Canada Medical Association, and General Medical Council specify Confidentiality can be breached if requires by law or in circumstances where there is a significant risks of serious harms to others.


Mr. A is 35 years old. He had had unprotected sex with prostitute on at least two occasions. Although he is asymptomatic, he is worried about the possibility that he may have a Sexually Transmitted Disease (STD) and consult his physician. After conducting a careful physical examination and blood test, a result came with the HIV Positive. The Physician offers to meet with his wife and assist to disclose the information but he states that he does not want his wife to know about it.

Mr. A’s physician should advise him that his wife needs to be made aware of his condition and that if necessary his wife will be informed without his consent. It is important to explain the reason why his confidentiality may be breached in this situation and to make every effort to maintain a therapeutic relationship with him.
In Jurisdictions, where notification of HIV status to a public health authority is legally required. The risks of serious harm to Mr. A’s wife would be the justification for a breach of confidentiality.

Protection of Privacy and Confidentiality

It is very important to protect the privacy of individuals and participants and to ensure that this information is released only when necessary. Soler and Peters (1993) outline several reasons for protecting the privacy of children and families and participants.

·  Confidentiality restrictions protect embarrassing personal information from disclosure. This information may include histories of emotional instability, marital, conflicts, medical problems, physical or sexual abuse, alcoholism, drug use, limited, education or erratic employment.
·  Confidentiality provisions also prevent the improper dissemination of information about children and families that might increase the likelihood of discrimination against them. Such information—about HIV status, mental health history, use of illegal drugs, or charges of child abuse, can be harmful if released. Harm can occur even if records show that the information in unproven or inaccurate.
·  Protecting confidential information can be necessary to protect personal security. For example, in a domestic violence situation, an abused woman who leaves home may be in great danger if law enforcement personnel disclose her new location.
·  Confidentiality provisions also protect family security. Many immigrant families, for example, shy away from using public health clinics or other social services for fear that the Immigration and Naturalization Service (INS) will take action against them.
·  Restricting the information that human service agencies receive may also protect job security. Some information such as a history of mental health treatment may have no connection with a person’s actual job performance but could jeopardize the individual’s position, likelihood of promotion, or ability to find new positions.
·  Children and families also want to avoid prejudice or differential treatment by people such as teachers, school administrators, and service providers. Teachers may lower their expectations for the children they know are eligible for food stamps or free school lunches. This may set in motion a self fulfilling prophecy in which lowered expectations lead to lowered performance.
·   Confidentiality provisions also may be necessary to encourage individuals to make use of service designed to help them. Adolescents may avoid seeking mental health service at a school based clinic, for example if they believe that information will get back to their teachers, parents or peers. The same holds for birth control or HIV related medical consultations.

McWhinney, Haskins Herkenham and Hare note that confidentiality provisions actually promote that participation of families in seeking and receiving services:
“Assurance of confidentiality is important because it enables people to seem help without fear of such results as stigma, retaliation, disapproval or damage to other relationships. Confidentiality encourages both full disclosures, which is essential for effective treatment, and the maintenance of trust, the means by which treatment is effected.”

Compensation for participants

It is very necessary and important to compensate participants for their Time, Travel, and Inconvenience. The amount or value of this compensation should not be so high as to unduly influence a potential participant’s decision to participate in the study.

Input from community representatives is needed at the beginning of the study to determine the appropriate in the study.
Information must be disclosed about available treatment, the degree and duration of treatment, and who would pay for it in the case of injury or complications related to the research. Community representatives need to be aware of the research, institution, national or sponsor policies on compensations available to the research participants.

Sometimes treatment will be provided free of charge for injury or complications associated with the research. However the resources available for this purpose may be limited. For example, in an experiment study to prevent HIV, some of the participants may become infected; it is important to state whether such participants will receive treatment and if so, for how long. The degree or kind of health care that will actually be provided should be well understood by the potential participant.

Be sure all participants understand that they will not receive free general health care during the study.

There is difference between benefits and compensation and should be made known to participants. Compensation, usually in form of payment for transportation expenses or a token of appreciation, is generally given at the enrollment stage or after a visit to the study clinic. Benefits such as drugs, health care, and the like are usually given only during the study.


Confidentiality and Informed consent, Center for mental Health in schools UCLA

June Smith Tylor, “Informed Consent, Confidentiality, and Subject Rights in Clinical Trials”

Research Ethics Training Curriculum For Community Representatives.


MD.ASAD said...

This is nice one.

MD.ASAD said...

It will really be helpful for students.