Ethical and legal aspects of clinical trials

Therefore, a good balance is required where all required information should be put in concise and simple manner to make it understandable.

Hence, the informed consent process becomes a mockery of the principle and ends up in getting the signature or thumb impression of the participants by someone who is not directly responsible for the proposed research. The other requirement like having a witness to sign also falls under the same category.

If this is what happens in the case of an autonomous adult who is capable of giving a voluntary informed consent, one can imagine the ground realities while taking consent from other vulnerable groups who lack the autonomy to take voluntary decisions.

While many claim to take the legally acceptable representative to confidence before taking their consent on behalf of the vulnerable participant, the issues like assent of the mature minor, getting consent of the unconscious, or mentally disabled, later when they recover, need for an unrelated witness, etc.

The Informed consent process is a continuous responsibility from the start till the end of the research, which is another aspect which needs to be remembered by the researchers. There is a possibility to obtain waiver of informed consent when the research poses less than minimal risk. Often, ethics committees are also not sure of situations where a waiver of consent can be given. The challenge remains that many such proposals never reach the ethics committee as the investigators decide for themselves that the research does not require an ethics review and hence do not submit it to the committee.

It is still not understood by many that any type of biomedical research involving human participants should be reviewed by the EC which only can decide about the waiver of the informed consent or written informed consent. For the latter, the other methods of recording the informed consent process such as audiovisual recordings should be mentioned in the protocol and approved by the ECs. The principle of autonomy also relates to other issues such as privacy and confidentiality, right of participants to refuse or withdraw without any reason and without affecting their routine treatment at the relevant clinic or hospital.

There is clear-cut distinction between privacy and confidentiality. While preparing the participant information sheet, all these issues need to be mentioned clearly including the mechanism to protect the privacy and confidentiality and the possibility of withholding some information for the sake of validity of research.

However, as far as possible, debriefing should be done with the participants after completion of the research, giving reasons for not providing full Information, and as part of the debriefing process, it might often be necessary to provide services such as counseling and referral. Embedded in the principle of justice, participation in research should be accessible to everyone, regardless of socioeconomic status.

Hence, recruitment of participants is a major issue in ensuring that burden of research and benefit of that research is borne by the same group of individuals and there is no exploitation of any vulnerable group because of their socioeconomic, ethnic, or cultural status. Should all participants be compensated for their time? Should health professionals be compensated if participation means they will need to work overtime to make up for the time spent for research work in place of service?

Industry funded research introduces the potential for a very different sort of benefit and thereby potentially alters, in a fundamental way, the moral concerns raised by clinical research.

Commentators on the ethics of clinical research tend to be sceptical of the appropriateness of paying research subjects, despite the prevalence of the practice, on the grounds that it might undermine the ethical protection of free informed consent. Compensation to research participants for participation, better referred as reimbursement, is not a benefit and hence should not be listed in the benefits section of the protocol or informed consent documentation.

Compensation is that which has to be provided to the research participants when temporary or permanent injury occurs due to participation in the clinical research.

The investigator should inform the EC of any such claims. Recently, the Drugs Controller General of India has issued a notification and guidelines on Compensation and specified that the ECs have to monitor such financial compensation and decide about the quantum of relief to the participants. The principle of justice also insists these days, after the revision of Helsinki Declaration in , that researchers, sponsors, and ethics committees have to consider whether an intervention found to be efficacious in a completed study should continue to be provided to the research participants, and to the local community as a post study access to successful interventions.

Uncertainty about whether an experimental intervention will prove to be successful or locally affordable, and the difficulty of guaranteeing that it can be provided to participants in the longer term, have discouraged sponsors from making commitments of this nature before embarking on a trial.

How much effort should be made by sponsors to secure access in order to ensure that research is ethically acceptable is therefore difficult to judge. However, there is a growing consensus that the ethical review process, undertaken before the research starts, should address the issues that may arise when the trial or study is concluded. Most of our ECs are quite unaware of this requirement and hence do not consider the discussion on post research access to successful interventions as part of their mandate.

This is an issue that needs to be discussed further to see how it can be implemented. This is indeed important for equity and justice. This needs continuing negotiation and discussion as the study proceeds. These include the issues of conflicts of interest such as the one already noted above on the potential conflict of the role of the clinician as an investigator. Others are more subtle such as the vested interest of the investigator to publish, to gain prestige, to yield to commercial pressures and interest.

Ethical conundrums, however, are not limited to the ones noted in this article so far. There are several others that have been highlighted and in the public eye in the past two years and these will also be discussed in general terms in this article. The most salient ones are discussed here. In general, mistrust exists amongst the public, health professionals and others on the accuracy and veracity of the outcomes for clinical trials. Consequently, moves around the world to generate registries where clinical trials are registered and their results posted.

There are several already in existence, but the current endeavours are intended to ensure that these become of universal scope. WHO has established a series of standards that can be used as a primary register with individual countries cross-referencing to these as secondary registers.

In this manner, a network of linked registries can be created to make all clinical trials and their results accessible to all interested parties whether lay people or health professionals. The use of a placebo in clinical trials has become one of the most controversial topics in biomedical sciences.

Much discussion has been generated as to how the use of a placebo will affect the health and well-being of subjects enrolled in trials and whether the use of placebos should be permitted at all in the face of the existence of accepted treatment.

Unfortunately, accepted therapy may not have always been based on rigorous research and the evidence for such use may be slim. However, the use of placebos is permissible under certain conditions, even though the Declaration of Helsinki, the biomedical ethics literature and some guidelines have come down opposing their use.

It is to be noted that placebos in themselves can, and do have, therapeutic effects. These tests are carried out promptly and confidentially at the Clinical Center. If you cannot remember or are uncertain if you received transfusions, your physician can ask the Clinical Center Department of Transfusion Medicine to check its records to see if you received a transfusion here.

This information will be accurate and complete for transfusions given at the Clinical Center but will not include a record of transfusions given elsewhere. If you have questions about access to your medical record or the release of information contained in it, please call the Medicolegal section of the Medical Record Department at or stop by room 1N If you wish to take a photograph of your fellow patients, please ask their verbal permission.

You may photograph patients in their rooms or in the unit lounge, solaria, or outside the Clinical Center. Please refrain from taking photographs in gathering places such as cafeterias and lobbies. Some types of medical information cannot be recorded completely in writing. Photography, tape recording, and other audiovisual methods are sometimes much better.

Audiovisual records which could reveal your identity are never made unless you have given your prior written permission on a special form, which states the particular uses that will be made of the records. Patients who give information about themselves or their families to the doctors and other workers in a hospital expect the information to be kept confidential.

We will do this to the best of our ability. However, you should be aware that neither the Clinical Center nor any other medical institution can absolutely guarantee confidentiality. This law puts strict limits on how Federal agencies may use and disclose personal information, including medical information. It requires every agency to inform each individual why he or she is asked for information and how it will be used. The research in which patients or volunteers participate - clinical research - takes place mainly in the Clinical Center in Bethesda, Maryland.

The medical and other personal information you are asked to give, as well as the information from various tests, is gathered for two purposes: to provide the best care and treatment for you as a patient, and for research to increase understanding of health and illness. Both good treatment and good research depend on accurate and complete information. However, just as your coming to the Clinical Center as a patient is voluntary, your giving the information we request and participating in various tests and research procedures is also voluntary.

Some of the information obtained from you may appear in scientific publications or be presented to professional audiences at meetings. It may be used for the purpose of teaching health professionals or students in the health professions.

Under these circumstances, measures are taken to conceal your identity. Occasionally, we receive media requests for information about patients who are being treated at the Clinical Center. Inquiries may be made especially if a patient is a public figure or celebrity. These requests are handled by Clinical Center Communications, the public affairs office for the hospital.

Our primary concern is patient welfare, but we also have an obligation to cooperate with the media. The only information that may be released to the media without the patient's prior written permission is verification that the person is a current Clinical Center patient. Medical records, including diagnosis, are confidential and will not be released to the media. If you are contacted by the media while you are a patient here, or if you have questions about Clinical Center media policies, please call Clinical Center Communications at At the time of your admission, you were asked to give your social security number and your religion.

Giving this information is strictly voluntary, and the admissions clerk will emphasize this. If your social security number is required for any financial transactions, this will be explained to you. Knowing your religion enables the hospital chaplains to offer spiritual service, which for many patients is an essential part of their care. The information needed for care and treatment, and much of the research information, is recorded and stored in your written medical record and in a computer system.

In addition, records containing some of the same or similar information are maintained by the many departments and offices essential in a modern hospital.

These include admissions, anesthesiology, transfusion medicine, dental clinic, nursing, nutrition, pharmacy, reception desk, recreation therapy, social work, spiritual ministry, and travel office. These also include the departments and offices that perform electrocardiograms, electroencephalograms, metabolic rates, pathological anatomy, pulmonary function, radioisotope studies, and x-rays. NIH scientists and their technical assistants maintain research records in their offices and laboratories.

These may be records of clinical research procedures carried out in each laboratory, or they may be compilations of data abstracted from the medical records of many patients, some of whom may have no personal contact with the scientist.

Such records are essential to prepare the hundreds of clinical research reports published in scientific journals each year. Students in the health professions, particularly medicine and nursing, are regularly assigned to the NIH as part of their formal training.

They may be unpaid volunteers, but they are under the direct supervision of the NIH staff. They have access to medical information as necessary to carry out their training assignments. Generally, access to medical information is restricted to NIH employees who need it to carry out their official duties. There are, however, occasions when confidential information is shared with individuals or organizations that are not part of the NIH.

These are as follows:. The NIH compensates study participants for their time and, in some instances, for the inconvenience of a procedure. There are standard compensation rates for the participant's time; the study's principal investigator determines inconvenience rates. Ethical and Legal Aspects of Clinical Trials. Arch Neurol. Coronavirus Resource Center. Our website uses cookies to enhance your experience.

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