Informed Consent Process in Vulnerable Population

Hippocrates suggested “First, do no harm” to the all the subjects taking part in the clinical trials. Informed consent is defined as consent given by a competent individual who has received the necessary information, has understood the information and having understood the information has arrived at a decision about participation without having been under coercion, undue influence or inducement or intimidation. The informed consent is obtained before the commencement of any study and has to be approved by Ethics Committee. Based on Declaration of Helsinki subjects have the right to know all the aspects of a clinical trial to which they are enrolled (Gupta 2007).

People who are moderately or completely incapable of protecting their own interests are called as vulnerable population/ research participants. Stakeholders of any research have to take special responsibilities to ensure their rights. According to Schedule-Y, FDA, ICH-GCP, WHO and ICMR guidelines, vulnerable population includes poor/low-income people, illiterate patients, children, psychiatric patients, prisoners, foetuses and pregnant women.

In developing countries, subjects usually agree for the study because they find these studies as the only option to obtain free medical care. Also, there are patients who consider doctors next to god and hence anything suggested by these doctors are accepted by the illiterate patients. All these issues give rise to the crucial ethical problems concerned with the informed consent process.

Background

Poor/low-income women may always be coerced since they may not have the right to decide or express their views on a particular situation especially in developing countries. It is very difficult to obtain the consent from a poor resource especially in HIV/AIDS infected women since their level of understanding about the biomedical basis of HIV/AIDS is very poor. The informed consent form was given to all the participants infected with HIV prior to the commencement of study. Specific interview was taken through questionnaires before signing the consent form. The form was then evaluated to check how the subjects signed. It may increase the comprehension of study who takes part in the clinical trials. Subjects who are unaware of medical terms and language problems were given the options like multiple-language, ‘oral’-forms and discussion groups for explaining the protocol (Ekouevi et al 2004).

According to FDA guidelines (45 CFR 46, 21 CFR 50 & 56), children are considered as a vulnerable population since the children are in the developmental stage and they lack the capability of understanding the concepts. Often parents or local guardians are legally responsible for signing the informed consent which makes the process very complicated as sometimes, only children can feel the pain or understand the difficulties they come across during a study. The individual process may remain serious to the ethical behavior and regulation of studies.

Parents who gave consent for their children were enrolled for a study to assess the understanding and maintenance of the existing informed consent process. Comprehension of the informed consent process varied with each parent depending upon how well they are educated and has knowledge about the clinical trials. Many parents were unaware that they could withdraw their children from the study during the research. Younger parents had better comprehension with respect to the process than the old ones. Many of the parents allowed their children to enroll in the study as they could obtain free medical care and they suggested the researchers to dedicate more time for making the parents in understanding the informed consent process in detail especially in explaining the doubts. Also, the informed consent should be available in local languages and the process may be conducted at home (Oduro et al 2008).

The guidelines/regulations set by international review boards for informed consent process show discrepancies with respect to different vulnerable population. One such vulnerable population is poor women infected with HIV/AIDS where sometimes these subjects are unaware of informed consent process. Many of the investigators complain that it may be difficult to make the subjects understand about the biomedical basis and treatment strategies of a study as these subjects are having different image about diseases. But it should not be the reason for not obtaining informed consent from subjects. As a result, developing countries like India conduct Group Education and Counseling (GEC) for better understanding of informed consent process and HIV/AIDS. Basic knowledge about the informed consent process and HIV/AIDS were taught through questionnaires and classes. With minimal education, many subjects could understand the importance of informed consent and sometimes it is necessary to go for a new model for informed consent rather sticking to the standard model (Sastry et al 2004).

Since psychiatric patients lack the ability to understand and lack the ability to make decisions, they are always considered as a vulnerable population. In 2001, a new law was passed for Norwegian psychologists who were hospital based as a clinical specialist that they may take legal decisions/actions with respect to coercion of mentally-ill patients. This was purely unethical as the there was no respect to the subjects (autonomy). Also, it was unclear that on what basis these psychologists decide to enroll the patients for a study involuntarily. Hence a study was conducted on three different cases of schizophrenia where greater part of psychologists would coerce the patients if they are violent, more than a third may coerce the mentally-ill patients if they had problems in balancing with the daily activities of life and very few psychologists agreed that they coerce the schizophrenic patients if they had minimal symptoms. People with higher age, patients with previously experienced with coercion and females are the patients who showed positive willingness for coercion. No proper informed consent process was seen as the psychologists were the one to decide over the enrollment of a subject (Wynn et al 2007).

Prisoners are also considered as a vulnerable population (45 CFR 46 subpart C) because they do not have the right to decide over any thing and the warden or jailor always has the right to coerce the prisoners for a clinical study. Hence they have limited access for the informed consent. Prisoners should have the knowledge about the terminologies use in the study, there should not be any coercion, and no special treatment should be given for the study participation.

Parole of a prisoner should be depending upon the participation and the parole board of the jail should consider this while giving the parole. Mentally-ill prisoners (30) and healthy prisoners (30) were used as subjects for a study to assess the capability of decision-making, openness to coercion and their ability to give informed consent for an imaginary drug trial. Decisional capacity of many subjects were worse where as most of the subjects were ready to participate in the study as they can meet someone new, avoiding boredom and hoping that they might get better treatment. Neuropsychological functioning was associated with the decisional capacity and unhelpfully associated with openness to possible coercion. Prison setting and the environmental situations made many subjects to take part in the study. The study suggested that special care should be taken for mentally-ill prisoners while considering them for a research (Moser et al 2004).

According to the author Rounsaville et al (2008), individuals who use illegal drugs may also be considered under vulnerable population since they do not have a mental stability to decide whether to take part in a clinical trial. There is no standard way of obtaining informed consent from these individuals neither they understand the fundamentals of clinical trials. Many of the young individuals who use marijuana where asked to understand and give a written consent after giving an examination with multiple choice questions. It is necessary for each individual who are taking part in a study to have knowledge about the nature of treatment. Participants were exposed to standard drug counseling and interviews which may motivate them to build up better skills for understanding the research. It was found that around 55% subjects answered to all the questions and 20% participants did not know the reasons why they should refuse to participate in a study which concluded that these individuals may be possibly compelled to enroll in any research study (Rounsaville et al 2008).

Critical Evaluation

The guidelines for the informed consent process in developed countries are concrete where as, there are no proper set of regulations/guidelines for the same in developing countries. But the case study shows that corruptions or violations of the rules with respect to the informed consent process can happen in developed countries too. Even though the medical officers justified the death of Joyce by telling that she died of AIDS as the disease spread during later stages, they still did not change the medication.

Also, they told that they will be keeping close monitoring for other subjects. If the medical officers were right on their part, they would not have done searches for an alternative option like close monitoring. The hospital was not ready to disclose the details of Joyce’s baby’s medical records even though the baby was HIV negative. All babies of HIV+ve mother may turn negative after 18 months. That may be the reason why medical officers kept the records of baby secret. The investigators never made the victim understand that during pregnancy HIV tests can show false positive results. The justification given for the death of Joyce was unethical as they did not disclose the facts behind the death.

In June 2003, WHO department for HIV/AIDS came up with new solutions for poor women who are illiterate. The informed consent will be available in multiple languages; ‘oral’-forms and also a special group were assigned for clearing the doubts in the protocol (Ekouevi et al 2004). These may be applied to all the vulnerable population who are illiterate. Another model includes GEC which can also be applied for the vulnerable population who find difficulty in understanding the biomedical basis of any disease.

According to the guidelines, even though individuals using illegal drugs are not considered as a vulnerable population, a study shows that these individuals may be considered as a vulnerable population because they abuses the drug and they come under the criminal justice system. This may interfere the subjects in understanding the nature of a clinical trial, their ability to voluntarily participate and capability to withdraw from the study (Rounsaville et al 2008). Helsinki Declaration proposes that the illiterate subject who is infected with HIV can sign in the presence of a witness. But it is not possible practically because of high risk of confidentiality and stigmatization (Ekouevi et al 2004).

Coercion or bribery plays a very important role in obtaining informed consent from vulnerable population like mentally-ill patients, prisoners and poor or illiterate women which is purely unethical. Since prisoners are under the influence of others, they may not be able to exercise the free power of choice or consent. The guidelines say that there should not be any coercion/bribery. The hospital based Norwegian psychologists have the right to coerce psychiatric patients which is against the autonomy of a subject. Even though a law was passed for these psychologists to take these actions, these doctors did not know under what influence they should coerce these patients. Also there was no proper set of guidelines or limitations for this legal action.

It was found that many of the illiterate parents of children and HIV infected women did not know that they can withdraw from the trial at any moment. It shows negative impression on the investigators who failed to make these subjects understand about the study while taking the consent.

Conclusion

Declaration of Helsinki gave the guidelines/regulations for the protection of rights of subjects taking part in a trial. But it failed to describe the physicians in developing countries to explain how to obtain the informed consent with respect to the socio-cultural context where the most of the participants are illiterate (Ekouevi et al 2004). Indirectly the subjects or local guardians where coerced to enroll in a study for various reasons like free medical care, better treatment, avoiding the boredom (prisoners) etc.

It is important to conduct ethical research without affecting the rights of vulnerable individuals. There should be a set of proper guidelines or rules to protect the human rights/ autonomy of all the subjects taking part in a trial. This may help in the prevention of corruption at any medical centers. More over, there should be a scientific rationale behind recruiting or taking the consent from vulnerable population. Better understanding of the informed consent may help in removing the bias and ethical issues concerned with the process. The investigators should be dedicated and there should not be any partiality in selecting or recruiting the patients. Above all these – do no harm to all the vulnerable individuals as they are also human beings with same rights like others exercise.

References

1.      EKOUEVI, KOUMAVI DIDIER, A, B, BECQUET, R.,B, VIHO, I.,A, BEQUET, L.,A, DABIS, F.,B and LEROY, V.,B., 2004. Obtaining informed consent from HIV-infected pregnant women, Abidjan, Cote d'Ivoire. HAL Archives Ouvertes-France, 18(10), pp. 1486–1488.

2.      FARBER, C. (2006), “AIDS and Corruption of Medical Science” , Harper’s Magazine, [Online] Accessed on: 2nd February 2009. Available at: https://www.mindfully.org/Health/2006/AIDS-Medical-Corruption1mar06.htm

3.      GUPTA, S.K., (2007), Basic Principles of Clinical Research and Methodology, 1st edn, Jaypees Brothers Medical Publishers Pvt Ltd, New Delhi.4: 64-65.

4.      MOSER, D.J., ARNDT, S., KANZ, J.E., BENJAMIN, M.L., BAYLESS, J.D., REESE, R.L., PAULSEN, J.S. and FLAUM, M.A., 2004. Coercion and informed consent in research involving prisoners. Comprehensive Psychiatry, 45(1), pp. 1-9.

5.      ODURO, A., ABORIGO, R., AMUGSI, D., ANTO, F., ANYORIGIYA, T., ATUGUBA, F., HODGSON, A. and KORAM, K., 2008. Understanding and retention of the informed consent process among parents in rural northern Ghana. BMC Medical Ethics, 9(1), pp. 12.

6.      ROUNSAVILLE, D.B., HUNKELE, K., EASTON, C.J., NICH, C. and CARROLL, K.M., 2008. Making Consent More Informed: Preliminary Results From a Multiple- Choice Test Among Probation-Referred Marijuana Users Entering a Randomized Clinical Trial. J Am Acad Psychiatry Law, 36(3), pp. 354-359.

7.      SASTRY, J., PISAL, H., SUTAR, S., KAPADIA-KUNDU, N., JOSHI, A., SURYAVANSHI, N., BHARUCHA, K.E., SHROTRI, A., PHADKE, M.A., BOLLINGER, R.C. and SHANKAR, A.V., 2004. Optimizing the HIV/AIDS informed consent process in India. BMC Medicine, 2(1), pp. 28.

8.      WYNN, R., MYKLEBUST, L. and BRATLID, T., 2007. Psychologists and coercion: Decisions regarding involuntary psychiatric admission and treatment in a group of Norwegian psychologists. Nordic Journal of Psychiatry, 61(6), pp. 433.