Clinical trials require the advancement of medical sciences. It is very important to determine the differences in safety and effect of a new drug in various problems. Hence it is also important that the new drug be tested over a greater population that is from various ethnic and cultural backgrounds. In recent years, there has been an increase in the number of clinical trials, and since the population of any one place is becoming more and more multi-ethnic, it is important to have a consent process that suits various ethnic groups.
In some of these trials, the federal or the state government may be involved in order to study how the drug works in different populations. Hence, a clear understanding of the ethnic principles is required. The subject has certain privileges under the right to autonomy clause, wherein he/she can refuse or accept any intervention performed on their body. Individuals need to be treated as autonomous agents. The company or any organization cannot perform any medical procedure on the individual without taking the informed consent from the individual.
The informed consent is a process in which the details of the procedure and the reasons for conducting it are mentioned to the individuals along with the benefits, risks involved and viable alternatives. It is important that the individual understands each and every process and their role in the trial. The informed consent form would have to be printed in the local language in order to help the community members understand the issue more closely.
Besides, a local community member should be hired by the organization and involved in the trial, as the organization would be able to better understand the problems, attitudes and values of the local community subjects. It is also important to understand the practices, attitudes and behavior of individuals belonging to the same cultural group but residing in various other parts of the world. The US government has developed several statutes and laws to ensure that cross-cultural considerations are given during informed consent processes.
Before any drug is to be introduced into the market, it has to be tested over a longer period of time over a multiethnic population. Before it is actually tested on human beings, animal and stimulated laboratory trials need to be performed, in order to gain a brief outline as to how the drug can work on human beings. When clinical trials are conducted, it needs to be performed over various geographical locations, ethnic backgrounds, ages, socioeconomic factors, etc, as various factors that influence the manner in which the drug would act and cause its effects need to be determined.
Besides, blinding procedures need to be performed in the clinical trial. These may lead to several ethical issues being challenged by the researchers. In many cultures, there may be specific and traditional manners of obtaining informed consent process. A modern clinical research organization would only be using the western approach in order to obtain the informed consent. Hence, a conflict is liable to exist. When an individual in a particular ethnic group often makes an effort against an organization, it is sometimes viewed as a collective effort by that particular community.
Hence, it is very important for the company to actually consider each individual taking part in the clinical trial as a community being involved. A greater amount of respect and autonomy is expected to be developed. Also, the physician-patient relationship needs to be constantly maintained. The physician needs to act as an authority protecting the interests of the subjects, thus constantly gaining the support of various ethnic groups. It is also important to note that several communities may not be well educated and are not able to clearly understand the process of western medicine.
The process of consent is not just taking the signature of the subject in the form, but making him/her understand each and every step, the ethical principles involved and the need for conducting such research. In some populations, it may be difficult to mention it to them in English or a foreign language. Hence, the physician who would be overseeing the entire research program would have to prepare the informed consent form in the local language and also explain the entire process to them in their local language.
It would be better for the company to actually hire physicians belonging to the local community, as they are able to understand the problems, attitude and the values of the local people. The local community leaders also need to be involved in the process of clinical trials as any legal problems can be addressed at the appropriate levels. Some of the local community members may fear signing the informed consent form as they may not like performing unexpected obligations.
Some of the laws that may apply to provide consent forms in various languages for the multiethnic community includes:- 1. Multiethnic Placement Act (MEPA) – helps to ensure that the child undergoing adoption is being placed with best interests. http://www. senate. mo. gov/97info/bills/SB225. htm 2. The FDA-GCP Guidelines – To ensure that the information collected from various ethnic groups is standardized. Certain standard formats and procedures have to be followed. http://www. fda. gov/oc/gcp/guidance. html 3.
title VI of the Civil Rights Act of 1964 – This law means no person would be discriminated based on race or color in any program from which the funds come from the federal government. http://www. bc. edu/bc_org/avp/law/lwsch/journals/bctwj/21_1/02_TXT. htm 4. The Declaration of Helsinki – All the subjects would be provided with the best possible treatment http://www. unrisd. org/UNRISD/website/document. nsf/ab82a6805797760f80256b4f005da1ab/603ac6bdd4c6af8f80256b6d005788bd/$FILE/drandall. pdf 5. HIPAA – Helps in the safe and secure transmission of health data
Several of these laws ensure that the communities are able to get the health information in their own languages before they actually decide to accept being a subject. Several local minority groups have made request to incorporate such laws. Although there are chances that they may give greater amount of consideration for the multiethnic population in the US, there are also chances that it would improve the quality of clinic trials and ensure that the subjects are all that more ready to take place in such trials.
Today with several issues affecting the health of various populations across the earth (including the HIV/AIDS pandemics, the SARS outbreak, etc), it has become all that more necessary to involve individuals belonging to various cultures in the clinical study. It is also important that the clinical trial is of a beneficial application in which the trials have been conducted. It is also important to consider the practices, attitudes and behavior of individuals belonging to the same culture but residing in various places across the earth.
References: Kim, M. J. (2002). Ethics and clinical trials in multicultural society, B-Net. http://findarticles. com/p/articles/mi_qa3932/is_200205/ai_n9026829/pg_1 Rainbow Center for Pediatric Ethics (2006). Informed Consent Research, Retrieved on May 16, 2008, from Rainbow Center for Pediatric Ethics Web site: http://www. uhhospitals. org/rainbowchildren/tabid/421/Default. aspx