This paper seeks to investigate the research undertaken in third world and developing countries. The extent to which the research goes, how it is regulated, what are the measures that protect the country population from being exploited.
What are the regulations of research in Malta?
One regulation is that any research involving biomedical things must be submitted to a medical research ethics committee. Any research that touches on human beings must be taken to University research ethics committee. Any researchers whose research involves animals must submit a proposal of the intended research to an ethics committee. It is the only exemption since the other researchers do not require proposal approvals.
That a patient in a hospital has to agree and allow any form of research medicine to be given to her. Anyone who cannot expressly decline or allow research to be conducted on her should not be subject. In most instances, an individual can only be subjected to the trial if they are 16 years and above. However, some cases need a person to be above 18 or even above 21.
No company can be given patent rights to a cloned human subject, neither the process of altering germ line genetic of a human body nor the use of the human embryo for industrial use. Also, a patent can it be given with regard to the human body in any stage of its formation and development. This is to prevent companies making profits from these researches. There are no agreed sources of embryos except those that are miscarried naturally.
The Maltalese parliament has also introduced regulations to guide the conduct by which researches are conducted. These regulations are; That the person controlling the information, of the concerned persons involved in the research, shall protect it from being misplaced, destroyed by negligence or from being accessed by an authorized persons. That the person processing the subject, must adhere to the Act of parliament outline the preservation of the said subject’s privacy. That the information about the person who gives, consent must be kept confidential and only accessible by the authorized people,.
That any person can elect to discontinue the program if he or she raises strong ground for his decision. That the information can only be processed if the subject has given express consent or has made the data public. The controller must provide the subject whose data they are processing with the identity of the company, their place of work, the reason as to why the data is being processed, right to rectify, delete the data concerning him.
That information involving members of Professional Secrecy Act cannot be disclosed under any circumstances except by the issuance of a court order. Also, the regulations state that the processing of the data must be done properly and according to the law; personal data must be compatible with why it was processed, it must be specific and of the legitimate purpose. The only way the data obtained can only be made available is in case of prosecution or to officers of statistics within and while on duty under the Malta statistical Authority. It’s the only way this information can be related with unidentifiable person.
Are there any rules of fair research; There are few rules of fair research. The country gives favorable conditions to any firm that wishes to carry out research. It gives them a better environment in which they are able to get results to advance science.
The meaning of Naples not allowing drug tests on its citizen until they are in the second face is to minimize risks. There are a lot of risks involving first phase trails. Some of the drugs have temporally side effects while others have adverse side effects that last. Some of these side results might not show until after the studies have been completed.
Naples requires that research be conducted from phase two. This is because most anomalies are detected and dealt with in phase 1. The drug is closer to perfection, and there are not many side effects. Since phase two is designed to gauge how well the drug operates. Phase one involves getting the right dosage to be ingested, the trials subjects are observed around the clock. This phase is the one that has just graduated from animal testing. Subjects are put under much changed environment; they are given small dosage of the compounds that killed animals.
The Nepalese government seeks to protect its citizen from being exposed to those conditions that subject in phase 1 go through. Phase two gives a safer picture, and since it has been tested on people and worked, they would feel safer to allow the second phase where they can control the proceedings. Although this provision by the government inhibits the rules of fair research. This is because people react differently to medicine and given that people in Naples are somehow different from other people; it would be wise to allow.
I used the website to research on Malta. Its constitution, legislation, and the regulations put in place. I found the regulations posted on the website eu.europa.eu posted by Dr. Pierre Mallia, who is the writer of the said article.
The five most important points of the regulations are;
These regulations are identified as the ones that stand out.
Summary of Moral Standards for Research in Developing Countries: From ‘Reasonable availability’ to ‘Fair Benefits,”‘ Hastings Center Report 4, no. 3 (2004): 17-27.
The excerpt talks about how the research being conducted in the developing countries has gathered controversy. They seem to advocate reasonable availability which would prevent the native population from being taken advantage of by the researchers. That the medicine being tested should be made available to the country where it is being tested in after it has been perfected.
The excerpt also question who should enforce the reasonable availability treaty. Should it be the government of the host country, should it be the sponsors of the research? It also asks what it means by saying reasonable availability. Whether the drugs should be free, discounted or sold them at the given selling price.
It argues that the target population may not have the political power, financial power to accesses health services hence it is important to have the rule enforced. This would prevent exploitation. It defines exploitation as how much but not what the party is owed. This stresses equality and fairness in how the sponsors share the benefits.
The excerpt stresses on the sponsors and government entering into a contractual agreement and deciding on what will be shared, how it will be and the benefits to be awarded to the host country. It gives a scenario of Thailand and a manufacturer of hepatitis vaccine A and B. The excerpts give a great outline on the guidelines that should be followed when sponsors and host country enter into negotiation. It gives a good definition of what Reasonable availability is.
Comparisons of question D and E with findings In chapter 1,2 and 3 of Ethical challenges in study design and informed consent for health research in resource-poor settings .
A good practice is where the community in the country that the trials take place should be afforded fair benefits. Where all the ratified treaties are observed by the sponsors. Where the population is protected by and from the sponsors. This awards them a good health care.
Which has strong regulations that recognizes fair research and observes the international treaties?
Davis, J. R. (1999). Assuring data quality and validity in clinical trials for regulatory decision making workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. Washington, DC: National Academy Press.
Evans, C. H. (2001). Small clinical trials issues and challenges. Washington, D.C.: National Academy Press.
Fisher, J. A. (2009). Medical research for hire the political economy of pharmaceutical clinical trials. New Brunswick, N.J.: Rutgers University Press.
Giraldo, G. (1994). Advanced technologies in research, diagnosis and treatment of AIDS and in oncology: international workshop, Naples, October 21-22, 1993. Basel: Karger.
Homepage. (n.d.). – European Commission. Retrieved May 7, 2014, from http://ec.europa.eu/
Setouhy, M., Agbenyega, T., Mfutso-Bengu, J., Molyneux, M., Taylor, T., Diarra, D., et al. (n.d.). jstor. JSTOR. Retrieved May 8, 2014, from http://www.jstor.org/stable/3528416