Vehicle identifiers and serial numbers, including license plate numbers Device identifiers and serial numbers Web Universal Resource Locators URLs Internet Protocol IP address numbers Biometric identifiers, including finger and voice prints Full-face photographic images and any comparable images Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re-identification. A Limited Data Set is similar to the de-identified data set but has fewer of the 18 identifiers removed. The Limited Data Set is health information that may include city, state, zip code, elements of date, and other numbers, characteristics, or codes not listed as direct identifiers. Limited data sets are often utilized in multi-center studies when using fully de-identified data is not useful.
Introduction C ollaboration among peoples from different nations, whether in the form of engaging in trade, providing material assistance, or participating in cultural interchange, can substantially benefit all parties involved.
Such controversies are perhaps more likely to occur when the nations involved do not share the same cultural, economic, political, and ethical perspectives, or when they are at different stages of development. In recent years, the increasingly global nature of health research, and in particular the conduct of clinical trials involving human participants,1 has highlighted a number of new ethical issues.
This often happens when researchers or research sponsors from one country wish to conduct research in another country. It might also represent a joint effort to address an important health concern faced by both parties.
In any case, as the pace and scope of international collaborative biomedical research have increased during the past decade, long-standing questions about the ethics of designing, conducting, and following up on clinical trials have re-emerged.
Some of these issues have begun to take center stage because of the concern that research conducted by scientists from more prosperous countries in poorer nations that are more affected by disease may, at times, be seen as imposing ethically inappropriate burdens on the host country and on those who participate in the research trials.
For example, some commentators have denounced as unethical clinical trials to test drugs that might reduce perinatal transmission of HIV that were conducted in Africa, Asia, and the Caribbean and sponsored by parties from resource-rich countries Angell ; Lurie and Wolfe In this case, concerns focused on two areas.
First, using placebo-controlled trials when an effective treatment exists means that individuals in the control group are being treated differently than those in control groups in developed nations where the control is an established effective treatment.
This may imply that they are not considered equally worthy or worthy of equal concern. Second, some have claimed that an alternative research design could have addressed the health needs of those in the host country without using a placebo control.
The example of the AIDS trials is only one of the better-known cases of international research that has heightened ethical concerns. Recently, accounts have appeared in the popular media of troubling cases of drug testing conducted overseas in which participants allegedly were exposed to risky research-often without their voluntary informed consent-in studies of questionable value to the citizens in the host country DeYoung and Nelson ; Flaherty et al.
The specter of exploitation raised by these allegations is cause for a concerted effort to ensure that protections are in place for individuals participating in international clinical trials. Although this treatment became the standard of care in the United States and other industrialized countries, several factors made it impossible to follow the regimen in developing countries, primarily cost and the lack of a health care infrastructure to administer the regimen.
As a result, some of the clinical trials conducted in Thailand and Africa were designed to test a lower dose of AZTin HIV-positive women, which was much less expensive than the standard dose, in a placebo-controlled trial.
In addition, these studies initiated the treatment much later in pregnancy, since women in these countries do not receive early prenatal care, and the AZTwas administered orally rather than intravenously, in line with the availability of medical facilities.
Moreover, newborns did not receive full treatment, if any. For ethical reasons, placebo-controlled trials testing this experimental treatment regimen could not have been conducted in the United States and other developed countries once the efficacy of the ACGT regimen had been established.
In other words, it would be considered unethical to withhold from women in a research study an effective treatment that they could obtain as part of their routine medical care.
The justification for conducting the research in developing countries was that it compared a new regimen with the existing level of care in those countries. Critics of the study argued that it is wrong for researchers who come from a country where an effective treatment is used to withhold that treatment from any study participant and that infants in the study, who could be prevented from acquiring HIV, would become infected and die unnecessarily.
These critics argued for the use of a different study design to compare the experimental treatment with the standard treatment rather than with the placebo, thereby avoiding these unnecessary deaths Lurie and Wolfe Subsequently, such a study design was adopted in another NIH-sponsored study in another location in Thailand at the same time that the placebo-controlled trials were being carried out elsewhere in the same country.
The "standard of care" for HIV-positive women in these developing countries is no treatment at all, so they are left no worse off as a result of participating in the study; Aplacebo-controlled trial can be conducted with fewer participants and completed in a much shorter time than an AZT-controlled study, so useful information and effective interventions pertinent to this population will be available much sooner; The ACTG treatment regimen that has become standard in the West is not now, and will not in the foreseeable future, be available to this population because of its prohibitive costs.
Therefore, use of this active control would render the results of very little relevance to the health needs of the developing country Levine ; Wilfert et al. These placebo-controlled trials which have long since been completed, although follow-up is still occurring did succeed in showing that the cheaper, short-course AZTregimen was significantly better than a placebo.
Yet, the controversy surrounding the ethical principles relevant to such research has not abated. A second circumstance-the changing landscape of international research-also prompted the decision to prepare this report.i.
Ethics of research in a developing country poses exciting challenges for scholars, practitioners and communities that are driven by the principles of equity, human rights. Deepening Research Ethics in Nigeria (DREIN), is a project funded by the European & Developing Countries Clinical Trials Partnership (EDCTP).
The project seek . In this essay, we discuss ethical issues in the design and conduct of clinical trials in developing countries. In particular, we focus on phase 3 and other drug trials that, if successful, can. Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects.
Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research.
Systematic investigation incorporates . Exploitation and Developing Countries, edited by Jennifer Hawkins and Ezekiel Emanuel, is an outstanding contribution to the literatures on exploitation and on the ethics of clinical trials in developing ashio-midori.com book comprises an introduction and nine chapters with contributions from six distinguished authors in addition to the editors.
In this paper, I will discuss the responsibilities of researcher/funder when the research trial is conducted in developing countries and especially in our country Pakistan and I will also talk on ethical justifications of doing research trials in Pakistan and other poor and developing countries.