Obligations Of Investigators Research Articles

ON ONE CONTINUED ACT IN TAX CRIME IN INDONESIA

Delicts in criminal acts in the field of taxation comply with the lex specialis derogate legi generali principle of the Criminal Code (KUHP) and are included in complex criminal acts in their implementation. Given the violation of criminal acts and there are several offenses in criminal acts of taxation, it is necessary to consider the concept of renewal of a continuing action (one further action) in criminal acts in the field of taxation with the obligation of investigators and public prosecutors to produce case files and indictments that are accurate, clear, and right, which results in the amount or accumulation of imprisonment and fines against a suspect or taxpayer in a fair, legal and efficient manner. Based on the normative juridical method, this study produces two conclusions. First, one follow-up law that has not been regulated directly in criminal provisions in the field of taxation is still under general criminal offenses, namely Article 64 paragraph (1) of the Criminal Code. Second, the concept (law) of follow-up action is needed in criminal acts in the field of taxation in Indonesia to be fair to accusations or taxpayers who commit violations and provide legal certainty and legal effectiveness to tax investigators in handling tax crimes which are complex and required to deal with cases carefully, clearly and completely

Informed consent: Issues and challenges.

Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.

Standard of Care, Professional Obligations, and Distributive Justice

The problem of standard-of-care in clinical research concerns the level of care that investigators ought to provide to research subjects in the control arm of their clinical trials. Commentators differ sharply on whether subjects in trials conducted in lower income countries should be provided with the same level of care as subjects in trials conducted in higher income countries. I consider an argument that commentators have employed on both sides of this debate: professional role arguments. These arguments claim to justify a conclusion to the standard-of-care problem solely by appeal to the professional obligations that investigators possess. I argue that prominent versions of professional role arguments cannot justify a solution to the problem of standard-of-care that is both determinate and reasonable simply by appeal to the professional obligations of investigators. Instead, to do so, one must also (1) determine the level of care or types of treatment that individuals are entitled to as a matter of distributive justice, and (2) identify which agents possess the duties that correspond to these entitlements. The level of care that investigators owe to subjects in the control arm of their clinical trials is thus in part dependent on the level of care that these subjects are entitled to as a matter of distributive justice, and whether it is the investigators who possess the corresponding distributive obligation to provide them with the care that they are entitled to.

Ethical Analysis of Research Partnerships with Communities

Community-researcher partnerships constitute one of the most important recent developments in biomedical ethics. The partnerships protect vulnerable communities within which research is conducted and help ensure that the communities benefit from the research. At the same time, they embody deep, core values about the social nature of persons and the value of community that significantly modify the radical individualism too often associated with the prevailing concepts of autonomy and respect for persons. This article examines the burgeoning literature on community-researcher partnerships to identify the main ways of thinking ethically about the obligations of investigators and the roles and rights of communities in scientific research. The paper helps to uncover the deep commonalities and differences that mark the current debate in this emerging arena of research ethics, a debate over the social nature of persons that is beginning to influence the understanding of other bioethical issues.

Can unequal be more fair? Ethics, subject allocation, and randomised clinical trials.

Randomised clinical trials provide the most valid means of establishing the efficacy of clinical therapeutics. Ethical standards dictate that patients and clinicians should not consent to randomisation unless there is...

Obligations of Investigators in Clinical Research a Pharmacist's Perspective

AbstractThe Department of Pharmacy Practice at the University of Illinois at Chicago, College of Pharmacy currently employs 40 fulltime clinical pharmacists who have minimal drug distribution responsibilities and provide pharmacy services to a specific patient care team and are involved with the education of pharmacy and medical students. In addition, these clinical pharmacists have collaborated in the clinical research activities of the medical and surgical staffs at the University of Illinois, Since many of these pharmacists have gain recognition as primary and co-investigators by various study sponsors, the Department of Pharmacy Practice has developed a program to inform each clinical pharmacist of his/her responsibilities as a clinical investigator. The following document summarizes the Department's policies and procedures.

Ground Rules for Physicians Who Evaluate Drugs

Drug regulations and terminology may be confusing (perhaps discouraging) to academic and practicing physicians interested in investigating drugs in clinical studies. The obligations of investigators vary with the administrative category in which the drug studies fall; this is a summary of the administrative categories of drugs and of the obligations of investigators studying drugs from these categories.