Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro‐research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

Recent changes in FDA's good laboratory practice regulations

In the Federal Register of December 22, 1978, the Food and Drug Administration (FDA) published regulations which described Good Laboratory Practice for safety tests conducted on regulated products (Anonymous, 1978). The regulations, popularly known as GLPs, have become universally recognized as the basic criteria for the conduct of a valid safety test and for assuring the quality and integrity of the collected data. Along with the publication of the GLPs, FDA instituted a vigorous program of inspection of toxicology laboratories to determine the degree of adherence to the regulations. In 1984, based on inspectional findings which revealed that a large majority of toxicology laboratories were adhering to the GLPs, FDA published a proposal intended to reduce the burden of compliance with the regulations (Anonymous, 1984). The proposal outlined major changes in the provisions on quality assurance, protocol preparation, test and control article characterization, and retention of specimens and samples. The final order based on the proposal was published in the federal register of September 4, 1987 (Anonymous). The purpose of this communication is to describe the procedures used by FDA to develop the final order, to discuss certain major issues that arose during its development, and to answer several questions that have arisen subsequently.     

Evaluation of scientific merit in col laboratories: A new look at an old question

What role can information science play in promoting public understanding of science and technology? In order to answer this question, it is important to understand the new perspective which is emerging for research in the information science field. Internet, and the information superhighways announced both in Europe and the United States, are increasingly focusing attention on computer‐mediated communication within research communities. “Collaboratories”; is the name given to work aimed at using computer‐based technologies to help promote the social processes of knowledge production. One goal of information science lies in efforts to measure the contribution of technical devices to knowledge production practices. This is called infometrics research; it requires a clear understanding of how the social system of science regulates information flows to promote these practices.     

Ethics of research design

Discussions of ethical issues in research involving human subjects most usually provoke concerns about valid informed consent procedures. However, considering the recognized limitations of informed consent, arguably the way a study is designed is a more consequential concern for subject well‐being. This paper summarizes ethical issues in the design of clinical research, with reference to historic and current guidelines. Special attention is given to randomized clinical trials (RCTs) and psychiatric research.     

Schizotypal Personality Disorder: A Clinical Social Work Perspective

Schizotypal personality disorder (SPD) is considered to be a “schizophrenia spectrum disorder” as evidenced in part by its cross-listing in that chapter of the DSM-5. SPD is considered to be a condition with limited potential for positive change because one of its major features is the presence of a biologically based cognitive deficit. This assumption, however, is an example of the medical model’s creating a bias against psychosocial features that are always involved in character development. The social work profession’s bio-psycho-social perspectives focus more comprehensively on all features of the condition and promote a more optimistic view of clients’ change potentials. The purposes of this paper are to examine SPD from a social work perspective and to demonstrate, with a case example, how effective intervention can be organized and delivered.     

Interview schedule development for a Sequential explanatory mixed method design: complementary-alternative medicine (CAM) study among Indonesian psychologists

Sequential explanatory mixed method design is the most frequently applied in both health and social sciences literature. It is denoted by ‘QUAN → qual’ which represents the quantitative study occurs first and has greater weight in addressing the study’s aims, and the qualitative study follows to explain quantitative results. Despite the extensive use of sequential explanatory design, there are limited references to this design. Therefore, this methodological paper attempts to fill the gap by providing an illustration in developing a sequential explanatory interview schedule based on complementary-alternative medicine (CAM) study among clinical psychologists in Indonesia. The most important step to develop sequential explanatory interview schedule was the construction of aspects and questions that were immensely grounded on the most notable quantitative results. In this study, eight aspects of interview schedule were constructed after analyses of the nationwide survey. The interview schedule then piloted among participants with fairly similar characteristics to the participants in the main interviews. This process enhanced the quality of questions through feedback from participants and improved the interviewer’s skills through familiarization with questions. It is expected that this reflection report could be adopted as a practical guideline in developing interview schedule for sequential explanatory mixed method design, particularly in the field of psychology.     

Re-inscribing Gender in New Modes of Medical Expertise: The Investigator-Coordinator Relationship in the Clinical Trials Industry

This article analyses the ways in which research coordinators forge professional identities in the highly gendered organizational context of the clinic. Drawing upon qualitative research on the organization of the clinical trials industry (that is, the private sector, for profit auxiliary companies that support pharmaceutical drug studies), this article explores the relationships between predominantly male physician-investigators and female research coordinators and the constitution of medical expertise in pharmaceutical drug development. One finding is that coordinators actively seek to establish relationships with investigators that mirror traditional doctor-nurse relationships, in which the feminized role is subordinated and devalued. Another finding is that the coordinators do, in fact, have profound research expertise that is frequently greater than that of the investigators. The coordinators develop expertise on pharmaceutical products and diseases through their observations of the patterns that occur in patient-participants' responses to investigational drugs. The article argues, however, that the nature of the relationships between coordinators and investigators renders invisible the coordinators' expertise. In this context, gender acts as a persistent social structure shaping both coordinators' and investigators' perceptions of who can be recognized as having authority and power in the workplace.     

Bayes shrinkage estimator for consistency assessment of treatment effects in multi-regional clinical trials

The primary objective of a multi-regional clinical trial is to investigate the overall efficacy of the drug across regions and evaluate the possibility of applying the overall trial result to some specific region. A challenge arises when there is not enough regional sample size. We focus on the problem of evaluating applicability of a drug to a specific region of interest under the criterion of preserving a certain proportion of the overall treatment effect in the region. We propose a variant of James-Stein shrinkage estimator in the empirical Bayes context for the region-specific treatment effect. The estimator has the features of accommodating the between-region variation and finiteness correction of bias. We also propose a truncated version of the proposed shrinkage estimator to further protect risk in the presence of extreme value of regional treatment effect. Based on the proposed estimator, we provide the consistency assessment criterion and sample size calculation for the region of interest. Simulations are conducted to demonstrate the performance of the proposed estimators in comparison with some existing methods. A hypothetical example is presented to illustrate the application of the proposed method.     

Utilizing Bayesian predictive power in clinical trial design

The Bayesian paradigm provides an ideal platform to update uncertainties and carry them over into the future in the presence of data. Bayesian predictive power (BPP) reflects our belief in the eventual success of a clinical trial to meet its goals. In this paper we derive mathematical expressions for the most common types of outcomes, to make the BPP accessible to practitioners, facilitate fast computations in adaptive trial design simulations that use interim futility monitoring, and propose an organized BPP-based phase II-to-phase III design framework.     

When the Learning Disabled Go to College

Abstract

During the last decade, federal laws have provided for remedial education in elementary and secondary schools for students with learning disabilities, preparing large numbers of them for college. Federal law also mandates helping learning-disabled students with their needs once they matriculate. Declining numbers of high school graduates in the aftermath of the baby boom have made more colleges open their doors to these students. The disabilities, and the accommodations they require, arrive in college with the rest of a student's baggage, demanding attention. Colleges and universities have chosen a variety of approaches, from specific remedial programs and individual accomodations according to need to more general programs. Some colleges pretend these disabilities do not exist and seem oblivious to their presence on campus. Learning disabilities can have an impact in every class and lecture hall and can contribute to unhappiness and the college's attrition rate. On the other hand, responsive and responsible programs provide students with the resources for the same education, honors, and opportunities as their nondisabled peers.