Empirically supported ethical research practice: the costs and benefits of research from the participants' view

Researchers and institutional review boards are routinely called upon to evaluate the cost-benefit status of proposed research protocols that involve human participants. Often these assessments are based on subjective judgments in the absence of empirical data. This reliance on subjective judgments is of particular concern for studies involving clinical samples where unfounded assumptions may adversely affect research progress or clinical outcomes. The Reactions to Research Participation Questionnaire (RRPQ) was designed to address this shortcoming and to help promote ethical decision making about research practice. The present study describes development of the RRPQ and presents a series of exploratory and confirmatory analyses investigating its structure. Based on these findings, a revised version of the instrument and suggestions for future research are presented. This approach provides a foundation for scientifically informed protection of human subjects.     

Clinical trials integrity: a CRO perspective

When contract research organizations (CROs) were first formed, pharmaceutical companies outsourced to them only certain aspects of the conduct of their clinical trials. At first CROs were highly specialized entities, providing, for example, either biostatistical advice, clinical research associates who monitored investigational sites for regulatory compliance, or regulatory support. Gradually, full service CROs emerged, offering a full range of services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and data management and biostatistics. This evolving relationship between CROs and the pharmaceutical and medical device industries has resulted in CROs assuming more and more of the regulatory and ethical risks and responsibilities inherent in the conduct of clinical trials. In this full service role, CROs, unlike sponsors, are not interested in the outcome of study, but like sponsors, are subject to heavy regulation by the federal government, must follow applicable state laws, must respect international guidelines, and are obliged to follow their own operating procedures. Moreover, they are judged by the industry on the basis of the scope and quality of services provided, including the degree of adherence to the research protocol, regulatory requirements, and timelines; the quality of the professional working relationships with investigators and institutions, both academic and community-based; and the validity of the data. Further, CROs are subject to comprehensive audits by sponsoring companies, FDA, and other regulatory authorities. For all these reasons, CROs are being tasked with strict vigilance of all stages of the clinical trial process to ensure that the laws, regulations, and industry standards designed for the protection of human subjects and data integrity are maintained.     

Recruitment & retention. A successful model in forensic psychiatric nursing

1. The recruitment and retention of forensic psychiatric nurses in this highly competitive environment has been identified as a critical issue. 2. In response to the need to expand services, the development, implementation, and evaluation of an innovative model that has demonstrated success in the recruitment and retention of nurses for this highly specialized area of practice are described. 3. The successful recruitment and retention of forensic psychiatric nurses may be facilitated by developing and implementing strategies that integrate the goals and objectives of the organization with the needs of individual nurses.     

Beyond enmeshment: evidence for the independence of intrusiveness and closeness-caregiving in married couples

In a 1996 article on family theory, we (Green & Werner) proposed that family enmeshment should not be equated with high cohesion and that the construct of enmeshment fails to discriminate between two distinct relationship processes: Closeness-caregiving and intrusiveness. In this study, our model of these two independent dimensions of family connectedness was tested by assessing spouses from 264 couples, using the California Inventory for Family Assessment (CIFA). The CIFA scales showed acceptable reliability. Significant interspouse validity correlations also were obtained. As predicted by our theory, factor analyses distinguished dimensions of intrusiveness (blurring of boundaries) from dimensions of closeness-caregiving (such as warmth and nurturance). On all but two factors, behaviors of only one spouse (but not of both) had interpretable loadings. That is, in most areas, the two spouses' behaviors did not load together to form meaningful factors. The latter finding suggests that family systems theory--with its central notion of reciprocally contingent behaviors between family members--may be useful in understanding only a few dimensions of spouses' behavior (such as reciprocal aggression) whereas personality-in-context theories may be better for understanding most other dimensions (such as warmth and nurturance).     

Vitamins, herbs, and supplements: tools of empowerment

1. Consumers who elect to use natural products are electing to do more than simply use a product. Their choice is an act of self-empowerment. 2. Education is necessary because these products most often are not being obtained in a professional, consultative setting but rather in chain discount department stores and supermarkets. 3. If consumers choose to address their health concerns using a natural-based treatment plan, consultation with a health care practitioner who shares this shift in perspective and who follows the literature is important. 4. A paradigm shift could be on the health care horizon, which when complete would make herbs and other natural products part of mainstream health care practice.     

The program effect of batterer programs in three cities

Recent meta-analyses and experimental designs of batterer program evaluations suggest little or no program effect. This finding may be compromised by a variety of analytical issues. Instrumental variable analysis addresses some of these issues, especially the relationship of program dropout to batterer reassault. This method of analysis was, therefore, used to test for program effect in a multi-site evaluation. The sites were three well-established batterer programs using a gender-based, cognitive-behavioral approach (n = 640). Completing a batterer program reduced the likelihood of reassault by 44% to 64%, depending on the specification used. Completing a 3-month program appeared to be as effective as completing a 5 1/2- or 9-month program. This moderate effect is an accomplishment considering the problems associated with the program participants and the inconsistency in the criminal justice system at the research sites. The findings remain tentative because of weak instrumental variables for reassault, but do confirm the need for more complex analyses of program effect.