美国人体研究的监督：科学发展中的伦理与规定

美国保护人体受试者的制度建立在伦理学基础之上,并正式通过相关法律。对人体研究的监督是保护受试者个人的健康和权益,确保研究的有效性,整体性,以及科学与社会更大范围的利益,监督审查机构是联邦卫生部下属的两个机构-食品与药品管理局（FDA）和人体研究保护办公室（OHRP）,大部分人体研究受两机构监督。美国人体受试者保护系统的基础部分是伦理审查委员会（IRB）及知情同意,IRBU电在提供一种机制,以进行客观的审查,同意和研究过程听持续监督;知情同意意在保证个人在了解与实验相关的风险,不适,收益后能自由做出参加与否的决定,美国人体研究保护制度正面临着挑战。美国也为促进人体受试者保护在进行新的努力。     

Effectively Obtaining Informed Consent for Child and Adolescent Participation in Mental Health Research

With the recent expansion of child mental health research, more attention is being paid to the process of informed consent for research participation. For the consent to be truly informed, it is necessary that the relevant information be both disclosed and actually understood. Traditionally, much effort has gone to ensuring the comprehensiveness of consent/assent documents, which have progressively increased in length and complexity, whereas less attention has been paid to the comprehensibility of these documents. Available data indicate that many parent and children have difficulties appreciating the research nature of treatment studies and that a higher level of formal education among the parents is associated with a greater degree of understanding. Promising approaches to achieving truly informed research participation have emerged, such as additional time for parents to meet with the researchers and using postexplanation questionnaires for identifying issues in need of further clarification. Research is needed to develop and test strategies for improving the effectiveness of the informed consent process in child mental health.     

Emergency Research without Consent under Polish Law

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.     

美国对受试者研究中特殊挑战的观点:遗传研究中的伦理问题

虽然基因研究比其他任何时候更有望了解人类疾病及其在世界各类人群中的表现形式,并且对预防和治疗疾病产生了深远影响,但是它的应用也会极大地改变我们对个体及群体特征。从个体属性及群体意识的角度来看,特别是关于知情同意这个议题,我们会非常清楚地看到遗传研究所面临的挑战。阐述了在美国遗传研究所面临的挑战,讨论了遗传研究进行过程中出现的一系列伦理问题,如：如何正确执行知情同意;研究中可能对受试者产生的标签和歧视行为;遗传流行病研究中出现的伦理问题以及需要关注的社区和民族的伦理问题;对人类组织样本的储存和使用中所出现的伦理问题。强调了知情同意和社区参与遗传研究及在研究中社区代表性的重要性;强烈主张在遗传研究中建立多民族的合作是确保研究的顺利进行的基础。     

Sexual Health Research Among Youth Representing Minority Populations: To Waive or Not to Waive Parental Consent

Human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) significantly burden youth 13–24 years of age in the United States. Directly engaging youth in sexual health research is a public health priority and urgently needed to develop targeted, youth-friendly, and culturally relevant HIV/STI prevention interventions. Controversies arise, however, regarding informed assent and consent, parental permission or consent, and the definition of “child”/“minor” as it relates to medical, legal, and ethical issues. In this article, we describe challenges in the human subjects review processes that were undertaken before beginning an HIV/STI prevention research project with sexually active youth in an urban setting. These findings provide important contextual information to facilitate youth sexual health research and care, and Institutional Review Board approval processes with fewer delays.     

印度干细胞及遗传学研究的途径

在印度,科学家和政府对印度的基因组研究了干细胞研究充满了热情。而有关的伦理准则就显得尤为重要。印度在2000年颁布的准则是针对胎儿研究结果的保密性,以研究为目的而剩余的胚胎不能用于商业用途。辅助生殖技术应确保参与者的知情同意。保密性和遗传学秘密对遗传学研究是非常重要的。专家认为在干细胞与基因组研究领域中,伦理学及政府的阻碍并不是主要的负担,而主要的问题在于科技的发展与应用中的经济问题。同时,公众的积极参与也是非常重要的。     

Rethinking Research Ethics

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research.     

Ethical and legal risks associated with archival research

Mental health facilities and practitioners commonly permit resarchers to have direct access to patients' records for the purposes of archival research without the informed consent of patient-participants. Typically these researchers have access to all information in such records as long as they agree to maintain confidentiality and remove any identifying data from subsequent research reports. Changes in the American Psychological Association's Ethical Principles (American Psychological Association, 1992) raise ethical and legal issues that require consideration by practitioners, researchers, and facility Institutional Review Boards. This article addresses these issues and provides recommendations for changes in ethical standards as well as alternative avenues for conducting research using archival mental health records.     

The Risks,Benefits, and Ethics of Trauma-Focused Research Participation

With the rising interest in the field of trauma research, many Institutional Review Boards, policymakers, parents, and others grapple with the impact of trauma-research participation on research participants' well-being. Do individuals who participate in trauma-focused research risk experiencing lasting negative effects from participation? What are the potential benefits that may be gleaned from participation in this work? How can trauma research studies be designed ethically, minimizing the risk to participants? The following review seeks to answer these questions. This review indicates that most studies in this area have found that only a minority of participants experience distress when participating in trauma-focused research. Furthermore, these negative feelings tend to dissipate quickly over time, with the majority of participants self-appraising their participation as positive, rewarding, and beneficial to society. Design characteristics that may serve to minimize participants' risk of experiencing distress are discussed, as well as implications for public policy and future research.     

Are research participants truly informed? Readability of informed consent forms used in research

Researchers typically attempt to fulfill disclosure and informed consent requirements by having participants read and sign consent forms. The present study evaluated the reading levels of informed consent forms used in psychology research and other fields (medical research; social science and education research; and health, physical education, and recreation research). Two standardized measures of readability were employed to analyze a randomly selected sample (N = 108) of informed consent forms used in Institutional Review Board-approved research projects at a midwestern university during the 1987-1988 academic year. Results indicate that informed consent forms are typically written at a higher reading level than is appropriate for the intended population and that there are no consistently significant differences in readability among areas of research or between college student and noncollege student participants. Due to the unacceptably high reading level of the consent forms, one must question whether participants can comprehend the information contained in the consent form.     

Impact of Institutional Review Boards on cancer research

The concepts of informed consent and surveillance of human research designed to protect human subjects is commendable. The regulations of the Institutional Review Board (IRB) are having a major impact on clinical cancer research. There is greater administrative time needed of the investigator, the mechanisms of patient care have become cumbersome and some patients reject optional medical management that could be life saving. IRB regulations must be flexible to meet the needs of human subjects as well as those of the clinical investigator.     

Ethical Dilemmas in Psychological Research with Vulnerable Groups in Africa

The present article highlights ethical challenges and practical solutions to the problems that arise when designing and conducting the fieldwork data collection with the members of violent youth gangs, prison inmates, and arrestees held in police cells in Nigeria. Issues related to the process of seeking approval and then implementing the research, gaining access, achieving informed consent, confidentiality, the use of interpreters, and remuneration are presented through case studies. The conclusion stresses the need for researchers to be well prepared and sensitive to the research participants' community and cultural backgrounds while following ethical practices in multicultural contexts, especially in Africa and other developing nations.     

Regulating Research for the Decisionally Impaired: Implications for Mental Health Professionals

Mental health professionals, in fulfilling their different roles, often become involved with research protocols involving decisionally impaired current or prospective human subjects, many of whom are elderly. The opening section of this paper briefly describes the present regulatory environment regarding human subjects research, followed by an overview of the Institutional Review Board (IRB) process. There then ensues an enumeration of some of the general criticisms of the current regulatory scheme that have been enunciated recently. Particular concerns concerning decisionally impaired persons as research subjects are then addressed, referring when applicable to the recommendations made by the National Bioethics Advisory Commission (NBAC) in its 1998 report on this subject and the implications of those recommendations for mental health professionals.     

Do Undergraduate Student Research Participants Read Psychological Research Consent Forms? Examining Memory Effects,Condition Effects,and Individual Differences

Although research has examined factors influencing understanding of informed consent in biomedical and forensic research, less is known about participants' attention to details in consent documents in psychological survey research. The present study used a randomized experimental design and found the majority of participants were unable to recall information from the consent form in both in-person and online formats. Participants were also relatively poor at recognizing important aspects of the consent form including risks to participants and confidentiality procedures. Memory effects and individual difference characteristics also appeared to influence recall and recognition of consent form information.     

Psychology of the Informed Consent Process: A Commentary on Three Recent Articles

In conducting research on humans, respect for human dignity requires investigators to obtain informed consent. Institutional pressures, however, often reduce the informed consent form to a signature on a document. Unfortunately, people often do not read or understand these documents. In the present effort, we argue that the key problem here arises because investigators often do not take into account the psychology of participants. Based on 3 articles, we argue that informed consent requires investigators to help participants “make sense” of a study, and its implications, for both themselves and others. Informed consent procedures that might encourage participant sensemaking are discussed.     

Confronting Condescending Ethics: How Community-Based Research Challenges Traditional Approaches to Consent, Confidentiality, and Capacity

Community based research is conducted by, for, and with the participation of community members, and aims to ensure that knowledge contributes to making a concrete and constructive difference in the world (The Loka Institute 2002). Yet decisions about research ethics are often controlled outside the research community itself. In this analysis we grapple with the imposition of a community confidentiality clause and the implications it had for consent, confidentiality, and capacity in a province-wide community based research project. Through untangling these implications we provide recommendations for reframing how to think about research ethics and strategies for enabling research ethics’ processes to be more responsive to and respectful of community-based research.     

Elevating the Voices of Girls in Custody for Improved Treatment and Systemic Change in the Juvenile Justice System

The U.S. juvenile justice system does not meet the needs of girls in custody, and often fails to address girls’ symptoms of trauma and high rates of sexual exploitation histories. As the system shifts away from punitive detention to a trauma‐informed approach with community‐based services, community psychologists and other helping professionals can help center the needs and experiences of girls in custody. As part of a multi‐year collaboration, our research team created a confidential youth advisory process in one juvenile detention center (JDC). We acted as liaisons between the girls in custody and JDC administrators, reporting girls’ feedback to agencies at monthly meetings. Participant confidentiality, safety, and consent were priorities. The girls’ feedback, which was conceptualized within a System Responsiveness and hierarchy of needs framework, led JDC probation and mental health staff to improve services (e.g., better laundry system, longer showers, warmer food), climate (e.g., consistent reward system, confidentiality of grievances), and treatment (e.g., increase focus on gender and culture) to reduce the trauma of incarceration among girls in custody. Girls’ feedback also catalyzed systemic change that led to a reduction in the JDC population in favor of wraparound community‐based services better suited to meet girls’ needs. Implications for community psychology values and the juvenile justice system, including the benefits and challenges of this type of collaboration, are discussed.     

How the Powerful Decide: Access to Research Participation by those at the Margins

How do those in power decide to include and exclude those at the margins from community life? We used simulated review of research vignettes to examine how researchers and members of Institutional Review Boards make decisions concerning the research participation of adults with and without intellectual disabilities. Results indicate that decision‐makers are influenced by the disability status of the sample, characteristics of the research in which they are engaged, and their attitudes toward the research participation of adults with intellectual disabilities as well as their own relationship to the research process. For example, decision‐makers may create situations that limit the self‐determination of adults with intellectual disabilities and adults without disabilities within the research context, particularly when the research poses some risk of harm to participants. Implications for theory, action and research are explored.     

The Ethics of Smart Pills and Self-Acting Devices: Autonomy,Truth-Telling,and Trust at the Dawn of Digital Medicine

Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management, self-tracking, self-management of diseases, and improved treatment adherence. These devices pose ethical challenges for patients, providers, and the social practice of medicine. For patients, having both informed consent and a user agreement raises questions of understanding for autonomy and informed consent, therapeutic misconception, external influences on decision making, confidentiality and privacy, and device dependability. For providers, digital medicine changes the relationship where trust can be verified, clinicians can be monitored, expectations must be managed, and new liability risks may be assumed. Other ethical questions include direct third-party monitoring of health treatment, affordability, and planning for adverse events in the case of device malfunction. This article seeks to lay out the ethical landscape for the implementation of such devices in patient care.     

A Study of the Impact of Informed Consent Procedures on Participant Responses in Trauma-Related Research

Researchers and ethics board members are often concerned about the possibility of adverse reactions to trauma-related research. While research has shown that participants in trauma-related studies rarely experience adverse reactions, mild short-term emotional distress is common. While a number of protections have been suggested to minimize risks for more vulnerable subgroups of participants, no research to date has tested how modifications to informed consent procedures may affect the data collected and participant reactions to the research. One-hundred and forty-five college students were separated into five conditions with different modifications to the informed consent procedures. Participants completed surveys on trauma experience, posttraumatic stress, coping, and reactions to research participation. The results showed no differences among the conditions on all outcome measures. It appears that modifications to informed consent procedures geared toward minimizing risk do not affect the quality of the data collected nor change reactions to participating in trauma-related research.