Ethical issues surrounding human participants research using the Internet

The Internet appears to offer psychologists doing research unrestricted access to infinite amounts and types of data. However, the ethical issues surrounding the use of data and data collection methods are challenging research review boards at many institutions. This article illuminates some of the obstacles facing researchers who wish to take advantage of the Internet's flexibility. The applications of the APA ethical codes for conducting research on human participants on the Internet are reviewed. The principle of beneficence, as well as privacy and confidentiality, informed consent, deception, and avoiding harm are all illustrated through the use of a hypothetical online study.     

Collecting Informed Consent with Juvenile Justice Populations: Issues and Implications for Research

Researchers must provide participants with opportunities to make informed decisions about whether to participate in research studies. Investigators conducting research with youth in the juvenile justice system face unique ethical, legal, and practical challenges to obtaining informed consent. Juvenile justice researchers must navigate multiple legal and ethical standards for collecting informed consent, take into account youths’ dual vulnerabilities as children and prisoners, and overcome practical limitations to obtaining parental/guardian permission. Given the challenges and complexity of obtaining standard informed consent of youth in juvenile justice facilities, this paper provides suggestions for overcoming obstacles to recruiting these youth for research participation. It offers guidance for fostering the enrollment of juvenile justice youth in research studies using procedures that comply with ethical and legal standards for research with this dually vulnerable population. Copyright © 2013 John Wiley & Sons, Ltd.     

Ethical and legal issues in conducting research involving elderly subjects

Older people are increasingly the focus of biomedical and behavioral research not only because the elderly constitute the fastest growing segment of our population but because there is a societal concern to improve the elderly's quality of life. The profound need to advance that research carries with it an equally profound obligation to protect the rights and welfare of elderly research subjects, and thus raises difficult ethical and legal issues. Against a background of foundational principles for the protection of human subjects, we discuss whether older subjects should be treated as a special class, the ethical and legal issues over informed consent, capacities for consent, and special problems related to cognitive impairment. We discuss surrogate/proxy consent procedures in research, recruitment of elderly subjects, conflicts of interest, special problems regarding institutional research, and risk/benefit analyses. We offer recommendations and practical guidelines for conducting current and future research involving elderly participants.     

Rethinking research ethics

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration 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.     

Rethinking research ethics

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration 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.     

Informed Consent: An Ethical Issue in Conducting Research with Male Partner Violent Offenders

Ethical codes help guide the methods of research that involves samples gathered from “at-risk” populations. The current article reviews general as well as specific ethical principles related to gathering informed consent from partner violent offenders mandated to outpatient treatment, a group that may be at increased risk of unintentional coercion in behavioral sciences research due to court mandates that require outpatient treatment without the ethical protections imbued upon prison populations. Recommendations are advanced to improve the process of informed consent within this special population and data supporting the utility of the recommendations in a sample 70 partner violent offenders are provided. Data demonstrate that participants were capable of comprehending all essential elements of consent.     

Conducting industrial and organizational psychological research: institutional review of research in work organizations

Although informed consent is a primary mechanism for ensuring the ethical treatment of human participants in research, both federal guidelines and American Psychological Association ethical standards recognize that exceptions to it are reasonable under certain conditions. However, agreement about what constitutes a reasonable exception to informed consent is sometimes lacking. We presented the same protocols to samples of respondents drawn from 4 populations: Institutional review board (IRB) members, managers, employees, and university faculty who were not members of IRBs. Differences in perceptions of IRB members from the other samples with respect to the risks of the protocols without informed consent and on the feasibility of conducting the research in employment organizations are discussed in terms of implications for industrial and organizational psychology research.     

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.     

When clinical care is like research: the need for review and consent

The prevailing “segregated model” for understanding clinical research sharply separates it from clinical care and subjects it to extensive regulations and guidelines. This approach is based on the fact that clinical research relies on procedures and methods—research biopsies, blinding, randomization, fixed treatment protocols, placebos—that pose risks and burdens to participants in order to collect data that might benefit all patients. Reliance on these methods raises the potential for exploitation and unfairness, and thus points to the need for independent ethical review and more extensive informed consent. In contrast, it is widely assumed that clinical care does not raise these ethical concerns because it is designed to promote the best interests of individual patients. The segregation of clinical research from clinical care has been largely effective at protecting research participants. At the same time, this approach ignores the fact that several aspects of standard clinical care, such as clinician training and scheduling, also pose some risks and burdens to present patients for the benefit of all patients. We argue that recently proposed learning health care systems offer a way to address this concern, and better protect patients, by developing integrated review and consent procedures. Specifically, current approaches base the need for independent ethical review and more extensive informed consent on whether an activity is categorized as clinical research or clinical care. An ethically sounder approach, which could be incorporated into learning health care systems, would be to base the need for independent ethical review and more extensive informed consent on the extent to which an activity poses risks to present patients for the benefit of all patients.     

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。     

Genetic Counseling Practice in Next Generation Sequencing Research: Implications for the Ethical Oversight of the Informed Consent Process

The potential for next generation sequencing research (NGS) to generate individual genetic results could have implications for the informed consent process and the provision of genetic counseling. We undertook a content analysis of informed consent templates and guidelines produced by Canadian institutional review boards, purposively sampling documents used by researchers to obtain consent from participants in genetics studies. Our goal was to examine the extent to which the informed consent documents addressed genetic counseling and the return of individual genetic results. Our analysis reveals that the majority of informed consent documents did not mention genetic counseling while several did not mention the return of results. We found differences in the ways in which documents addressed availability of counseling, eligibility criteria for referral to a genetic counselor, genetic counselor involvement, provision of services to family members of participants and incidental findings. From an ethical standpoint, consent documents should provide appropriate information so that participants may make an informed decision about their participation in research. The need to ensure adequate counseling for study populations in an NGS research context will necessarily involve adapting values that underlie care in genetic counseling practice. If the interests of research participants are to be truly promoted, the drafting and review of informed consent documents should give proper due to genetic counseling.     

Ethics in violence against women research: the sensitive, the dangerous, and the overlooked

Traditional disciplinary guidelines are inadequate to address some of the ethical dilemmas that emerge when conducting research on violence against women and girls. This article is organized according to the ethical principles of respect for persons, privacy and confidentiality, justice, beneficence, and nonmaleficence. In the article, I describe dilemmas involved in cross-cultural research, research on children, informed consent, voluntariness, coercion, deception, safety, mandated reporting, and dissemination. In the article, I include examples from qualitative and quantitative studies in many nations. I also offer suggestions for researchers and institutional review boards.     

Biomedical research and mining of the poor: The need for their exclusion

Almost all ethical guidelines and legislative policies concerning biomedical research involving human subjects contain provisions about relevance of research for the participating populations, informed consent, adequate care for research induced injuries and several other safeguards but the poor continue to suffer. Globalization has further aggravated poor people’s vulnerability by exposing them to international markets. Since the developing countries are abode of higher population of the poor they have become the unholy mines of this human ore for researchers. In this paper I examine various dimensions of poverty and analyze the international ethical responses in the area of biomedical research involving human subjects in order to determine their adequacy to protect the poor against exploitation and misuse and conclude that in view of the poor’s inherent and extreme vulnerability and the failure of ethical pronouncements to protect them from misuse and exploitation, they should be excluded from being enrolled as research subjects This paper was presented at the 6th International Bioethics Conference on the subject of ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005.     

Informed Consent in Asymmetrical Relationships: an Investigation into Relational Factors that Influence Room for Reflection

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered nanomaterials. To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply.     

Participants' understanding of the process of psychological research: informed consent

Sixty-five undergraduates participating in a wide range of psychological research experiments were interviewed in depth about their research experiences and their views on the process of informed consent. Overall, 32% of research experiences were characterized positively and 41% were characterized negatively. One major theme of the negative experiences was that experiments were perceived as too invasive, suggesting incomplete explication of negative aspects of research during the informed consent process. Informed consent experiences were viewed positively 80% of the time. However, most of the participants had a limited view of the purpose of informed consent: less than 20% viewed the process as a decision point. Results suggest a number of common pitfalls to standard informed consent practices that have not generally been recognized. Results are discussed in terms of both ethical and methodological implications. Suggestions for improving the informed consent process are also provided.     

Defining the Subject of Consent in DNA Research

The advent of population-specific genomic research has prompted calls for invention of informed consent protocols that would treat entire social groups as research subjects as well as endow such groups with authority as agents of consent. Critics of such an unconventional ethical norm of “group consent” fear the rhetorical effects of approaching social groups with offers to participate in dialogues about informed consent. Addressing a specific population as the collective subject of genomic research, on this logic, adds currency to the potentially dangerous public opinion that such a group is bound by genetic ties. The paper considers the problem of group and individual identity within the rhetorical dynamics of the discourse and politics of consent.     

Increased research literacy to facilitate community ownership of health research in low and middle income countries

ABSTRACT

The expansion of health research to low and middle income countries has increased the likelihood of exploitation and undue influence in economically vulnerable populations. In behavioral research, “reasonable availability”, which was originally developed for biomedical research and advocates for the equitable provision of any product developed during the research process, cannot always prevent exploitation. In such cases and settings, the informed consent process may lack cross-cultural validity and therapeutic misconceptions may arise. This article advocates for a mutual learning framework where international researchers can gain cultural competence while training and empowering local partners, increasing community ownership of health research.     

Ethical practices and beliefs of psychopathology researchers

Ethical guidelines are vague concerning how situations should be handled when researchers encounter participants in preexisting psychological distress. Ethical issues of beneficence, autonomy, and the nature of informed consent may arise in these situations. This study investigated the ethical practices and beliefs of 84 psychopathology researchers when confronting research participants in distress. Results indicated that psychopathology researchers in general engaged in diverse ethical practices in providing debriefing, treatment referrals, and providing for distressed participants. Characteristics of the designated studies and of the researchers accounted for significant differences in ethical practices. In addition, the type of psychopathology being assessed accounted for significant differences in ethical practices and beliefs. Guidelines are offered to aid researchers who encounter participants in preexisting distress.     

Ethical Practices and Beliefs of Psychopathology Researchers

Ethical guidelines are vague concerning how situations should be handled when researchers encounter participants in preexisting psychological distress. Ethical issues of beneficence, autonomy, and the nature of informed consent may arise in these situations. This study investigated the ethical practices and beliefs of 84 psychopathology researchers when confronting research participants in distress. Results indicated that psychopathology researchers in general engaged in diverse ethical practices in providing debriefing, treatment referrals, and providing for distressed participants. Characteristics of the designated studies and of the researchers accounted for significant differences in ethical practices. In addition, the type of psychopathology being assessed accounted for significant differences in ethical practices and beliefs. Guidelines are offered to aid researchers who encounter participants in preexisting distress.