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Research ethics regulation in parts of the Global North has sometimes been initiated in the face of biomedical scandal. More recently, developing and recently developed countries have had additional reasons to regulate, doing so to attract international clinical trials and American research funding, publish in international journals, or to respond to broader social changes. In Taiwan, biomedical research ethics policy based on 'principlism' and committee-based review were imported from the United States. Professionalisation of research ethics displaced other longer-standing ways of conceiving ethics connected with Taiwanese cultural traditions. Subsequently, the model and its discursive practices were extended to other disciplines. Regulation was also shaped by decolonizing discourses associated with asserting Indigenous peoples' rights. Locating research ethics regulation within the language and practices of public policy formation and transfer as well as decolonization, allows analysis to move beyond the self-referential and attend to the social, economic and political context within which regulation operates. [ABSTRACT FROM AUTHOR]

There is intense debate around the use of altered and waived consent for pragmatic trials. Those in favor argue that traditional consent compromises the internal and external validity of these trials. Those against, warn that the resultant loss of autonomy compromises respect for persons and could undermine trust in the research enterprise.This article examines whether international ethical guidelines and the policy frameworks in three countries-the United States, England, and Australia-permit altered and waived consent for minimal-risk pragmatic trials conducted outside the emergency setting. Provisions for both are clearly articulated in U.S. regulations, but many countries do not have equivalent frameworks. Investigators should not assume that all consent models permitted in the United States are legal in their jurisdictions, even if they are deemed ethically defensible.The authors summarize ethical and regulatory considerations and present a framework for investigators contemplating trials with altered or waived consent. [ABSTRACT FROM AUTHOR]

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of the adverse events (AEs) they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants' interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity. [ABSTRACT FROM AUTHOR]

For the first time, the revised Common Rule specifies that public health surveillance activities are not research. This article reviews the historical development of the public health surveillance exclusion and implications for other foundational public health practices. [ABSTRACT FROM AUTHOR]

This article argues in general support of the sIRB rule, but also draws on recent empirical research to highlight several residual weaknesses in the US regulatory structure for research ethics review, and suggests ways in which these weaknesses might be addressed in future regulatory reforms to improve upon the sIRB rule. [ABSTRACT FROM AUTHOR]

Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly "common" in 1991. This change, the addition of a "key information" requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the author discusses various reports within the journal on topics including the U.S. Federal Policy for the Protection of Human Subjects (Common Rule), a reasonable person standard for research disclosure, and human subject-related informed consent in the U.S.

The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided to largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections (SACHRP), and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation. [ABSTRACT FROM AUTHOR]

The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Yet the revised rule is not as radical as it might seem. During the 1970s, judges started using the standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed consent to the harmful procedures. In its influential Belmont Report, the National Commission recommended application of a "reasonable volunteer standard" to guide IRBs evaluating research disclosures. Evidence also suggests that IRBs often invoke the reasonable person standard in deliberations about consent forms. But past application of the standard has been informal and uneven. Robust application of the reasonable person standard will require researchers and IRBs to learn more about what ordinary people want and need to know about the studies they are invited to join. Input from people with personal experience as study participants could be particularly useful to this effort. [ABSTRACT FROM AUTHOR]

This Article analyzes the application of federal regulations governing human subjects research to the National Football League (NFL). More specifically, this Article examines research conducted via the NFL Scouting Combine. The NFL Combine is an annual event in which approximately 300 of the best college football players undergo medical examinations, intelligence tests, interviews, and multiple football and other athletic drills in the hopes of demonstrating their prowess and landing a spot in the NFL. Combine participants are under intense pressure to impress NFL clubs. Indeed, the Combine is routinely called the "biggest job interview of their lives." The examinations, tests and drills provide a plethora of data for NFL clubs to analyze in considering which players to select in the NFL Draft. NFL club medical personnel scour the data on behalf of the clubs, looking for medical conditions that might affect a player's short-term or long-term usefulness to the club. Many of these medical personnel have then also published studies utilizing the medical data from the NFL Combine. Such studies can provide a better understanding of the medical conditions faced by elite football players. At the same time, these studies help clubs predict how a Combine participant's medical condition or history might affect his performance on an NFL field. Against this backdrop is the field of human subjects research regulation. Born out of some horrific historical incidents, bioethicists, doctors, lawyers and related experts constructed a paradigm setting forth the requirements for research--particularly medical research--involving humans as subjects. Included in this paradigm are federal regulations, known as the "Common Rule," which typically require that research be reviewed and approved by an Institutional Review Board (IRB) and that the researchers obtain the participants' informed consent before proceeding. Moreover, the Common Rule requires that additional protections be implemented where the population being researched is considered "vulnerable." This Article examines whether 42 medical studies published using the medical records and data of NFL Combine participants comply with the Common Rule and other human subjects research guidelines. Given the intense pressure to please NFL clubs, and the precariousness of a career in the NFL, NFL Combine participants have significantly constrained choices about whether to participate in the research being conducted. Consequently, it is highly questionable whether informed consent--as required by the spirit and letter of the Common Rule--is being obtained. Additionally, given most players' limited financial resources and the inequitable power relationship between players and NFL clubs, there is a strong argument that NFL Combine participants should be considered a vulnerable research population. This argument is bolstered by similarities between the workplaces of NFL players and military personnel-a population regularly recognized as vulnerable. The Article concludes with five recommendations for better protecting NFL Combine participants in the context of human subjects research: (1) requiring researchers and/or the Combine participants to read the consent form aloud and audio record the process; (2) requiring all research to be approved by the National Football League Players Association; (3) requiring consent forms to be provided to the Combine participants' agents; (4) having IRBs engage the perspective of a player when evaluating research; and (5) requiring that Combine participants' decision whether or not to participate in the research remain confidential. By requiring such protections, IRBs have the potential to ensure that NFL Combine participants are being subjected to research in the dignified and respectful matter required by the Common Rule. [ABSTRACT FROM AUTHOR]

The article offers information regarding payment-related policies and practices of institutional review boards (IRBs) and also offers information on regulations governing human-subjects research and bioethical guidelines. It mentions that the U.S. Food and Drug Administration (FDA) guidance ties payment to coercion and undue influence and suggests that payment might undermine consent. It presents considerations for investigators proposing payment offers.

The year 2017 marks both the 70th anniversary of the NurembergCode and thefirstmajor revisions of federal research regulations in almost 3 decades. I suggest that the informed consent provisions of the federal research regulations continue to follow the requirements of the Nuremberg Code. However, modifications are needed to the informed consent (and institutional review board) provisions to make the revised federal regulations more effective in promoting a genuine conversation between the researcher and the research subject. This conversation must take seriously both the therapeutic illusion and the desire of both the researcher and the research subject not to engage in sharing uncertainty. [ABSTRACT FROM AUTHOR]

In emergency care research, it may be the case that neither informed consent nor surrogate consent is possible. In order to nonetheless allow for such research, codes and regulations of research ethics have increasingly incorporated provisions regarding this specific situation. The protection that those provisions offer need to be better understood. This article addresses in what ways they protect individuals, and especially the extent to which the suggested protection compensates for the loss of surrogate consent. The Declaration of Helsinki, the Additional Protocol to the Convention on Human Rights and Biomedicine, and the EU Clinical Trials Regulation serve as the main illustrations. [ABSTRACT FROM PUBLISHER]

In 2001, DePuy, a wholly-owned subsidiary of Johnson & Johnson (J&J/DePuy), initiated a seeding study called the “Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty” (PIN Study). J&J/DePuy designed this study to develop new business opportunities during the launch of their Pinnacle Hip System (PHS) and generate survivorship data for marketing. This article, the first review of a seeding trial for a medical device, examines internal company documents relating to the PIN Study; the analysis herein focuses on the integrity of J&J/DePuy’s research practices in conception, implementation, and analysis. J&J/DePuy violated the study protocol and manipulated data; consented participants in violation of standards protecting human subjects; and did not secure Institutional Review Board approval for all study sites. J&J/DePuy used PIN Study results as the “fundamental selling point” for the PHS. Medical device seeding trials are distinct from previously-documented pharmaceutical seeding trials because companies can profit directly from device sales and because these studies may be the first clinical evaluation of the device (as was the case for the PIN Study). Seeding trials are malleable marketing projects, not rigorous scientific studies. Regulatory bodies, physicians, and others should be vigilant for persuasive marketing accounts disguised as science. [ABSTRACT FROM PUBLISHER]

The article discusses how the release of the updated Common Rule by the Office for Human Research Protections (OHRP) on January 19, 2017, involved six-year period of administrative processes to modernize and improve the regulations concerning research with humans. It notes how hundreds of thousands of scientists worldwide carry out experiments to improve human health, solve social problems, or enhance the understanding of the natural world.

The article presents an overview of the revised and final common rule. The revised Common Rule does not substantially change the definition of research. Oversight should rely on the actual risks incurred or likely to incur in the research or care setting, with the governance and nature of the oversight differing depending upon anticipated risk.

The article discusses the author's claim that the informed consent that is needed for comparative effectiveness research (CER) should include disclosures about the risks associated with standard care interventions, and it mentions risks of research and oversight by the U.S. Office for Human Research Protections (OHRP). Regulations to protect human subjects are examined, along with the medical research ethics, the Nuremberg Code, and American common law protections for individuals.

The article discusses the author's claim that the use of a central institutional review board (CIRB) is an essential requirement for cancer-related clinical trials as of 2017, and it mentions the legal and ethical aspects of CIRBs, as well as issues related to human subjects research involving chronic and deadly diseases. Disease-associated DNA mutations and cancer treatment research are examined, along with the costs associated with human subjects-based medical research.

The article discusses the author's claim that teenagers should be allowed to consent to participate in Institutional Review Board (IRB)-approved human subject medical research, and it mentions cognitive and moral development in children and adolescents, as well as information about the U.S. Supreme Court's rulings in cases involving teenage capacity, life imprisonment, and the application of the nation's death penalty. Maturity and the legal rights of adults in America are assessed.

The article discusses the author's claim that adolescents are not mature enough to legally consent to participate in medical research in America as of 2017, and it mentions psychological and neurophysiological development in teenagers, as well as information about medical decision making laws and parental consent requirements in the U.S. The American Supreme Court constitutional law case Parham v. J.R. is examined, along with the nation's informed consent and human subjects research laws.

Outsourcing clinical trials sponsored by pharmaceutical companies from industrialized countries to low- (middle)-income countries - summarized as transnational biomedical research (TBR) - has lead to many concerns about ethical standards. Whether study participants are particularly vulnerable is one of those concerns. However, the concept of vulnerability is still vague and varies in its definition. Despite the fact that important international ethical guidelines such as the Declaration of Helsinki by the World Medical Association or the Ethical Guidelines for Biomedical Research Involving Human Subjects by the Council of International Organizations of Medical Sciences refer to vulnerability as ethical principle, each of their approaches are different. To overcome these shortcomings, we analyze and unite different approaches of vulnerability and develop practical criteria in order to operationalize the concept especially for the context of TBR. These criteria refer to the context of a study as well as the characteristics and the current living situation of study participants. Based on a case study of an HIV-vaccine-trial conducted in India we demonstrate how those criteria can be applied in a retrospective way to identify potential ethical conflicts. The criteria can also indicate a prospective function for ethical pre-assessment. For this, we provide an outlook for three major topics: 1. Vulnerability as a normative concept: Different ways of protection; 2. The relevance of transparency and 3. Vulnerability as an instrument to increase decision participation of human subjects. [ABSTRACT FROM AUTHOR]

Background: Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure has been identified that evaluates participant understanding for IC based on their contributions during consent interactions. This paper outlines the development and formative evaluation of the Participatory and Informed Consent (PIC) measure for application to recorded recruitment appointments. The PIC allows the evaluation of recruiter information provision and evidence of participant understanding.Methods: Published guidelines for IC were reviewed to identify potential items for inclusion. Seventeen purposively sampled trial recruitment appointments from three diverse trials were reviewed to identify the presence of items relevant to IC. A developmental version of the measure (DevPICv1) was drafted and applied to six further recruitment appointments from three further diverse trials to evaluate feasibility, validity, stability and inter-rater reliability. Findings guided revision of the measure (DevPICv2) which was applied to six further recruitment appointments as above.Results: DevPICv1 assessed recruiter information provision (detail and clarity assessed separately) and participant talk (detail and understanding assessed separately) over 20 parameters (or 23 parameters for three-arm trials). Initial application of the measure to six diverse recruitment appointments demonstrated promising stability and inter-rater reliability but a need to simplify the measure to shorten time for completion. The revised measure (DevPICv2) combined assessment of detail and clarity of recruiter information and detail and evidence of participant understanding into two single scales for application to 22 parameters or 25 parameters for three-arm trials. Application of DevPICv2 to six further diverse recruitment appointments showed considerable improvements in feasibility (e.g. time to complete) with good levels of stability (i.e. test-retest reliability) and inter-rater reliability maintained.Conclusions: The DevPICv2 provides a measure for application to trial recruitment appointments to evaluate quality of recruiter information provision and evidence of patient understanding and participation during IC discussions. Initial evaluation shows promising feasibility, validity, reliability and ability to discriminate across a range of recruiter practice and evidence of participant understanding. More validation work is needed in new clinical trials to evaluate and refine the measure further. [ABSTRACT FROM AUTHOR]

Background: Patient engagement efforts often rely on a participatory research approach, which means engaging patients and community members in all aspects of research. As research team members, they require familiarity with the principles of human subject protection, privacy, and institutional review boards (IRB). However, the time required for individual IRB training may be a barrier to engaging community members in participatory research. As more community members participated in research, the State Networks of Colorado Practices and Partners (SNOCAP) was faced with finding a balance between including community members as part of the research team and the significant time commitment and institutional requirements for human subjects research oversight.Objective: Design and implement a community training on human subject protection in research.Methods: The SNOCAP team worked with the leadership from the Colorado Multi-Institutional Review Board (COMIRB) to develop a training programme that included the ethical principles and guidelines for the protection of human subjects.Results: The final training programme was based on the core principles of the Belmont Report: respect for persons, beneficence and justice. Privacy was taught using the Health Insurance Portability and Accountability Act (HIPAA) national guidelines.Conclusions: The members of the High Plains Research Network Community Advisory Council were fully engaged in developing the training programme, as well as in the training itself. They were committed to the principles and guidelines for protecting the rights and welfare of human subjects. Patients and community members have become a critical part of our research team. They understand the principles of human subjects protection and privacy and incorporate these principles into their research activities. [ABSTRACT FROM AUTHOR]

U.S. researchers and scholars often point to two legal factors as significant obstacles to the inclusion of pregnant women in clinical research: the Department of Health and Human Services' regulatory limitations specific to pregnant women's research participation and the fear of liability for potential harm to children born following a pregnant woman's research participation. This article offers a more nuanced view of the potential legal complexities that can impede research with pregnant women than has previously been reflected in the literature. It reveals new insights into the role of legal professionals throughout the research pathway, from product conception to market, and it highlights a variety of legal factors influencing decision-making that may slow or halt research involving pregnant women. Our conclusion is that closing the evidence gap created by the underrepresentation and exclusion of pregnant women in research will require targeted attention to the role of legal professionals and the legal factors that influence their decisions. [ABSTRACT FROM AUTHOR]

The article reports on the efforts of investigators and institutions to prepare for new federal protections of study participants set to be effective in 2018. Topics mentioned include a discussion on the new structure and content of informed consent, how to evaluate comprehension of prospective research participants, and differences between the notice of proposed rulemaking and the final rule.

The article discusses the U.S. laws and regulations governing commercial disclosures in biomedical research as of 2017, and it mentions potential negotiations involving commercial interests human biospecimens. The American government's issuance of a Final Rule regarding human subjects research is examined, along with biospecimen-related cases such as Moore v. Regents of the University of California, Greenberg v. Miami Children’s Hospital, and Washington University v. Catalona.

Medical science and research depend on human subject testing. In the United States, the Federal Policy for the Protection of Human Subjects, colloquially known as the "Common Rule," is the regulation ensuring the protection and dignity of all human subjects. Whether the participants are answering questionnaires or testing prescriptions, the Common Rule describes the ethical requirements of testing on human subjects. Initially promulgated in 1991, the Common Rule has remained mostly unchanged, despite the vast changes in human subject research. As technology changes, the current regulations are failing to provide adequate protection to research participants. In response, the Department of Health and Human Services published an Advanced Notice of Public Rule Making in the Federal Register in 2011. Four years later, on September 8, 2015, HHS published a Notice of Proposed Rule Making in the Federal Register. On January 19, 2017, the final rule for the Federal Policy for the Protection of Human Subjects was announced. This Comment analyzes the relationship between the NPRM and the Final Rule regarding three specific protections of the Common Rule regulations proposed in the NPRM: (1) the additions to the informed consent documents; (2) the evolving role of the Internal Review Board's obligations and procedures; and (3) the treatment of secondary biospecimens. Further, this Comment addresses the history of human testing, the current Common Rule, the proposed changes, and the implications of the Final Rule. In doing so, this Comment analyzes submitted public comments to the Notice of Proposed Rule Making and how the Final Rule incorporates, or fails to incorporate, these provisions. The Final Rule shows that despite the failure to incorporate every aspect of the proposed rule, the changes to the Common Rule will promote human subject dignity and autonomy without jeopardizing crucial, and much-needed, research. [ABSTRACT FROM AUTHOR]

The article focuses on medical research studies conducted on children by discussing the requirements of the justice principle and history of medical research studies that targeted economically disadvantaged minority children. It mentions researchers should be required to use the proposed Vulnerability and Equity Impact Assessment (VEIA) tool and research subjects violates the redefined justice principle. It also mentions creation of a Board of Children to review all medical research studies.

The article offers information on the ethical and philosophical issues arising in citizen science. Topics discussed include information on the regulations to cover the expansive new approaches to health and other research; discussions on the challenges to the citizen science due to regulations; and the information on the approach to ethical oversight of research with human beings.

The article offers information on the researcher/patient partnerships in rare disease research. Topics discussed include information on the facilitating sample and data collection or covering travel costs for patients to visit a researcher; discussions on the unavoidable funding and recruitment challenges in the careers to rare diseases; and the patient groups overcoming the barriers by bringing a ready-made project to researchers.

The article offers information on the rise of citizen science in health and biomedical research. Topics discussed include information on the emerging ethical issues related to citizen science in biomedical research; discussions on the increasingly important as citizen science moves beyond disciplines like astronomy and ecology; and the ethical review and oversight of public-driven citizen science projects.

The article discusses the revisions to the Common Rule which provides protection to research subject in clinical trials and mentions the ethical issues in syphilis clinical trial conducted by the U.S. Public Health Service in Guatemala during the 1940's. It mentions the report Ethically Impossible: STD Research in Guatemala from 1946 to 1948 by the Presidential Commission for the Study of Bioethical Issues. Topics include organizational accountability and community involvement in research.

Background: Society is failing in its moral obligation to improve the standard of healthcare provided to vulnerable populations, such as people who lack decision making capacity, by a misguided paternalism that seeks to protect them by excluding them from medical research. Uncertainties surround the basis on which decisions about research participation is made under dual regulatory regimes, which adds further complexity. Vulnerable individuals' exclusion from research as a result of such regulation risks condemning such populations to poor quality care as a result of 'evidence biased' medicine.Main Text: This paper explores the research regulation provisions for proxy decision making for those unable to provide informed consent for themselves, and the subsequent legal and practical difficulties for decision-makers. There are two separate regulatory regimes governing research involving adults who lack capacity to consent in England and Wales. The Mental Capacity Act 2005 governs how incapacitated adults can be involved in research, however clinical trials of medicinal products are separately regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004. There are significant differences under these dual regimes in the provisions for those lacking capacity to participate in medical research. The level of risk permitted differs, with a greater requirement for justification for participation in a clinical trial than other types of research. Who acts as proxy decision maker, how much information is provided to the person lacking capacity, and whether they retain the power of veto also significantly differs.Conclusion: The development of two separate regulatory regimes has resulted in significant differences between the provisions for clinical trials and other forms of research, and from usual medical practice. The resulting uncertainty has reinforced the tendency of those approving and conducting research to exclude adults lacking capacity to avoid difficult decisions about seeking consent for their participation. Future developments, such as the incoming EU Regulations, may address some of these differences, however the justification and level of risk permitted requires review to ensure that requirements are appropriate and proportionate to the burdens and risks for the individual, and also to the benefits for the wider population represented. [ABSTRACT FROM AUTHOR]

The article discusses the U.S. government protection review process concerning human subjects involved in what is referred to as exempt research. It analyzes rule changes proposed by the U.S. Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP), Institutional Review Board (IRB) regulation of exempt research, and possible IRB reforms.

Compensation for research-related injuries (RRIs) remains a challenge in the current environment of global collaborative biomedical research as exemplified by the continued reluctance of the US government, a major player in international biomedical research, to enact regulation for mandatory compensation for RRIs. This stance is in stark contrast to the mandatory compensation policies adopted by other democracies like the European Union (EU) countries. These positions taken by the USA and the EU create a nexus of confusion when research is exported to low-income and middle-income countries which have no laws guiding compensation for RRIs. In this paper, we begin by exploring the background to policies concerning RRIs, how they reflect on the traditional dispute resolution mechanisms in African societies, and how this compares with the no-fault compensation model. We then explore the underlying African ethical framework of Ubuntu in the sub-Saharan region, guiding traditional practices of dispute resolution and compensation, and how this framework can help to form the moral justification for no-fault compensation as the preferred compensation model for RRIs for African countries. Finally, we call upon countries in the African Union (AU), to adopt a no-fault policy for compensation of RRIs, and enact it into a regulatory requirement for insurance-based no-fault compensation for biomedical research, which will then be enforced by member states of the AU. [ABSTRACT FROM AUTHOR]

The article discusses the South Korean government's regulation of biobanks through the country's 2005 Bioethics and Biosafety Act, including its initial impact on limiting genetic testing. The role that the aforementioned law plays in protecting human research subjects is discussed. The law's requirement that research organizations have institutional review boards (IRBs), including their role in validating informed consent, is also discussed.

The possibility of using advance directives to prospectively consent to research participation in the event of dementia remains largely unexplored in Europe. Moreover, the legal status of advance directives for research is unclear in the European regulations governing biomedical research. The article explores the place that advance research directives have in the current European legal framework, and considers the possibility of integrating them more explicitly into the existing regulations. Special focus is placed on issues regarding informed consent, the role of proxies, and the level of acceptable risks and burdens. [ABSTRACT FROM AUTHOR]

The article discusses the changes to the legal and ethical guidelines proposed which could impact the conduct of human subjects research.

The article discusses the legal aspects of biobanking, privacy rights, and the regulation of biomedical research in the U.S. as of 2016, and it mentions the guidelines for sharing biological samples and health information in America. Technological innovations are addressed in relation to the creation and storage of personal- and health-related data. The internal governance of biobanks is examined, along with informed consent and confidentiality and human subjects protections.

In New Zealand non-consensual research studies on incapacitated adults are of doubtful legality under current laws. This column argues that the current situtation goes too far, inevitably depriving incompetent participants as individuals and as a group of access to medications for which there is good reason to be confident may be directly beneficial to them, as well as to future patients and society. At the same time, incapacitated participants are particularly vulnerable to exploitation and harm. All jurisdictions in which non-consensual research is undertaken have to balance these competing ethical considerations. In the United Kingdom, three different pieces of legislation have been enacted which permit non-consensual research to proceed, subject to a comprehensive regime of strict protections for participants. The column analyses these and argues that an excellent model can be constructed from them. In late 2014, the New Zealand Health and Disability Commissioner agreed to investigate this issue with a view to proposing law reform, but the promised public consultation has never eventuated. It must do so without further delay for the protection of participants and researchers, and in the interests of society. [ABSTRACT FROM AUTHOR]

Whether adolescents can participate in clinical trials of pharmacologic therapies for HIV prevention, such as pre-exposure prophylaxis, without parental permission hinges on state minor consent laws. Very few of these laws explicitly authorize adolescents to consent to preventive services for HIV and other sexually transmitted infections. Unclear state laws may lead to research cessation. We have summarized legal, ethical, and policy considerations related to adolescents' participation in HIV and sexually transmitted infection prevention research in the United States, and we have explored strategies for facilitating adolescents' access. [ABSTRACT FROM AUTHOR]

Proposed revisions to the rules governing the ethical conduct of research involving humans aim to enhance respect and safeguards for research participants and to increase research efficiency by reducing unnecessary burdens and calibrating oversight to the level of risk. [ABSTRACT FROM AUTHOR]

The proposed changes to the Common Rule for human subjects research, though imperfect, are a significant step forward. They would enhance protections of research participants and improve the efficiency of the review process. [ABSTRACT FROM AUTHOR]

The privacy of biobank research participants in France is protected by a combination of bioethics laws, research laws, and data protection laws. Although the law has attempted to facilitate research by creating an opt-out regime for research with pre-existing samples, other aspects of the law hinder research. The requirement for multiple consents throughout the process of biobank sample collection and use, the lack of acceptance of a broad consent for biobanking, and genetic exceptionalism in the law all complicate biobank research. With IRB approval, opt-out consent may be used for genetic research using human tissue collected for other purposes, but express consent is still required for research with the associated genetic data. Among the important issues remaining to be addressed are harmonizing and simplifying the various informed consent processes. [ABSTRACT FROM AUTHOR]

In genomics research, it is becoming common practice to return individualized primary and incidental findings to participants and several ongoing major studies have begun to automatically transfer these results to a participant's clinical medical record. This paper explores who should decide whether to place genomic research findings into a clinical medical record. Should participants make this decision, or does a researcher's duty to place this information in a medical record override the participant's autonomy? We argue that there are no clear ethical, legal, professional, or regulatory duties that mandate placement without the consent of the participant. We conclude that informing participants of results, together with a clear explanation, relevant recommendations and referral sources, and the option to consent to placement in the medical records will best discharge researchers' ethical and legal duties towards participants. [ABSTRACT FROM AUTHOR]

This paper considers the meaning of the term 'intrusive research', as used in the UK Mental Capacity Act 2005 (MCA), in relation to studies in which an informant is asked to provide information about or on behalf of a person who lacks capacity to consent, and who is not otherwise involved in the study. The MCA defines 'intrusive research' as research that would legally require consent if it involved people with capacity. The relevant ethical principles are that consent should be sought from people who would be affected by a piece of research and that this requirement should be implemented proportionately. The critical question, for investigators and research ethics committees, is: would provision of the personal information specified in the research protocol significantly affect a person whose capacity is not impaired? If the answer to this question is 'no', then the study falls outside the definition of 'intrusive research', and the MCA does not apply. [ABSTRACT FROM AUTHOR]

The Declaration of Helsinki requires that health care research takes place with the informed consent of those who participate in the study. This approach upholds the autonomy of the participants, but restricts research to subjects who have decision-making capacity. The Mental Capacity Act 2005 introduced safeguards that enable researchers to investigate the care and treatment of people with incapacity, while protecting this vulnerable patient group. These safeguards allow people who lack decision-making capacity to benefit from research findings. In this article, Richard Griffith outlines the requirements that must be met when district nurses conduct research on subjects who lack decision-making capacity. [ABSTRACT FROM AUTHOR]

The article offers information on the private right of action or negligence claims for damages due to failure to provide informed consent in the treatment by physicians and in human subjects research by research participants. It informs that the emergence of genetic testing and use of medical imagingmay help to transform relationship between the investigator and research participant and establish the duty of care.