OBJECTIVE: To apply component analysis, a structured approach to the ethical analysis of risks and potential benefits in research, to published emergency research using a waiver of/exception from informed consent. The hypothesis was that component analysis could be used with a high degree of interrater reliability, and that the vast majority of emergency research would comply with a minimal-risk threshold. METHODS: A Medline search and manual search were done to identify studies using a waiver of/exception (...) class='Hi'>from informed consent published between July 1996 and December 2000. A review panel of physicians and bioethicists independently classified nontherapeutic procedures in each study as minimal risk, probably minimal risk, or probably more than minimal risk. RESULTS: Seventy studies using a waiver of/exception from informed consent were identified. A majority of reviewers classified nontherapeutic procedures in 62 studies (88.6%) as minimal risk. Reviewers classified nontherapeutic procedures in six studies (8.6%) as minimal risk or probably minimal risk. In two studies (2.9%), nontherapeutic procedures were classified as probably more than minimal risk. The intraclass correlation coefficient was 0.89 (95% CI = 0.85 to 0.93), indicating very high interrater reliability. CONCLUSIONS: Component analysis can be used with high reliability to review emergency research and may improve the consistency of institutional review board review of emergency research. The vast majority of published emergency research performed using a waiver of/exception from consent complies with a properly-applied minimal-risk threshold. A minimal-risk threshold for nontherapeutic procedures protects subjects better than current U.S. regulations while permitting important emergency research to continue. (shrink)

Exception from Informed Consent (EFIC) regulations detail specific circumstances in which Institutional Review Boards (IRB) can approve studies where obtaining informed consent is not possible prior to subject enrollment.To better understand how IRB members evaluate community consultation (CC) and public disclosure (PD) processes and results, semi-structured interviews of EFIC-experienced IRB members were conducted and analyzed using thematic analysis.Interviews with 11 IRB members revealed similar approaches to reviewing EFIC studies. Most use summaries of CC activities to determine (...) community members’ attitudes; none reported using specific criteria nor recalled any CC reviews that resulted in modifications to or denials of EFIC studies. Most interviewees thought metrics based on Community VOICES’s domains (feasibility, participant selection, quality of communication, community perceptions, investigator/IRB perceptions) would be helpful.IRB members had similar experiences and concerns about reviewing EFIC studies. Development of metrics to assess CC processes may be useful to IRBs reviewing EFIC studies. (shrink)

The ethical concept of Informed Consent provides individuals with the right and the opportunity to approve of events that will occur regarding his or her own person. In medicine, informed consent is obtained for treatment and for research participation. However, under some circumstances, prospective informed consent cannot be obtained because of the devastating clinical condition of the patient. In emergency circumstances, treatment is never withheld if obtaining informed consent from a critically ill person is not (...) possible or if a delay while seeking surrogates would further endanger life. In emergency research circumstances, waiving informed consent for study participation is fraught with additional ethical considerations. This article will review a presentation given at the June 2, 2006 conference entitled “The Ethics of Research in Emergency Medicine”. (shrink)

Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received (...) little attention or analysis but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study. (shrink)

Objectives: To examine the willingness of patients to participate in a resuscitation study that requires exception from informed consent and to determine if willingness to participate is associated with demographic and other characteristics.Methods: Adult patients in an emergency department and in a geriatric outpatient clinic were surveyed. Patients were asked to imagine that they presented to an emergency department with cardiac arrest and asked about their willingness to receive a new drug outside of a study, receive a (...) new drug as part of a study and participate in a randomised controlled trial for a new drug. Patients were also asked about participation in studies of invasive procedures.Results: 213 patients from a geriatric clinic and 207 from an emergency department were surveyed. Two thirds of patients from the geriatric clinic and 83% from the emergency department were willing to receive an experimental drug outside of a study. Patients were less willing to participate in a study of the new drug and even less likely to participate in an RCT for the new drug . Patients were less likely to participate in a study of thoracotomy than in a study that required placement of a femoral catheter . Willingness to participate was not associated with trust in the doctors.Conclusions: Study design and invasiveness of the intervention were associated with the willingness of patients to participate in resuscitation studies that require exception from informed consent. (shrink)

Background: Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards need to determine if the regulations have been met.Aim: To determine IRB members’ experience reviewing research protocols using emergency exception to informed consent.Methods: This qualitative research used semistructured telephone interviews of 10 selected IRB members from around the US in the fall (...) of 2003. IRB members were chosen as little is known about their views of exception to consent, and part of their mandate is the protection of human subjects in research. Interview questions focused on the length of review process, ethical and legal considerations, training provided to IRB members on the regulations, and experience using community consultation and notification. Content analysis was performed on the transcripts of interviews. To ensure validity, data analysis was performed by individuals with varying backgrounds: three emergency physicians, an IRB member and a layperson.Results: Respondents noted that: emergency exception to informed consent studies require lengthy review; community consultation and notification regulations are vague and hard to implement; current regulations, if applied correctly, protect human subjects; legal counsel is an important aspect of reviewing exception to informed-consent protocols; and IRB members have had little or no formal training in these regulations, but are able to access materials needed to review such protocols.Conclusions: This preliminary study suggests that IRB members find emergency exception to informed consent studies take longer to review than other protocols, and that community consultation and community notification are the most difficult aspect of the regulations with which to comply but that they adequately protect human subjects. (shrink)

We read with great interest Garland, Morain and Sugarman’s manuscript on the obligations of clinicians to participate in pragmatic clinical trials (PCTs) (Garland, Morain and Sugarman 2023). We bel...

BackgroundIn specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent.MethodsHere, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy.ResultsWe identified three main categories of (...) arguments for the acceptability of a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures.ConclusionsThe reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB. (shrink)

Surgical Informed Consent has long been recognized as an important component of modern medicine. The ultimate goals of SIC are to improve clients’ understanding of the intended procedure, increase client satisfaction, maintain trust between clients and health providers, and ultimately minimize litigation issues related to surgical procedures. The purpose of the current study is to assess the comprehensiveness of the SIC process for women undergoing obstetric and gynecologic surgeries. A hospital-based cross-sectional study was undertaken at Hawassa University Comprehensive Specialized (...) Hospital in November and December, 2016. A total of 230 women who underwent obstetric and/or gynecologic surgeries were interviewed immediately after their hospital discharge to assess their experience of the SIC process. Thirteen components of SIC were used based on international recommendations, including the Royal College of Surgeon’s standards of informed consent practices for surgical procedures. Descriptive summaries are presented in tables and figures. Forty percent of respondents were aged between 25 and 29 years. Nearly a quarter had no formal education. More than half of respondents had undergone an emergency surgical procedure. Only 18.4% of respondents reported that the surgeon performing the operation had offered SIC, while 36.6% of respondents could not recall who had offered SIC. All except one respondent provided written consent to undergo a surgical procedure. However, 8.3% of respondents received SIC service while already on the operation table for their procedure. Only 73.9% of respondents were informed about the availability of alternative treatment options. Additionally, a majority of respondents were not informed about the type of anesthesia to be used and related complications. Only 54.2% of respondents reported that they had been offered at least six of the 13 SIC components used by the investigators. There is gap in the provision of comprehensive and standardized pre-operative counseling for obstetric and gynecologic surgeries in the study hospital. This has a detrimental effect on the overall quality of care clients receive, specifically in terms of client expectations and information needs. (shrink)

In the practice of medicine there has long been a conflict between patient management and respect for patient autonomy. In recent years this conflict has taken on a new form as patient management has increasingly been shifted from physicians to insurers, employers, and health care bureaucracies. The consequence has been a diminshment of both physician and patient autonomy and a parallel diminishment of medical record confidentiality. Although the new managers pay lip service to the rights of patients to confidentiality (...) of their records, in fact they advocate very liberal medical records access policies. They argue that a wide range of parties has a need to know the contents of individually identifiable medical records in order to control costs, promote quality of care, and undertake research in the public interest. Broad interpretations of the need to know, however, are at odds with strict interpretations of the right to confidentiality. Strict confidentiality policies require that, with few exceptions, patient consent be obtained whenever a patient's record is used outside the treatment context. The traditional criterion for overriding the consent requirement has been that without the override some harm would directly result. This rule is now challenged by the claim that patients have a duty to make their records available for a wide range of research and public health purposes. The longstanding tension between physician responsibility for patient welfare and respect for patient autonomy is being replaced by a debatable requirement that both physician and patient autonomy be subordinated to the goals of data collection and analysis. (shrink)

Canada has recently published a new Clinical Practice Guideline on the diagnosis and management of brain death. It states that consent is not necessary to carry out the interventions required to make the diagnosis. A supporting article not only sets out the arguments for this but also contends that ‘UK laws similarly carve out an exception, excusing clinicians from a prima facie duty to get consent’. This is supplemented by the claim that recent court decisions in (...) the UK similarly confirm that consent is not required, referencing two judgements inBattersbee. We disagree with the authors’ interpretation of the law on consent in the UK and argue that there is nothing inBattersbeeto support the conclusion that consent to testing is not necessary. Where there is a disagreement about testing for brain death in the UK, court authorisation is required. (shrink)

This article presents an overview for clinician investigators on the concepts of decision-making capacity and vulnerability as related to human subjects research. Tools for capacity assessment and unacknowledged sources of vulnerability are discussed, and the practical gaps in current informed consent requirements related to impaired capacity and potential vulnerability are described. Options are suggested for research discussions when full regulatory consent is not possible and an exception from informed consent does not apply.

In the last 25 years writing in bioethics, particularly in medical ethics, has generally claimed that action is ethically acceptable only if it receives informed consent from those affected. However, informed consent provides only limited justification, and may provide even less as new information technologies are used to store and handle personal data, including personal genetic data. The central philosophical weakness of relying on informed consent procedures for ethical justification is that consent is a propositional (...) attitude, so referentially opaque: consent is given to specific propositions describing limited aspects of a situation, and does not transfer even to closely related propositions. Assembling genetic data in databases creates additional difficulties for ethical justification. This is not because genetic information is intrinsically exceptional, but because the merger of genetic and information technologies make it possible to assemble massive quantities of complex information that defeat individuals' best efforts to grasp what is at stake, or to give or withhold informed consent. The future agenda for bioethics will need to take account of both these limitations of appeals to informed consent. (shrink)

Recent cases involving biosamples taken from indigenous tribes and newborn babies reveal the emptiness of informed consent. This venerable doctrine often functions as a charade, a collective fiction which thinly masks the uncomfortable fact that the subjects of human research are not actually afforded full information regarding the types of research that may be contemplated, nor do they provide meaningful consent. But if informed consent fails to provide adequate protection to the donors of biological materials, why (...) not turn to principles of property law? Property is power, yet current law permits everyone except for those who donate biological materials to possess property rights. The reluctance to invoke property probably stems from fears of resurrecting slavery and the commodification of human beings. But ironically, avoidance of property transforms the subjects of human research into objects that can be owned only by others, resulting in new forms of oppression and exploitation. Human research subjects are autonomous individuals who should not only possess the power to contribute their biological materials, but also the right to help control the course of research, and to share in the resulting benefits or profits. Conferring body property might enable research subjects to regain power and a measure of self-sovereignty. (shrink)

James Sterba uses the Pauline Principle to argue that the occurrence of significant, horrendous evils is logically incompatible with the existence of a good God. The Pauline Principle states that (as a rule) one must never do evil so that good may come from it, and according to Sterba, this principle implies that God may not permit significant evils even if that permission would be necessary to secure other, greater goods. By contrast, I argue that the occurrence of significant (...) evils is logically compatible with the existence of a good God because victims of significant evils may themselves reasonably consent to their suffering. In particular, I argue that they may be able to accept their suffering if it turns out that there was no way for God to secure relevant greater goods (or prevent other, greater evils) except by way of allowing their suffering, and God also provides them with other compensating, heavenly comforts. After using this consent-based argument to address Sterba’s logical problem from evil, I briefly consider how this argument may also help address a related evidential problem from evil, which suggests that while it is possible that victims of significant evils would consent to their suffering, it is unlikely that they would do so. While I do not provide a definitive solution to this evidential problem of evil, I highlight one important example of a trade-off that God may need to make that would—along with the provision of compensating, heavenly comforts—potentially persuade victims of significant evils to consent to their suffering. Specifically, I argue that there may be a necessary trade-off that God needs to make between permitting significant evils (on the one hand) and protecting a certain, morally significant form of free will (on the other hand). (shrink)

Background Record linkage is a useful tool for health research. Potential benefits aside, its use raises discussions on privacy issues, such as whether a written informed consent for access to health records and linkage should be obtained. The authors aim to systematically review studies that assess consent proportions to record linkage. Methods 8 databases were searched up to June 2011 to find articles which presented consent proportions to record linkage. The screening, eligibility and inclusion of articles were (...) conducted by two independent reviewers. The authors carried out meta-regression, subgroup and sensitivity analyses to assess heterogeneity. Results Of the 141 studies identified, only 11 presented empirical consent proportions and were included in the systematic review. The consent proportion varied widely from 39% to 97%. Seven studies presented consent proportions of 88% or higher, one of 72%, and only three presented consented proportion equal to or lower than 53%. None of the studies' characteristics evaluated explained heterogeneity. Conclusion The results of this review show that, in general, individuals tend to consent to the use of their data for record linkage, with exceptions in specific populations or minorities. The authors believe that this, as well as the cited literature, lends support to policies that, while keeping relevant ethical controls in place, do not require individual informed consent for each and every study that relies on secondary data. (shrink)

In this paper, I discuss exploitative transactions in bioethics. Examples of this kind of transactions allegedly include, among others, commercial surrogacy, organ selling, and research with human subjects in developing countries. The most problematic kind of exploitation is what Allan Wertheimer calls “mutually advantageous exploitation:” the weak party’s consent for the transaction is an effective and rational consent. Moreover, W does not suffer any harm by the transaction; on the contrary, the transaction benefits W. My aim in this (...) paper is twofold. From the perspective of individual ethics, I offer a model to understand the nature of the wrongfulness of the strong party’s action. And from the perspective of legal ethics, I suggest some reasons to believe that the prohibition of beneficial exploitative contracts is problematic and can only be justified in very exceptional cases. (shrink)

Although rapid genomic sequencing (RGS) is improving care for critically ill children with rare disease, it also raises important ethical questions that need to be explored as its use becomes more widespread. Two such questions relate to the degree of consent that should be required for RGS to proceed and whether it might ever be appropriate to override parents’ decisions not to allow RGS to be performed in their critically ill child. To explore these questions, we first examine the (...) legal frameworks on securing consent for genomic sequencing and how they apply to the specific context of RGS for critically ill children. We then use a tool from clinical ethics, the Zone of Parental Discretion, to explore two case studies and identify under which circumstances it might be appropriate for parental refusal of RGS to be overridden. We argue that RGS may be a context where, in addition to assessing the complexity of the test offered, it is ethically appropriate to consider an effect on patient outcomes when deciding the degree of consent required. We also suggest that there are some contexts where it may be ethically justified to perform RGS, even when it is actively against the wishes of the parents. More work is needed to examine exactly how ‘time-sensitive’ exceptions to current guidance on consent for genomic sequencing could be formulated and operationalised for RGS for critically ill-children. (shrink)

In 1993 the Law Lords upheld the original conviction of five men under the 1861 Offences Against the Person Act for participating in sado-masochistic practices. Although the five men were fully consenting adults, the Law Lords held that consent did not constitute a defence to acts of violence within a sado-masochistic context. This paper examines the judgements in this case and argues that sado-masochistic practices are no different from the known exceptions cited by the court to the idea (...) that consent is no defence to violence (sport, parental chastisement and surgery). It also argues that if we can make sense of rape as a non-consensual, violent act, expressed through sex, then we can make sense of sado-masochism as a consensual sexual act, expressed through violence. (shrink)

Literature on the ethics of researching refugees, both as participants and partners, presents strong arguments for why anonymity is the safer option in the event of questionable consent. However, blanket anonymity, without asking refugee interviewees if they wish to be anonymous, may cause more harm than good in certain contexts. One such context which this article will explore is the context of Israel, where a working Refugee Status Determination (RSD) system has yet to be established. This case study highlights (...) that, even in extreme circumstances where identity exposure can create risks, there may be a case for allowing identity exposure and perhaps an obligation on the part of the researcher to publish a name if this is the strong wish of the interviewee. This article builds on literature addressing confidentiality of identities (Duvell et al., 2010; Giordano et al., 2007; Kelly, 2009; Lahman et al., 2011; Lee, 1993; Mackenzie et al., 2007; Pittaway et al., 2010) and literature addressing informed consent (Hugman et al., 2011; Mackenzie et al., 2007; Pittaway et al., 2010; Zion et al., 2010). Primary sources demonstrating the use of waiving anonymity were collected between 2007 and 2012. Data were collected from refugee and activist civil society publications, television and newspaper media reports, participatory observation in the Israeli Knesset, and in-depth interviews with refugees and asylum seekers from South Sudan, Sudan, DR Congo, Liberia and Eritrea living in Tel Aviv, Jerusalem and Eilat. (shrink)

The #MeToo movement generated a feminist insistence that we “believe women.” But the men accused of assault, harassment, and other violations frequently defended themselves with the insistence that they had always “respected women” – sometimes, going so far as to get numerous women to sign letters swearing that these men had always respected them. This common MeToo defense reveals the core inconsistency – and the core entitlement – at the heart of misogyny and sexual injustice: some women deserve respect. But (...) the duty to respect those women relies on an invisible entitlement to disrespect – indeed, to assault, harass, dominate, or exploit – others. This chapter explores consent’s role within the superstructure of misogyny and sexual injustice, arguing what consent is a key apparatus of white supremacy. It argues that consent has been constructed through dynamics of colonial and racist sexual entitlement, mapping some (white) women as deserving of respect and the right to consent, while marking other women as expendable or disposable within the sexual economy. This means not only that consent is historically constructed as white, but also that whiteness, and in particular, white womanhood, is constructed through consent. Thus, white women’s right to consent – or to refuse – is premised upon the inability of other women to do so. In this way, the right to sexual consent does not disrupt the norm of male sexual entitlement. Consent has always been premised on non-consent, from coloniality and slavery to contemporary porn, which offers a vision of the world without proper consent, so that granting consent to actual women is an exceptional practice, an “act of respect.” By including race and class alongside gender in my analysis of consent, I argue that contemporary feminist visions of sexual justice must do more than defend or ameliorate consent, but develop intersectional interrogations of sexual justice that reckon with the complicities of consent. (shrink)

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: 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.. 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: the emergency research could not be conducted using other research participants capable of giving informed consent; and 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. 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. (shrink)

For obscure reasons, courts exclude some statutorily patentable inventions (‘judicial exceptions’) from patent protection. These exclusions have been criticized for impeding innovation, contrary to the purpose of patent law. I argue that freedom requires these exclusions even if they impede innovation. Patents, like property, can be unilaterally acquired, limiting others’ freedom without their consent. Kant explains why, to reconcile property with equal freedom, only rivalrous objects in acquirers’ first possession can be unilaterally acquired. States can rightfully authorize unilateral (...) acquisition of only these objects. Drawing from Kant, I explain how patent protection conflicts with equal freedom unless patented inventions involve inventive uses of rivalrous objects external to human bodies. Enabled by inventive concepts, these uses would be impossible without these concepts, and are thus in the first possession of their inventors. I then show how the most recent United States Supreme Court judicial exception decisions limit patent protection to inventive uses of rivalrous external objects. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Update on Waiving Informed Consent in Emergency ResearchCharles R. McCarthyMadam: The closing statement of my article on Waiving Informed Consent in Emergency Research published in the June 1995 issue of the Kennedy Institute of Ethics Journal was: "No doubt we shall hear more of this issue."Indeed, we have heard much more on this issue. (1) In May 1995, after my article had already gone to press, the (...) Food and Drug Administration (FDA) and the National Institutes of Health (NIH) jointly published a report on the Public Forum on Informed Consent in Clinical Research Conducted in Emergency Circumstances. (2) On July 26, 1995, the Department of Health and Human Services (HHS) published in the Federal Register a Notice of Action Related to Emergency Research Activity (60 FR 38353-54). This action constituted a waiver of the requirement to obtain prior informed consent from subjects, as required by the Department's Regulations for the Protection of Human Subjects (45 CFR 46), for one specific NIH-funded project under strictly defined circumstances. (3) On September 21, 1995, FDA published a proposed rule to amend its current informed consent regulations (21 CFR 50) to permit harmonization of federal policies on emergency research and to reduce confusion as to when such research can proceed without obtaining prior informed consent from research subjects. The proposed regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human research subject.The HHS waiver (a harbinger of a proposed amendment to its regulations) and the FDA proposed rule are intended to be harmonized so that an Institutional Review Board (IRB) in compliance with one set of regulations relative to the waiver of informed consent will be, ipso facto, in compliance with the other set of regulations.In brief: The FDA proposed amendments will allow an IRB to waive informed consent in emergency situations when:1. The human subjects are in a life threatening condition;2. Obtaining informed consent is not feasible because: (i) the subjects will not be able to provide consent because of their medical condition, (ii) the intervention must be administered before consent from legally authorized representatives is feasible, (iii) there is no reasonable way to identify prospectively the individuals likely to become eligible for the research because the emergence of the condition to be studied cannot be predicted reliably in particular individuals; [End Page 385]3. The opportunity to participate is in the interest of the subjects because: (i) a life threatening situation necessitates intervention, (ii) the risk of the intervention is reasonable in the light of what is known about the medical condition and the patient, the risks and benefits of current therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity;4. The research could not practicably be carried out without the waiver;5. Additional protection of the rights and welfare of the subjects will be provided including, at least: (i) consultation (which may include consultation carried out by the IRB itself) with representatives of the communities from which the subjects will be drawn, (ii) public disclosure prior to commencement of the study sufficient to describe the study and its risks and benefits, (iii) public disclosure of sufficient information following completion of the study to apprise the community and researchers of the study and its results, and (iv) the establishment of an independent data and safety monitoring board;6. The IRB has reviewed and approved an informed consent document for use with subjects or legal representatives in situations in which obtaining such consent may be feasible for some subjects.The preamble to the proposed amendments to the regulations and the amendments themselves contain much more information than is presented here. Readers are therefore encouraged to study the proposals carefully. The public comment period ended November 6, and the FDA is expected to issue a final rule in 1996.Charles R. McCarthyKennedy Institute of Ethics Georgetown University Washington, DCCopyright © 1995 The Johns Hopkins University Press... (shrink)

This paper looks at the issue of consent from children and whether the test of Gillick competency, applied in medical and healthcare practice, ought to extend to participation in research. It is argued that the relatively broad usage of the test of Gillick competency in the medical context should not be considered applicable for use in research. The question of who would and could determine Gillick competency in research raises further concerns relating to the training of the researcher (...) to make such a decision as well as to the obvious issue of the researcher’s personal interest in the project and possibility of benefiting from the outcome. These could affect the judgment of Gillick competency if the researcher is charged with making this decision. The above notwithstanding, there are two exceptional research situations in which Gillick competency might be legitimately applied: when the research is likely to generate significant advantages for the participants while exposing them to relatively minor risks, and when it is likely to generate great societal benefit, pose minimal risks for the participants and yet raise parental objection. In both cases, to ensure that autonomy is genuinely respected and to protect against personal interest, Gillick competency should be assessed by an individual who has no interest or involvement in the research. (shrink)

It is argued here that the practice of medical students performing pelvic exams on women who are under anesthetic and have not consented is immoral and indefensible. This argument begins by laying out the ethical justification for the practice of informed consent, which can be found in autonomy and basic rights. Foregoing the process of consent within medicine can result in violations of both autonomy and basic rights, as well as trust, forming the basis of the wrong of (...) unauthorized pelvic examinations. Several objections to this argument are considered, all of which stem from the idea that this practice constitutes an exception to the general requirement of informed consent. These objections suggest that nonconsensual pelvic examinations on women under anesthetic are ethically acceptable on utilitarian grounds, in that they offer benefits either to the patient or to society, or on the grounds of triviality, in that consent is already presumed, or the practice is insignificant. Each of these objections is rejected and the practice is deemed indefensible. (shrink)

This journal has frequently taken the position that /consent/, or at least /informed consent/, is all that from a secular viewpoint is necessary for an activity to be ethical. We argue to the contrary, that /consent/ is and /only/ is a /political/ criterion for determining /criminality/—even for a libertarian. Consensual behavior can be /unethical/—although it should not be criminalized—if the consent will never be truly revocable in the future of if such revocability is severely compromised. (...) We give three examples, one from common experience, and two from the areas normally covered in this journal. -/- Note: I was asked my the senior chief editor to limit categories to five, and have never exceeded (below) six, with one exception which has seven; proper fine-grained categorization of this piece would exceed ten categories, so I have done my best with five. (shrink)

The new biotechnology raises expectations for modifying human behaviour through its use. This article focuses on the ethical analysis of the not so remote possibility of rehabilitating criminals by means of neurotechnological techniques. The analysis is carried out from a synthetic position of, on the one hand, the consequentialist conception of what is right and, on the other hand, the emphasis on individual liberties. As a result, firstly, the ethical appropriateness of adopting a general predisposition for allowing the neurorehabilitation (...) of prisoners only if it is safe and if they give their consent will be defended. But, at the same time, reasons will be given for requiring, in certain circumstances, the exceptional use of neurotechnology to rehabilitate severely psychopathic prisoners, even against their will, from the same ethical perspective. (shrink)

During the last 25 years, rape law has undergone a profound transformation, as the articles in this symposium clearly show. To mention just three of the more striking doctrinal reformations: All states have repealed the most egregious aspects of die marital rape exception; most have abandoned the “utmost resistance” requirement; and all have enacted rape shield laws to protect complaining witnesses from intrusive inquiries into their sexual history. All three reforms were the product of feminist agitation, all three (...) were aimed toward the general end of redirecting rape law toward the protection of women's, rather than men's, interests, and all three did, to some degree, broaden and democratize the scope of the law's protection: Wives, prostitutes, promiscuous girls, and women not inclined to risk their deaths by fighting off their rapists “to the utmost” are now protected by the law of rape against sexual assault, at least in theory, and at least to the same degree as non-wives and non-prostitutes, fighters, and virgins. All of this, virtually every contributor to this symposium agrees, is very much to the good. (shrink)

This paper considers the ethics of routine antenatal HIV testing and the role of informed consent within such a policy in order to decide how we should proceed in this area—a decision that ultimately rests on the relative importance we give to public health goals on the one hand and respect for individual autonomy on the other.A recent illuminating qualitative study by Zulueta and Boulton1 explores the practicalities of informed consent in routine antenatal HIV testing. Its results support (...) what I have argued1 is inevitable with routine testing policies of this kind: that routine antenatal testing regimes are incompatible with requirements for informed consent. It has become clear that intervention could reduce the risk of transmitting HIV from mother to child from 15–20%2 to around 8%,3 or possibly as low as 2%.4,5 The evidence of this possibility produced a general trend towards introducing routine antenatal HIV screening in developed countries worldwide.6,7,8,9,10 The aim was to dramatically reduce the rate of HIV transmission from mother to child by encouraging universal antenatal HIV testing. The UK has been no exception, and in 1999 the government instructed health authorities to implement a policy of offering and recommending an HIV test to all pregnant women.11This UK antenatal screening policy and others like it, although well-meaning, are problematic in their formulation. In order to reflect contemporary ethical and legal practice, such policies attempt to marry the public health aims of maximising uptake of testing with a commitment to respect the choices of patients by requiring informed consent before they participate in screening. Thus, in the case of UK policy, health professionals are instructed to recommend the HIV test to all pregnant women in order to achieve the target of a 90% …. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:To Be or Not to Be:Waiving Informed Consent in Emergency ResearchCharles R. McCarthy (bio)The requirements for prior, legally authorized informed consent constitute a necessary condition for recruiting subjects into biomedical or behavioral research. However, informed consent requirements pose a serious problem for most research conducted in emergency care settings. For this reason, the Food and Drug Administration's (FDA) regulations governing investigational devices and the Department of (...) Health and Human Services' (HHS) regulations for the protection of human subjects allow narrow exceptions to the general requirements of informed consent. In a joint effort to clarify the applicability of the current FDA regulations and to better understand the intent of the HHS regulations as they apply to emergency research, the FDA and the National Institutes of Health (NIH) cosponsored a public forum on the ethical conduct of emergency research in January 1995.Although the forum was not designed as a consensus conference and participants vigorously disagreed on some of the details, a broad consensus emerged on several major points: (1) both HHS and FDA regulations should, in the immediate future, be interpreted to allow for randomized clinical trials in emergency situations so long as the subjects are carefully protected; and (2) consideration should be given to producing new, closely harmonized regulations from both agencies that will provide greater clarity concerning what kinds of emergency research may be allowed without obtaining prior informed consent.The FDA-NIH forum in January was occasioned primarily by controversy about the hypothermia research protocol described below, but it is obvious that many other kinds of emergency research also await the outcome of deliberations concerning waiver of informed consent in emergency situations. These include research into the care and treatment of: occlusive stroke; subarachnoid hemorrhage due to intracranial aneurysm; metabolic coma; status epilepticus; cardiac arrest; myocardial infarction; cardiac arrhythmia; hemorrhagic shock; pulmonary embolism; acute asthmatic attack; and poisoning. All of these conditions [End Page 155] are encountered in emergency settings where obtaining informed consent from the patient-subjects to participate in research is seldom possible, and obtaining consent from legally authorized representatives of the subjects is either not feasible, or, if obtained, is of doubtful validity.The Hypothermia Research Case and HHS RegulationsA $7.2 million grant for research on the use of hypothermia in the treatment of severe head trauma, the largest award ever made to the University of Texas Health Sciences Center at Houston, is in danger of expiring before the study is completed. The protocol, which involves the use of cooling blankets to induce hypothermia in patients suffering from severe head injuries, is designed to test the hypothesis that: "Early lowering of the body temperature of patients suffering from severe head trauma to approximately 91 degrees Fahrenheit will slow patients' metabolism and will/will not, as a consequence, reduce the rates of both morbidity and mortality in these patients." The protocol was approved by seven Institutional Review Boards (IRBs), each of which waived the requirement to obtain informed consent from research subjects in accordance with Sec. 46. 116(d) of the HHS Regulations for the Protection of Human Subjects.1However, NIH's Office for Protection from Research Risks (OPRR), which is responsible for assuring compliance with the HHS regulations, has taken a controversial regulatory position by requiring informed consent from a legally authorized representative of each subject to be entered in the hypothermia trial. Because the obtaining of surrogate consent has proved to be very difficult, OPRR's position has slowed the research to a point where it may have to be terminated.At issue in the controversy is a fundamental question of ethics and public policy. Is it ever permissible to involve incompetent subjects in research without either their consent, or the consent of their legally authorized representatives? Pertinent HHS regulations for the protection of human subjects seem to answer the question affirmatively by allowing local IRBs to waive some or all of the elements of informed consent under carefully limited circumstances (45 CFR 46 116(d)). Nevertheless, OPRR has signalled the research community that use of the informed consent waiver provision for the Houston hypothermia study is not permitted under the regulations. OPRR judged that the risks... (shrink)

The right to withdraw from research without penalty is well established around the world. However, it has been challenged in some corners of bioethics based on concerns about various harms—to participants, to scientific integrity, and to research bystanders—that may stem from withdrawal. These concerns have become particularly salient in emerging debates about the ethics of controlled human infection (CHI) studies in which participants are intentionally infected with pathogens, often in inpatient settings with extensive follow‐up. In this article, I (...) provide support for preserving the right to withdraw from research without penalty and demonstrate that it is also typically justified in the specific context of CHI studies. The right is well aligned with individual freedoms outside the research setting, where autonomous individuals are permitted to engage in behaviors that will foreseeably cause them harm; where they cannot be compelled to satisfy contracts for their services, nor penalized for failure to do so; and where their behavior is not constrained by public health authorities except in extreme circumstances. These freedoms are supported by U.S. law, as well as by ethical analysis that is more globally relevant. The problems associated with the right to withdraw, however, remain. The best approach to addressing them is not to restrict the right but rather to avoid initiating research when withdrawal would be especially problematic. If research proceeds, steps can still be taken to minimize participant withdrawal without infringing the right. Investigators can avoid participant surprise through informed consent focused on a study’s most burdensome aspects and promote study completion through financial incentives. Should participants nonetheless seek to withdraw, investigators may attempt to persuade them not to do so by encouraging consideration of the range of potential harms that may result. Researchers conducting CHI studies and other research from which withdrawal might be especially problematic should prepare for the possibility of participant withdrawal, respect participant requests to withdraw without penalty, and incorporate various measures to avoid such requests. (shrink)

Using patients as teaching tools raise many ethical issues like informed consent, privacy, confidentiality and beneficence. The current study highlights issues on respecting patient’s choice and acquiring informed consent with its spirit rather than as mere formality. The study was conducted in out-patient department of The Kidney Center Postgraduate Training Institute Karachi Pakistan in May 2008 to July 2008. All patients who had come for the first time to see the author were included in the study. The said (...) study explored the willingness of patients to allow medical students to be present during history taking and physical examination by the consultant. There were 18 male and 03 female patients. Age ranging from 22 to 73 years with mean age of 53.5 ± 13.7 years. There were total of 21 patient–students encounters out of which two encounters were with male students only and two with female students only. So in 17 Patient–students encounters, students of both genders were present. All patients permitted history taking in the presence of medical students except one who had a history of extramarital sexual contact and signs and symptoms suggestive of sexually transmitted disease. Of the male patients 50% (9/18) did not allow intimate examination before medical students. Out of these nine patients who refused, four consented earlier but when enquired again about their true willingness, they expressed their preference not to have medical students in the room while undergoing digital rectal and external genital examinations. Physicians need to develop sensitivity to acquire informed consent in its true essence rather than just as a formality by exploring actual willingness of the patient. One should refrain from being judgmental on the basis of gender, looks, religion or norms. (shrink)

There is significant research value in the secondary use of surplus human tissue which has been removed during clinical care and is stored in diagnostic archives. However, this value is limited without access to information about the person from whom the tissue was removed. As the research value of surplus tissue is often not realised until after the patient’s episode of care, it is often the case that no consent has been given for any surplus tissue to be (...) used for research purposes. The Human Tissue Act 2004 does permit research use of surplus tissue without consent, but the researcher must not be in possession of information which could identify the person from whom the tissue was removed. Due to the commonly applied ‘consent or anonymise’ approach, linking tissue and data is challenging and full anonymisation would likely render much research on surplus tissue ineffectual. This article suggests that in recognising the value in surplus tissue linked with information about the person, a ‘share and protect’ approach which considers safeguards other than anonymisation, where obtaining consent for research use would not be feasible, would better balance the public benefit of health research with the protection of individual rights and interests than a requirement for either consent or anonymisation. (shrink)

Business ethics – both stockholder and stakeholder theories – makes the same mistake as the one made by the traditional ethics of medicine. The traditional ethics of medicine was a teleological ethics predicated on the assumption that the goal of medicine was to prolong life and promote better health. But, as bioethicists have made plain, these are not the only or even the overriding goals of most patients. Most of us have goals and values that limit our desire for medical (...) treatments. Similarly, the view of the stockholder in business ethics is that the stockholder has only one interest – profit. If stockholders have no other values or interests that would limit their desire for additional profit, their sole interest is in profit maximization. But investors are real people with interests and values that balance and limit their desire for profit. It would be an extremely odd individual who cared for nothing except more profit. And institutional investors are supposed to serve the interests of individual investors. Stockholders hold many stakes in the firms in which they invest. The conclusion that most stockholders have interests that would limit the pursuit of maximum profit has significant implications both for business ethics and for the management of for-profit corporations. Something like “informed consent for investors” is needed. Corporate managers, to the extent that they are to be agents of their stockholders, must not simply pursue profit maximization. They must ascertain the interests and values of their investors that limit the single-minded pursuit of profit. (shrink)

American legal theorists frequently ask whether and how theorists, citizens, lawmakers, judges, and other public officials can attain truth, correctness, or certainty in their legal and moral views. This essay discusses the views of contemporary liberal legal theorists who have attempted to answer these questions in a way that is neither objectivist nor formalist, on the one hand, nor subjectivist or relativist, on the other, referring to authors that make up this group as theorists of the "middle way." The essay (...) suggests areas in which such legal thinkers might profit from studying Aristotle's writings about ethics and politics. Two approaches of contemporary liberal legal theory of the middle way are discussed. The first is characterized by a reluctance to have recourse to substantive moral and political principles that exist independently of a particular legal order. Because of their reluctance to import substantive standards external to a nation?s legal system into legal reasoning, this approach advocates to a much greater degree than the second approach reliance on communal deliberation and various structural, procedural, and related devices to constrain deliberations about human values and conduct. This study outlines some of the central beliefs of this process-oriented approach to practical knowledge and then analyzes how Aristotle might react to them. The beliefs discussed are the place and method of communal reasoning about practical matters; self governance and consent; self-governance and transformative political participation; and the emphasis on ideal speech conditions to legitimate the products of communal deliberation. The second approach of contemporary liberal legal theory of the middle way discussed in the essay is characterized by a belief that moral or political philosophy can arrive at some measure of truth about principles and values having to do with the lives of individuals and the conduct of communities. With one exception, the theorists discussed in this part of the essay are willing to recognize and incorporate such principles and values into practical reasoning that takes place within the confines of a particular legal system such as our own. These thinkers disagree about the degree to which and the occasions on which recourse to values external to a political community should occur. This essay discusses how Aristotle might react to the major ideas common to these thinkers. The ideas discussed in this part are the sources of external substantive values that legal reasoning might incorporate; the relative roles of consent and habit in securing obedience to the law; and the connection between deliberation and character. (shrink)

This article analyzes business and union strategies in the reform of job security regulations. It argues that unions are the main political actors pushing for their expansion of regulations, but given employers’ opposition, unions are able to enforce better protection only in exceptional periods. Once the first restrictions are in place, employers use their power advantages at the workplace level to circumvent regulations, which unions combat by reducing the level of discretion awarded to employers in interpreting regulations. In recent decades, (...) job security regulations have come under increasing pressure. Unions have reacted to this new situation by consenting to the continuous deregulation of temporary employment, while they fight any attempt at deregulating job security in open-ended contracts in order to protect their members’ interests and their institutional involvement in the administration of dismissals. The theoretical argument is supported by empirical evidence from four Western European countries since the postwar period. (shrink)

Within a state-space approach endowed with a generalized potential function, mental states can be systematically characterized by their stability against perturbations. This approach yields three major classes of states: (1) asymptotically stable categorial states, (2) marginally stable non-categorial states and (3) unstable acategorial states. The particularly interesting case of states giving rise to exceptional experiences will be elucidated in detail. Their proper classification will be related to Metzinger’s account of self-model and world-model, and empirical support for this classification will be (...) surveyed. Eventually, it will be outlined how Metzinger’s discussion of intentionality achieves pronounced significance within a dual-aspect framework of thinking. (shrink)

BackgroundThis paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi.DiscussionThe current research ethics regulations and guidelines in Malawi do (...) not allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes.SummaryIn conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi. (shrink)

Volume 19, Issue 9, September 2019, Page 37-39.

This article will focus on the ethical issues of vaccine mandates and stake claim to the relatively extreme position that outright requirements for people to receive the vaccine are ethically correct at both the governmental and institutional levels. One novel strategy employed here will be to argue that deontological considerations pertaining to consent rights cut as much in favor of mandating vaccines as against them. The presumption seems to be that arguments from consent speak semi-definitively against forcing (...) people to inject something into their bodies, and so any argument in favor of mandates must produce different and overriding logical and ethical considerations. Our central claim will be that the same logic that might seem to prohibit vaccine mandates as violations of consent actually supports such mandates when viewed from the perspective of the potential bystander who might otherwise be exposed to COVID-19. (shrink)

This here snake skin jacket is a symbol of my individuality and belief in freedom.—Sailor Ripley, in Wild at Heart (dir. David Lynch, 1990)Like Sailor Ripley’s manic odyssey down the American yello...

In many ways, questionable epidemiological measures by which the authorities restricted civic and private life during the COVID-19 pandemic have challenged many implied notions of the inviolability of citizens’ rights and freedoms, as well as obedience to state authority. It is a problem of the incommensurability between freedom and law seen through the conflict between personal rights and the demands of the common good. This article examines how a state of emergency, such as a pandemic, affects the perception of the (...) legitimacy of the State. In this, it relies on some key concepts from Carl Schmitt’s political theology, such as the “exception”, “the sociology of legal concepts”, the “nature of sovereignty”, the formal criterion of the political as a specific way of thinking, and acting and “stasiological” nature of the political. (shrink)

Much of the debate concerning political obligation deals with the question of which, if any, moral principles could make obedience to the directives of the government a matter of obligation. What makes political obligation political has not received attention in the literature on the topic. In this article I argue that the lack of systematic reflection on what makes political obligation political is responsible for the failure of a number of influential theories of political obligation. I demonstrate this failure using (...) the consent theory of political obligation as my major example. I conclude my analysis by formulating some positive conditions that a successful principle of political obligation should satisfy. (shrink)