The importance of the values attached to cells for a good informed consent procedure in cell donation for tissue engineering purposes

In this article the scope and contents of informed consent for cell donation in tissue engineering are discussed. We evaluate the various values donors may attach to cells and that may influence their decision to donate. Awareness of the various meanings of the value of the cells is therefore essential for all involved in cell transfer. We discuss four types of value: biological, relational, material and informational value and discuss their relevance for collection, for the relationships that are established between donor and cell collector and for informed consent procedures. The actual setting of cell donation and the contents of informed consent can either maintain or disrupt these relationships. While one can exclude donors from any further say in the destination of their cells and from any financial return, one cannot exclude them from a persistent interest in the genetic information of the cells.     

Informed consent to tissue donation: policies and practice

Nearly 10 years ago, the tissue industry’s informed consent practices with donor families in the United States were criticized. In response, the industry, along with the Inspector General of the Department of Health and Human Services, suggested elements to be included in the informed consent process. This study examines which of these elements were present in the informed consent documents of 45 (78%) of the nation’s 58 Organ Procurement Organizations (OPOs). Some elements, such as involvement of for-profit companies, were present in almost all. Others, such as labeling tissue as a gift from donor families, never were. The authors conclude that the time is ripe for reexamination of the informed consent process with an eye to meaningful consent that promotes the benefits of tissue transplantation and at the same time protects the rights and interests of donor families; can be realistically implemented; and, maintains the trust of the American public.     

Ethical obligation and legal requirements: On informed consent practices in Bangladesh

Informed consent to medical intervention is fundamental in both ethics and law. But in practice it is often not taken seriously in developing countries. This paper provides an appraisal of informed consent practices in Bangladesh. Following a review of the ethical and legal principles of informed consent, it assesses the degree to which doctors adhere to it in Bangladesh. Based on findings of non-compliance, it then investigates the reasons for such non-compliance through an appraisal of informed consent practices in Bangladesh and provides recommendations aimed at improving such practices. The significance of this paper lies in unveiling the interdependence between the ethical and legal traits of informed consent and their ramifications on strengthening the patient-oriented approach of duty to care.     

Ethical frameworks for obtaining informed consent in tumour profiling: an evidence-based case for Singapore

Background

Genomic profiling of malignant tumours has assisted clinicians in providing targeted therapies for many serious cancer-related illnesses. Although the characterisation of somatic mutations is the primary aim of tumour profiling for treatment, germline mutations may also be detected given the heterogenous origin of mutations observed in tumours. Guidance documents address the return of germline findings that have health implications for patients and their genetic relations. However, the implications of discovering a potential but unconfirmed germline finding from tumour profiling are yet to be fully explored. Moreover, as tumour profiling is increasingly applied in oncology, robust ethical frameworks are required to encourage large-scale data sharing and data aggregation linking molecular data to clinical outcomes, to further understand the role of genetics in oncogenesis and to develop improved cancer therapies.

Results

This paper reports on the results of empirical research that is broadly aimed at developing an ethical framework for obtaining informed consent to return results from tumour profiling tests and to share the biomolecular data sourced from tumour tissues of cancer patients. Specifically, qualitative data were gathered from 36 semi-structured interviews with cancer patients and oncology clinicians at a cancer treatment centre in Singapore. The interview data indicated that patients had a limited comprehension of cancer genetics and implications of tumour testing. Furthermore, oncology clinicians stated that they lacked the time to provide in depth explanations of the tumour profile tests. However, it was accepted from both patients and oncologist that the return potential germline variants and the sharing of de-identified tumour profiling data nationally and internationally should be discussed and provided as an option during the consent process.

Conclusions

Findings provide support for the return of tumour profiling results provided that they are accompanied with an adequate explanation from qualified personnel. They also support the use of broad consent regiments within an ethical framework that promotes trust and benefit sharing with stakeholders and provides accountability and transparency in the storage and sharing of biomolecular data for research.

     

A multimedia tool for the informed consent of patients prior to gastric banding

Objective: Severe obesity is a clear indication for appropriate, effective weight loss therapy. One option is operative intervention, e.g., gastric banding. Risks of the operation and therapeutic alternatives need to be comprehensibly presented to the patient. The literature has shown that better informed consent is obtained using information presented in a multimedia/video‐based format. The current study developed and evaluated a multimedia program aimed at obtaining informed consent from obese patients before gastric banding. Research Methods and Procedure: An interactive multimedia program was developed with information about preoperative examinations, the operation itself, hospital stay, operative risks, alternative therapies, and the pathophysiology and health risks of obesity. Two groups (Group 1, n = 20, mean age 38 years, informed consent attained with conventional document information; Group 2, n = 20, mean age 37 years, informed consent attained with additional multimedia information) were interviewed regarding comprehensibility of the information presented, personal satisfaction, and anxiety levels during the informed consent process. Results: Group 2 showed significantly better (p < 0.05) understanding of the presented information and higher levels of satisfaction with the informed consent process. Anxiety levels did not significantly differ between the two groups. Discussion: Because patient satisfaction with the informed consent process and understanding of the presented information significantly improved, the multimedia program clearly benefits both surgeons and patients. Personal contact from the surgeon remains essential. High volumes of information presented in multimedia format do not alleviate patient anxiety, and personal contact may be beneficial.     

'Science is really needed--that's all I know': informed consent and the non-verbal practices of collecting blood for genetic research in northern Sweden

In Vasterbotten County in northern Sweden a start-up biotech company has recently gained all commercial rights to one of the worlds largest population based research biobanks. The biobank and the company have publicly emphasized that all donors have given their informed consent to participate, but within the academy it has become debated whether people have been adequately informed. Based on anthropological fieldwork it is shown that many people do not read the information provided. The data do not, however, suggest that donors themselves perceive a lack of information. This article endeavours to make meaningful the apparent lack of interest among donors in the information they are offered. It is argued that the donation of blood should be analysed in its social and historical context rather than as a response to rational assessment of information of research purposes. It implies a conceptualisation of agency more aware of the intersubjective nature of moral negotiation than usually implied in studies of informed consent.     

Understanding informed consent for participation in international health research

To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 led to a response from drug companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually – based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences.     

Participant informed consent in cluster randomized trials: review

Background

The Nuremberg code defines the general ethical framework of medical research with participant consent as its cornerstone. In cluster randomized trials (CRT), obtaining participant informed consent raises logistic and methodologic concerns. First, with randomization of large clusters such as geographical areas, obtaining individual informed consent may be impossible. Second, participants in randomized clusters cannot avoid certain interventions, which implies that participant informed consent refers only to data collection, not administration of an intervention. Third, complete participant information may be a source of selection bias, which then raises methodological concerns. We assessed whether participant informed consent was required in such trials, which type of consent was required, and whether the trial was at risk of selection bias because of the very nature of participant information.

Methods and Findings

We systematically reviewed all reports of CRT published in MEDLINE in 2008 and surveyed corresponding authors regarding the nature of the informed consent and the process of participant inclusion. We identified 173 reports and obtained an answer from 113 authors (65.3%). In total, 23.7% of the reports lacked information on ethics committee approval or participant consent, 53.1% of authors declared that participant consent was for data collection only and 58.5% that the group allocation was not specified for participants. The process of recruitment (chronology of participant recruitment with regard to cluster randomization) was rarely reported, and we estimated that only 56.6% of the trials were free of potential selection bias.

Conclusions

For CRTs, the reporting of ethics committee approval and participant informed consent is less than optimal. Reports should describe whether participants consented for administration of an intervention and/or data collection. Finally, the process of participant recruitment should be fully described (namely, whether participants were informed of the allocation group before being recruited) for a better appraisal of the risk of selection bias.     

Lay concepts in informed consent to biomedical research: the capacity to understand and appreciate risk

Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the capacity to understand and appreciate the information. There has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk.     

Factors associated with consent for organ donation: a retrospective population-based study

Background:Optimizing the approach to and consent of potential organ donors maximizes patient autonomy and the availability of organs for transplants. We set out to identify modifiable factors associated with donation consent.Methods:We conducted a retrospective cohort study of consecutive adults (≥ 18 yr) referred for organ donation in Ontario between April 2013 and June 2019. We analyzed patient clinical data and demographics, data on substitute decision-makers and characteristics of the donation consent approach. Study outcomes were consent for organ donation and approach rate. We evaluated independent associations between consent and approach-and system-level factors.Results:We identified 34 837 referrals for organ donation, of which 6548 (18.8%) substitute decision-makers were approached for consent. Of these, 3927 (60.0% of approaches) consented for organ donation and 1883 (48.0% of consents) patients proceeded to be organ donors. The most common reason substitute decision-makers were not approached for consent in a case with donation potential was a late referral by the health care team (45.2%). Modifiable factors independently associated with consent included a telephone approach for consent (adjusted odds ratio [OR] 0.46, 95% confidence interval [CI] 0.35–0.58) and a collaborative approach by a physician and donation coordinator (adjusted OR 1.26, 95% CI 1.01–1.59).Interpretation:Consent for organ donation was associated with several modifiable factors. Organizations should target interventions to ensure timely referrals to organ donation organizations, increase in-person consent approaches and increase physician participation in the approach process.

Many people die on transplant waiting lists because the demand for organs outstrips supply. Almost 4500 people are on organ transplant waiting lists in Canada. Despite public support for organ donation across Canada,¹ donation rates vary between 8.8 and 21.2 donors per million population, ² and a substantial pool of potential donors is not being realized. ^2,3 The identification, referral and approach of potential donors can be facilitated by policy, legislation and best practices, ^3,4 although the efficacy of interventions is variable across jurisdictions.^5,6 Some comprehensive interventions to increase donor numbers have not changed consent rates,⁷ suggesting that the consent approach process may be a target for improvement.Substitute decision-makers play an important role in the organ donation process, even in jurisdictions with donation consent registries or opt-out consent systems. Substitute decision-makers are almost always asked permission for organ donation, even when there is a registered donation consent,⁸ and their consent rates vary widely.⁹ Substitute decision-makers faced with consent decisions often do so in emotionally charged circumstances, and many do not know the explicit wishes of the patient.¹⁰ Given this context, the process of obtaining consent and the supports provided may have a substantial impact on the decision. Practices have been identified that improve consent rates from substitute decision-makers,¹¹ and these are routinely performed by large, high-performing organ donation organizations. Several epidemiological studies have identified nonmodifiable factors associated with donation consent (e.g., race, age, socioeconomic status and education).^12–15 The persistent variability in consent rates suggests that other modifiable factors may influence a substitute decision-maker’s decision to consent.We aimed to identify modifiable approach-and system-level factors that were associated with positive consent for organ donation in Ontario, Canada.     

Are women sufficiently well informed to provide valid consent for the cervical smear test?

Three hundred women attending colposcopy for the first time, following an abnormal cervical smear, were invited to fill in a questionnaire. This covered aspects of their understanding of the cervical smear test and the NHS Cervical Screening Programme (NHSCSP). In addition, it covered aspects of consent to the test. The response rate was 83%. Seventy percent thought that the NHSCSP is working well and 72% were aware that probably over 3000 cases of cervical cancer per year are being saved by the NHSCSP. However, 55% did not know that the death rate from cervical cancer is decreasing. 96% were aware that the main reason for a cervical smear is to prevent the development of cervical cancer, by finding early treatable abnormalities. Similarly, 94% were aware that the presence of abnormal cells on a cervical smear indicated a possible but not definitive indication of cervical precancer or cancer. Disappointingly, only 5 had seen the new NHSCSP information poster on the cervical smear test and only 44% had been given written information about the test. Consent for the test in 59% of women had been implied rather than expressed and 30% of women providing expressed consent had signed to that effect. In 42% of women, the smear taker or a doctor had failed to discuss the reason for having a cervical smear and had not explained about its advantages and limitations. In 72%, the smear taker or doctor had not explained that the cervical smear test can never be 100% accurate and that some laboratory errors are unavoidable. It is likely that women attending for colposcopy are a highly motivated cohort in relation to their understanding of the cervical smear test and the NHSCSP. Accordingly, understanding in the more general female population is likely to be considerably less. It would appear that women are often suboptimally informed to provide valid consent for the cervical smear test.