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.     

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.     

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.     

Modified informed consent in a viral seroprevalence study in the Caribbean

An unlinked seroprevalence study of HIV and other viruses was conducted on pregnant women on the Caribbean island of Grenada in 1994. Investigators were from both the developed world and the Grenadian Ministry of Health (MOH). There was then no board on Grenada to protect research subjects or review ethical aspects of studies. Nurses from the MOH were asked to verbally inform their patients about the study, and request that patients become subjects of the study and give blood for screening. If consent was given nurses took blood and administered a survey about each subjects' knowledge of HIV transmission routes. Nurses shared a spoken dialect and cultural heritage with prospective subjects and were probably more effective than foreign researchers at informing subjects. Informed consent was obtained with a simplified consent form supplemented by conversation with each prospective research subject. Facilitating discussion between people with common cultural backgrounds helps apply the Western approach to informed consent to communities in the developing world. Researchers must disclose all information to nurses or other mediators, and ensure that nurses disclose as much information as possible to prospective subjects. So modified, informed consent maintains respect for persons and becomes applicable and relevant to various cultures.     

The role and responsibilities of witnesses in the informed consent process

Various mechanisms to ensure the protection of subjects in human research have been suggested, including the presence of witnesses during the informed consent process. For our commentary on the use of witnesses and their potential role and responsibility during the consent process, we start by addressing current guidelines for human subjects research in four Latin American countries. By using examples from public health research, we highlight some of the practical difficulties of using witnessed consent, from becoming a meaningless ritual at one end of the spectrum to the research subject feeling intimidated or coerced to participate at the other. Apart from these practical difficulties, it is unclear what responsibility the witness could and should have. We argue that there are important ethical questions about the role of witnesses that have not been adequately addressed in national and international regulations. This work addresses these gaps and argues that more debate is required to define the role and responsibilities of witnesses in the consent process, their training requirements and whether a universal legal requirement for witnessed consent, regardless of the type of research, is desirable.     

Evaluation of the content and process of informed consent discussions for neonatal research

studies of informed consent for neonatal research suggest that there are gaps in parental understanding of key aspects of research. Few studies have examined parental understanding and investigator disclosure simultaneously. This pilot study evaluated the content and processes of 21 audio-recorded consent discussions with parents of eligible newborns, as well as parents' self-reported comprehension of research elements following these discussions. Gaps in both investigator disclosure and parental understanding were found. Nevertheless, parents reported comprehension of a greater number of research elements than were actually disclosed by investigators. Our preliminary results indicate the feasibility and potential utility of jointly examining parental understanding and investigator behavior to characterize consent for neonatal research. Directions for future research are suggested.     

Anonymity and informed consent in artificial procreation: a report from Denmark

The practice of informed consent in biomedicine is so widely spread that it must be considered the most important principle within bioethics, and the most universally appealed to within recent legislation. There seems to be a consensus as to its value in research on autonomous persons, but also a problem concerning its application when dealing with people having a serious mental, social or even physical disability.
Within the field of artificial procreation there are even more problems. Informed written consent is often demanded from anonymous donors of gametes in order to ensure their consent to the legal and moral consequences of their anonymity. The child resulting from the artificial procreation, on the contrary, cannot consent to, nor be informed before being conceived, of the secrecy laid on the identity of its genetic parents. Some countries resolve this problem by allowing the children, when they reach their majority, to obtain some information pertaining to the health or the identity of their genetic parents.
This presents ethical problems. It can be argued that the anonymity of the parents chiefly affects the children, so that an agreement on this point among parents, doctors and others must be regarded as invalid. The paper will argue that a law ensuring the complete anonymity of the parents is disregarding the informed consent and the interests of the children resulting from artificial procreation, and is thus doing more damage to society than good.