Anonymity and Informed Consent in Artificial Procreation

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.     

The Role of Regret in Informed Consent

Informed consent to medical procedures tends to be construed in terms of principle-based ethics and one or other form of expected utility theory. These constructions leave problems created by imperfect communication; subjective distress and other emotions; imperfect knowledge and incomplete understanding; complexity, and previous experience or the lack of it. There is evidence that people giving consent to therapy or to research participation act intuitively and assess consequences holistically, being influenced more by the magnitude of outcomes than their probability. People avoid decisions they may regret, but modern regret theory has received little attention in discussions of informed consent. This essay suggests ways in which regret may be acknowledged in the consent process and in the assessment of the information that is an intrinsic part of it.     

Research, Informed Consent, and the Limits of Disclosure

According to this paper, respect for informed consent implies that subjects should often be told a good deal more than ethical guidelines explicitly or implicitly require. Unless subjects are informed of the researchers' personal characteristics, views, and sponsors whenever they would be likely to consider them significant, their autonomy is being overridden. However, overriding subjects' autonomy is sometimes required by the interests of researchers in not being discriminated against or suffering intrusions into their privacy. This paper resolves the conflict between informed consent and the interests of researchers by recommending that (i) subjects generally should be told of the personal characteristics of researchers when relevant as part of the researchers' job and (ii) that subjects should be told of researchers' views when conceptually connected to the research and (iii) that subjects should almost always be told about sponsorship. While the paper explicitly limits the role of informed consent, these recommendations go significantly beyond most guidelines in their requirements about what information should be disclosed.     

The Definition of Placebo in the Informed Consent Forms of Clinical Trials

Aim

Lack of knowledge concerning the nature of placebo and why it is necessary may influence the participation of patients in clinical trials. The objective of the present study is to review how placebo is described in written information for participants in clinical trials to be evaluated by a Human Research Ethics Committee.

Methods

All research protocols submitted for evaluation in a Spanish hospital during 2007–2013 were reviewed. The main characteristics of the studies using a placebo were collected. Three authors read each of them to determine how the term “placebo” was explained and if there was any comment on its efficacy and safety.

Results

Two thousand seven-hundred and forty research protocols were evaluated, of which three hundred and fifty-nine used a placebo. Pharmaceutical companies sponsored most placebo-controlled clinical trials (91.9%), and phase III studies were the commonest (59.9%). Oncology (15.0%), cardiology (14.2%), and neurology (13.1%) made the greatest contributions. A review of the informed consent forms showed that placebo was described in a similar manner in most studies: the explanation was limited to between four and eight words. Very few gave information about the risks of its use or adverse reactions from its administration. None of the studies provided details about the placebo effect. And 23 lacked any information about placebo at all.

Conclusions

Explanations about placebo in informed consent forms is often scarce, and information about the placebo effect and associated risks are absent. This situation may influence a full understanding of placebo by participants in clinical trials and might reduce their informed decision to participate.     

Informed Consent in Cross-cultural Perspective: Clinical Research in the Tibetan Autonomous Region, PRC

Procedures of Informed Consent are considered a high priority for international biomedical research. However, informed consent protocols are not necessarily transferable across cultural, national or ethnic groups. Recent debates identify the need for balancing ethical universals with practical and local conditions and paying attention to questions of cultural competence when it comes to the Informed Consent process for clinical biomedical research. This article reports on the results of a two-year effort to establish a culturally appropriate Informed Consent process for biomedical research in the Tibet Autonomous Region in the People's Republic of China. A team of Tibetan and American researchers, physicians, health professionals and medical anthropologists conducted the research. The Informed Consent was specifically for undertaking a triple-blind, double placebo-controlled randomized clinical trial of a Tibetan medicine compared with Misoprostol for reducing postpartum blood loss. The findings suggest greater need for flexibility and cooperation in establishing Informed Consent protocols across cultures and nations.     

Western Notions of Informed Consent and Indigenous Cultures: Australian Findings at the Interface

Despite the extensive consideration the notion of informed consent has heralded in recent decades, the unique considerations pertaining to the giving of informed consent by and on behalf of Indigenous Australians have not been comprehensively explored; to the contrary, these issues have been scarcely considered in the literature to date. This deficit is concerning, given that a fundamental premise of the doctrine of informed consent is that of individual autonomy, which, while privileged as a core value of non-Indigenous Australian culture, is displaced in Indigenous cultures by the honouring of the family unit and community group, rather than the individual, as being at the core of important decision-making processes relating to the person. To address the hiatus in the bioethical literature on issues relating to informed consent for Aboriginal peoples, the following article provides findings from a two-year research project, funded by Australia’s National Health and Medical Research Council (NHMRC), conducted in the Northern Territory. The findings, situated in the context of the literature on cultural safety, highlight the difference between the Aboriginal and biomedical perspectives on informed consent.     

Physiological Factors Limiting Grain Size in Wheat

The effects on grain size of changing the supply of assimilates,by thinning before anthesis or by shading the plants or by halvingthe ears either early or late in grain growth, were studiedin two glasshouse experiments with Kleiber spring wheat (Triticumaestivum L.), in 1976 and 1977. Late treatments had no effect,presumably because little grain growth occurred thereafter.Thinning the plants before anthesis increased, and shading theplants soon after anthesis decreased grain size. Halving theears soon after anthesis increased the size of the remaininggrains, but grain weight per ear decreased. The effect on grainsize of halving the ear tended to be smaller under conditionsmore favourable for photosynthesis, except when the plants werethinned before anthesis. Shading decreased the total amountof nitrogen per culm and the proportion of total nitrogen recoveredin the ear. Halving increased the retention of nitrogen in thestem of unshaded shoots and had no effect on nitrogen distributionwithin shaded shoots. In 1977 halving the ear increased the rate of dry matter accumulationin the grain throughout the grain filling period, but in 1976the increase in dry weight was faster in the grains of halvedears only during early grain growth. Later the grains in halvedand intact ears increased in dry weight at the same rate, eventhough the supply of photosynthate and the capacity of the grains(as measured by volume) were greater in the halved ears. Theseresults are discussed in relation to the influence on finalgrain weight of assimilate supply and the storage capacity ofthe grain.     

Improving Validity of Informed Consent for Biomedical Research in Zambia Using a Laboratory Exposure Intervention

Background

Complex biomedical research can lead to disquiet in communities with limited exposure to scientific discussions, leading to rumours or to high drop-out rates. We set out to test an intervention designed to address apprehensions commonly encountered in a community where literacy is uncommon, and where complex biomedical research has been conducted for over a decade. We aimed to determine if it could improve the validity of consent.

Methods

Data were collected using focus group discussions, key informant interviews and observations. We designed an intervention that exposed participants to a detailed demonstration of laboratory processes. Each group was interviewed twice in a day, before and after exposure to the intervention in order to assess changes in their views.

Results

Factors that motivated people to participate in invasive biomedical research included a desire to stay healthy because of the screening during the recruitment process, regular advice from doctors, free medical services, and trust in the researchers. Inhibiting factors were limited knowledge about samples taken from their bodies during endoscopic procedures, the impact of endoscopy on the function of internal organs, and concerns about the use of biomedical samples. The belief that blood can be used for Satanic practices also created insecurities about drawing of blood samples. Further inhibiting factors included a fear of being labelled as HIV positive if known to consult heath workers repeatedly, and gender inequality. Concerns about the use and storage of blood and tissue samples were overcome by a laboratory exposure intervention.

Conclusion

Selecting a group of members from target community and engaging them in a laboratory exposure intervention could be a useful tool for enhancing specific aspects of consent for biomedical research. Further work is needed to determine the extent to which improved understanding permeates beyond the immediate group participating in the intervention.     

Trouble in the Gap: A Bioethical and Sociological Analysis of Informed Consent for High-Risk Medical Procedures

Concerns are frequently raised about the extent to which formal consent procedures actually lead to “informed” consent. As part of a study of consent to high-risk medical procedures, we analyzed in-depth interviews with 16 health care professionals working in bone-marrow transplantation in Sydney, Australia. We find that these professionals recognize and act on their responsibility to inform and educate patients and that they expect patients to reciprocate these efforts by demonstrably engaging in the education process. This expectation is largely implicit, however, and when it is not met, this can give rise to trouble that can have adverse consequences for patients, physicians, and relationships within the clinic. We revisit the concept of the sick role to formalize this new role expectation, and we argue that “informed” consent is a process that is usually incomplete, despite trappings and assumptions that help to create the illusion of completeness.     

Patients' Perception of Quality of Pre-Operative Informed Consent in Athens,Greece: A Pilot Study

Background

We sought to perform a study to record and evaluate patients'' views of the way surgeons communicate informed consent (IC) in Greece.

Methodology/Principal Findings

A prospective pilot study was carried out in Athens from 9/2007 to 4/2008. The study sample was extracted from patients, operated by eight different surgeons, who volunteered to fill in a post-surgery self-report questionnaire on IC. A composite delivered information index and a patient-physician relationship index were constructed for the purposes of the analysis. In total, 77 patients (42 males) volunteered to respond to the questionnaire. The delivered information index scores ranged from 3 to 10, the mean score was 8, and the standard deviation (SD) was 1.9. All patients were aware of their underlying diagnosis and reason for surgery. However, a considerable proportion of the respondents (14.3%) achieved a score below or equal to 5. The patient-physician relationship scores ranged from 0 to 20, the mean score was 16 and the standard deviation (SD) was 4.3. The better the patient-physician relationship, the more information was finally delivered to the patient from the physician (Spearman''s rank-order correlation coefficient was 0.4 and p<0.001). Delivered information index was significantly higher among participants who comprehended the right to informed consent, compared to participants who did not (p<0.001), and among participants who were given information regarding other possible therapeutic options (p = 0.001). 43% of the respondents answered that less than 10 minutes were spent on the consent process, 58.4% of patients stated that they had not been informed about other possible therapeutic choices and 28.6% did not really comprehend their legal rights to IC.

Conclusions

Despite the inherent limitations and the small sample size that do not permit to draw any firm conclusions, results indicate that a successful IC process may be associated with specific elements such as the patient-physician relationship, the time spent by the physician to inform the patient, a participant''s comprehension of the right to IC and the provision of information regarding other possible therapeutic options.     

Quantifying Environmental Limiting Factors on Tree Cover Using Geospatial Data

Environmental limiting factors (ELFs) are the thresholds that determine the maximum or minimum biological response for a given suite of environmental conditions. We asked the following questions: 1) Can we detect ELFs on percent tree cover across the eastern slopes of the Lake Tahoe Basin, NV? 2) How are the ELFs distributed spatially? 3) To what extent are unmeasured environmental factors limiting tree cover? ELFs are difficult to quantify as they require significant sample sizes. We addressed this by using geospatial data over a relatively large spatial extent, where the wall-to-wall sampling ensures the inclusion of rare data points which define the minimum or maximum response to environmental factors. We tested mean temperature, minimum temperature, potential evapotranspiration (PET) and PET minus precipitation (PET-P) as potential limiting factors on percent tree cover. We found that the study area showed system-wide limitations on tree cover, and each of the factors showed evidence of being limiting on tree cover. However, only 1.2% of the total area appeared to be limited by the four (4) environmental factors, suggesting other unmeasured factors are limiting much of the tree cover in the study area. Where sites were near their theoretical maximum, non-forest sites (tree cover < 25%) were primarily limited by cold mean temperatures, open-canopy forest sites (tree cover between 25% and 60%) were primarily limited by evaporative demand, and closed-canopy forests were not limited by any particular environmental factor. The detection of ELFs is necessary in order to fully understand the width of limitations that species experience within their geographic range.     

An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents

The aims of this study were to measure the readability of Australian based informed consent documents and determine whether informed consent readability guidelines have been established by Australian human research ethics committees (HRECs). A total of 20 informed consent documents, 10 HIV/AIDS and 10 type 2 diabetes, were measured for readability using the Simple Measure of Gobbledygook (SMOG) and Gunning Fog Index (Fog). Published guidelines and policy statements of the two local HREC who approved the 20 clinical trials under study where examined to identify whether they had any formal policies/guidelines on the readability of informed consent documents. The two HRECs were contacted via e-mail to also determine whether they utilised any informal readability standards or “rules of thumb” that may not have been mentioned in the published documents. The HIV/AIDS and type 2 diabetes informed consent documents were, on average, written at a grade 13 reading level. Formal readability standards had not been established by the two local HRECs, however, they did verify the use of informal rules for assessing readability of informed consent documents. Based on Australian literacy data, the majority of informed consent documents were written well beyond the reading ability of many Australians. Unreadable informed consent documents may result in patients rejecting trial participation altogether or conversely may result in their participating in a trial with inadequate consent. Therefore, a step toward reducing the complexity of informed consent documents may be to implement objective readability assessments into the human research ethics application and review process.     

Using Community-Based Participatory Research Principles to Develop More Understandable Recruitment and Informed Consent Documents in Genomic Research

BackgroundHeart Healthy Lenoir is a transdisciplinary project aimed at creating long-term, sustainable approaches to reduce cardiovascular disease risk disparities in Lenoir County, North Carolina using a design spanning genomic analysis and clinical intervention. We hypothesized that residents of Lenoir County would be unfamiliar and mistrustful of genomic research, and therefore reluctant to participate; additionally, these feelings would be higher in African-Americans.MethodologyTo test our hypothesis, we conducted qualitative research using community-based participatory research principles to ensure our genomic research strategies addressed the needs, priorities, and concerns of the community. African-American (n = 19) and White (n = 16) adults in Lenoir County participated in four focus groups exploring perceptions about genomics and cardiovascular disease. Demographic surveys were administered and a semi-structured interview guide was used to facilitate discussions. The discussions were digitally recorded, transcribed verbatim, and analyzed in ATLAS.ti.

Results and Significance

From our analysis, key themes emerged: transparent communication, privacy, participation incentives and barriers, knowledge, and the impact of knowing. African-Americans were more concerned about privacy and community impact compared to Whites, however, African-Americans were still eager to participate in our genomic research project. The results from our formative study were used to improve the informed consent and recruitment processes by: 1) reducing misconceptions of genomic studies; and 2) helping to foster participant understanding and trust with the researchers. Our study demonstrates how community-based participatory research principles can be used to gain deeper insight into the community and increase participation in genomic research studies. Due in part to these efforts 80.3% of eligible African-American participants and 86.9% of eligible White participants enrolled in the Heart Healthy Lenoir Genomics study making our overall enrollment 57.8% African-American. Future research will investigate return of genomic results in the Lenoir community.     

Factors Limiting the Supply of Sucrose to the Developing Wheat Grain

The level of sucrose in the flag leaf blade of wheat plantsgrowing in the field fluctuates in a conspicuous diurnal pattern,although in the endosperm the concentration of sucrose remainsunaltered throughout the night and the day. The effects of defoliationon the quantity of sucrose in the grain are relatively small,and appear to depend on the length of the period between treatmentand observation. In ears cultured on solutions of sucrose, the sugar accumulatesto higher concentrations than normal in all parts of the earexcept the grain where it remains at the concentration foundin intact plants. It is concluded that the magnitude of photosynthesis is adequateto maintain at a maximum the flow of sucrose into the grain,and that the flow of sucrose is limited by the capacity of theprocess(es) transporting the sugar on the final stages of itspassage into the grain.