South African law may impede human health research
Linda Nordling
Science, 22 February 2019; 363(6429)
Summary
South Africa’s varied population makes it a magnet for research on public health and human diversity. But a new privacy law called The Protection of Personal Information Act, scheduled to go into effect in 2020, could upend such research. The law aims to protect South Africans from abuse of their personal data and says that such information, including genetic data, must be collected for a specific purpose—and that data subjects need to be “aware of the purpose.” But giant sample and data repositories called biobanks are transforming health research around the world by allowing multiple researchers to ask new questions of the same data. At a meeting in Cape Town on 4–5 February, lawyers, ethicists, and researchers discussed how the new South African rule could limit such secondary use of data and hamstring international collaborations.

Implementing Free Prior and Informed Consent: The United Nations Declaration on the Rights of Indigenous Peoples (2007), the Challenges of REDD+ and the case for the Precautionary Principle
Malayna Raftopoulos, Damien Short
Forthcoming in the International Journal of Human Rights, 2019
Abstract
Over 21 years after the United Nations Declaration on the Rights of Indigenous Peoples (September 2007 – hereafter UNDRIP) was passed, it is useful to examine the functionality and utility of a core principle it contains- the notion of Free Prior and Informed Consent (FPIC) with respect to the twin challenges of environmental destruction and a key ‘mitigation’ policy: REDD+. While UNDRIP, and to a lesser extent, the International Labour Organisation Convention No. 169 (ILO 169) has strengthened the legal status of FPIC, its application has proved to be extremely difficult. This article argues that when considering the potential harm of environmental and REDD+ climate change policies there needs to be a greater emphasis placed on the ‘precautionary principle’ when applying FPIC. Demonstrating why precaution needs to be taken in order to ensure human rights, this article argues that increasing the prominence of the precautionary principle within FPIC can impact significantly on the protection of biodiversity as well as the way in which environmental harm, laws and regulations are understood in relation to their social and cultural impact and shape future responses to the climate change crisis.

The picture talk project: Aboriginal community input on consent for research
Emily FM Fitzpatrick, Gaynor Macdonald, Alexandra LC Martiniuk, June Oscar, Heather D’Antoine, Maureen Carter, Tom Lawford, Elizabeth J Elliott
BMC Medical Ethics, 29 January 2019; 20(12)
Abstract
Background
The consent and community engagement process for research with Indigenous communities is rarely evaluated. Research protocols are not always collaborative, inclusive or culturally respectful. If participants do not trust or understand the research, selection bias may occur in recruitment, affecting study results potentially denying participants the opportunity to provide more knowledge and greater understanding about their community. Poorly informed consent can also harm the individual participant and the community as a whole.
Methods
Invited by local Aboriginal community leaders of the Fitzroy Valley, the Kimberley, Western Australia, The Picture Talk project explores the consent process for research. Focus groups of Aboriginal community members were conducted to establish preferences for methods of seeking individual consent. Transcripts were analysed through NVivo10 Qualitative software using grounded theory with inductive and deductive coding. Themes were synthesised with quotes highlighted.
Results
Focus groups with Aboriginal community members (n = 6 focus groups of 3–7 participants) were facilitated by a Community Navigator as a cultural guide and interpreter and a researcher. Participants were recruited from all main language groups of the Fitzroy Valley – Gooniyandi, Walmajarri, Wangkatjungka, Bunuba and Nikinya. Participants were aged ≥18 years, with 5 female groups and one male group. Themes identified include: Reputation and trust is essential; The Community Navigator is key; Pictures give the words meaning – milli milli versus Pictures; Achieving consensus in circles; Signing for consent; and Research is needed in the Valley.
Conclusion
Aboriginal communities of the Fitzroy Valley recommend that researchers collaborate with local leaders, develop trust and foster a good reputation in the community prior to research. Local Aboriginal researchers should be employed to provide cultural guidance throughout the research process and interpret local languages especially for elders. Pictures are preferred to written text to explain research information and most prefer to sign for consent. The Fitzroy Valley welcomes research when collaborative and for the benefit of the community. Future research could include exploring how to support young people, promote health screening and improve understanding of medical knowledge.

Are predominantly western standards and expectations of informed consent in surgery applicable to all? A qualitative study in a tertiary care hospital in Sri Lanka
Udagedara Mudiyanselage Jayami Eshana Samaranayake, Yasith Mathangasinghe, Anura Sarath Kumara Banagala
BMJ Open, 25 January 2019
Abstract
Objective 
To identify the different perceptions on informed surgical consent in a group of Sri Lankan patients.
Methods 
A qualitative study was conducted in a single surgical unit at a tertiary care hospital from January to May 2018. The protocol conformed to the Declaration of Helsinki. Patients undergoing elective major surgeries were recruited using initial purposive and later theoretical sampling. In-depth interviews were conducted in their native language based on the grounded theory. Initial codes were generated after analysing the transcripts. Constant comparative method was employed during intermediate and advanced coding. Data collection and analyses were conducted simultaneously, until the saturation of the themes. Finally, advanced coding was used for theoretical integrations.
Results 
Thirty patients (male:female=12:18) were assessed. The mean age was 41±9 years. Sinhalese predominated (50.0%, n=15). Majority underwent thyroidectomy (36.7%, n=11). The generated theory categorises the process of obtaining informed consent in four phases: initial interaction phase, reasoning phase, convincing phase and decision-making phase. Giving consent for surgery was a dependent role between patient, family members and the surgeon, as opposed to an individual decision by the patient. Some patients abstained from asking questions from doctors since doctors were ‘busy’, ‘short-tempered’ or ‘stressed out’. Some found nurses to be more approachable than doctors. Patients admitted that having a bystander while obtaining consent would relieve their stress. They needed doctors to emphasise more on postoperative lifestyle changes and preprocedure counselling at the clinic level. To educate patients about their procedure, some suggested leaflets or booklets to be distributed at the clinic before ward admission. The majority disliked watching educational videos because they were ‘scared’ to look at surgical dissections and blood.
Conclusion 
The informed consent process should include key elements that are non-culture specific along with elements or practices that consider the cultural norms of the society.

Psychometric evaluation of the Informed Consent Process Scale in Chinese
Shu Yu Chen, Shu-Chen Susan Chang, Chiu-Chu Lin, Qingqing Lou, Robert M Anderson
Nursing Ethics, 6 January 2019
Abstract
Background
Informed consent is essential for the ethical conduct of clinical research and is a culturally sensitive issue. But, a measurable Chinese version of the scale to evaluate the informed consent process has not yet been explored in the existing literature.
Research objectives
This study aimed to develop and psychometrically test the Chinese version of the Informed Consent Process Scale.
Research design
Back-translation was conducted to develop the Chinese version of the questionnaire. A cross-sectional survey was administered, after which an exploratory factor analysis was conducted.
Participants
We recruited a total of 375 participants who had experience in signing an informed consent form within the previous 3 years in Taiwan.
Ethical considerations
This study was approved by two Institutional Review Boards and the autonomy of the participants was respected.
Findings
The Chinese version of the Informed Consent Process Scale is composed of three factors with 23 items showing evidence of acceptable reliability and validity. Three major factors were extracted and labeled: Factor 1 – ‘Understanding of the research’, Factor 2 – ‘Trust and confidence’ and Factor 3 – ‘Doubt and uncertainty’. The three factors accounted for is 52.954 of the total variance with Cronbach’s α of .917.
Discussion and conclusion
The finding corroborates previous studies showing that participants had too little understanding on the informed consent forms they signed and implied the need to clarify the critical points in clinical research. The psychometric results indicated good internal consistency and validity for this newly constructed instrument, and it was found worthy of conducting further testing and application.

Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability
Biolaw and Policy in the Twenty-First Century, 25 January 2019, LIME(78) pp 33-40
Abstract
The main goal of this chapter is to discuss the epistemological and practical features of the basic ethical principles in European bioethics and biolaw as a result of a relevant project supported by the European Commission between 1995 and 1998. That project was based on cooperation between 22 partners coming from most EU countries. Its aim was to identify the ethical principles relating to autonomy, dignity, integrity and vulnerability as four important ideas or values for a European bioethics and biolaw. In this chapter it will be showed how the authors reach the conclusion that the basic ethical principles cannot be understood as universal, everlasting ideas or transcendental truths but they rather function as “reflective guidelines”, and important values in European culture.