Model consent clauses for rare disease research
Minh Thu Nguyen, Jack Goldblatt, Rosario Isasi, Marlene Jagut, Anneliene Hechtelt Jonker, Petra Kaufmann, Laetitia Ouillade, Fruszina Molnar-Gabor, Mahsa Shabani, Eric Sid, Anne Marie Tassé, Durhane Wong-Rieger, Bartha Maria Knoppers
BMC Medical Ethics, 1 August 2019; 20(55)
Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, there is a need for model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants’ overall protection.
A global Task Force was set up to develop model consent clauses specific to rare diseases research, that are comprehensive, harmonized, readily accessible, and internationally applicable, facilitating the recruitment and consent of rare disease research participants around the world. Existing consent forms and notices of consent were analyzed and classified under different consent themes, which were used as background to develop the model consent clauses.
The IRDiRC-GA4GH MCC Task Force met in September 2018, to discuss and design model consent clauses. Based on analyzed consent forms, they listed generic core elements and designed the following rare disease research specific core elements; Rare Disease Research Introductory Clause, Familial Participation, Audio/Visual Imaging, Collecting, storing, sharing of rare disease data, Recontact for matching, Data Linkage, Return of Results to Family Members, Incapacity/Death, and Benefits.
The model consent clauses presented in this article have been drafted to highlight consent elements that bear in mind the trends in rare disease research, while providing a tool to help foster harmonization and collaborative efforts.
An Important Gap in Informed Consent Documents for Oncology Clinical Trials: Lack of Quantitative Details About Expected Treatment Outcomes
Charles A. Schiffer
JAMA Oncology, 22 August 2019
Written informed consent must be obtained in addition to the discussions that physicians have with patients considering participation in clinical trials. Implicit in this requirement is the assumption that these dialogues with the caregivers are insufficient, requiring supplementation by written documents to reinforce what had been presented and/or to provide details that may not have been mentioned. The consents should be written in lay language with clear explanations of scientific and medical terms.1 Over the years, consent forms have become longer and more detailed and there is an extensive literature about how much information is actually retained by the patient after reading about Health Insurance Portability and Accountability regulations, handling of biologic specimens, long lists of potential adverse effects, the nature of randomization, etc.2 There are concerns that this litany of details distracts attention from the most critical features, including the aims of the study and the extra requirements and inconveniences compared with standard care.
A survey of informed consents from FDA’s center for devices and radiological health
Fabienne Santel, Isatu Bah, Katherine Kim, Ja-An Lin, Jack McCracken, Adaeze Teme
Contemporary Clinical Trials, 21 August 2019
Legally effective informed consent has been a long-standing requirement for FDA-regulated clinical studies. However, informed consent forms (ICFs) are often thought to be too long, too complex, and too difficult for participants to understand. In this article, investigators from the FDA’s Center for Devices and Radiological Health (CDRH) surveyed 399 ICFs from approved investigational device exemption (IDE) applications for fiscal years 2015 and 2016 to evaluate the readability of ICFs.
The investigators collected data from the ICFs, using variables related to structure, readability, and comprehension.
The investigators found that the mean grade-reading levels of the ICFs ranged from 10th grade to college level (Table 2), higher than the recommended 6th to 8th grade level , when measured by major readability evaluation tools (the SMOG readability grade level formula, the Flesch-Kincaid Index Grade Level Readability Formula, the Flesch Reading Ease test, and the Dale-Chall readability formula).
Overall, the ICFs and informed consent (IC) processes, as described in the IDE application, lacked components that enhanced participants’ comprehension, such as short sentences (e.g., no more than 8 to 10 to words) and the use of pictures, tables, and diagrams.
CDRH investigators believe that information about ICFs’ readability, comprehension, and structure will help support current and future efforts to improve the IC process. The intent of the article is to demonstrate that improvements are needed in the IC process and to encourage clinical trial stakeholders to consider implementing those approaches that optimize patient comprehension in the development of their IC processes.
Informed consent at stake? Language barriers in medical interactions with immigrant anaesthetists: a conversation analytical study
Damaris Borowski, Uwe Koreik, Udo Ohm, Claudia Riemer, Niels Rahe-Meyer
BMC Health Services Research, 23 August 2019; 19(597)
Language barriers in doctor-patient interactions are still an understudied phenomenon. This is particularly true concerning interactions with immigrant physicians who are learners of the patient’s language; there is a lack of research even though labour migration is increasing internationally. This conversation analytical study focusses on language errors in one specific type of doctor-patient interaction, namely pre-anaesthesia evaluations with immigrant anaesthetists.
The study combines the research field of language acquisition with that of medical interaction. It is a qualitative study with an ethnomethodological framework which addresses the following research question: How do language errors, produced by immigrant anaesthetists, impact pre-anaesthesia evaluations? The primary data comes from naturally occurring pre-anaesthesia evaluations carried out by immigrant anaesthetists. The analysis method is a combination of conversation and error analysis.
The study shows that the anaesthetists produced a considerable number of unintelligible utterances, due to various language errors. Despite the lack of understanding, hardly any negotiation of meaning occurred and both sides (anaesthetists and patients) claimed to be satisfied.
The findings appear to be contradictory. An explanation for this can be found in the effect of the roles and scripts that are given in pre-anaesthesia evaluations. Since no negotiation of meaning is initiated during the interactions, the anaesthetists’ insufficient language competence leads to a considerable impairment of informed consent, which is the main goal of the pre-anaesthesia evaluations. Based on these findings, the study reveals an urgent need for action regarding immigrant anaesthetists’ language skills.
Paternal consent in prenatal research: ethical aspects
Mats Johansson, Göran Hermerén, Nils-Eric Sahlin
Medicine, Health Care and Philosophy, 10 August 2019; pp 1–7
The role of mothers in prenatal research has been discussed extensively. Significantly less work has been done on the father’s role. In this article, focusing on ethical issues, we seek to redress this imbalance. Examining the father’s position in research conducted on pregnant women, we ask whether or not paternal consent ought to be required in addition to that of the pregnant woman. Having distinguished between different concepts of father and mother, we proceed by giving an overview of the reasons for requiring consent of the woman who is carrying the child. We then examine which of these reasons apply to the biological father, and show that some of them are relevant to the father. The case, roughly speaking, revolves around privacy issues, the father’s future legal responsibilities, and the likelihood that he will care about the health and wellbeing of his future child. These factors in the decision problem should all be recognized, as should the fact that they can in principle be trumped by other considerations.
Researchers’ Perspectives on Informed Consent and Ethical Review of Biobank Research in South Africa: A Cross-Sectional Study
Erisa Mwaka, Lyn Horn
Journal of Empirical Research on Human Research Ethics, 5 August 2019
There is limited literature on the opinions and perspectives of researchers on the ethical issues in biobank research in South Africa. This study aimed to explore researchers’ perspectives on informed consent and ethical review of biobank research in South Africa. An online survey was conducted among researchers and scientists at Stellenbosch University and the University of Kwazulu-Natal. The majority of researchers opined that broad consent is appropriate for biobank research. However, there was no consensus on the necessity for re-consent. Researchers were also in agreement that issues concerning informed consent and future use of samples require thorough discussions during the ethical review process. Overall, the attitude of researchers on informed consent and ethical review of biobank research was positive and ethically informed.
Exploring the Role of Shared Decision Making in the Consent Process for Pediatric Genomics Research in Cameroon, Tanzania, and Ghana
Daima Bukini, Jantina deVries, Marsha Treadwell, Kofi Anie, Jemima Dennis-Antwi, Karene Kengne Kamga, Sheryl McCurdy, Kwaku Ohene-Frempong, Julie Makani, Ambroise Wonkam
American Journal of Bioethics Empirical Bioethics, 5 August 2019; pp 182-189
It is customarily perceived that in Africa, decisions around research participation may be based not only on individual reflection but also on discussions with others. Some authors have argued that such decision making is reflective of a more traditional communitarian African worldview; one critique of such a perspective is that it is lacking an empirical grounding. In this study, we explore decision making around enrollment in sickle cell genomics research in three countries in Africa, namely, Ghana, Cameroon, and Tanzania. Particularly, we focus on exploring the role of shared decision making with regard to participating in genomic studies.
We involved 64 participants in 15 individual interviews or in 49 focus-group discussions with research participants in rural and urban Tanzania (n = 20), Ghana (n = 30), and Cameroon (n = 14). We used a vignette to explore decision making around enrollment of children in sickle cell genomics research. Data were imported in NVivo11 and analyzed using thematic content analysis. Our findings indicate that the majority of the participants from both rural and urban settings prefer to make their own individual decisions and not consult with extended family or community leaders. Shared decision making was only considered necessary for individuals who were perceived to be in some way vulnerable.
We found very limited support for shared decision making as the primary process for decision making about research participation. While consultation was considered important to support individual decision making, particularly when parents were perceived as vulnerable, there was no suggestion in our data that shared decision making would be a more important or valuable means of seeking consent for research participation in the African research context.
A Formative Qualitative Study on the Acceptability of Deferred Consent in Adult Emergency Care Research in Malawi
Lucinda Manda-Taylor, Fanuel Meckson Bickton, Kate Gooding, Jamie Rylance
Journal of Empirical Research on Human Research Ethics, 8 August 2019
Research in emergency medical care is challenging due to a limited therapeutic window for intervention, which may compromise informed consent. “Deferred consent” allows initiation of study procedures before full consent is recorded. We conducted a formative qualitative study exploring perspectives on deferred consent in Malawi among research ethics committee members, health care professionals, and lay representatives. Participants identified several advantages of deferred consent including scientific value and potential health benefits to the study subjects and wider population. Participants also had concerns, including regulatory barriers and the risk of abuse and malpractice. Conditions affecting acceptability are related to the role of proxies, the nature of the research, the availability of robust regulatory oversight, and the need for community engagement. Our findings show deferred consent would be acceptable in Malawi, provided that a clear case can be made to advance medical knowledge and that adequate regulatory and ethical protections are in place.
Consent Challenges and Psychosocial Distress in the Scale-up of Voluntary Medical Male Circumcision Among Adolescents in Western Kenya
Winnie K. Luseno, Samuel H. Field, Bonita J. Iritani, Stuart Rennie, Adam Gilbertson, Fredrick S. Odongo, Daniel Kwaro, Barrack Ongili, Denise D. Hallfors
AIDS and Behavior, 2 August 2019; pp 1-11
In priority sub-Saharan African countries, on the ground observations suggest that the success of voluntary medical male circumcision (VMMC) programs should not be based solely on numbers of males circumcised. We identify gaps in the consent process and poor psychosocial outcomes among a key target group: male adolescents. We assessed compliance with consent and assent requirements for VMMC in western Kenya among males aged 15–19 (N = 1939). We also examined differences in quality of life, depression, and anticipated HIV stigma between uncircumcised and circumcised adolescents. A substantial proportion reported receiving VMMC services as minors without parent/guardian consent. In addition, uncircumcised males were significantly more likely than their circumcised peers to have poor quality of life and symptoms of depression. Careful monitoring of male adolescents’ well-being is needed in large-scale VMMC programs. There is also urgent need for research to identify effective strategies to address gaps in the delivery of VMMC services.
Knowledge and Attitudes of Mental Health Professionals Regarding Informed Consent and Patient Confidentiality in Clinical Practice and Research in Udupi District
Vidyashree S.V., Kumar Naveen, Kamath Rajesh, D’Souza Brayal, Ashok Lena, Kamat
Indian Journals, 8 August 2019; 19(2) pp 180-184
The control of patient information regarding mental illness is a challenging issue in mental health care. Patients have the right to control and know all information concerning their health. In India, an individual’s identity is intimately connected to his or her family’s; family is integral to one’s self. This study was conducted to increase awareness among mental health professionals regarding informed consent and patient’s confidentiality protection in clinical practice and research. The findings of this study can help hospitals frame policies. The objectives of the study were to assess the knowledge(K) and attitudes(A) of mental health professionals regarding ‘informed consent’ and confidentiality protection in clinical practice and research. The study was conducted in three different phases. In phase one, a questionnaire was formulated, validated and distributed among the mental health professionals to analyze K&A regarding informed consent and confidentiality protection in clinical practice and research. In phase two, an education module was developed and distributed among healthcare professionals. In phase three, the participants were reassessed on their K&A using the same questionnaire. The results show no significant difference in the mean values (mean=7.46, SD =1.22) in both confidentiality and consent during phase one. However, after administering the education module, the mean score of knowledge and attitude towards consent and confidentiality has increased (mean=9.86, SD=0.40) compared to the pretest. It was concluded that the delivery of the education module incorporating the updated information on acts and amendments related to the mental health profession has been effective.