The return of genetic research results after death in the pediatric setting comes with unique complexities. Researchers must determine which results and through which processes results are returned. This paper discusses the experience over 15 years in pediatric cancer genetics research of returning research results after the death of a child and proposes a preventive ethics approach to protocol development in order to improve the quality of return of results in pediatric genomic settings.

BackgroundObtaining consent has become a standard way of respecting the patient’s rights and autonomy in clinical research. Ethical guidelines recommend that the child’s parent/s or authorised legal guardian provides informed consent for their child’s participation. However, obtaining informed consent in paediatric research is challenging. Parents become vulnerable because of stress related to their child’s illness. Understanding the views held by guardians and researchers about the consent process in Malawi, where there are limitations in health care access and research literacy will (...) assist in developing appropriate consent guidelines.MethodsWe conducted 20 in-depth interviews with guardians of children and research staff who had participated in paediatric clinical trial and observational studies in acute and non-acute settings in the Southern Region of Malawi. Interviews were audio-recorded, transcribed verbatim, and thematically analysed. Interviews were compared across studies and settings to identify differences and similarities in participants’ views about informed consent processes. Data analysis was facilitated by NVIVO 11 software.ResultsAll participants across study types and settings reported that they associated participating in research with therapeutic benefits. Substantial differences were noted in the decision-making process across study settings. Guardians from acute studies felt that the role of their spouses was neglected during consenting, while staff reported that they had problems obtaining consent from guardians when their partners were not present. Across all study types and settings, research staff reported that they emphasised the benefits more than the risks of the study to participants, due to pressure to recruit. Participants from non-acute settings were more likely to recall information shared during the consent process than participants in the acute setting.ConclusionThe health care context, culture and research process influenced participants’ understanding of study information across study types and settings. We advise research managers or principal investigators to define minimum requirements that would not compromise the consent process and conduct study specific training for staff. The use of one size fits all consent process may not be ideal. More guidance is needed on how these differences can be incorporated during the consent process to improve understanding and delivery of consent.Trial registration Not applicable. (shrink)

Ethical guidance for genomic research is increasingly sought and perceived to be necessary. Although there are pressing ethical issues in genomic research – concerning for example the recruitment of patients/participants; the process of taking consent; data sharing; and returning results to patients/participants – there is still limited useful guidance available for researchers/clinicians or for the research ethics committees who review such projects. This report outlines the ethical principles and guidance for genomic research co-produced with stakeholders during two workshops which took (...) place in the UK between November 2016 and May 2017. The stakeholders involved in these workshops included: healthcare professionals, genomic research teams, academics, patients, biobank managers, and representatives from the Health Research Authority, NHS Research Ethics Committees, patient support groups, pharmaceutical industry, and health policy think tanks. The co-produced principles and guidance are specifical... (shrink)

No known cure exists for COVID-19, and medical practitioners are exhausted and at their wits’ end trying to find treatments that prevent patients from ending up in hospital or intensive care, or even dying. A variety of treatments tried by medical practitioners include standard registered medicine, investigational or so-called experimental, unapproved or preapproved medicines, emergency or compassionate-use authorised medicine and pre-market approved medicine. However, the medicines that can be accessed via each of these categories are at different stages of efficacy (...) testing and knowledge about adverse effects, dosages and risks. To obtain ethical and legal informed consent, medical practitioners must deal with a lot of medical uncertainty, and care must be taken to ensure that the patient understands the difference in risks they may be willing to take depending on the medicine’s stage of development. Often additional information is required to obtain ethical consent as opposed to legal consent. A purely legal approach to informed consent, especially when dealing with the medical uncertainties of health emergencies and pandemics, may lead to patients’ consent lacking in enough substance to be truly considered legal and ethical. Informed consent as respect for autonomy in this sense requires more than the patient’s explicit agreement or compliance with a certain treatment proposal. This article explains the difference in consent content attached to each different stage of a medicine’s development, especially considering the additional difficulties posed by obtaining truly informed consent during a pandemic with uncertain characteristics, treatment and solutions. (shrink)