Table 2 summary of specific phrases reflecting broader discourse
Document Source and year of publication | Title | Discourses | ||||
|---|---|---|---|---|---|---|
Participant protection | Supererogation | Participant needs prevail over science | Provide care as appropriate | Ancillary care researcher’s obligation | ||
Nuremberg Code [2], 1947 | Permissible medical experiments | Protect participants against study related harm | ||||
World Medical Association [4], 1964 | Human Experimentation: Code of Ethics of the World Medical Association (Declaration of Helsinki) | Researchers protect life and health of the participant | Respect the right of participants to safeguard their integrity | |||
National Commission for the Protection of Human Subjects of Biomedical Behavioral Research [5], 1978 | The Belmont report: ethical principles and guidelines for the protection of human subjects of research | Secure participants well-being | Beneficence (act of kindness) as an obligation | |||
Council for International Organizations of Medical Sciences [51], 1991 | International ethical guidelines for review of epidemiological studies | Protect the rights and assure the welfare of subjects | Where participants need health care, arrangements should be made to have them treated or they should be referred to a local health service | |||
International Conference on Harmonisation—Guideline for Good Clinical Practice [6], 1996 | International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use | Protect rights, safety, and well-being of participants | Participants rights, safety, and well-being prevail over science | Provide adequate care for study related conditions | Provide care be considered for intercurrent conditions | |
World Medical Association [24], 2000 | Ethical principles for medical research involving human subjects (Declaration of Helsinki) | Protect the life, health, privacy, rights, and dignity of participants | Participant well-being to take precedence over science | Providing care as combined with research | Responsibility for the human subject must always rest with a medically qualified person and never rest on the participant | |
World Health Organization [42], 2000 | Operational guidelines for ethics committees that review biomedical research | Safeguarding the dignity, rights, safety, and well-being of participants | Research interests should not override the health, well-being, and care of research participants | Provide care to research participants during and after the course of the research | ||
Coucil for International Organisation of Medical Sciences [7], 2002 | International ethical guidelines for biomedical research involving human subjects | Protect the rights and welfare of vulnerable persons | Morally praiseworthy for researchers to provide ancillary care to participants | For ancillary health needs researchers should, as appropriate, advise them to obtain, or refer them for, medical care | ||
Nuffield Council on Bioethics [28], 2002 | The ethics of research related to healthcare in developing countries | Protect participants from hard in RCS | Where it is feasible researchers have a duty to provide care for ancillary health needs | |||
Medical Research Council [41], 2004 | MRC Ethics guide: Medical research involving children | Participants' interests must prevail over those of science | ||||
World Medical Association [38], 2004 | Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects | Protect participants health, life, privacy, and dignity | The well-being of the participants must take precedence over all other interests | |||
Medical Research Council [40], 2007 | MRC Ethics guide: Medical research involving adults who cannot consent | Respect the interests of an individual participant is more important than any potential benefits of the research to others | ||||
Malawi National Health Sciences Research Committee [30], 2007 | General Guidelines on Health Research | Provide care to research participants during and after the course of the research | ||||
World Medical Association [25], 2008 | Ethical principles for medical research involving human subjects (Declaration of Helsinki) | Protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects | The well-being of the individual research subject must take precedence over all other interests | |||
Council for International Organisations of Medical Sciences [26], 2009 | International ethical guidelines for review of epidemiological studies | Morally praiseworthy for researchers to provide ancillary care to participants | ||||
College of Medicine Research Ethics Committee [31], 2010 | General guidelines on health research | Promote dignity, rights, safety, and well-being of research participants | ||||
Malawi Ministry of Health [32], 2012 | National Health Research Agenda 2012–2016 | Protect and promote the dignity and rights of all research participants | ||||
World Medical Association [9], 2013 | Ethical principles for medical research involving human subjects (Declaration of Helsinki) | Promote and safeguard the health, well-being, and rights of participants | The goal of research should never take precedence over the rights and interests of individual research subjects | |||
Council for International Organisations of Medical Sciences [8], 2016 | International ethical guidelines for health-related research involving humans | Make adequate provisions for addressing participants’ health needs during research and, if necessary | ||||
Health Research Authority [43], 2017 | UK policy framework for health and social care research | Ensuring participants’ safety and well-being in relation to their participation in the research | Safety and well-being of the individual prevail over the interests of science | |||
ICH E6(R1) Good Clinical Practice ICH E6(R2) ICH Consensus Guideline [10], 2016 | Integrated addendum to ICH E6 (R1): guideline for good clinical practice E6 (R2) | Protect rights, safety, and well-being of participants | When the investigator becomes aware of an intercurrent condition, should notify the participant | |||
Wellcome Trust [48], 2018 | Good research practice guidelines | protect the rights, interests and safety of research participants | ||||
H3Africa [47], 2018 | Guideline for the Return of Individual Genetic Research Findings | Depending on clinical validity and relevance, advisable to provide referral as ancillary care | ||||
Ministry of Health and Population [33], 2019 | National Health Research Policy: Strengthening health research to improve national health security | Protect the rights of research participants | ||||
Wellcome Trust [44], 2020 | Research involving human participants policy | Protect the rights, interests and safety of participants | Provision of care as collateral benefits of carrying out research, whether or not they are necessary for the research design | |||
Council for International Organisations of Medical Sciences [27], 2021 | Clinical research in resource-limited settings. A consensus by a CIOMS Working Group | Researchers have an ethical obligation to care for participants’ health needs during research, if necessary | ||||
Guenter et al. [52], 2021 | Ethical considerations in HIV prevention trials: Joint United Nations Programme on HIV/AIDS and the World Health Organization | Researchers to take measures to protect the safety, dignity, human rights and welfare of participants | ||||
National Institutes of Health [49], 2021 | National Institute of Health Grants Policy Statement | Protect the rights and welfare of these participants | NIH-funding for research projects may include for costs towards participants hospitalisation, testing, or care services | |||