Mandatory reporting obligations within the context of health research: Grappling with some of the ethical-legal complexities
Type of article: Clinical Research Summary
MedED Catalogue Reference: MHER001
Compiler: Linda Ravenhill
SourcesL SAMJ
Key Take Aways
1. Under South African law, several mandatory and discretionary reporting requirements can be found in various pieces of legislation.
2. Reporting requirements relate to two groups of legislation: the first, special protections for three vulnerable groups – children, the elderly and the disabled; the second to a knowledge of a crime having been committed
3. Challenges arise in the interpretation of these requirements due to the differences between what is required by law and what the ethical guidelines state
4. Of the vulnerable groups, mandatory reporting concerning children is the most extensive
5. In some instances reporting abuse as required by the legislation may cause harm. In such cases, the national ethics framework should guide researchers.
6. It is possible to apply for an exemption from the reporting requirement. However, such a request requires clear justification and identification of actions that will be taken in its absence.
7. Researchers need to thoroughly understand the legislation and the national ethics framework, ensuring those elements are integrated into their strategy design, implementation and review
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Summary | Discussion | Key Issues for Researchers | Key Issues for RECs | Conclusion
Summary
For your convenience, we have summarised the key points of this article. Please access the complete paper in the link provided. This article, published in the latest edition of the South African Journal of Bioethics and Law, takes a closer look at the impact of mandatory reporting requirements on healthcare research. According to the authors, the challenge for researchers arises due to the differences between what is required by law and what the ethical guidelines state. In their article, which builds on previous research, authors Strode & Badul set out to:
"..describe the mandatory reporting obligations in South African (SA) law; to discuss the ways in which these provisions apply within the context of health research; and to propose some factors which could be used to determine whether it is ethical to not report information."
Discussion
Under South African law, there are two main groupings under which reporting is obligatory: the first relates to special protections for three vulnerable groups – children, the elderly and the disabled; the second refers to a knowledge of a crime having been committed.Reporting Requirements Relating to Vulnerable Persons
Reporting in terms of the Children's Act of 2005
Strode & Badul detail the reporting requirements described in the Children's Act of 2005, which include: physical, sexual and emotional abuse; neglect; children needing care and protection; bullying; and exploitive child labour.
Almost all research among this vulnerable group has a mandatory reporting obligation for professionals and any other party involved in the research. This requirement should be considered when designing the reporting strategy, and the consent document should include information concerning this strategy.
Reporting in terms of the Older Persons Act of 2006
In terms of the Older Persons Act, 13 of 2006, the authors find that:
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The Act requires any person, professional or not, who suspects abuse or has knowledge of an injury that may have resulted from abuse to report it to either a police official or the Director-General of the Department of Social Development. Any member of the research team who suspects such abuse is therefore obligated to report it.
- Regarding older persons needing care and protection as defined under the Older Persons Act, this applies only to professionals and is a mandatory obligation. A discretionary obligation exists for any other person who observes an older person needing care or protection.
Reporting in terms of the Mental Health Care Act of 2002
Under the Mental Health Care Act of 2002, anyone who witnesses one of three forms of abuse occurring against a vulnerable individual in a mental healthcare facility must report it. The three forms are:
"exploitation, abuse and any degrading treatment; being required to do 'forced' labour and being provided with care, treatment and rehabilitation services as a form of punishment."
The authors conclude that the obligations under this Act should have minimal impact on RECs unless their research relates to institutional care in a mental healthcare facility. However, should their research occur in such a setting and they become aware of abuse, all research team members are obligated to report it.
The authors determined that while there is no general legal obligation, obligations exist concerning specific situations.
Reporting in terms of the Drugs and Drug Trafficking Act of 1982
The reporting obligation under this law is discretionary and relates only to healthcare professionals. It is likely only relevant to researchers if the research involves providing participants with healthcare and the information is disclosed within the confines of the study.
Reporting in terms of the Sexual Offences and Related Matters Act of 2007
Reporting under this Act relates to offences against children, sexually active adolescents and disabled persons.
Offences against children: There are six categories of sexual offences against children, and anyone who knows of such offences must report to the police.
Health research in sexually active adolescents: The authors indicate that the obligation to report cases of abuse in sexually active adolescents is extremely broad and may indeed cause harm to the adolescent. Such reporting should therefore be undertaken per the national ethics framework.
They review two previous studies, citing, in particular, a study by McQuoid-Mason, in which he indicates that reporting should only be done in cases where it is in the child's best interests. According to the authors, McQuoid Mason recommends the following be considered when reporting such an incident: if the child is younger than 12 years of age: where sex is consensual, but one or both of the participants are between the ages of 12-15 years of age; where one participant is between 16 and 17 years of age, and the other is more than two years older; where sex is not exploitive, and occurs between an adult and a child aged 12 -1 5 years old.
Sexual offences against disabled persons: Any person who knows of a sexual offence against a disabled person is obliged to report such an offence to the police. The Act defines a mentally disabled person who: "has a mental disorder or disability that impacts on their ability to appreciate the sexual act, or is unable to resist the sexual act, or is unable to communicate their unwillingness to participate in the sexual act." Eight possible offences under the ACT are considered abuse.
The challenge for researchers in this vulnerable group is understanding the context in which their research will occur and considering the ethical considerations of reporting should abuse be uncovered during their study.
Reporting on Domestic Violence
Under the Domestic Violence Amendment Act, two categories of persons are obligated to report any domestic violence against children, persons with disabilities and older persons: the first group, functionaries, includes healthcare professionals and educators; the second refers to any adult aware of the abuse.
According to the authors, recent changes to the Act have made reporting abuse within the three vulnerable groups mandatory, and such cases should be reported to a social worker or the police. Of note: no such reporting obligation occurs in cases of adult domestic violence.
Reporting in terms of the Prevention and Combating of Corrupt Activities Act of 2004
The authors conclude that this Act will impact researchers in a few instances. The one exception would be when the research involves a person in authority. In such cases, the researchers have an obligation to make the person aware that if information related to corruption is uncovered during the research, the researcher is obligated to report it.
Key Issues for Researchers
The authors consider the key issues for researchers under two broad themes:Based on their review, Strode & Badul conclude that mandatory reporting obligations can be found in several pieces of legislation. They briefly review the requirements for providing proof when reporting such instances, the implications of reporting based on incomplete or incorrect information and the consequences of failing to comply with mandatory obligations, concluding that:
Applications for ethical approval
Regarding the national ethical guidelines, researchers must address issues relating to mandatory reporting in their protocols. Specifically, they must justify their approach to reporting and provide details on how the reporting will be managed.
Should they request a waiver of these requirements, they must explain how issues such as potential harm will be addressed and what alternatives are in place to protect participants in such cases. Information relating to these reporting obligations must be detailed in the informed consent documents, and participants must be empowered to self-select to indicate they wish to participate.
Key issues for RECs Mandatory reporting and the potential for further harm
Although mandatory reporting restricts privacy, it is necessary for participant welfare and harm reduction. Nevertheless, concerns may arise regarding the unintended trauma caused by reporting, particularly in elder and child abuse cases. Ethical guidelines recognize the dilemma of mindlessly adhering to the law and propose instances, like reporting consensual underage sex, where moral considerations may supersede legal requirements.
Researchers should consider factors such as the social welfare system, research relationship trust, informed consent, the child's best interests, and appropriate interventions to determine whether reporting obligations should be waived.
Legal implications of waiving reporting for RECs
The authors examine the legal and ethical implications for Research Ethics Committees (RECs) when they waive reporting obligations. Researchers should weigh the ethical obligations to prevent harm against legal obligations to report information, considering the potential harm that may occur if the report is not made, including potential harm to the REC itself. Clear ethical justifications are crucial in the decision-making process
Conclusion
Strode and Badul argue that researchers frequently face a dilemma when deciding whether to report information, despite the legal and ethical guidelines in place to safeguard vulnerable populations. While there may be a legal obligation to report, it is important to consider the potential unintended harm that reporting can cause. Researchers and RECs should carefully analyze their reporting obligations and prioritize ethical considerations when navigating these challenges in research.
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