CHIRON scholar Maile Tauali’i guides us on the why and the how of building researchers’ capacity to limit group harm, the role of research institutions and regulatory bodies, and community power in biorepository contexts by Maile Tauali'i and Megan Doerr
Published on May 16, 2024. DOI 10.21428/4f83582b.abfecd5c
The CHIRON toolkit operates under the assumption that researchers and oversight committees have a responsibility to anticipate and align with the wishes of patient and participant communities in big data research. What is the basis for this assumption? Moreover, what can research institutions and regulatory bodies do beyond the scope of the CHIRON toolkit? And what role can communities play? In this week’s post, Maile Tauali’i explores the why and the how of building researchers’ capacity to limit group harm.
Roles & Responsibilities of Researchers & Communities in Research
Role of the Researcher
The role of the researcher carries the legal and ethical responsibility “to ensure that research involving humans meets high scientific and ethical standards that respect and protect the participants." Required training, such as the US-based Collaborative Institutional Training Initiative (CITI), provides researchers with rich and critically important instruction on the ethical conduct of biomedical research. Structured pedagogies like CITI ensure that researchers are aware of their ethical role and their responsibilities to research participants. However, the focus of human subject research training programs–especially within the US–lies exclusively on ethical consideration of research participants as individuals and does not address the community that the participant is (inadvertently) representing. This laser focus likely arises as a result of the inadequacies of research regulation itself; nonetheless, it leaves researchers to fend for themselves when it comes to considering harms that extend beyond the participant as an individual.
Many researchers–especially those doing big health data research–may lack the experience or training to anticipate the possible harms that could occur at a community level from their research. Researcher responses to ethics board questionnaires reinforce this view, myopically focusing on harm at the individual level: on how the data will be deidentified and the management of records that could link the study findings to the participant. These canned ethical protection responses (e.g., “participant data will be kept in a locked cabinet in a locked room”) do little to address possible harm that could occur to a community as a result of research.
What is Needed
Action must be taken to educate and equip researchers and those with research oversight to look beyond individual participant-focused research outcomes. The literature is rich with examples of previous missteps (and new requirements) that can be woven into a curriculum, so members of the research community become skilled at anticipating and preventing group/community harm. Didactic material and testing must be added to research training requirements that directly addresses group harm. Research ethics and oversight committees must require research proposals to anticipate and prevent harm that could occur to a group or community. Tissue access boards and committees must have a process to seek input and guidance by communities impacted by research in the form of community advisory boards or councils.
Possible Tools to Support the Education of Researchers:
Community Health Interests for Researchers & Oversight Networks (CHIRON): When it becomes publicly available in 2026, researchers, ethics boards, and data access committees can use the CHIRON toolkit to consider group interests as they plan, execute, and report on big health data research.
Cultural Safety Training: Cultural safety is about creating a workplace where everyone can examine their own cultural identities and attitudes, and be open-minded and flexible in one's attitude towards people from cultures other than our own.
Draft meaningful Ethical, Legal and Social Implications Statements that address group harm: Researchers must stop the use of inadequate boilerplate language within their ELSI statements and think critically about the community implications of their work. Ethics committees and other research oversight boards should be educated on how to advise, guide, and elicit meaningful statements from researchers about the risks to communities posed by their research. And, if a meaningful statement isn’t provided in an application, ethics and oversight boards and oversight boards should not approve research. Gratifyingly, some publishers and journals are beginning to make this requirement a reality.
Role of the Community
Until researchers and the organizations that sanction research have formally and respectfully included community participation in research oversight, communities can halt the process of group harm by continuing to abstain from research. But instead of passively protecting their community by not participating, communities can take an active role and express their demands for respectful and ethical inclusion and representation.
Communities can write to research oversight committees and ask for written processes to recognize and address group harm. Communities, through organizations that represent their interests, can inform researchers, research funders, philanthropic organizations, universities, institutional review boards, scientific journals, and other shareholders about their collective rights and how research can cause group harm if not cautious about unintended consequences. Communities can voice their concerns and demand for respectful inclusion.
Possible Strategies and Tools to Support Communities:
Communities can set directives that must be followed by researchers in exchange for their participation. They can define the parameters for how the data is used, set limits, exclusions and preferences. They can require final oversight and be co-authors on publications to ensure they are represented in a manner which respects their values and practices.
Partner with organizations that advocate for community control. One example is the Genetic Alliance, a non-profit organization founded in 1986, which is a leader in deploying high tech and high touch programs for individuals, families, and communities to transform health systems by being responsive to the real needs of people in their quest for health.
Seek out resources that support Engaging Communities as Experts throughout the Assessment Process