Research team could redefine biomedical research

(Press-News.org) Professor Leslie Wolf, a Distinguished University Professor and Ben F. Johnson Jr. Chair in Law at Georgia State University College of Law, is a part of a research team that has been provided $1.9 million to conduct research designed to increase participation in biomedical studies by involving participants in the research design process. The award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

Wolf, along with colleagues at the Medical College of Georgia at Augusta University , the University of Wisconsin-Madison, and the HUB Augusta Collaborative Inc., received the award from the Patient-Centered Outcomes Research Institute (PCORI), an independent, non-profit organization, authorized by Congress in 2010, that funds patient-centered research in the U.S.

The study funded by the award, entitled Co-Creating Novel, Feasible and Inclusive Research Methods (CONFIRM), aims to discover whether people are more likely to take part in a research study if they play a role in how the study is designed and what activities are involved. This collaborative approach seeks to empower participants as co-researchers to ensure that the study methods are acceptable and relevant to the needs of participants and their community.

In an Augusta Chronicle article, PCORI Executive Director Nakela L. Cook, MD, touted the anticipated benefits of such an approach. “This study was selected for PCORI funding for its potential to strengthen patient-centered... research by providing evidence about specific engagement methods and measures that promote representative engagement of patients and other stakeholders in research,” she said.

The researchers aim to improve a longstanding challenge in research: ensuring that study designs are both inclusive and representative of the populations they intend to serve.

Research studies of all kinds are often limited to the people who are willing and able to participate in them, which can lead to results that do not reflect the full diversity of the population. Increasing participation in underrepresented communities can give researchers more accurate insights and lead to more meaningful results.

“All of us who worked on this grant are deeply committed to conducting research that is responsive to community needs and in engaging community members in that process,” said Wolf.

If successful, this study would indicate that it is beneficial to flip the usual order of research, where tasks and activities are decided first and participants are recruited later. A positive outcome could also have implications for research methods in a variety of fields.

“If we are correct, our findings would provide support for other researchers to adopt this model, and ultimately increase the relevance, trustworthiness and usefulness of research findings,” said Wolf.

Wolf will be working with the academic research team and community co-researchers on all aspects of this study, sharing her expertise on the law and ethics of research involving humans to inform their choices, as well as helping to develop processes that facilitate decision-making within the group.

This project draws on Wolf’s broad background of expertise identifying how researchers can best respect the rights and well-being of participants while conducting essential research. Wolf is also a leading expert in methods to conduct ethical, responsive research in non-traditional settings and in non-traditional ways.

“My recent research has focused on how we can make research more inclusive and, thus, better realize the core research ethics principle of justice. This project is consistent with that research, extending it in exciting ways by building on my collaborations with colleagues at Augusta University to answer a question that could transform biomedical research.”

Anne Tucker, associate dean of Research & Faculty Development at Georgia State Law, praised Wolf for her accomplishment. “This study demonstrates why Professor Wolf is a nationally recognized expert in research ethics,” she said. “Her work seeks to increase participation in research studies, a need that is particularly acute for women and racial minorities to combat health disparities.”

Professor Wolf currently serves as the director of the Center for Law, Health & Society at Georgia State Law and teaches Torts, seminars in Bioethics, Human Subjects Research, and related health law courses.

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