Protecting Human Subjects in Community Research

Protecting Human Subjects in Community Research

By Hannah Kuehl, Senior Research Assistant, OHSU, School of Public Health

Community Engaged Research

Oregon Health & Science University (OHSU), in its strategic plan, Vision 2020, has committed to improve the health and well-being of all Oregonians. Many steps have been outlined toward meeting this goal, including partnering with communities, industry, other colleges and universities, and private citizens in order to develop community-based solutions to their health related problems.

Engaging with communities in research is a vital cornerstone to building, implementing and disseminating solutions that consider the unique characteristics of the population and region. As Oregon’s academic health center, we take on some responsibility to ensure Oregon communities understand the complexities of working with individuals in the role of research participation. Protecting human subjects is imperative to the ethical conduct of research and federal guidelines, whether the work is taking place in a hospital or clinic setting, or in the outskirts of rural Oregon.

The Integrated Program in Community Research

The mission of the OHSU Integrated Program in Community Research (the Integrated Program) is to improve capacity, enhance the relevance of research, and increase research receptivity throughout Oregon. Traditionally, academic research that takes place in communities has been more of a one-way street. We encourage a bi-directional approach to research that benefits both the researcher and community collaborators.

One of the Integrated Program’s first initiatives was to develop and implement an informed approach to addressing the concern of human subjects’ protections in support of community research. This initiative was established in response to numerous concerns voiced by community partners, pilot-funded grantees, our Oregon Community Health Information Network (OCHIN) partners, OHSU investigators and administrators. A frequently cited barrier to growing and unifying community research across OHSU was the difficulty community researchers express about navigating the human subjects’ protection system – the Institutional Review Board (IRB) – for community-run projects.

Our goal was to make the IRB more approachable and easily understandable to community members, while also meeting regulatory requirements, and promoting and supporting the implementation of high quality, well-designed and ethically-conducted research around the state. We proposed the development of a program that encompassed multiple components; informational, technological perspectives and framework, as well as tools supportive of community-based researchers. As an added benefit, we believe we have encouraged change to the idea of protecting community based human subjects both inside and outside the walls of OHSU.

Human Subjects’ Protection Program

The Integrated Program developed a program that encompassed community research oriented support, training, and tools. The goal was to stimulate a broad change to the culture of how OHSU engages with communities in order to increase engagement in community research, improve relations with community partners, enhance understanding of human subjects’ protections, and create a more timely implementation and completion of projects.

Support: OHSU Community Research Navigators are a resource to community and academic investigators. Navigators provide a consistent, personalized touch between researchers engaged in their communities, communities initiating research, and the human subjects’ protection system. They support protocol development, human subjects’ determinations, IRB submissions, training and modification/development of tools to support community investigators. Navigators collect detail about each project from project leaders and researchers and determine how to most clearly communicate with the OHSU IRB about the design of projects, their intent, and generalizability.

Training: Navigators provide training and coaching to academic investigators and community researchers about the IRB process and regulatory steps. The Human Subjects’ Protection team works with grantees to prepare protocol and study documents for submission. After submission and determination, navigators provide ongoing support for training, implementation, and project modifications.

OHSU’s Research Integrity and Integrated Program Offices have collaborated around building community-friendly sociobehavioral CITI training modules. Community researchers can now access CITI training modules directly, without having to go through the process of OHSU employee-level registration.

Tools: We’ve made modifications to IRB materials and created educational materials designed to be community-friendly. We utilize OHSU’s Request for Determination (RFD) form and also OHSU’s Quick Reference Guide for Quality Improvement (QI) or Research. The purpose of an RFD is to give an IRB analyst enough information to make a decision about whether a project is considered human subjects’ research or non-human subjects’ research. The Quick Reference Guide for QI or Research helps navigators guide discussion around what projects can be considered program evaluation or QI; squeezing out additional detail from researchers about the design of their proposed projects.

Tested Design and Approach: We piloted our approach alongside the Knight Cancer Institute’s Community Partnership Program. Our Navigators spent individual time in direct communication with project leaders to ask detailed questions about their newly-funded projects. We utilized the RFD form to guide the grantees through a discussion about the design of their projects. By spending time with each project leader or team to hear details about their project, we, as Navigators were able to accurately and effectively communicate with the IRB about each project, keeping the project leader engaged in the conversation at all times. We continue utilizing the same process with new project leaders, new grantees, and new investigators as well as with long-time community partners and academicians.

During these consultations, we can provide suggestions about, for example, how best to de-identify data collection tools and explain the importance of keeping distribution list identifiers separate from health information. By taking the time to communicate acceptable human subjects’ protection strategies while also making the ideas relevant in the moment and to the overall conduct of the study, we strive to continuously improve and keep our brand of community research support relevant and timely.

We Help Academic Researchers and Community Researchers

The Human Subjects’ Protection Program exists to help community researchers and OHSU investigators:

  • Better understand how the IRB process supports community-based research
  • How to navigate Federal guidelines and the IRB process
  • Grasp what the IRB is required to oversee and how it applies to community-based research.
  • Figure out what a project leader is required to do to protect project participants

 

The Community Research Navigator’s ultimate goal is to help researchers meet their planned and stated outcomes.

If this personalized approach is something that speaks to you, your community partner could benefit from, or you’re looking for this type of assistance for yourself as an academic investigator or community researcher, request a Community Research Navigator consultation via communityresearch@ohsu.edu or call us at 541-728-0665.