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Resources for the Community
Use these tools and resources to learn more about community involvement in health research. By putting this knowledge into action, you can help improve research studies that can lead to better health for all.
Clinical research is the study of health and disease in people. It can be conducted in many ways like completing a survey, sharing feedback in a small group meeting or observing people in certain settings. Participating in clinical research helps investigators uncover better ways to treat, prevent, diagnose and understand human diseases.
Clinical trials are a type of clinical research that may involve testing a new treatment like a drug, medical device, a surgical procedure, or a new way to use an existing treatment. Scientists may have many reasons for doing a clinical research study:
- To explore the cause of a disease or a set of symptoms
- To test if a treatment will help with a symptom or condition
- To learn how a certain behavior affects people’s health
Strict regulations and safeguards are in place for everyone who volunteers to be a part of clinic research.
Translational science research is about “translating” new knowledge found in the scientific laboratories into health benefits through collaboration. It transforms scientific discoveries into improved patient care, community-based practices and policies to improve health.
Basic science research is the study of a subject to increase knowledge and understanding about it without a specific or immediate use in the healthcare setting. This research can be, for example, at the cellular or genetic levels.
An institutional review board, commonly called an IRB, is a committee that includes physicians, statisticians, researchers, community advocates and others and ensures any research done on and about humans is ethical and that the rights of study participants and communities are protected.
The group follows federal regulations, state laws and Penn State policy to review, monitor and approve research in order to protect the ethical rights and privacy of the subjects involved.
All human-subject research done in the United States must be approved by an IRB before a study begins.
How Am I Protected?
The goal of clinical research is to develop knowledge that improves human health or increases understanding of human biology. This is possible because of people volunteering to participate in research. The path to finding out if a new drug is safe or effective is to test it on patient volunteers. Because placing some people at risk of harm can benefit the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science. Ethical guidelines in place today were primarily a response to past research abuses.
Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. The process of providing information to participants continues throughout the study. To help someone decide whether to participate, members of the research team explain details of the study. The research team provides an informed consent document, which includes such details about the study as its purpose, duration, required procedures and who to contact for various reasons. The informed consent document also explains risks and potential benefits.
If the participant decides to enroll in the trial, the informed consent document will be signed. Informed consent is not a contract. Volunteers are free to withdraw from the study at any time.
Most, but not all, clinical trials in the United States are approved and monitored by an institutional review board (IRB) in order to ensure that the risks are minimal and are worth any potential benefits. Potential research participants should ask the sponsor or research coordinator whether the research they are considering participating in was reviewed by an IRB.
Source: National Institutes of Health
Weighing all of your options, both risks and benefits will help you to make an informed decision about getting involved in research. The research team is there to assist you, so don’t be afraid to ask questions. Remember, participating in research is totally up to you, and you can stop at any time throughout the process.
Here are possible questions to ask when deciding to join a study or trial.
- Who has reviewed and approved the study?
- What do the researchers hope to learn from the study?
- What would you have to do? What kind of medications, procedures, or tests would you have?
- How would being in the study affect your daily life?
- What are the risks?
- How would your privacy and identifiable private information be protected?
- Will there be any travel or other study-associated costs (such as child care), and will researchers provide any money to cover those costs?
- Who should you contact if you have questions about participating?
Basic Science Research
The study of a subject to increase knowledge and understanding about it without a specific or immediate practical application. Examples include studies of cell signaling, genetic mutations associated with specific types of cancer and how tumors evade the body’s immune system.
Research that determines the safety and effectiveness of medications, devices, diagnostic products and techniques and treatment regimens.
Comparative Effectiveness Research
The direct comparison of existing treatments to determine with works best. Comparative effectiveness research has emerged as an important mechanism to improve health outcomes, accelerate the translation and dissemination of evidence-based diagnostic and treatment strategies and deliver more patient-centered healthcare.
A distinct approach to research involving the building of trusted and authentic partnerships between researchers and the community. Community-engaged research requires that a relationship be built between the academic institution and the community in which it serves based on respect, trust and mutual benefit and addresses community needs and health issues as defined by the community itself.
Community Engaged Research Core
The Community-Engaged Research Core offers assistance to both researchers and community organizations. The core helps build community-academic research partnerships by offering training and assistance on the development and implementation of community-engaged research projects.
Community-Based Participatory Research
Community-based participatory research is research that is conducted as an equal partnership between traditionally trained “experts” and members of a community. In these projects, the community participates fully in all aspects of the research process. Community is often self-defined, but general categories of community include geographic community, community of individuals with a common problem or issue, or a community of individuals with a common interest or goal.
Clinical and Translational Science Award (CTSA)
A consortium of 60 medical research institutions working to improve the way medical research is conducted. The vision of the Clinical and Translational Science Award network is to reduce the time it takes for scientific discoveries to become treatments, practices or policies to improve health.
A planned process that involves consideration of who should hear research findings and where, and, where appropriate, communicating and interacting with wider policy and health service audiences in ways that will encourage use of research findings in decision-making.
Institutional Review Board (IRB)
A committee of physicians, statisticians, researchers, community advocates and others that ensures that any research done on and about humans is ethical and that the rights of study participants and communities are protected. All human subjects’ research done in the United States must be approved by an IRB before it begins.
Human Subjects Protection
Laws set by the U.S. Department of Health and Human Services to protect a person from risks in research studies that any federal agency or department has a part in. Also called 45 CFR 46, 45 Code of Federal Regulations Part 46, and human participant protection regulations. Research institutions require that anyone engaged in research that involves humans must complete training in human subjects protection.
National Institutes of Health (NIH)
The primary federal agency for conducting and supporting medical research. NIH includes 27 different institutes and centers.
Patient-Centered Outcomes Research
Patient-Centered Outcomes Research helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options. This research aims to answer patient-centered questions as defined by individual patients.
Patient-Centered Outcomes Research Institute
A nonprofit organization to improve the quality and relevance of research to help patients, caregivers, clinicians, employers, insurers and policy makers make informed health decisions.
Principal Investigator (PI)
The researcher in charge of an experiment or research project and the person responsible for the overall management and direction of the project. A principal investigator may also be called the lead investigator or lead scientist.
Individuals, organizations or communities that have a direct interest in the process and outcomes of a research project.” Stakeholders may be patients, caregivers, advocates, research volunteers and community leaders.
This type of research transforms scientific discoveries into improved patient care, community-based practices and policies to improve health.
Resources for Researchers
Community engagement and collaboration is weaved throughout the fabric of Penn State. An integrated approach is essential for effective clinical and translational science. Community involvement in all phases of research can help to ensure that new treatments and health discoveries are more effective and meaningful for those it is intended to reach.
These tools for researchers includes resources geared specifically towards working with patients, advocates and community members and organizations to improve and enhance research. The toolkit also includes ways to partner with the community to participate fully throughout the research process.
In Penn State College of Health and Human Development’s “Ask the Experts” series, Dennis Scanlon, PhD, Penn State Center for Health Care and Policy Research, speaks with Jen Kraschnewski, MD, MPH, co-chair of Penn State Clinical and Translational Science Institute’s Community-Engaged Research Core. They discuss community-engaged research, why it is important, where it is happening at Penn State and how to learn more about it.
Collaborative Institutional Training Institute (CITI) Program offers three elective community-engaged research modules. The modules, which were developed, authored and reviewed by researchers, community partners and institutional review board representatives, provide learners with increased knowledge and understanding in order to participate in research partnerships and communities.
These modules are found under the Protection of Human Research Subjects – Biomedical Course – Basic Course. Scroll down to the optional modules.
- Ethical and Practical Considerations in Community-Engaged Research
- Introduction to Community-Based Participatory Research
- Introduction to Community-Engaged Research
These modules are a result of a collaboration between the CITI Program and the Harvard Catalyst Community Engaged Research Subcommittee.
Penn State Clinical and Translational Science Institute provides community-centered translational science infrastructure that builds on existing networks of community engagement already in place at Penn State and focuses on the development, implementation, evaluation and diffusion of evidence-based interventions. As part of the services, the Community-Engaged Research Team provides consultations to members of the Penn State community.
What can a consultation include?
- Assistance establishing a research project within the community
- Assistance to identify stakeholders who can provide input at all stages of research from conceptualization and discovery to dissemination
- Guidance in selection of approaches for community engaged health research (CEHR) that promote trust and benefit all parties
- Research project design involving interdisciplinary teams and community partners
- Community-based research approaches and protocols that effectively engage stakeholders in urban and rural settings
- Support coordination among community members, health care providers and research scientists
- Identification of needs and priorities for health-related research in Central Pennsylvania communities
- Tools for increasing diversity of community member participation in health research through awareness and involving community members in the development of effective recruitment, retention and dissemination strategies
- Assistance with patient and stakeholder engagement for Patient Centered Outcomes Research Institute (PCORI) applications
Who is eligible for a consultation?
Consultations are open to members of the Penn State community. Consultations are required for all Clinical and Translational Science funding recipients.
How much does a consultation cost?
Consultations are free.
How do I request a consultation?
Email firstname.lastname@example.org. In order to provide sufficient time for scheduling, the Community-Engaged Research Core requires at least two weeks notice to schedule a consultation prior to a grant submission. Requests received with less than two weeks noticed may not be honored.
What is a Community Engagement Studio?
The Community Engagement Studio is a one-time, 90-minute meeting where community members give feedback and advice to improve upon investigators’ research projects. A studio provides a cost-effective and time efficient method to engage patients and stakeholders to enhance current research practices and improve upon dissemination.
Why participate in a Community Engagement Studio?
- Gain valuable feedback on your research concept or study design before spending valuable time and resources.
- Engage stakeholders and patients to enhance current research practices and improve dissemination.
Does a Community Engagement Studio require IRB approval?
No, the studio is not considered research. It is a process to inform the development, conduct or dissemination of research. The participants in a studio are not considered research subjects but community advisors.
What does a Community Engagement Studio cost?
Community Engagement Studios are supported by Penn State Clinical and Translational Science Institute and free to Penn State researchers. However, researchers are encouraged to include studio costs in their future grant proposals. Studio community members are compensated for their time.
What is the time commitment required?
Community engagement studios provide significant benefit for minimal investment of time. On average, researchers spend less than four hours of their time preparing for and participating in a studio. After contacting the Clinical and Translational Science Institute, researchers will meet with the studio team for an initial planning meeting (one hour), preparing the presentation (one hour) and attending the studio (two hours).
How do I get started?
Penn State Clinical and Translational Science Institute’s Community Engagement Studio is adapted from the Meharry-Vanderbilt Community Engaged Research Core.
The Community-Partnered Research Ethics Training (CPRET) course is an interactive training tool covering important issues in human participant research and ethical guidelines that embody best practices through scenarios, role plays, and group discussion of relevant study-related topics. Patient partners that are part of a study’s Advisory Board are then eligible to become Co-Investigators on the study, officially recognizing the valuable role they play in community participatory research.
What is CPRET?
A great way to enhance the partnership between researcher and community member and also improve stakeholder engagement in key research milestones is through the Community-Partnered Research Ethics Training (CPRET) course. This training program, originally developed by the University of Pittsburgh’s Clinical and Translational Science Institute, is approved by Penn State’s Institutional Review Board as an ethics training tool for community partners engaged in research activities within Penn State. The training covers important issues in human participants research and the ethical guidelines that embody best practices through an interactive format, including scenarios, role plays, and group discussions.
Why does this type of training matter?
A key benefit of this program is that it avoids a “one size fits all” training format and instead provides the ability to tailor ethical issues in the context of the research the community member is participating in. Therefore, the training can be modified to ensure project relevance and hone in on key concepts, rather than a blanket training that reduces applicability. By providing a deeper understanding of ethical issues that may arise in a specific research study community partners are engaged in, they are better positions to ensure the protection of human subjects and handle situations ethically. In addition, post-training certification enables community members to become official Co-Investigators on the study, thus recognizing the valuable role stakeholders play in community participatory research.
Where can I access the CPRET training?
Provided in the toolkit are sample Powerpoint training presentations, guidelines for tailoring scenarios, feedback and evaluation forms and certifications, among other resources.
How do I get started?
As investigators begin to tailor the scenarios provided in the CPRET PowerPoint template, they will need to consider the level of involvement community partners will have in each phase of the research. For example, will community partners help with recruitment efforts and/or patient consent? Will they have access to patient health data? These inquires will help guide the adaption of the training tool to best meet the needs of the community partners and enhance training relevance.
Allowing for flexibility in its design, investigators have the ability to tailor scenarios and role play based on project specifics. This results in meaningful discussion and helps with the transfer of knowledge. Scenarios and role play should cover key ethical principles (i.e., respect for persons, beneficence, justice).
Once research teams develop tailored scenarios the Principal Investigator must approve them, however, no other further approvals are required from the IRB or elsewhere. Roleplay activities can also enhance the training program and should be provided in an appropriate and relevant context. For example, if community partners will be providing consent to patients in the research study, including a role play of the informed consent process during the training and discussing ethical considerations would be applicable.
How long does the training take?
Delivery of the CPRET can be effectively completed in one to one and a half hours, depending on the size of the audience. This will allow for meaningful interactions and discussions surrounding key concepts while leaving ample time for questions/answers.
Once community partners have completed the CPRET program, they can receive a certificate, a template for which is provided on the University of Pittsburgh’s CPRET page. In addition, if they will be engaged in key research milestones such as recruitment, informed consent, data analysis, etc, they can be listed as co-investigators on the research study. Research teams would need to complete a modification to the IRB to add these community members to the study and also provide an attendance record as proof they underwent the training.
It is important to collect data on how useful this training is to community-engaged research groups. Post-training, community members can complete an evaluation to capture their thoughts on the training. A sample of this is provided through the University of Pittsburgh’s CPRET website. Training facilitators (the research team) can also evaluate the CPRET by completing a similar form. These can be submitted to the IRB so the program may enhanced in the future.
When providing CPRET training to community members, be sure to credit the individuals at the University of Pittsburgh who developed the CPRET. TO do so, include a slide recognizing these efforts:
Developed by the University of Pittsburgh
(Michael Yonas, Elizabeth Miller, Maria Catrina D. Jamie and Shannon Valenti)
Adapted by Penn State Health
(List Penn State research team members here)
Additionally, on each PowerPoint Slide, include credits below:
Adapted from Version 1.0
Copyright 2014, University of Pittsburgh. All Rights Reserved.
This work is licensed under a Creative Commons Attribution-Non Commercial 4.0 International License
After a community stakeholder team has been formed, it is important to get to know them and gain an understanding of what their backgrounds and experiences are in a research context, either as a participant, community partner or other exposure. This will help the research team identify knowledge gaps and provide future trainings in key research activities to enhance engagement throughout the study. An effective way to collect such data is to conduct a needs assessment at the beginning of the project.
Some sample questions are provided here.
- Have you ever participated in a research study before?
- If yes, what was the study about? Explain your involvement.
- Do you feel you benefited by being a part of the study? If so, explain why.
- Was this a positive or negative experience for you? Please explain.
- Why did you become a community partner?
- Have you participated in other studies as a community partner?
- If yes, how do you feel you were best engaged in the process? Least engaged?
- What matters most to you in a research study?
- What are you most interested in learning over the course of your involvement on the current project?
- How do you see yourself making a difference in this project?
- How do you best learn? Visual (learn by seeing), auditory (learning by hearing) or kinesthetic (learn by doing)?
Community Engagement Enhancement Funding
Penn State Clinical and Translational Science Institute provides pilot funding aimed at increasing researchers attention to and capacity for collaboration with a range of communities. Community Engagement Enhancement Funding is designed to help investigators build community-engaged health research (CEHR) into ongoing projects as a broad mechanism to advance the dissemination of research funding and engage communities throughout the process.
What can Community Engagement Enhancement Funding be used for?
- Direct investigators’ efforts toward community engagement.
- Enhance communities’ opportunities for participation as research partners including consultations about health priorities.
- Promote relationships of mutual respect and trust.
- Reward community partners for their expertise.
- Develop sustainable implementation and dissemination strategies to improve the health and well-being of communities.
We are happy to provide a letter of support or language to include for grant applications that are planning on using community engagement.
Letters of support are subject to review, editing and approval and will typically be signed by the Co-Leads of the CTSI Community Engagement Research Core.
To obtain a letter, email email@example.com.
There are many other resources to consider as you strive for community engagement. Please note: The inclusion of resources and websites on this list does not constitute endorsement.
Principles of Community Engagement (Second Edition)
Principles of Community Engagement (Second Edition) provides public health professionals, health care providers, researchers, and community-based leaders and organizations with both a science base and practical guidance for engaging partners in projects that may affect them.