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IRB Approval

Seeking IRB approval

Use this information to pursue approval of Research Ethics for All for your protocol or project.

Research Ethics for All is for community research partners without advanced degrees in scientific disciplines who will interact with research participants and/or their individually identifiable information. Community research partners may or may not have an appointment at an academic institution. 

It is important to distinguish community research partners—people who help design and conduct research—from research participants—people who agree to provide their data for a research study. 

Research Ethics for All supports community research partners to learn about ethical practices and decision-making in patient-centered research, including responsible conduct of research. Individuals who complete the training can earn certification in research ethics and research-related compliance for topics relevant to community research partners engaged in patient-centered research.

Research Ethics for All supports community research partners to achieve the following learning outcomes:

  1. Define research with people, jobs of different people on a research team, and ways community research partners can make research more ethical and respectful. 
  2. Describe rules related to research with people (Belmont principles, The Common Rule, HIPAA, FERPA, FDA, GINA)
  3. State why there are rules for research with people and rights of research participants.
  4. Describe how to use IRB-approved recruitment and consent materials, follow eligibility criteria, and work with children and adults with and without guardians to make informed, voluntary, and ongoing decisions about being in a research study. 
  5. Discuss how to keep research participants safe, including in clinical trials and patient-centered comparative clinical effectiveness research, and what to do when there is information that cannot stay confidential. 
  6. Explain responsibilities of community research partners, including ways to protect the rights and well-being of people who are in research and community researchers, one’s own team's rules, conflicts of interest, and authorship.

Research Ethics for All provides general research ethics education in patient-centered social-behavioral-educational and biomedical research tailored to the roles and learning needs of community research partners with developmental disabilities. Research Ethics for All offers initial and renewal certification.

Research Ethics for All is not a substitute for research protocol-specific training, though Research Ethics for All does include add-on activities that may be used with protocol-specific training.

Research Ethics for All and CITI Foundations comparison (PDF)

Research Ethics for All was created by people with developmental disabilities, disability service providers, researchers, and human research protections experts.

We developed Research Ethics for All by deciding together what community research partners with developmental disabilities need to know. We reviewed other research ethics training programs, identified ethical issues related to doing patient-centered comparative clinical effectiveness research and research with people with developmental disabilities, and shared our experience and expertise. We worked together to make Research Ethics for All disability accessible.

Learn more about the development of Research Ethics for All.

We recommend Research Ethics for All be taught by experienced research project leaders (usually principal investigators) or research ethics trainers. These individuals should have current CITI certification in social-behavioral-educational and biomedical research and experience conducting research with people with developmental disabilities and/or teaching about research ethics. Training facilitators can assess learner understanding and issue certification.

People learning on their own can also access Research Ethics for All. However, people learning on their own cannot obtain certification.

After completing the training, the training facilitator works with individual learners to check their understanding of core Learning Outcome concepts. When the person who led the training is satisfied that the learner has demonstrated a basic level of understanding, they can use the certificate template to issue a certificate to the learner. Project leaders can submit individual certificates in their IRB application.

Dear [Human Research Protections Program Director]:

I am writing to request approval to offer Research Ethics for All to my community research partners instead of [name of institutionally approved research ethics education program]. These community research partners are working with me on [name of research project and, if available, IRB protocol number].

Research Ethics for All is tailored to meet the unique educational needs of community research partners with developmental disabilities. Research Ethics for All provides community research partners with disability accessible education in ethical issues in patient-centered research, including patient-centered comparative clinical effectiveness research and responsible conduct of research. Research Ethics for All is focused on the roles and responsibilities of community research partners who are engaged in human subjects research, spanning social-behavioral-educational and biomedical research.

Research Ethics for All was developed by people with developmental disabilities, disability service providers, researchers, and human research protections experts.

Research Ethics for All is also available via the CITI Program to subscribers of the Human Subjects Research (HSR) series subscribers. The office that manages your access to CITI educational programs can add Research Ethics for All via the CITI order form.

Attached is additional information about the development and content of Research Ethics for All. More information can also be found at www.re4all.org.

I look forward to discussing the use of Research Ethics for All at our organization.

Email attachment describing Research Ethics for All for IRBs

If you present information about Research Ethics for All to your IRB or authorized institutional official, you can use these slides:

Presentation describing Research Ethics for All for IRBs

Research Ethics for All was made by people with developmental disabilities, disability service providers, researchers, and IRB administrators and members.