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Community Based Research: IRB Considerations Cheryl L. Byers, MHA, CIP Assistant Vice President for Research Compliance Olivia Hart, MPA IRB Manager, Social & Behavioral IRB. What is Community Based Research?. - PowerPoint PPT Presentation
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Community Based Research: IRB Considerations
Cheryl L. Byers, MHA, CIPAssistant Vice President for Research Compliance
Olivia Hart, MPAIRB Manager, Social & Behavioral IRB
What is Community Based Research?
• Community-engaged research is “the process of working collaboratively with and through groups of people affiliated by geographic proximity, special interest, or similar situations to address issues affecting the well-being of those people (Centers for Disease Control and Prevention, 1997, p.9).”
• A framework or approach for conducting research that guides the research and the relationships between the communities and academic researchers.
• Requires partnership development, cooperation, negotiation, and commitment to address local health issues
How is Community Based Research Different from Traditional Research?
• Input from the community is utilized to identify the issue that will be addressed
• Researchers work directly with the local community on many aspects of the study including study design, recruitment methods, data collection, etc.
• Results are shared with the local community
Characteristics of Community Engaged Research
• Community members and researchers contribute equally and in all or most phases of research
• Trust, collaboration and shared decision making are integral parts of the process• Findings and knowledge benefits all partners• Researchers and community members recognize each other’s expertise in a
bidirectional, co-learning process• Researchers embrace the skills, strengths, resources and assets of local individuals
and organizations• The community is recognized as a unit of identity• Emphasis is on multiple determinants of health• Partners commit to long-term research relationships• Core elements include local capacity building, systems development,
empowerment and sustainabilityHorowitz, Robinson & Seifer, 2009
Benefits to Conducting Community Based Research
• Research takes place in “real world” conditions• Increases applicability of findings which leads to practical
applications of the research• Connects researchers/University to the community• Find out what issues are important to the local
community• Recruitment of participants is sometimes easier;
especially if you have buy-in from key community leaders and individuals understand the benefit of their participation
Other Benefits to Community Based Research
• Improve study design and tools with assistance from the community – ensures information is culturally appropriate
• Input from community leaders can bring about issues the researcher may not have considered previously
• Builds trust within the local community• (Hopefully) leads to improvement in community
health
• In 1990, researchers at Arizona State University collected specimens from tribe members to study diabetes as the tribe had an alarming incidence of the disease.
• Informed consent said the research was to “study the causes of behavioral/medical disorders.”
• The Havasupai leaders learned that the blood samples were used to study many other things, including mental illness and theories of the tribes geographical origins that contradict their traditional stories
• Havasupai v. Arizona State University– 2010 Settlement:
• $700,000 to 41 tribe members• Medical care & educational services• Return of known remaining specimens (151)
The Havasupai
http://www.nytimes.com/2010/04/22/us/22dna.html
• The IRB is responsible for the review, approval, and continuing oversight of all research involving human subjects
• Per Federal regulations IRBs are mandated to maintain a specific composition 5 Members, Scientists, Non-Scientists, Community
Members, Non-Affiliated party
What is an Institutional Review Board (IRB)?
‣ Issued April 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
‣ Made necessary due to a long history of various questions, concerns, difficulties and problems that arose in medical experimentation and other forms of research efforts involving the enrollment of human subjects
‣ Distinguished between medical practice (treatment) and research
‣ Established the responsibility of the investigator to submit research activity for review by an Institutional Review Board
Belmont Report
The Three PillarsRespect
for Persons Beneficence Justice
• Per Federal regulations (45CFR46.102(d)), research is defined as the systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge
What is Research?
• Per Federal regulations (45CFR46.102(f)), a human subject is defined as: A living individual about whom an investigator
(whether professional or student) conducting research obtains• Data through intervention or interaction with the
individual, or• Identifiable private information
What is a Human Subject?
Navigating the IRB• In reviewing community based research,
the IRB must ensure the following:– Research is being conducted in a manner
consistent with the federal regulations, state statutes, and USF HRPP policies & procedures
– The research is appropriate for the population– Consideration is given to cultural, national or
ethnic issues – Consideration is given to potential vulnerable
subjects
Completion of the IRB Application
• Study Locations– Identify the site/community where the research will take
place– If study will take place at a non-USF location (i.e., church,
shelter, etc.) a letter of support is required for approval• If working in school system, a letter from the District is required
– IRB needs the name and contact info from key point of contact at the site
– Confirm if the non-USF site has own IRB which will be also be reviewing the research
• Informed consent is central to the protection of human subjects. It is both a process and a procedure The process is the exchange of information that takes place
between the prospective subject, and the investigator and study staff, before, during and sometimes after the study
The procedure includes the shaping and signing of an informed consent document (ICD)
There are also times the IRB can waive consent
What IS Informed Consent?
• Per federal regulations, the list of required elements includes: A statement that the study involves research, an explanation of the
purposes, the expected duration, a description of the procedures, and identification of any experimental procedures;
A description of foreseeable risks/benefits; Disclosure of appropriate alternatives; A statement on the extent to which confidentiality will be maintained; Discussion of compensation and explanation regarding availability of
medical treatments for research-related injury; Contact information for questions about research subject rights and
research-related injury; A statement that participation is voluntary
Required Elements of ICD
Other Considerations for Informed Consent
• The document must be in a language that is understandable by the research subject– Therefore, if you are recruiting non-English speaking
individuals, the consent must be translated
• The IRB can waive consent in certain situations including when the consent is the only record linking the subject to the research and there would be potential harm resulting from a breach in confidentiality
Process for Approval• Once your study has made it through department review
in ARC (eIRB), a Research Compliance Administrator (RCA) will review the application– He/she will contact you via the system if there are questions or
revisions needed• The study will be reviewed per its “category”
– Exempt & Expedited review studies are reviewed by the Chair and/or Designee (Most Social & Behavioral fall into these categories)
– Full-board studies are reviewed at the convened meetings • 4 Biomedical/1 Social & Behavioral per month
Important Notes on Timeframes• The review process requires careful
collaboration with multiple parties• Not all studies are approved on first
submission• Average turnaround time once in IRB queue:
– Expedited and Exempt-About two weeks– Full Board- About a month
Tips for Success• Complete the application in its entirety. • Use protocol guidelines if needed• Upload all relevant questionnaires, interview
questions, etc. for review by the IRB• Provide appropriate consent documents or
request a waiver • Seek assistance from your faculty mentor
Questions??