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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?.
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Community Based Research: IRB ConsiderationsCheryl L. Byers, MHA, CIPAssistant Vice President for Research ComplianceOlivia 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 • Findingsand 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 sustainability Horowitz, 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
The Havasupai • 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) http://www.nytimes.com/2010/04/22/us/22dna.html
What is an Institutional Review Board (IRB)? • 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
Belmont Report • 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
The Three Pillars Respect for Persons Beneficence Justice
What is Research? • Per Federal regulations (45CFR46.102(d)), research is defined as the systematic investigation, including research development, testing and evaluation, designedto develop or contribute to generalizable knowledge
What is a Human Subject? • 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
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
What IS Informed Consent? • 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
Required Elements of ICD • 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
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