IRB Review and Approval of Community Based Research University of Alabama Office for Research Compliance (ORC)
Transcript
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University of Alabama Office for Research Compliance (ORC)
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Overview Definition and Purpose of the IRB CBR IRB Challenges
Steps Before Submitting the IRB Application Application Guidance
Ways to Submit the Application to the ORC The Application Review
Process Continuing Review Tips for Easing the Review Process CRB
IRB Opportunities Question and Answer
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What is the IRB IRB is short for Institutional Review Board The
IRB is a University Committee that reviews, approves, and monitors
human subjects research The existence of the IRB is required by the
federal government because UA receives federal research money
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Purposes of the IRB To protect the health, welfare and rights
of HUMAN research participants To review and approve all UA
research with human participants To monitor ethical conduct of
research To educate the UA community as well as the outside
community about ethical research and research rights
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Community Based Research and the IRB Challenges Lack of
understanding of CBR. Accessibility of IRB. Current Regulations do
not fully address CBR. More likely that ethical considerations will
evolve during project Requires the ability to deal with unexpected
issues as they arise. Researchers conducting CBR may be unfamiliar
with how to meet IRB requirements. Ethical issues in CBR are active
and on going as research continues. Current IRB reviews are not set
up to deal with ongoing ethical issues. Risk and Benefits of CBR
project needs to be weighed by the entire community. Typical IRB
review includes risk/benefit ratio assessment.
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Steps Before Submitting the IRB Application Develop an Idea
about the Research Consider: The topic to research Will this
involve human subjects as participants Time from conception of the
idea to a written draft
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Steps Before Submission continued Visit the IRB web site for
guidance on what information you need to provide the ORC
http://osp.ua.edu/site/irb.html http://osp.ua.edu/site/irb.html
Basic Information Needed Includes: Study Description &
Background Information Human Subjects Training Certificate Copies
of Study Stimulus (survey instruments, video stimulus, interview
guides, etc.) Consent form/Assent form or waiver request Plan for
carrying out the research
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Application Guidance IRB applications should be arranged in the
following order Request for Approval Form (face sheet) Personnel
list Research Description Appendices (which can include Consent and
Assent forms or waivers, advertising/recruitment materials, and any
supplementary forms, as for vulnerable populations)
http://osp.ua.edu/site/irb.html
http://osp.ua.edu/site/irb_guidance_documents.html
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Consent Form Required Elements Statement that the study
involves research Statement of Purpose What participation will
involve (what will participants be asked to do) Time Required for
Participation Description of Risks Description of Benefits
Disclosure of Alternatives to taking part in the research
Confidentiality Compensation / Reimbursement Participation is
voluntary Whom to Contact
http://osp.ua.edu/site/irb_guidance_documents.html
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Consenting in CBR Crucial to realize that consent is a process
NOT a document. Issues of literacy and language are primary
consideration. Potential participants may have crucial information
but must understand that they have the right to choose not to
participate. CBR more likely to use methods like face to face
interviews making privacy an issue. Participants in CBR studies
often live in small communities and can be easily identified by
quotes. CBR researcher need to be aware of laws and mandated
reporting requirements. Consideration should be given to whether
this information needs to be a part of the consent.
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Vulnerable Populations Children Cognitively Impaired Prisoners
Pregnant Women, Fetuses, and Neonates Projects involving these
groups require supplemental forms which can be found on the IRB
website http://osp.ua.edu/site/irb_forms.html
http://osp.ua.edu/site/irb_forms.html
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Minors as Research Subjects A minor is defined in Alabama as a
person less than 19 years old and not emancipated by the court, not
legally married. Minors cannot legally grant consent. Must provide
assent (active agreement - lack of a no does not mean yes). The
assent process must be appropriate to the study as well as to: the
age (recommended for ages 7 and older) maturity and psychological
state of the child
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Ways to Submit the Application Our office receives protocol
submissions via the following methods Email Traditional Mail
eProtocol Submission (online submission system)
http://eprotocol.ua.edu:8080/hs/?sa=Online+Protocol+ Submission
http://eprotocol.ua.edu:8080/hs/?sa=Online+Protocol+ Submission
Please note: In order to use the eProtocol system you will need to
request a user ID and password from
[email protected]@fa.ua.edu
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The Review Process Applications for Human Subjects Research
fall into three categories: Exempt Review Expedited Review Full
Board Review Please note: The type of review that an application
receives is determined within the Office for Research Compliance,
but researchers may request a particular type of review.
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The Review Process continued General Steps include the
following: 1) The Human Subjects Application is reviewed by a
Research Compliance Specialist for completeness. 2) Feedback is
provided to the Principal Investigator (PI) via email 3) Responses
from the PI are reviewed
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The Review Process continued For Exempt review- Applications
are reviewed by the Research Compliance Officer (RCO) to verify
exempt status, if determined exempt, then the RCO approve the
project and the IRB approval is granted For Expedited review-
Applications are sent to one or two members of the IRB to verify
expedited status; if determined that the application can be given
an expedited review, then the reviewer may ask additional questions
or approve the project. Please note in some instances, the reviewer
will refer the protocol for review by the convened IRB For Full
Board Review-Applications are reviewed by a subcommittee of the IRB
in which additional information may be requested; Applications are
then reviewed at the convened IRB meeting, in which the board may
make any of the following determinations: approve, approve with
modifications, disapprove, table, or ask the PI to revise the
application and resubmit to the board
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Closure Continuing review is not required for studies in which
data collection from human participants has ended, if the dataset
no longer contains participant identifiers and there are no means
of re-establishing the link. If data will remain identifiable,
investigators must keep the IRB approval active. Investigators are
urged to state in their applications how long they will retain the
data and whether data will remain identifiable.
http://osp.ua.edu/site/irb_forms.html
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Tips for Easing the IRB Review Process Ask Questions- Office
for Research Compliance staff are available Monday through Friday
from 8 AM to 4:45 PM 358 Rose Administration Building Phone
205-348-8461 Fax 205-348-8882 Email general questions to
[email protected]@fa.ua.edu
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Tips for Easing the IRB Review Process continued Allow yourself
enough time to complete the process Submit to 358 Rose
Administration Email : [email protected]@fa.ua.edu
Prior to IRB submission, complete your human subjects training; if
you are not sure whether or not your training is current, you may
call our office to verify training website:
http://osp.ua.edu/site/irb_training.html
http://osp.ua.edu/site/irb_training.html
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Continuing education for IRB members regarding CBR. Community
based researchers and the IRB need to develop closer relationships
than usually required of standard research. Opportunities &
Solutions Relationship building with IRB currently 3 community
members on the Non-Medical IRB and one on the Medical IRB. Provide
better education for researchers on the IRB process. Add additional
CB researchers to the IRB to expand expertise. Community Based
Research and the IRB
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Contact Information Office for Research Compliance (205)
348-8461 Tanta Myles Director of Research Compliance
[email protected] Jeanelle Graham Research Compliance Specialist
[email protected] Ed Shirley Research Compliance Specialist
[email protected] Tyler Uzzell Research Compliance Specialist
[email protected] Mukesha Voltz Research Compliance Specialist
[email protected]