the irb: why, what and how core concerns: subject selection, subject consent to participate,...
TRANSCRIPT
The IRB: Why, what and how
Core Concerns: Subject selection, subject consent to participate, confidentiality
IRB Protocol Forms
Contact Information
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The IRB:WhyWhatHow
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Support WP compliance with ethical concerns regarding the use of human subjects as defined in the Belmont Report Respect for Persons, Beneficence, Justice
Support WP compliance with Federal regulatory requirements in The Common Rule (45 CFR Part 42) and by the Office of Human Research Protection
The IRB focuses on How a research plan involves living human subjects How the results in that research will advance specific or
generalizable knowledge to other investigators or the general public.
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Federal regulations required all investigators to certify that they have received ethics training related to the use of human subjects in research
WPUNJ Training Modules: (1) Investigators and Educators, (2) Students in Research, and (3) IRB Reference Resource for IRB Members
Flexibility for investigators who completed certification somewhere else
Compensation for some faculty teaching but not otherwise engaged in research
WPUNJ Training Page, CITI Program
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Biomedical or social/behavioral research undertaken by faculty, staff, doctoral students and outside investigators
Categorize research based on level of risk to subjects; level of risk determines type of review process
WPU policy specifically excludes some types of research from review by the IRB: Classroom activities and homework
Pedagogical research done in the investigator’s own classroom
Oral history interviews done for historical research purposes
Research and assessment conducted by the University concerning its core activities and with its various constituencies
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Undergraduate and Master’s Degree Student research is reviewed when: The research involves a vulnerable population
The research collects identifying information on the research subject
The research goes beyond what is normally expected for the course
The research concerns a highly sensitive subject
The research plan has potential serious physical or psychological risk for the subject or the researcher
Faculty or Research Mentors Decide what student work needs review
Supervise their students and are responsible for students activities
Must complete and provide IRB with Certification of Training
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Initial Review Protocol prepared, approved and submitted Review, negotiation and approval by members
of the IRB working on behalf of the full committee
Full committee review and approval Continuing Review
Required within 365 days of initial approval for all investigators except students
Form completed and submitted Compliance review and temporary re-approval Full committee review and approval
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Core Concerns: Subject selectionSubject consent to participateConfidentiality
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Respect: Are subjects treated justly, are they given the
opportunity to chose to participate, is their personal information protected?
Beneficence: Are the benefits maximized while the risks are
minimized? Justice:
Are the burdens and benefits distributed appropriately between subjects and the beneficiaries of the research?
Are the correct subjects being used?
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Federal guidelines define vulnerable populations as those people who do not have the ability or capacity to freely choose to participate in the proposed research.
Specifically Identifies & Protects: children and minors prisoners fetuses pregnant women
Other Covered Populations: persons with diminished capacity English language limitations 12
WPUNJ expanded specifically identified groups to include respondents who may perceive that their responses may have an impact on them, such as:
residents of nursing homes patients in hospitals students in classes of the researcher employees of businesses
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An Informed Consent Statement must provide enough information to insure that subjects understand: They are free to choose whether or not to participate
They are free to leave the study at any time without penalty
They know what is expected of them to participate and if they will receive compensation for participating
They know the risks and benefits associated with participating
They know how their participation and personal information is kept confidential
They know whether or not their participation will be anonymous and who will know their identity if it is not
Understand who to contact with questions or concerns about the research project or the way it is conducted 14
Active Consent Signature required by subject; witness rare
For interviews and physical contact with subjects, collection of personally identifying information, or ongoing contact with subject
For young children and minors, must include their assent along with parent/guardian consent
Passive Consent Participation is subject’s statement of consent to
participate in the research
Limited to anonymous surveys
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Consent must be durable: subjects must have the opportunity to renew consent during long term studies
Permission to use a site does not provide consent for the subjects at that site
Witnesses and surrogate consent: why, how and who Personal Information and Data
Names must be coded in data bases using a system approved by the IRB
Data must be stored in a secure location with a defined termination date and data disposition plan
The “code key” for connecting data, databases and informed consent statements must be kept in a separate secure location
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Identification of investigators Identification of research topic, what
subjects will be asked to do to participate, and what subjects will receive for participating
Identification of risks and benefits Statements concerning confidentiality,
anonymity, and data storage/security Identification of where subjects can get
additional information concerning their rights
Instructions on how consent is given17
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IRB Protocol FormsFaculty, Staff, Doctoral Students
Outside Investigators Undergraduate and Master’s Degree Students
Continuing Review Form20
IRB Protocol Face Sheet, signed by investigator(s) and supervisor(s)
Protocol narrative Details!
Data instruments Letters, emails, posters or other
items that will be used to recruit or contact subjects
Other information as needed
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Form All sections must be completed: DETAILS Fillable PDF version that can be printed,
signed and submitted to the IRB Data instruments Letters, emails, posters or other
items that will be used to recruit or contact subjects
Other information as needed Student Research FAQ
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Michael FigueroaChair, WPUNJ IRB, 2012-2013Associate Professor, [email protected]
Martin WilliamsIRB AdministratorDirector, Office of Sponsored [email protected]
Maureen PetersProgram Assistant, Office of Sponsored [email protected]
Phone: 973-720-2852Location: Raubinger Hall, Room 309Website: http://www.wpunj.edu/osp/irbAll Forms Available On Website!
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