Embed Size (px)
Citation preview
Human Subject Human Subject Research by Research by StudentsStudents
atat
William William Paterson Paterson UniversityUniversity
March 2015March 2015
IRB PrimerIRB Primer
Human Experimentation: The Good, The Bad, & The
Ugly. ◦ SciShow Sept 18, 2013
(12.26 min.)
◦ http://www.youtube.com/watch?v=hRwWxELXakA
Research Ethics (7 min.)◦ Chris Flipp January 13, 2014
◦ http://www.youtube.com/watch?v=Zbi7nIbAuMQ
2
William Paterson William Paterson IRBIRB
WP’s committee that approves and monitors use of human subjects in research
Belmont Report and regulations in The Common Rule (45 CFR Part 46)
Policy, forms and resources on web
3
The WP IRB is concerned with Social-Behavioral and Biomedical research that:◦Is a systematic
investigation
◦Is designed to develop or contribute to generalizable knowledge
◦Involves living human subjects about whom an investigator obtains either personally identifying data through intervention or interaction OR identifiable personal information
◦Is regardless of location, reason or factors motivating the research
4
Ethical Basis (Belmont Report):◦Respect for Persons Autonomous individuals
are entitled to be protected, are fully informed and freely volunteer to participate
◦Beneficence Do no harm! Maximize
benefits while minimizing risks
◦Justice Burdens and benefits are
appropriately distributed between subjects and beneficiaries
5
The IRB does not review: classroom demonstrations,
exercises and/or experiments designed for the exclusive purpose of education.
Pedagogical research done in the investigator’s own classroom.
Oral history interviews done for historical research but not any social/behavioral or biomedical purposes.
Research conducted by the University (or parts thereof) concerning its activities and with its own constituencies.
Library research, archival research, or the use of publicly accessible databases
6
Student research is reviewed when:◦The outcomes will be shared
outside the classroom
◦The research involves a special class of subjects
◦The research collects identifying information on the research subject beyond a signature
◦The research concerns a highly sensitive subject
◦The research may elicit a negative psychological or physical response by the subject OR have a potential physical risk for the researcher 7
Faculty or Research Mentors◦Decide what student work
needs review – but may send anything to the IRB
◦Supervise their students and are responsible for what their students do
◦Must insure that subjects are effectively respected by their students
◦Must complete and provide IRB with Certification of Training
8
Certification of Training in the Ethical Use of Human Subjects in Research◦Required to be provided by
instructors of students who actively engage students in research
◦Special course provided for students that covers being an investigator and a subject
◦http://www.wpunj.edu/osp/irb/training-and-certification-program.dot
9
Special Classes of Subjects – also known as Vulnerable Populations
◦The Common Rule: People who do not have the
ability or capacity to freely choose or communicate their decision to participate in the proposed research
◦Specifically Protects: children and minors prisoners fetuses and pregnant
women◦Also covers persons with diminished
capacity English language limitations
10
◦WP Policy: Subjects who may
perceive that their responses may have a direct impact on them, such as:residents of nursing homes
patients in hospitalsstudents in classes of the researcher
employees of businesses
11
Informed Consent Statement must provide enough information to insure that subjects…
◦Have the freedom to choose whether or not to participate in the research,
◦Understand that they may leave the study at any time without penalty,
◦Understand and agree to do what is expected to participate in the research,
12
◦Understand and agree to the risks and benefits associated with participating,
◦Understand how their participation is kept confidential,
◦Understand 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
13
Four types of Informed Consent Statements at WP
1.Passive consent Participation is subject’s
statement of consent to participate in the research
Method of consent matches the survey tool
Limited to anonymous surveys
14
2. Active consent
Signature required
For interviews and other physical contact with subjects, collection of personally identifying information, and ongoing contact with subject
Parent/guardian consent required for children and minors as well as others who may not be able to decide or communicate decision
Witness included for special classes of subjects and special situations
15
3. Assent◦For anyone for whom an
Active Consent was signed by a parent or guardian on their behalf
◦Children and Minors
◦Adults with cognitive or physical challenges that prevented them from either understanding the consent document or communicating their consent
◦Method of obtaining verbal consent will vary by one population and situation
◦Minors may provide an assent signature on the Active Consent Statement their parents signed
16
4. Waiver of Consent• Provided by IRB when
obtaining active or passive consent is impracticable
• Used for observation of public behavior and emergency treatment situations
• Permission by site ≠ consent subjects are able to decide 17
The format of an Informed Consent Statement is based on the amount of detail required by the research plan and the extent of contact with subjects.
◦Invitation to participate
◦Spoken formula
◦Short statement at top of page
◦Separate sheet without signature
◦Separate sheet with signature
◦First page online 18
The WPU IRB provides samples of Passive and Active Informed Consent Statements◦Use to create draft to be
submitted with protocol
◦Do not have subjects sign!
Sample Informed Consent Statements are available with other IRB Forms:◦http://www.wpunj.edu/osp/
irb/irb-forms.dot
19
Data Management
◦Names cannot be connected directly to data tools or instruments.
◦Use a coding system that connects data tools or connects data to subjects without revealing subject identity.
◦Maintain data and code key separately.
◦Data must be stored safely and destroyed when it is no longer needed
20
Practical IRB
◦ Anonymous Vs. Confidential
◦ What kind of research are you anticipating: surveys, interviews, both or something else?
◦ Who are you thinking about as subjects: WP students, other adults, children or teens, non-English speaking, or another group?
◦ Where will the research take place: classroom, Internet, public space, private space, school, business or somewhere else?
◦ Who will you share your outcomes with: Professor, other students, the subject’s patients or supervisors, or general public?
◦ Data Management: How will you code it? How will you safely store it? How long will you keep it?
21
Student Protocol Process
1.Student develops research plan, instruments and informed consent with their research supervisor
2.Student prepares the Student Research Protocol Review Request which is signed by their research supervisor before submission
3.Protocol delivered to the IRB with copy of all data collection instrument(s), draft Informed Consent Statement(s), and draft recruitment resources
4. IRB generally completes review within 3 business days unless there are questions or issues to resolve 22
Student Research Protocol
Contact Information
The research plan
◦Hypothesis
◦Research Design
What information will be collected?
How will it be collected?
How will information be stored?
How will it be analyzed?
23
The Research Plan, continued
◦Human Subjects
Who will they be?
How will they recruited?
How with their personal information be protected?
◦Outcomes
◦Benefits, Risks
◦Schedule
Available online in Word and .PDF at:
http://www.wpunj.edu/osp/irb 24
Attach:
1.Informed Consent Statement(s)
2.Data Collection Tools◦ Survey or questionnaire
Original or Acquired
◦ Interview Questions◦ Observation sheet, other items
3.Recruitment Resources◦ Flyer or Poster◦ Email◦ Announcement for Social Media
25
Questions . . . Questions . . . Contact
Martin WilliamsIRB AdministratorDirector, Office of Sponsored [email protected]
Maureen PetersProgram Assistant, Office of Sponsored
Phone: 973-720-2852Location: Raubinger Hall, Room
309Website:
http://www.wpunj.edu/osp/irb
All Forms As Well As Additional Information Is Available On Website! 26
