1. 5/26/2018
Human Subject Research at William Paterson University February

2. 5/26/2018
The WP IRB is concerned with Social-Behavioral and Biomedical research that is:
A systematic investigation
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
Regardless of location, reason or factors motivating the research
Belmont Report
The Common Rule (45 CFR 46)

3. Human Experimentation: The Good, The Bad, & The Ugly. SciShow
Human Experimentation: The Good, The Bad, & The Ugly. SciShow Sept 18, (12.26 min.)

4. Research Ethics Chris Flipp. January 13, 2014. (7 min. ) http://www

5. Ethical Basis (Belmont Report): Respect for Persons
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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; no coercion to participate

6. Special Classes of Subjects (Vulnerable Populations)
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Special Classes of Subjects (Vulnerable Populations)
Federally Designated
Children and Minors
Fetuses and Pregnant Women
Prisoners
WPU Designated
Anyone who perceives that their participation will hav a negative impact on them
Cognitive or development disability
Not fluent in English
Other limitations that prevent them from understanding or responding to the terms or conditions of participation

7. 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

8. Undergraduate and Master’s Degree Student Research
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Undergraduate and Master’s Degree Student Research
Only reviews research where:
The outcomes will be shared outside the classroom
The research involves a special class or 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
Based on department and topic of research
Decided by instructor/mentor

9. Undergraduate and Master’s Degree Student Research
5/26/2018
Undergraduate and Master’s Degree Student Research
Only reviews research where:
The outcomes will be shared outside the classroom
The research involves a special class or 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
Based on department and topic of research
Decided by instructor/mentor

10. The IRB Reviews
Everything else that fits the definition for research involving human subjects
Initial Reviews
Continuing Reviews
Annual, an unanticipated event, a significant change, or when research is completed
IRB can suspend or terminate a protocol if it determines that
continuation would not be in the best interest of subjects
the information in a protocol or continuing review is wrong or misleading.

11. Certification of Training
Must be renewed every three years
IRB Policy requires investigators, instructors of students actively engaging subjects in research, IRB members and others to certify that they have received ethics training related to the use of human subjects in research
Flexibility for investigators who completed it somewhere else
Certification for professor covers everyone in her/his students that she/he is supervising
WPUNJ Training Page

12. Four types of Informed Consent Statements at WP Sample Statements:
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Four types of Informed Consent Statements at WP
Sample Statements:
1. Passive consent
Participation is subject’s statement of consent to participate in the research
Limited to anonymous surveys

13. 2. Active consent Signature required
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2. Active consent
Signature required
For interviews and 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

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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

15. 5/26/2018
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 to use a site does not provide consent for the subjects at that site, subjects still must also agree to participate

16. Areas of Particular Interest
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Areas of Particular Interest
Data Management
What data will be maintained
Coding system used to protect subject identity
How data and code key will be stored separately
How long data will be maintained and how it will be protected
Location of Research
Be Specific; disclose you affiliations with location
Subject Recruitment
Be specific: Who will they be & how will you contact them. Why are they the right subjects?

17. Faculty, Staff and Doctoral Student Protocols contain:
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IRB Protocol Face Sheet
Narrative
Purpose
Duration
Subject Recruitment/Selection
Protection of Subjects
Consent Procedures
Location of Research
Background
Research Plan
Storage and Disposition of Data and Recordings
Potential Risks and Benefits

18. Protocol Face Sheet Informed consent Recruitment letters
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Informed consent
Recruitment letters
Data Instruments
Other attachments as needed
Training certification
Conflict of Interest Disclosure if needed
Protocol Face Sheet

19. Student Research Protocol
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Student Research Protocol
A. Contact Information
B. 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?

20. Student Protocol Form The Research Plan, continued Human Subjects
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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
Student Protocol Form

21. C. Attach: Informed Consent Statement(s) Data Collection Tools
Survey or questionnaire
Original or Acquired
Interview Questions
Observation sheet, other items
Recruitment Resources
Flyer or Poster
Announcement for Social Media
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22. Questions . . . Contact Liane Robertson Martin Williams Maureen Peters
5/26/2018
Questions . . .
Contact
Liane Robertson
IRB Chair and Assistant Professor, English
Martin Williams
IRB Administrator and Director, Office of Sponsored Programs
Maureen Peters
Program Assistant, Office of Sponsored Programs
Phone:
Location: Raubinger Hall, Room 309
Website:
All Forms Available On Website!