2.  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) 2

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5.  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 5

6.  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 6

7.  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 7

8.  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 8

9.  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. 9

10.  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 WPUNJ Training Page 10

11.  Four types of Informed Consent Statements at WP  Sample Statements: http://www.wpunj.edu/osp/irb/irb-forms.dot 1. Passive consent  Participation is subject’s statement of consent to participate in the research  Limited to anonymous surveys 11

12. 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 12

13. 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 13

14. 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 14

15. 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? 15

16.  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 16

17.  Informed consent  Recruitment letters  Data Instruments  Other attachments as needed  Training certification  Conflict of Interest Disclosure if needed  Protocol Face Sheet Protocol Face Sheet 17

18. 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? 18

19.  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 Student Protocol Form 19

20. C. 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 20

21.  Contact Liane Robertson IRB Chair and Assistant Professor, English RobertsonL10@wpunj.edu Martin Williams IRB Administrator and Director, Office of Sponsored Programs WilliamsM@wpunj.edu Maureen Peters Program Assistant, Office of Sponsored Programs PetersM@wpunj.edu Phone: 973-720-2852 Location: Raubinger Hall, Room 309 Website: http://www.wpunj.edu/osp/irb All Forms Available On Website! 21