1. Human Subject Research by Students at William Paterson University March 2015

2. IRB Primer Human Experimentation: The Good, The Bad, & The Ugly. ◦ SciShowSept 18, 2013 (12.26 min.) ◦ http://www.youtube.com/watch?v =hRwWxELXakA http://www.youtube.com/watch?v =hRwWxELXakA Research Ethics(7 min.) ◦ Chris FlippJanuary 13, 2014 ◦ http://www.youtube.com/watch?v =Zbi7nIbAuMQ http://www.youtube.com/watch?v =Zbi7nIbAuMQ 2

3. William Paterson IRB 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

4. 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

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 5

6. 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

7. 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

8. 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

9. 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/train ing-and-certification-program.dot http://www.wpunj.edu/osp/irb/train ing-and-certification-program.dot 9

10. 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

11. ◦ WP Policy:  Subjects who may perceive that their responses may have a direct impact on them, such as:  residents of nursing homes  patients in hospitals  students in classes of the researcher  employees of businesses 11

12. 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

13. ◦ 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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 http://www.wpunj.edu/osp/irb/irb- forms.dot 19

20. 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

21. 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

22. 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

23. 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

24. 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 http://www.wpunj.edu/osp/irb 24

25. 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

26. Questions... Contact Martin Williams IRB Administrator 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 As Well As Additional Information Is Available On Website! 26