2.  The IRB: Why, what and how  Core Concerns: Subject selection, subject consent to participate, confidentiality  IRB Protocol Forms  Contact Information 2

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4.  The IRB:  Why  What  How 4

5.  Support WP compliance with ethical concerns regarding the use of human subjects as defined in the Belmont Report 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 ProtectionThe Common RuleOffice 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. 5

6.  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 WPUNJ Training PageCITI Program 6

7.  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 7

8.  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 8

9.  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 9

10.  Core Concerns:  Subject selection  Subject consent to participate  Confidentiality 10

11.  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? 11

12.  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

13.  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 13

14.  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

15.  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 15

16.  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 16

17.  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 given 17

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20.  IRB Protocol Forms  Faculty, Staff, Doctoral Students  Outside Investigators  Undergraduate and Master’s Degree Students  Continuing Review Form 20

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22.  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 22

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24.  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 Student Research FAQ 24

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27.  Michael Figueroa Chair, WPUNJ IRB, 2012-2013 Associate Professor, Kinesiology FigueroaM@wpunj.edu  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/irbhttp://www.wpunj.edu/osp/irb All Forms Available On Website! 27