THE IRB AND HUMAN SUBJECT RESEARCH AT WILLIAM

THE IRB AND HUMAN SUBJECT RESEARCH AT WILLIAM PATERSON UNIVERSITY SEPTEMBER 2013

AGENDA 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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The IRB: Why What How 4

Why Is An IRB Needed? Support WP compliance with ethical concerns regarding the use of human subjects as defined in the 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 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

What is Ethics Certification? 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 6

What Does The IRB Review? 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

Is Student Research Reviewed? 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

How are Protocols Reviewed? 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

Core Concerns: Subject selection Subject consent to participate Confidentiality 10

Subjects 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

Vulnerable Subjects: 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

Vulnerable Subjects: 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

Informed Consent 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

Two Types of Consent 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

Special Consent Concerns 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

Elements of Consent 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

Sample Consent Statements Are Provided on the IRB Webpage 18

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

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Faculty/Staff/Doctoral Protocol 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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Student Protocol 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 24

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Contact Information Michael Figueroa Chair, WPUNJ IRB, 2012 -2013 Associate Professor, Kinesiology Figueroa. M@wpunj. edu Martin Williams IRB Administrator Director, Office of Sponsored Programs Williams. M@wpunj. edu Maureen Peters Program Assistant, Office of Sponsored Programs Peters. M@wpunj. edu Phone: 973 -720 -2852 Location: Raubinger Hall, Room 309 Website: http: //www. wpunj. edu/osp/irb All Forms Available On Website! 27