Human Research Ethics: Issues and Procedures

Human Research Ethics: Issues and Procedures Dr. Constance Jones Chair, Committee for the Protection of Human Subjects

Overview • Why? • Who and What is Covered? • Levels of Risk • CSUF Procedures for Obtaining Human Subjects Approval • CSUF Paperwork for Obtaining Human Subjects Approval

Why? • All agencies receiving federal funds (all public universities) are required to have an Institutional Review Board • Protection of: • Research participants • Researcher • University

Committee for the Protection of Human Subjects • Covers research done with human subjects <by people at CSUF> • What is research? • What are human subjects?

Research is • Any systematic investigation or collection of data intended for scientific presentation or publication • Researchers may be undergraduate students, graduate students (projects or theses), faculty, staff, administrators

Research is not • Data collected for classroom evaluation, illustrative purposes, or educational purposes

Human Subjects Research can involve: • Contact with humans via telephone, mail (paper or electronic), or in-person interaction • Study of records of human behaviors or attitudes (e.g., case files, police records, hospital records) • Study of specimens collected from humans (e.g., blood, urine)

Risk Categories • No risk research • Minimal risk research • At risk research <risk = equivalent to daily life>

No Risk Research • Study of existing anonymous data • Study of existing documents • Study of publicly observable, legal behavior

Minimal Risk Research • Study of “normal adults’” attitudes opinions, cognitions, personality, etc. • Study of “normal adults’” moderate exercise • Study of “normal adults’” biological specimens

At Risk Research • Study involving possibility of physical or psychological harm • Study involving collection of reports of illegal / embarrassing behavior • Study using deception and debriefing

At Risk Research • Study of protected populations • Those younger than 18 years old • Those with psychological, cognitive, and/or physical impairments • Incarcerated individuals • Pregnant women

Levels of Review • Departmental Chair • Departmental Committee • University Committee

No Risk Research • Unfunded: • Memo to Departmental Chair • Funded: • Departmental Committee, then University Committee (Expedited)

Minimal Risk Research • Unfunded: • Departmental Committee • Funded: • Departmental Committee, then University Committee (Expedited)

At Risk Research • Unfunded: • Departmental Committee, then University Committee • Funded: • Departmental Committee, then University Committee (Full)

CPHS Webpage • Checklists • Example memos • Example Informed Consent Forms • Training modules

Paperwork / Timing Problems • No departmental review • No training certificate • Missing instruments • Missing informed consent forms • Premature submission of grants

Proposal Problems • Lack of clarity in terms of: • Who will be studied • How they will be studied • When they will be studied • Context of study • Minimization of risk • Incorrect classification • Too brief consideration and/or description of risk

Human Research Ethics: Issues and Procedures