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

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

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 ResearcherUniversity

Overview

Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining

Human Subjects Approval CSUF Paperwork for Obtaining

Human Subjects Approval

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)

Overview

Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining

Human Subjects Approval CSUF Paperwork for Obtaining

Human Subjects Approval

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 populationsThose younger than 18 years oldThose with psychological, cognitive,

and/or physical impairments Incarcerated individualsPregnant women

Overview

Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining

Human Subjects Approval CSUF Paperwork for Obtaining

Human Subjects Approval

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)

Overview

Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining

Human Subjects Approval CSUF Paperwork for Obtaining

Human Subjects Approval

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 studiedHow they will be studiedWhen they will be studiedContext of study

Minimization of risk Incorrect classificationToo brief consideration and/or

description of risk