1	Use of Human Subjects in Research Office of Research Educational Series October 17, 2004
2	Human Subjects in Research Human subject research must be ethical and legal
3	Cornerstones Nuremburg Code (1949) Declaration of Helsinki (1964) Belmont Report (1979)
4	Nuremberg Code Voluntary informed consent Research should yield useful results Base research on prior work (animals) Avoid suffering and protect from injury Risk must be outweighed by importance Freedom to withdraw
5	Declaration of Helsinki Health of patient is primary consideration Review of research by independent committees Boundaries between therapeutic and non-therapeutic Use of accepted scientific methods Voluntary informed consent Consent of legal guardian is permissible for those incapable of informed consent
6	Belmont Report National Research Act (1974) Belmont Commission Belmont Principles Respect for Persons Beneficence Justice
7	Respect for Persons
8	Beneficence Minimization of risks Competent researchers using appropriate methods & design Favorable risks/benefits assessment
9	Justice Fair and equitable selection procedures Fair selection outcomes
10	Human Subject Research - Legal Based on Belmont Principles Regulations finalized in 1981 45 CFR Part 46 – “Common Rule”
11	Basic Regulatory Protections Review of research by an Institutional Review Board (IRB) Informed consent of subject Institutional assurances
12	Government Oversight Office of Human Research Protection (OHRP) - Health and Human Services Food and Drug Administration (FDA)
13	Human Subject - Definition Living individual about whom an investigator conducting research obtains 1) data through intervention or interaction with the individual or 2) identifiable private information
14	Human Subject - Definition “Private Information” means (1) information about behavior in a context in which an individual can reasonably expect that no observation or recording is taking place (2) information, provided for specific purposes, that the individual can reasonably expect will not be made public (e.g., a medical record)
15	Definition of Research Research - A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge, or Activity is portrayed as research by faculty, staff or students, or Is intended fulfill the requirements for a masters thesis, doctoral dissertation or other University research requirements
16	Institutional Review Board (IRB) The administrative body established to protect the rights of human research subjects
17	Composition of the IRB Minimum of 5 members Diverse in gender and racial background Sufficiently qualified in experience and expertise One scientific member Non-scientific member Community member (non-affiliated)
18	Review Soundness of Research Protocol Assessment of Risks/Benefits Equitable selection of subjects Appropriate safeguards for vulnerable subjects Effective informed consent Provisions for data monitoring and safety
19	Informed Consent Written at appropriate level for intended audience Anticipates and answers questions of participants Clear picture of risks and benefits Free of errors Contain no exculpatory or coercive language Contains required elements (8)
20	Eight Required Elements 1. Statement that study is research and information on purposes/duration/procedures/experimental procedures 2. Reasonably foreseeable risks or discomforts 3. Benefits which may be reasonably expected 4. Alternative procedures 5. How confidentiality will be maintained
21	Eight Required Elements 6. For more than minimal risk, information on compensation for injury 7. Contact names -- at least one person not associated with the research is recommended 8. Statement that participation is voluntary and able to withdraw at any time
22	Waiver of Informed Consent Minimal Risk Practicable (feasible) without waiver Waiver will not adversely affect rights and welfare of subjects Information provided to subjects as appropriate after participation
23	Vulnerable Populations Children Prisoners Pregnant Women and Fetuses
24	IRB Authorities Approve Require Modifications Disapprove
25	Minimal Risk Probability of harm or discomfort anticipated in the research are not greater than normally encountered in daily life or during the performance of a routine physical or psychological examination.
26	Levels of Review Exempt Expedited Full Committee Review
27	Regulatory Exemptions Research conducted in commonly accepted educational settings involving normal educational practices Research involving the use of surveys, interviews, or observation of public behavior unless the identifying information is recorded and disclosure of the information would be damaging to the subject (Does not apply to children.) Research involving surveys, interviews, observation where subjects are elected or appointed public officials
28	Regulatory Exemptions Research involving the collection or study of existing data documents, records, or specimens if the sources are publicly available or the information is recorded in a manner that the subjects cannot be identified Research designed to study, evaluate or examine Public Benefit or Service Programs Taste and food quality evaluation and consumer acceptance studies involving wholesome foods
29	Other “Exempt” Activities Data collection for internal departmental or other university administrative purposes (e.g. teaching evaluations, student evaluations, and “customer service” surveys) Program evaluation carried out under independent contract for an external agency that is for their internal purposes only (e.g. personnel studies, human cost benefit analysis, and treatment effectiveness studies) Course related activities (e.g. research methods instruction) that involve the use of human participants, but have no connection with research beyond the instructional function
30	USC Human Subjects Protection Program – Procedures
31	What Must Be Reviewed Any research activity involving human subjects conducted by USC faculty, staff, or students must be reviewed and approved for compliance with regulatory and ethical requirements before it can be undertaken.
32	IRB Application Required Information Complete copy of Application for Approval of Human Research Subjects form Research proposal/protocol Informed consent form(s) and/or cover letter Survey instruments, questionnaires,recruitment materials Project summary written in laymen’s terms (one page maximum) Request for Study Exemption form (when appropriate)
33	Types of Review Exempt – Review by IRB Liaison to confirm exemption Expedited – Review by IRB Chair or designee Full Board – Review at a convened meeting of the IRB
34	IRBL Responsibilities Review each application to determine if the research meets exemption criteria Make recommendations for modifications to best protect the interests of the human subjects Provide a certification of exemption to the principal investigator and copies of required information to the Office of Research Compliance (Request for Study Exemption form, the project abstract, letter of certification)
35	IRBL Responsibilities Return unapproved applications to the principal investigator for submission to the University’s Institutional Review Board (IRB). Maintain a file of completed applications and correspondence for all projects reviewed for three years beyond the date of review.
36	Conducting Exempt Research Research that is exempt from IRB review is not exempt from the ethical principles pertaining to human subject research. Good research design dictates careful consideration of risks/benefits protections informed consent The research design should meet applicable research ethics standards of the investigator's professional association or society.