1	Compliance Overview School of Public Health February 6, 2004
2	Cornerstones Nuremburg Code (1949) Declaration of Helsinki (1964) Belmont Report (1979)
3	Belmont Report National Research Act (1974) Belmont Commission Belmont Principles Respect for Persons Beneficence Justice
4	Respect for Persons
5	Beneficence Minimization of risks Competent researchers using appropriate methods & design Favorable risks/benefits assessment
6	Justice Fair and equitable selection procedures Fair selection outcomes
7	Human Subject Research - Legal Based on Belmont Principles Regulations finalized in 1981 45 CFR Part 46 – “Common Rule”
8	Basic Regulatory Protections Review of research by an Institutional Review Board (IRB) Informed consent of subject Institutional assurances
9	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
10	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
11	Institutional Review Board (IRB) The administrative body established to protect the rights of human research subjects
12	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)
13	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
14	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)
15	IRB Authorities Approve Require Modifications Disapprove
16	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.
17	Levels of Review Exempt Expedited Full Committee Review
18	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.
19	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
20	HIPAA – Privacy Rule and Research
21	HIPAA - Scope Applies to Health plans Health care providers Health care clearinghouses Covered Entity = an organization that transmits health information in electronic form in connection with a “HIPAA transaction” (financial and administrative activities related to health care)
22	HIPAA - Scope USC is a “Hybrid Entity” Covered Components Affiliated covered components
23	HIPAA - Scope “Protected Health Information” (PHI): All individually identifiable health information transmitted or maintained by an organization covered by the HIPAA regulations (a “covered entity”) regardless of form
24	Privacy Rule Limits the use and disclosure of PHI Gives patients the right to access their medical records and to know who accessed their health information Restricts most disclosures of PHI to the minimum necessary Establishes criminal and civil penalties for improper use or disclosure Establishes new requirements for access to records by researchers
25	Use and Disclosure of PHI Authorization Plain language Description of information to be disclosed Purpose of disclosure Identification of person(s) authorized to use Expiration date or expiration event Right to revoke Statement regarding possible redisclosure Signature and date
26	Authorization vs. Consent A privacy authorization says: “It’s OK for you to look at my PHI and disclose it to a designated third party.” A consent form says: “I agree to participate in your research project and I understand the risks, benefits etc. Both are needed for research May be combined
27	Disclosure or Use Without Authorization Waiver by IRB or Privacy Board Reviews preparatory to research De-identified Information Use or disclosure of a limited data set Decedent information Public health disclosures
28	Waiver of Authorization Disclosure poses no more than minimal risk to the privacy of individuals Plan to protect identifiers from improper disclosure Plan to destroy identifiers at earliest opportunity Written assurance that PHI will not be reused or disclosed Research could not practicably be done without the waiver Research could not practicably be done without access to the PHI Privacy risks are reasonable in relation to expected benefits
29	Impact on Research Researchers requiring access to PHI must request the information from and meet the requirements of the covered entity Reluctance by health care providers to participate in research Barriers to subject recruitment Increased responsibility for IRB
30	Outside Professional Activities
31	What Is Conflict of Interest?
32	What Is Conflict of Interest? Not based on outcome, but on situation No distinction between “actual” and “potential” Not misconduct, per se
33	BACKGROUND Current USC Policy evolved over a five year period in response to Federal regulatory policy (1990-95) Public Health Service (PHS) – Objectivity in Research National Science Foundation (NSF) – Financial Disclosure Policy Final Rule Issued – July 11, 1995
34	Federal Policy Mandates Maintain an appropriate written and enforced policy on conflict of interest (complies with federal requirements and inform investigators of the policy) Designate an institutional official(s) to solicit and review financial disclosure statements from each investigator planning to participate in research Require that investigators submit disclosure of financial interests prior to submission of application for funding
35	Federal Policy - Disclosure Required for all NSF and PHS funding applications Applies to those involved with the design, conduct, or reporting of research Related financial interests must be disclosed
36	USC Policy – ACAF 1.50 Provides overall framework for unit policies Each unit having separate tenure and promotion criteria required to have a policy Review of unit policies by the USC Conflict of Interest Committee Last of 43 unit policies approved (July 1995)
37	ACAF 1.50 - Requirements Faculty will seek prior administrative approval of outside professional activities and will report these activities annually.
38	What Should Be Reported Compensated services Contract with any private sector entity Ownership or equity in a business or corporation Management or board position in a business or corporation Participation in a contract or proposal through an entity other than the University Participation in service or teaching contract with another college or university Academic remuneration noted as fees or honoraria Unpaid consulting or pro bono service
39	What Should Be Reported Activities not normally reported Colloquia Textbooks Paintings Performances
40	Faculty Reports - Content Type of activity Whether the activity is compensated Duration/time requirements Explanation of any potential conflict of interest or commitment Whether the activity involves the use of University facilities, resources, personnel (including students) or other commitment and whether appropriate procedures have been followed
41	Reporting Procedure
42	Supervisor Responsibilities Determination of conflict of interests or financial conflict Recommendations to prevent or reduce conflicts to a manageable level Required public disclosure Monitoring by independent reviewers Modification of research plan Disqualification from participation in research Divestiture of significant financial interests Severance of relationships that create conflicts
43	Research Misconduct Policies Establish definitions for misconduct in research, Outline procedures for reporting and investigating misconduct, and Provide protection for whistleblowers (persons who report misconduct) and persons accused of misconduct.
44	Research Misconduct Federal definition= “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results”
45	Research Misconduct - USC Serious deviation from accepted standards and practices in proposing, carrying out or in reporting the results of scholarly undertakings Material failure to comply with requirements for protection of researchers, human subjects or the public, or for ensuring the welfare of laboratory animals Failure to meet other material professional standards or legal requirements governing research Does not include honest error or honest differences in interpretations or judgments of data
46	Research Misconduct - Judging Represent a “significant departure from accepted practices;” intentionally, or knowingly, or recklessly;” and be “proven by a preponderance of evidence.”