•Three basic cornerstones for conducting ethical human subject research

Respect is embodied in the informed consent process – recognition that the subject is capable of self-determination “Yes, I want to participate. Or “No.” Likely the most important principle and certainly the one that gets the most attention Concrete product is the “consent form” but essential that it be an on-going process Information – description of the research and what is expected of the subject The consent document is not meant to reassure the subject, quite the contrary, it is meant to raise every possible concern that might be relevant to the subjects decision to participate (many consent documents are quite frightening, not unlike reading the PDR or the package insert in a drug)

There must be some benefit to the research and the benefit must outweigh risks assumed by the subjects In recognizing autonomy of individual,  we recognize the right of a person to exercise choice in accepting risk  -Debated by research ethicists that adhere to the medical model of “do no harm” – person should not be asked to assume risk without prospect of benefit - Respect for dignity and autonomy demand that individuals be allowed to make an alturistic choice.  (Phase I – Drug study = healthy volunteers testing for adverse side effects)

Subjects should not be selected because they are favored or disfavored by the researcher Subject population should be a fair representation of society or of the research’s “target population” Some classes of subjects should not be involved unless the research offers specific benefit – (prisoners) Principles should be placed on equal footing – One does not take precedence over another

Based on Belmont Principles

IRB is the focal point and “lynchpin” of the human subjects protection system Deliberative body of volunteers (usually) charged with reviewing research to make sure it legal (45cfr46) and ethical (Belmont) and make recommendations accordingly Is not – responsible for establishing and enforcing institutional policy or disciplining researchers

Regulations recognize that all research is not equal in terms of risk and allow for different levels of review based on anticipated risks.

Some research, by regulation, is exempt from review while other designated low-risk activities can be reviewed via an expedited process

Learned that there are questions and differences of interpretation – natural given a new policy being implemented across a variety of departments and disciplines Want to bring level of consistency to the institutional process so that we are all “reading from the same book” Those that attended the training session a couple of weeks ago got some general background Memo to deans and department chairs but not faculty in general Only seen a few exempt reviews since October 1 – Need copies of all reviews Review previous USC system – Funded vs. un-funded, volume & break out

A health care provider becomes a covered entity only if it transmits health information in electronic form in connection with a “HIPAA transaction” HIPAA transaction = the electronic transmission of information “to carry out financial or administrative activities related to health care”.  Sample transactions – claims information, enrollment in a health plan, payment, billing, etc. Electronic transmission is required to be considered a covered entity, but once a provider is a covered entity all of its health information is subject to the rule

Hybrid Entity option allows the University to treat its health care components as separate legal entities with regard to HIPAA compliance and implementation of Privacy Rule. Parts of USC qualify as Health Care Components (Student Health Center and Speech and Hearing Clinic). Coverage extends to supporting functions that create or receive PHI on behalf of an HCC (e.g. billing offices, benefits office, business office personnel) Extend coverage to non-covered entities through “business associate” agreements – (e.g. attorneys

Authorization must be in writing and include certain minimum elements including; description of information (can’t say all records), name of person authorized to receive information, expiration date for use of information... Authorization for research does not require a specific end date or event may state none or “end of study”

As rule of thumb, many IRBs are using the minimal risk criteria from Common Rule.  Others in health care organizations are being guided by use and disclosure.  Use = within organization = usually minimal risk.  Disclosure outside is held to a higher standard = likely to be considered more than minimal A CE is permitted to disclose PHI for research purposes without authorization if an IRB or Privacy Board has either waived authorization or approved a modified authorization.  CE may use its own IRB or Privacy Board or accept the review of some other IRB/PB. Privacy Board functions much like an IRB with regard to the review of requests for waivers of authorization.  Role is to assure that there is legitimate and compelling reason for allowing access to health information without patients consent IRB granting waiver must follow Common Rule plus added privacy criteria using either full or expedited review. Waiver of authorization criteria similar to that already used by IRB to waive informed consent Some university IRBs have already expressed an unwillingness to take on the dual role and responsibilities of a privacy board.  Not yet decided at USC, but initial inclination is to serve dual role.

Demand change in means and methods for recruiting subjects

The term Conflict of Interest is used often with the assumption that everyone has the same understanding of it’s meaning. When unable to give the dictionary definition….  often fall back on the Supreme Court Justice Black’s comment about pornography  “I may not be able to define it, but I know it when I see it”. I think most agree that they can recognize a conflict of interest (particularly when it’s someone else) Every faculty member has a primary interest/duty (teach, conduct research, & pursue scholarly activities) which includes Integrity in research, patient/subject welfare when dealing with human subjects in research and providing the education to students Conflict occurs when there is a competing secondary interest (equity/management position in start up company in field of research) Becomes problematic when the secondary interest exerts undue influence on judgment made in pursuit of primary interest/duty

All conflicts do not lead to an adverse outcome. Generally, are dealing with situations that may lead to an adverse or questionable outcome. Factors that create a “potential” conflict are generally the same as found in an “actual” conflict

Catalyst for creating policy was proposed federal regulations with PHS first proposed rule in 1989: revised in ’91 Under pressure from Universities – agencies worked together and produced final rules that were similar w/ few small differences

Chose to recognize that all disciplines are not the same and that “one size” does not fit all Ex:  Medicine vs. Arts   (Addresses clinical practice plans while performing arts allowed to develop a policy that is reasonable for them) 

Policy is very simple – outside professional activities must be approved and reported Addresses conflicts of interest AND conflict of commitment (e.g. professor of religious studies and pastor of a local church) Financial conflicts of interest – (per policy) “…situations in which individuals may have the opportunity to influence the University's activities in ways that could lead to inappropriate personal gain or give improper advantage to their associates.” Conflicts of commitment – (per policy) “…situations in which an individual's external professional activities, often valuable in themselves, interfere with the individual's paramount obligations to students, colleagues, and the University.”

Use of students in outside activities deserves special attention and should include a record of joint activities Generally – students should not be employed on Sponsored Projects where the PI has a financial interest in the sponsoring company.  In cases where a student is involved in research sponsored by a company-funded agreement, the research agreement should state that the presentation of results will not be controlled by the company (or similar non-limiting language related to publication)

Required disclosure is a given and should be included with any publication or presentation

Public concern about misconduct in research first surfaced in the early 1980’s following reports of cases of egregious misbehavior.  One researcher republished under his own name dozens of articles previously published by others.  Other researchers in one way or another falsified or fabricated research results.  To make matters worse, it seemed as if research institutions sometimes ignored or deliberately covered up problems rather than investigate them.  Eventually Congress stepped in ad required Federal agencies and research institutions to develop research misconduct policies. 

The government’s main concern in establishing this definition is to assure that publicly funded research is accurate and appropriately represented by clearly stating that three practices, commonly referred to as “FFP,” are wrong.

Federal research misconduct policies to all research.  Many research institutions have also broadened the basic Federal definitions to include other inappropriate practices.  In combination, Federal and institutional research misconduct policies define research practices that researchers must avoid.  Failure to do so can result in the termination of employment or ineligibility to receive Federal funding.

These further stipulations limit the Federal Government’s role in research misconduct (fabrication, falsification, or plagiarism) to well-documented, serious departures from accepted research practices.  It establishes a minimum standard fro measuring acceptable behavior, not a standard for judging all research behavior.