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There are certain recognized ethical principles that should be followed when conducting research with human subjects Will look at how these principles evolved and how they became the basis for the regulations that govern human subject research
Also, go over specifics of USC policies and procedures
•Three basic cornerstones for conducting ethical human subject research
•Nuremburg Code was the result of the Nuremburg Trials and articulated the basic concepts followed today – Principally -
•Voluntariness
•Informed Consent
•Freedom to withdraw
•Written as part of the judgement against Nazi doctors
•Prosecutors did not have a standard by which to judge the conduct of the doctors – It was obvious that they had done the wrong thing, but how do you decide.
•Doctors were ultimately convicted of murder – not for being bad researchers
•Ultimately had little effect on how research was being conducted in the US and most of the world – Viewed as something related to criminal research and not applicable to “well-meaning” physicians/researchers
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•Declaration of Helsinki – Adopted in 1964 by the World Medical Association. Contains the guiding principles for human subject research – internationally
•Important because this was a group of physicians and researchers deciding that “we” do need rules and guidance.
•Represented a reinterpretation of Nuremberg
•Provoked a reaction in the medical community
•Journal editors began requiring that research papers be accompanied by statement of compliance with Helsinki
•Established boundaries between therapeutic and non-therapeutic research
•Introduced concept of review of research by independent committees
•Use of accepted scientific methods
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•U.S. National Research Act (1974)  prior to then only published regulations in the US were stated as NIH policy.
•Established a Commission to study issues related to human subject research
•Met over a four year period
•Issued the Belmont Report – Became the basis for federal regulations that followed
•Took all the issues  and boiled them down to three simple principles
Though stated differently in each of the cornerstone documents express the same core principles
•Respect for persons – dignity and autonomy of individuals must be maintained and people should not be used as a means to an end
 
•Beneficence – Subjects must be protected from harm
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•Justice –  We should treat people fairly and there should be a fair sharing of the burdens and benefits of research (Should not burden one group with the risks in order to give the benefits to another group e.g. prisoners, poor) Risks and benefits are distributed evenly across the subject population. 
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
Must be an “active” process
Must encompass-
Information – description of the research and what is expected of the subject
Comprehension – appropriate to subject population
Voluntariness
- Freedom to withdraw
- Free from  coercion
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
Individual benefit vs. benefits to society at large
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”
Order of preference
Adults before children – with recent modification
Some classes of subjects should not be involved unless the research offers specific benefit – (prisoners)
Tuskegee is an example of unjust subject selection
Use of prisoners – convenient “captive audience”
Principles should be placed on equal footing – One does not take precedence over another
“This is beneficial, so why do I need informed consent.”
Based on Belmont Principles
OHRP – all federally funded research and institutions operating under a federally approved Assurance (virtually all universities and research hospitals)
FDA – Oversight over all drug and medical device research
Operate under separate but similar regulations (next slide)
IRB is the focal point and “lynchpin” of the human subjects protection system
Often gets too much credit and/or blame for how research is carried out
Role
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
Air traffic control vs. pilot analogy
(competent and ethical researcher vs. competent IRB)
Ultimately, it is the Researcher that is responsible
Also – the regulations allow for the waiver of written consent when:
1)The only record linking the subject and the research would be the consent document and the principal risk is breach of confidentiality.  Each subject must be asked whether he/she wants documentation linking the subject with the research.
2)
2) The research presents no more than minimal risk of harm and involves no procedures for which written consent is normally required outside the research context.
Subpart B – Stipulates conditions  whereby research can be conducted on pregnant women Covers areas related to risk to health of mother, risk to fetus, viability of fetus and appropriate levels of consent i.e. paternal consent required in some cases
Subpart  D – Children not involved in research of greater than minimal risk unless there is a prospect for direct benefit (with not direct benefit – IRB must find that increase over minimal is minor or presents experience commiserate with actual treatment and information is of vital importance. Consent (parental permission) and Assent – must be yes/yes unless overriding benefit (life and death)
Subpart C – Prisoner advocate on the IRB
Research related to prisoners – health problems prevalent in prisoners etc.
Incarceration
Criminal Behavior
Regulations recognize that all research is not equal in terms of risk and allow for different levels of review based on anticipated risks.
Regulations recognize that all research is “not equal” in terms of risk
Allow for low and no risk studies without review of full committee
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
Need more information concerning specific issues related to your job
Need to continue to get the word out to faculty – Relying on you
Memo to deans and department chairs but not faculty in general
Announce at every opportunity
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