Protection of Human Research Participants Scholarly Inquiry in Workforce Education & Development

today… History of protection of human research participants Principles and practices in protecting human research participants Difficult issues Penn State policy for review, approval, and monitoring of use of human research participants

History of protection of human research participants

Principles and practices in protecting human research participants

Difficult issues

Penn State policy for review, approval, and monitoring of use of human research participants

History Protection of Human Research Subjects

Progression In the 1950s, the federal government had a minimal role in regulating research with human participants Now, federal oversight of human subjects participation is substantial

In the 1950s, the federal government had a minimal role in regulating research with human participants

Now, federal oversight of human subjects participation is substantial

Milestones 1948 - Nuremburg trials 1955 - Wichita jury study 1963 - Thalidomide experience 1964 - NIH ethics committee 1964 - World Medical Association Declaration of Helsinki

1948 - Nuremburg trials

1955 - Wichita jury study

1963 - Thalidomide experience

1964 - NIH ethics committee

1964 - World Medical Association Declaration of Helsinki

Milestones (cont.) 1973 - Congressional hearings Willowbrook hepatitis study Milgram study of obedience to authority Tearoom trade study Tuskegee syphilis study

1973 - Congressional hearings

Willowbrook hepatitis study

Milgram study of obedience to authority

Tearoom trade study

Tuskegee syphilis study

Milestones (cont.) National Research Act of 1974 Established Commission on Protection of Human Subjects of Biomedical and Behavioral Research Wrote landmark Belmont Report that delineated principles and practices for protecting human participants in research

National Research Act of 1974

Established Commission on Protection of Human Subjects of Biomedical and Behavioral Research

Wrote landmark Belmont Report that delineated principles and practices for protecting human participants in research

Principles & Practices Protection of Human Research Subjects

Sound principals lead to good practices Respect for persons Beneficence Justice Informed consent Benefits > risks Selection of participants

Respect for persons

Beneficence

Justice

Informed consent

Benefits > risks

Selection of participants

Respect for persons / Informed consent Treat individuals as autonomous agents Protect individuals with limited autonomy Voluntary consent to participate Obtain informed consent Protect privacy and confidentiality

Treat individuals as autonomous agents

Protect individuals with limited autonomy

Voluntary consent to participate

Obtain informed consent

Protect privacy and confidentiality

Beneficence / Benefits > risks Do good Do no harm Risks justified by potential benefits to individual or society Study is designed to minimize risks Conflicts of interest are managed

Do good

Do no harm

Risks justified by potential benefits to individual or society

Study is designed to minimize risks

Conflicts of interest are managed

Justice / Selection of subjects Distribute burdens and benefits of research fairly Vulnerable subjects are not targeted for convenience People likely to benefit from research are not excluded from participation

Distribute burdens and benefits of research fairly

Vulnerable subjects are not targeted for convenience

People likely to benefit from research are not excluded from participation

Difficult Issues Protection of Human Research Subjects

Issues Study design Conflict of interest Advertising Denying access to outcomes Paying participants Deception No written informed consent Passive consent Exculpatory language Use of placebo Research involving children or prisoners

Study design

Conflict of interest

Advertising

Denying access to outcomes

Paying participants

Deception

No written informed consent

Passive consent

Exculpatory language

Use of placebo

Research involving children or prisoners

Penn State Policy Protection of Human Research Subjects

Required review and approval All research involving human participants must be reviewed and approved by the Institutional Review Board (IRB) before research begins http://www.research.psu.edu/orp/areas/humans/

All research involving human participants must be reviewed and approved by the Institutional Review Board (IRB) before research begins

Levels of review Exemption - Expedited Full

Exemption -

Expedited

Full

Training http://www.research.psu.edu/orp/education/modules/irb/

What you must do… Complete training, pass Human Participant Quiz, and submit certificate of completion Create hypothetical informed consent document

Complete training, pass Human Participant Quiz, and submit certificate of completion

Create hypothetical informed consent document

Protection of Human Research Participants Scholarly Inquiry in Workforce Education & Development