Ethics of human research

1939-1945 Nazi research

Japanese research during WW2

1947 Nuremburg code

But things were better in the US, right? NO

1930-1972: Tuskegee Study

1946-1948 Syphilis in Guatemala

1944-1974: Human Radiation Experiments

1963: Jewish Hospital Chronic Disease

1963-66: Willowbrook Study

1968 Tearoom Trade study

Zimbardo’s Prison Study (1971) BBC’s The Experiment (2002)

Belmont report (1979): Ethical Principles and Guidelines for the Protection of Human Subjects of Research http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm Respect for Persons individuals have autonomy and choice people can not be used as a means to an end provide protection to the vulnerable [fetuses, pregnant women, human in vitro fertilization, children, prisoners, or subjects who may have diminished capacity.] provide informed consent and privacy Beneficence minimize risks, maximize benefits obligation to do good obligation to do no harm obligation to prevent harm basis of risk/benefit assessment Justice treat all fairly share equitably burdens and benefits selection not based on convenience

1999 Jesse Gelsinger Gene Therapy death 2006 “elephant man” trial BBC, http://www.mirror.co.uk/news/uk-news/how-six-fit-young-men-9860903 1999 Jesse Gelsinger Gene Therapy death 2006 “elephant man” trial 2016 painkiller trial Stephanie Mahe, Reuters http://www.nature.com/news/fatal-french-clinical-trial-failed-to-check-data-before-raising-drug-dose-1.21190

APA guidelines https://www.apa.org/ethics/code/

1) Get IRB approval Institutional Review Board Office of Human Research Protections Review most research done at an institution or by those affiliated with that institution (required for all organizations that receive any federal funds) Made up of members with expertise from across the university, plus at least one outside person and at least one nonscientific person https://rsp.uni.edu/protection-human-research-participants

2) Get informed consent For research For use of recordings, images Dual relationships Parent consent, child assent Freedom to withdraw Confidentiality

3) inducements Large payments

4) Deception Only use when necessary 5) Debrief

Discuss cases How okay are these examples? How could they be made better or more ethical?