Protecting Human Subjects Overview of the Issues Applications to Educational Research The IRB Process

Why do we need to protect human subjects? Nazi medical experiments Nazi medical experiments Tuskegee syphilis study Tuskegee syphilis study Milgram’s obedience studies Milgram’s obedience studies Jessie Gelsinger Jessie Gelsinger

What is research? What is research? A systematic investigation designed to produce generalizable knowledge. A systematic investigation designed to produce generalizable knowledge. Who is a human subject? Who is a human subject? Anyone with whom a researcher obtains identifiable private information, or anyone with whom a researcher has contact or receives an intervention. Anyone with whom a researcher obtains identifiable private information, or anyone with whom a researcher has contact or receives an intervention.

Who is Responsible? Office of Human Research Protections (OHRP) Office of Human Research Protections (OHRP) Funding Agencies (NIH, DOE, NIJ) Funding Agencies (NIH, DOE, NIJ) Institutions (IRB) Institutions (IRB) Researchers Researchers

How do IRB’s make decisions? 45CFR46 (Federal Regulations) 45CFR46 (Federal Regulations) IRB Policy IRB Policy Belmont Report Belmont Report Justice Justice Beneficence Beneficence Respect for Persons Respect for Persons

More on making decisions Evaluate the risks Evaluate the risks Physical Physical Psychological Psychological Social Social Minimize the risks Minimize the risks Benefits out weigh the risks Benefits out weigh the risks Informed consent Informed consent Protect against coercion Protect against coercion Protection for vulnerable populations (e.g. children) Protection for vulnerable populations (e.g. children)

Type of IRB Review Exempt Exempt No risk No risk Still needs an IRB evaluation Still needs an IRB evaluation Expedited Expedited Minimal risk Minimal risk Review by one IRB member Review by one IRB member Full review Full review Greater than minimal risk Greater than minimal risk A vote by a convened meeting of the IRB (monthly) A vote by a convened meeting of the IRB (monthly)

Exempt Research Educational Research on commonly accepted educational practices, conducted as part of the regular curriculum, as long as no identifiable information is made public. Educational Research on commonly accepted educational practices, conducted as part of the regular curriculum, as long as no identifiable information is made public. Data taken from individual subjects, as long as no individual is identifiable. Data taken from individual subjects, as long as no individual is identifiable. Survey and interview procedures, provided individual subjects are not identifiable, and there are no other risks. Survey and interview procedures, provided individual subjects are not identifiable, and there are no other risks.

Exempt Research Observations of public behavior if no identifiable information. For children, must be no interaction with experimenter. Observations of public behavior if no identifiable information. For children, must be no interaction with experimenter. Analysis of data that already exists for other purposes (medical, educational, etc.) provided no individual is identifiable, or data are publicly available. Analysis of data that already exists for other purposes (medical, educational, etc.) provided no individual is identifiable, or data are publicly available.

Evaluation of programs run by the Social Security Administration or other public benefit program. Evaluation of programs run by the Social Security Administration or other public benefit program.

Expedited Review Studies involving minimal risk Studies involving minimal risk No greater than that encountered in daily activities No greater than that encountered in daily activities No vulnerable populations No vulnerable populations Can only study children under expedited review if you are the classroom teacher Can only study children under expedited review if you are the classroom teacher

Full Review of Education Research There are greater than minimal risk to participants There are greater than minimal risk to participants Vulnerable populations Vulnerable populations No parental consent No parental consent

Informed Consent Standard information required in consent form Standard information required in consent form Contact information for you, your supervisor, IRB Contact information for you, your supervisor, IRB Purpose of research Purpose of research Procedures Procedures Risks to participants Risks to participants Benefits to participants and to society Benefits to participants and to society Protections (confidentiality, no loss of benefits) Protections (confidentiality, no loss of benefits) In appropriate language In appropriate language

Informed Consent with Children Parental consent Parental consent Child verbal assent if appropriate Child verbal assent if appropriate Adolescents can give written assent Adolescents can give written assent Consent forms translated (and back-translated) if parents not likely to speak English Consent forms translated (and back-translated) if parents not likely to speak English

Consent Forms Consent is a dialog between researcher and participant, not a piece of paper. Consent is a dialog between researcher and participant, not a piece of paper. Form is the documentation of informed consent. Form is the documentation of informed consent. Documentation can be waived in special circumstances. Documentation can be waived in special circumstances.