Compliance Online: Understanding Federal Regulations
Compliance Online: Understanding Federal Regulations
Stephen D. Oller, PhD Lori Kupczynski, EdD
Human Subjects Research • What Constitutes Human Subjects Research? • 45 CFR (Code of Federal Regulations) 46 • Why We Have Protections for Participants • What are the Protections? • Levels of Review • What You Can and Can’t Do
Human Subjects Research
• (d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human Subject (f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains – (1) Data through intervention or interaction with the individual, or – (2) Identifiable private information.
What Constitutes Human Subjects Research 45 CFR 46
• Systematic investigation – including research development – testing and – evaluation
• designed to develop or contribute to generalizable knowledge
What Constitutes Human Subjects Research • Any activity meeting this definition is Human Subjects Research • …whether or not it is conducted or supported under a program which is considered research for other purposes • For example, some demonstration and service programs may include research activities.
“Common Rule” • The Federal Policy for the Protection of Human Research Subjects – Based on “HHS 45 CFR part 46 subpart A” – Informally known as the “Common Rule” – Led to the creation of the IRB
Why We Have Protections
• Because we haven’t proved Trustworthy – J.B. Watson and Baby Albert • https://www.youtube.com/watch?v=CYGXMXGkxtc
– Tuskegee Airmen (1932) • https://www.youtube.com/watch?v=9Rg75zEVB1g
– Milgram Studies (1961) • https://www.youtube.com/watch?v=yr5cjyokVUs
– Facebook Study (2012) • https://www.youtube.com/watch?v=oruh5Hb_95I
What Are The Protections?
• Nuremberg Code – First international code of research ethics – Established fundamental principles that must be considered in order to fulfill the moral, ethical, and legal concepts related to research of human subjects
Human Subject Research Protections
• Belmont Report – Provides an analytical framework for the guidance and resolution of any ethical problems – Respect for Persons, Beneficence, and Justice: foundation for ethical policy
Belmont Report Guiding Principles
• 3 Guiding Principles – Justice – Beneficence – Respect for Persons – From this, we have the idea of informed consent.
Human Subjects Research Protections
• IRBs – “An appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects” – Has the authority to approve of, disapprove of, and require modifications to a research project
IRBs • Review research to determine if it meets the three principles of the Belmont Report. • Ensure there is a consent process – Explanation of Research – Explanation of Activities involved • Benefits • Risk
– Monitor ongoing project to ensure protection
Levels of Review • Exempt – – – –
No personal identifiers Minimal Risk Most educational practices/testing, surveys, QI studies No manipulation of behavior
• Expedited – Minimal Risk – Interventions
• Full – Deception Studies – Vulnerable populations: Children, Pregnant Women, Prisoners, and possibly ID populations
Do’s and Don’ts
Do
Don’t
• Determine if it’s research involving human subjects • Submit for IRB review even if you think it qualifies as exempt • Explain your purpose and expectations to participants • Collaborate with others to assess new practices
• Coerce or appear to coerce participants. – Students – Friends/family
• Experiment on yourself
3 Types on Online Research • Passive Analysis-- Studies of online information patterns or discussions without the researchers involving themselves;
• Active Analysis--Researchers participate in online communications;
• Identified Research--Online semi-structured interviews, online focus groups, or Internet based surveys, or use the Internet to recruit subjects for traditional research. Kitchin, H.A. (2003). The Tri-council Policy Statement and research in cyberspace: Research ethics, the Internet, and revising a living document. Journal of Academic Ethics, 1(4), 397-418.
Potential Difficulties in an Online World
• Documenting Consent • Explaining the actual purpose of the research project • Evaluating online teaching paradigms
Documenting Consent
• Distinction between the private vs. public domain • Is consent required?
• Easy conductivity for anonymous and pseudonymous communications • How to validate consent?
• Global and easy accessibility • How to validate consent?
Considerations for Studying Internet Communities
• • • • • • •
Intrusiveness Perceived privacy Vulnerability Potential harm Informed consent Confidentiality Intellectual property rights
Questions?
Stephen D. Oller, PhD Lori Kupczynski, EdD
Human Subjects Research • What Constitutes Human Subjects Research? • 45 CFR (Code of Federal Regulations) 46 • Why We Have Protections for Participants • What are the Protections? • Levels of Review • What You Can and Can’t Do
Human Subjects Research
• (d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human Subject (f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains – (1) Data through intervention or interaction with the individual, or – (2) Identifiable private information.
What Constitutes Human Subjects Research 45 CFR 46
• Systematic investigation – including research development – testing and – evaluation
• designed to develop or contribute to generalizable knowledge
What Constitutes Human Subjects Research • Any activity meeting this definition is Human Subjects Research • …whether or not it is conducted or supported under a program which is considered research for other purposes • For example, some demonstration and service programs may include research activities.
“Common Rule” • The Federal Policy for the Protection of Human Research Subjects – Based on “HHS 45 CFR part 46 subpart A” – Informally known as the “Common Rule” – Led to the creation of the IRB
Why We Have Protections
• Because we haven’t proved Trustworthy – J.B. Watson and Baby Albert • https://www.youtube.com/watch?v=CYGXMXGkxtc
– Tuskegee Airmen (1932) • https://www.youtube.com/watch?v=9Rg75zEVB1g
– Milgram Studies (1961) • https://www.youtube.com/watch?v=yr5cjyokVUs
– Facebook Study (2012) • https://www.youtube.com/watch?v=oruh5Hb_95I
What Are The Protections?
• Nuremberg Code – First international code of research ethics – Established fundamental principles that must be considered in order to fulfill the moral, ethical, and legal concepts related to research of human subjects
Human Subject Research Protections
• Belmont Report – Provides an analytical framework for the guidance and resolution of any ethical problems – Respect for Persons, Beneficence, and Justice: foundation for ethical policy
Belmont Report Guiding Principles
• 3 Guiding Principles – Justice – Beneficence – Respect for Persons – From this, we have the idea of informed consent.
Human Subjects Research Protections
• IRBs – “An appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects” – Has the authority to approve of, disapprove of, and require modifications to a research project
IRBs • Review research to determine if it meets the three principles of the Belmont Report. • Ensure there is a consent process – Explanation of Research – Explanation of Activities involved • Benefits • Risk
– Monitor ongoing project to ensure protection
Levels of Review • Exempt – – – –
No personal identifiers Minimal Risk Most educational practices/testing, surveys, QI studies No manipulation of behavior
• Expedited – Minimal Risk – Interventions
• Full – Deception Studies – Vulnerable populations: Children, Pregnant Women, Prisoners, and possibly ID populations
Do’s and Don’ts
Do
Don’t
• Determine if it’s research involving human subjects • Submit for IRB review even if you think it qualifies as exempt • Explain your purpose and expectations to participants • Collaborate with others to assess new practices
• Coerce or appear to coerce participants. – Students – Friends/family
• Experiment on yourself
3 Types on Online Research • Passive Analysis-- Studies of online information patterns or discussions without the researchers involving themselves;
• Active Analysis--Researchers participate in online communications;
• Identified Research--Online semi-structured interviews, online focus groups, or Internet based surveys, or use the Internet to recruit subjects for traditional research. Kitchin, H.A. (2003). The Tri-council Policy Statement and research in cyberspace: Research ethics, the Internet, and revising a living document. Journal of Academic Ethics, 1(4), 397-418.
Potential Difficulties in an Online World
• Documenting Consent • Explaining the actual purpose of the research project • Evaluating online teaching paradigms
Documenting Consent
• Distinction between the private vs. public domain • Is consent required?
• Easy conductivity for anonymous and pseudonymous communications • How to validate consent?
• Global and easy accessibility • How to validate consent?
Considerations for Studying Internet Communities
• • • • • • •
Intrusiveness Perceived privacy Vulnerability Potential harm Informed consent Confidentiality Intellectual property rights
Questions?
