Ethical Challenge & Solution in Social Behavioral Research Melody Lin December 2012

Objectives Apply regulation & ethical principles Apply regulation & ethical principles Develop review parameter Develop review parameter Roles & responsibilities Roles & responsibilities Do actions protect human subjects Do actions protect human subjects

45 CFR 46 Understand regulations’ flexibility and aplly to SBER research Understand regulations’ flexibility and aplly to SBER research

Ethical principles The 3 ethical principles are: The 3 ethical principles are: Respect Respect Beneficence Beneficence Justice Justice EP are the basis for the regulations EP are the basis for the regulations

Primary Ethical Concerns (SBER) Informed consent Informed consent Confidentiality Confidentiality Privacy Privacy Risk category Risk category Psychological risk Psychological risk Social risk Social risk Economic risk Economic risk Subject selection Subject selection

Areas of IRB Review Use regulations, ethical principles, institutional guidance and their expertise to review research for: Respect Respect Recruitment Recruitment Informed consent Informed consent Confidentiality procedures Confidentiality procedures Beneficence Beneficence Subject compensation Subject compensation Background literature Background literature Investigator experience Investigator experience Research design Research design Justice Justice Risks and benefits Risks and benefits Subject selection practices Subject selection practices

Application of the Regulation Do not provide direct guidance on each of these ethical concerns Do not provide direct guidance on each of these ethical concerns Ethical issues are briefly mentioned: Ethical issues are briefly mentioned: Informed consent requirement (46.116) Informed consent requirement (46.116) Confidentiality Confidentiality In relation to informed consent (46.116(a)(5) In relation to informed consent (46.116(a)(5) Privacy Privacy IRB approval criteria (46.111) IRB approval criteria (46.111) Risk Risk IRB approval crietria (46.111) IRB approval crietria (46.111) Meeting or exceeding “minimal risk” (46.102)(i) Meeting or exceeding “minimal risk” (46.102)(i)

Review Challenges Regulations do not provide ethical guidance Regulations do not provide ethical guidance IRBs are not experienced in application of the regulations to non-medical research IRBs are not experienced in application of the regulations to non-medical research A one-size fits all approach may not work A one-size fits all approach may not work Lack of guidance creates confusion and tension Lack of guidance creates confusion and tension

Regulations Allow for Flexibility Exempt status Exempt status Expedited review via subcommittee Expedited review via subcommittee Waiver of informed consent and documentation Waiver of informed consent and documentation General open-mindedness in consideration of various research design choices General open-mindedness in consideration of various research design choices

Exempt Review Examples Use of biological samples Use of biological samples Involvement of school children in educational research Involvement of school children in educational research Survey gathering non-sensitive data Survey gathering non-sensitive data

Expedited Review: Examples Effect of stride frequency on oxygen uptake while running uphill Effect of stride frequency on oxygen uptake while running uphill Knowledge and attitudes on contraception and reproductive health in residents of a small Mexican town Knowledge and attitudes on contraception and reproductive health in residents of a small Mexican town A comparison of standard vs. hearing aid processing in cell phones for the hearing impaired A comparison of standard vs. hearing aid processing in cell phones for the hearing impaired

Full Committee: Examples Interviews with law enforcement agents, armed group leaders, drug users, and drug dealers on the drug trade in several Asian Countries Interviews with law enforcement agents, armed group leaders, drug users, and drug dealers on the drug trade in several Asian Countries Testing weight-reduction strategies for breast cancer survivors Testing weight-reduction strategies for breast cancer survivors Study of social rejection and depression using deception Study of social rejection and depression using deception

So, We Understand IB member responsibilities are highly complex IB member responsibilities are highly complex Social and behavioral sciences studies are highly complex Social and behavioral sciences studies are highly complex Each study must be reviewed case by case Each study must be reviewed case by case Regulations allow for flexibility Regulations allow for flexibility IRB members and administrative staff should be well-trained and supported by the institution IRB members and administrative staff should be well-trained and supported by the institution

What to Do? Improve understanding and relevant application Improve understanding and relevant application Streamline process and compliance Streamline process and compliance Determine whether actions actually protect subjects Determine whether actions actually protect subjects Where to focus? Where to focus?

Where Do We Begin? PI creates a good protocol PI creates a good protocol Produces valid, worthwhile science Produces valid, worthwhile science Responds ethically, not bureaucratically, to regulations Responds ethically, not bureaucratically, to regulations Demonstrates sensitivity to the context, culture and needs of subjects Demonstrates sensitivity to the context, culture and needs of subjects Shows understanding of the consent process, risk & benefit privacy & confidentiality, and the consultative role fo the IRB Shows understanding of the consent process, risk & benefit privacy & confidentiality, and the consultative role fo the IRB

Demonstrate Ethical Practices Conduct valid research (using accepted scientific methods) Conduct valid research (using accepted scientific methods) Appropriate sampling (to get valid results) Appropriate sampling (to get valid results) Respect people and their communities Respect people and their communities Protect research participants Protect research participants Benefit individuals and society Benefit individuals and society Create a basis for socially beneficial polices Create a basis for socially beneficial polices Disseminate findings effectively Disseminate findings effectively Facilitate the application of finding Facilitate the application of finding

Stakeholders Regulatory Regulatory Institutions Institutions Research subjects Research subjects

Shared Responsibilities Stakeholders have complementary and competing goals: Stakeholders have complementary and competing goals: Legal concerns Legal concerns Academic freedom Academic freedom Human rights Human rights

Perception of the IRB Supportive? Supportive? Controlling? Controlling? Inconsistent? Inconsistent? Fearful? Fearful? Restrictive? Restrictive? Helpful? Helpful? Powerful? Arbitrary? Facilitative? One dimensional? Mysterious? Uninformed? See JERHRE, March 2006 for results of study perceptions of iRBs

Opportunities or Challenges? Collaborate – us/them or team approach? Collaborate – us/them or team approach? Communicate – challenge or Facilitate? Communicate – challenge or Facilitate? Cooperate – problem or solutions? Cooperate – problem or solutions?

Collaboration, Communication and Cooperation Increase collaboration Increase collaboration Minimize confrontation Minimize confrontation Improve communications Improve communications Reduce barriers Reduce barriers Value added decisions Value added decisions Shared visions and responsibility Shared visions and responsibility Opportunities to partner in research endeavors Opportunities to partner in research endeavors

Tips for the IRB Organizational perception Organizational perception IRB composition/support IRB composition/support Educate, guide and consult Educate, guide and consult Streamline Streamline Meet the investigators Meet the investigators Appropriate flexibilty Appropriate flexibilty

Identify Challenge Protocol review/approval Protocol review/approval Appropriate consent process/documentation Appropriate consent process/documentation Appropriate risk assessment Appropriate risk assessment Turn around time Turn around time Consent form details Consent form details Knowledge of research design Knowledge of research design Use of exempt and expedited review Use of exempt and expedited review Providing education Providing education

The Review Process Does one size fit all? Does one size fit all? Consider methodology Consider methodology Disciplines involved Disciplines involved Risk assessment/management Risk assessment/management Infomred consent Infomred consent

Proactive Site Visits Create an opportunity to see the research in action Create an opportunity to see the research in action Create an environment where on-site monitoring is accepted/valued Create an environment where on-site monitoring is accepted/valued Enhance IRB awareness of practical issues from the investigator’s perspective Enhance IRB awareness of practical issues from the investigator’s perspective Promote communication between researchers and the IRB Promote communication between researchers and the IRB Increase opportunities for training of ethical/responsible research practices Increase opportunities for training of ethical/responsible research practices

Tip for Investigators Take RESPONSIBILITY become EMPOWERED Take RESPONSIBILITY become EMPOWERED Knowledge is power – know the Federal regulations, institutional policy / guidance Knowledge is power – know the Federal regulations, institutional policy / guidance Opportunities to learn Opportunities to learn Protocol submission Protocol submission Communicate Communicate Ethical awareness Ethical awareness Use resources Use resources

Resources Both NIH and NSF have developed guidance specific to SBER research p Both NIH and NSF have developed guidance specific to SBER research p p p National listserve National listserve