overview historical perspective human subjects & social and behavioral research questions and...
TRANSCRIPT
Conducting Human Subjects Research Responsibly:
IRBs and Social Science Researchers
Mark Roosa, Chair
Social and Behavioral Science IRB
Overview
• Historical Perspective
• Human Subjects & Social and Behavioral Research
• Questions and Answers
20th Century Research
1972 Tuskegee Study Exposed
1932 Tuskegee Syphilis Study begins
Nuremberg Code 1947
Declaration of Helsinki 1964
Belmont Report 1979
Common Rule 1991
Nazi Experiments
Milgram Study
Nuremberg Code (1947)[Parts relevant to social and behavioral scientists]
• Say it is research• Voluntary consent• Anticipate scientific benefits• Benefits for participants must outweigh risks• Do no harm - Research stops if harm occurs• Subjects can withdraw at any time• Investigators must be qualified
Belmont Report:Principles and Applications
Ethical Principles Applications
Respect for Persons Informed Consent
Beneficence Assessment of risks and benefits
Justice Equitable subject selection
Common Rule (45CFR46)
• No longer trust in investigators• No longer general principals• Very specific and narrow rules passed by
Congress– With enforcement
• Mandated IRBs– Invented Exempt & Expedited categories
Shut Downs- Consequences of Violations• Mar 1999 West Los Angeles VA Medical Center• May 1999 Duke University Medical Center• Aug 1999 University of Illinois• Sep 1999 University of Colorado• Sep 1999 University of Pennsylvania• Jan 2000 Virginia Commonwealth University• Jan 2000 University of Alabama at Birmingham• Jun 2000 University of Oklahoma – Tulsa• Jun 2001 Johns Hopkins Medical University• 2010 University of Indiana, Bloomington
(“voluntary”)
Case StudyUniversity of Iowa Stuttering Study
Discovery of Second Syphilis Study
• 2011 Discovery
• Same PIs as Tuskegee
• Post WWII studies in Central America
ASU• 4 Federal Audits in recent years• Havasupai Lawsuit
Protect researchers/university while facilitating research
Follow Regulations
Protect Participants
Social & Behavioral Research:If No or Minimal Risk
• No increased risks to participants– Many fit Exempt category (Federal criteria are
very narrow) – simpler application form– Expedite category – No more than minimal risk
(no more risk than participants experience in normal daily routines)
• Must fit into one of the Federal categories
Social & Behavioral Research: Risks• Most common S & B risk – Information Risk
– If information collected were exposed AND connected with participant, it could damage:
• Reputation• Employability• Family relationships• Insurability• Health (e.g., domestic abuse research)• Legal status/Freedom from imprisonment
Protections for Info Risk I• Anonymous surveys (one time surveys)
– No master list– Information letter, possibly no signed consent forms
• Reproducible IDs (multiple data points)– No master list required
• First two letters of mother’s first name __ __
• Day of month on which you were born (2 digits) __ __• Year you graduated high school (2 digits)
__ __• Last two digits of your SS#
Protections for Info Risk II
• Master list required because of use of addresses or phone numbers for follow up– Master list kept secure– Restricted access to master list– Master list destroyed as soon as possible
Protections for Info Risk III: No nos
• Never put ID#s on consent forms– Makes consent forms into a master list– Consent forms must be kept for 4 (four) years
• Never use student IDs, Social Security #s, employment numbers, prisoner #s, etc as IDs
• Research titles on consents and other forms should not identify a vulnerable population
Vulnerable Populationsas defined by 45CFR46
• Pregnant Women, Human Fetuses and Neonates– Rarely an issue for Social & Behavioral research
• Prisoners!!!– DHHS funded research requires separate approval from
Secretary of HHS after IRB approval– Always full board regardless of risk
• Children (individuals < 18)– Usually requires no increase in risk, parental permission, and
child assent (age appropriate)– Review requirements depend on procedures/risk
Other Vulnerable Populations• Those with a history of abuse by researchers (Indians)• Those susceptible to harm from research• E. G.: - Decisionally impaired
– Undocumented immigrants– Runaway or homeless children– Those with HIV/AIDS– The very poor– Those in third world countries– Participants in any study that asks sensitive questions
when a master list is required
ASU Human Subjects Review
• All human subjects research must be reviewed & approved prior to data collection
REVIEW TIME DEPENDS UPON THE TYPE OF STUDY!
Generally 1-6 weeks from receipt
Major determinants of time until decision
• Quality & completeness of info provided on application
• PI’s timeliness in responding to questions• Risk involved to participants
ASU IRB Application Process(Full Board and Expedited Studies)
• Submit Social Behavioral application form & supplemental materials– Applications accepted everyday – For full board, the deadline is 12 days prior to the monthly
meeting
• Applications must be complete by the deadline
Supplemental Materials to Submit– Grant/proposal for funded projects– Consent, parent permission, assent forms– Questionnaires, interview guides, interview
themes/categories– Approval/Support letters from institutions if
required– HSS training certificates for ALL researchers
Ways to make the process smooth
• Submit materials in English only• Submit complete applications • Write so that someone unfamiliar with the
field will understand (audits may be conducted by biomedical personnel)
• Respond in a timely fashion to inquiries from IRB staff
Principal InvestigatorASU faculty or staff member responsible for:• Submission of all required forms• Conduct of the research• Compliance with IRB decisions/federal regs• Submitting proposed changes
– prior to making changes
• Reporting unexpected & adverse events quickly
PI/Faculty is responsible party for student research
Study Approval
• Non-exempt studies approved for up to 1 year– Annual report and review required
• Study complete when data collection AND analysis are complete
What is Informed Consent?“A person's voluntary agreement, based upon
adequate knowledge and understanding of
relevant information, to participate in research or to
undergo a diagnostic, therapeutic, or preventive
procedure.”- OHRP IRB Guidebook
it is a process, not a form
Format can vary: cover letter, consent form, parent permission form, assent form, oral
General requirements - Informed Consent • Say it is research• Purpose & procedures in simple language• Health and financial risk, if any*• Compensation/costs, if any*• Confidentiality promise & process• Subjects’ rights (voluntary, can quit, can skip, no
penalties)• 5th-8th grade reading level
»* can be left out if not applicable
Criteria Used to Evaluate Protocols
• No risks or risks are minimized• Acceptable risk/benefit ratio• Equitable selection of subjects• Adequate informed consent process• Privacy and confidentiality protections• Additional safeguards for vulnerable populations
Ways to Minimize Risk
To Participants• Alternatives
– Procedures that are less risky
• Precautions– Procedures to decrease
likelihood of harm
• Safeguards– Procedures to deal
w/harms if they occur
To Researchers• Document Everything• Follow approved
procedures• Submit any changes to IRB
– Must be approved before implementing
• Report unexpected events
Full Board Studies
• More than minimal risk or protected population
• Or procedures not included in the authorized Exempt or Expedite categories
• Committee meets once a month– Approve– Approve with modifications (minor vs. substantial)– Disapprove
Making changes to a protocolSubmit ANY proposed changes for approval before
implementing them using a Modification Form
Examples of such changes include:• Alteration of study design, methodology, or recruitment• Changes to instruments • Changes to consent/assent documents/process• Addition/deletion of investigators• Alteration of project title• Addition of research sites
No review for change to exempt studies unless change makes the study non-exempt.
Contact Information
• Susan [email protected]
(480) 727-0871• Tiffany Dunning
(480) 965-6788• Leticia De Los Santos
(480) 727-6526• Shana Clark
(480) 727-5617• Debra Murphy, Director [email protected]
(480) 965-2179
Questions?