Conducting Human Subjects Research Responsibly:

IRBs and Social Science Researchers

Mark Roosa, ChairSocial 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 collectionREVIEW 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 uponadequate knowledge and understanding ofrelevant information, to participate in research or toundergo a diagnostic, therapeutic, or preventiveprocedure.”- 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 RiskTo 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 Metosky

Susan.Metosky@asu.edu (480) 727-0871• Tiffany Dunning

Tiffany.Dunning@asu.edu (480) 965-6788• Leticia De Los Santos

Leticia.Delossantos@asu.edu(480) 727-6526• Shana Clark

Shana.Clark@asu.edu (480) 727-5617• Debra Murphy, Director Debra.Murphy@asu.edu (480) 965-2179

Research.integrity@asu.edu

Questions?