Introduction to the Institutional Review Board CassiDe Street, Ph.D. Section Manager, HRPP casside.street@ttu.edu

Institutional Review Board Mission Institutional Review Board To protect the rights and welfare of human subjects involved in research at Texas Tech University Committee Must be highly diverse One non-scientific member One non-affiliated member One prisoner representative Faculty members from TTU

Human Research Protection Program Mission Human Research Protection Program Maintains all IRB records including meeting agendas and minutes, policies, regulations, forms, reference materials, and protocols Educate investigators and public on human research Serves as the point of contact for IRB Responds to non-compliance reports

Events that Lead to the Need for an IRB World War II Tuskegee Syphilis Study (1932 – 1972) N = 600 black men, 399 with syphilis Thought they were being treated for “bad blood” Study lasted 40 years and not offered penicillin Zimbardo (1971) Stanford prison study N = 24, clinically sane individual were randomly assigned to be prisoners or guards Study was suppose to last 2 weeks only lasted 6 days

Three Basic Ethical Principles The Belmont Report (1976) Three Basic Ethical Principles Respect for Persons Voluntary informed consent Respect for privacy Added protections (children, prisoners, pregnant women/fetuses) Beneficence “do no harm” Maximize benefits, minimize risks Risk: physical, psychological, social, economic, legal No greater than your normal daily life

The Belmont Report: Three Basic Ethical Principles Justice Equitable selection of subjects, inclusion and exclusion criteria Coercion Excessive or inappropriate reward Subjects are reimbursed for their time; not paid for their participation Equal distribution of both benefits and burdens of research

45 Code of Federal Regulations, Part 46 (45 CFR 46) The Common Rule Research A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge Human Subjects a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual (2) identifiable private information

45 Code of Federal Regulations, Part 46 (45 CFR 46) The Common Rule Intervention Manipulations of the environment Interaction with human subject(s) Individual can reasonably expect their actions will not be made public

International Research

International Approval Approval Process Texas Tech University IRB Texas Tech is the lead institution Approval secured here first. Reliance agreements for collaborators outside of Texas Tech Lead Institution’s IRB/Ethical Approval Texas Tech is a collaborator and not the lead institution Reliance agreement will be established Country Approval to Conduct Research Different for every country https://www.hhs.gov/ohrp/sites/default/files/2018-International-Compilation-of-Human-Research-Standards.pdf

Permission to Conduct Research Community Elders Tribal Leader Government Officials/Councils Organizations Companies Schools

Elements of Consent Purpose of Research Clear and Concise Consent Process Elements of Consent Purpose of Research Participant Activities Time involved Benefits and Risks Clear and Concise IRB requires consent document in English and Foreign Language Appropriate reading level for the target population Or appropriate consent process for age group

Cont. Volunteer Privacy Consent Process Cont. Volunteer Not forced or coerced to participate in research Can quit at anytime without penalty Privacy Only researchers will know who participated in the study Remove identifiers from data Investigator Contact Information HRPP Contact Information

Respect for the laws and regulations Aware of their cultural norms Age of minors v. adults Sensitive topics Appropriate person to conduct research Permission Recruitment Consent Data Collection

Data was collected ethically Secondary Analysis Data was collected ethically IRB/Ethics approval Letter Protocol Consent Process/Document Do the participants know their data is being shared for future studies? Be aware of data that was: Illegally obtained Hacked Unethically collected Not voluntarily Coerced into participation Risks

Environmental Health & Safety TTU Resources Export Control Contact TTU Export Control at jennifer.horn@ttu.edu, 806.834.3870 or william.wells@ttu.edu, 806.834.8003. TTU OP 74.10 Environmental Health & Safety Biospecimens stored on Texas Tech campus International Cultural Center

Review Types

Levels of Review Exempt Review Involves minimal risk and fits certain precisely defined categories Typically anonymous data Exemptions cannot be granted for: Projects with children as subjects that involve interview or survey procedures Research where public behavior is observed and the investigator participates or interacts

Exempt Review Established or commonly accepted educational settings Levels of Review Exempt Review Established or commonly accepted educational settings Regular and special educational instruction strategies Effectiveness of instructional techniques, curricula or classroom management Educational test, survey or interview procedures, or observations of public behavior Cannot be identified directly or through identifiers linked to the subjects Subjects responses could not place the subject at risk Elected officials or candidates for public office

Levels of Review Exempt Review Existing data, documents, records, pathological or diagnostic specimens under specific conditions Available to the public Subjects cannot be identified Taste and food quality evaluation Wholesome foods without additives are consumed Another provision of 45 CFR 46.101.(2)

Expedited Review Involves no more than minimal risk Levels of Review Expedited Review Involves no more than minimal risk May include identifiers and data that needs to be protected and kept confidential Children

Expedited Review Clinical studies of drugs and medical devices Levels of Review Expedited Review Clinical studies of drugs and medical devices Blood samples Biological specimens Noninvasive procedures Research involving materials that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis)

( NOTE: Some research in this category may be exempt.) Levels of Review Expedited Review Data from voice, video, digital, or image recordings Individual or group characteristics or behavior Employing survey Interview Oral history Focus group Human factors evaluation Quality assurance ( NOTE: Some research in this category may be exempt.)

Full Board Review Last Tuesday of the Month Levels of Review Full Board Review Last Tuesday of the Month Involves a higher degree of potential risk to human subjects Genetics (identifiable information, future use) Medical procedures Vulnerable populations Prisoners Exercise and sports activity Pregnant Women/fetuses

HRPP OFFICE Administration 357 806-742-2064 hrpp@ttu.edu