Cornell Evaluation Network

The Use of Human Participants in Research

Office of Research Integrity and Assurance

255-3943 ~ oria@cornell.edu

May 14, 2007

Office of Research Integrity and Assurance

• Began March 2006 to respond to Research Compliance Concerns

• Laws, Circulars, Regulations, Issues of Public Trust

ORIA

• Institutional Review Board for Human Participants (IRB)

• Institutional Animal Care and Use Committee• Biosafety Committee (rDNA and Biological

Agents)• Conflicts of Interest• Scientific Misconduct• Export Controls

Background for Human Participants

• Nuremberg Code• Declaration of Helsinki (World Medical

Association)• Belmont Report

– Principle Based– Separation of Clinical Care vs. Research– Process of Informed Consent

Belmont Report

– B. Basic Ethical Principles• 1. Respect for Persons • 2. Beneficence • 3. Justice

– C. Applications• 1. Informed Consent • 2. Assessment of Risk and Benefits • 3. Selection of Subjects

Federal Regulations

• No laws in US for Research with Human Participants

• Regulations– 45 CFR 46 and Relevant Subparts– 21 CFR 50 and 21 CFR 56

• Federal Wide Assurances

Definitions of Research & Human Participants

• Research: “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

• Human participants: “…living individuals about whom an investigator (faculty, student, and/or staff) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

IRB: Three Review Levels

• Exempt – Does not require review from the IRB, but investigator may not self-exempt – application must come to ORIA.

• Expedited – Requires a complete review by only one IRB member.

• Full Review – Requires a complete review of the convened IRB.

Exemptions [45 CFR 46.101(1-6)

• Must still come to the UCHS – no Investigator can self-exempt

• Less than minimal risk to participants

• No prisoners are involved

• If a study is granted exemption, it does not require annual review

Full Review• If you are including a vulnerable population in an

interaction– Prisoners, including those in juvenile detention centers (does not

include someone on probation or parole) – no exemptions apply to this population

– Pregnant or nursing women (when subjected to an interaction other than survey/interview-type data collection, i.e., a nutritional study)

– Children – Very minimal risk can be expedited; exemption #2 cannot be applied to this population unless it is strictly public observation.

• If serious deception is involved (these tend to be psychological studies)

• If your study puts participants at more than minimal risk

Full Review

• Submit 16 copies of application, recruitment and consent documents.

• Submit 4 copies of measurement instruments and, when applicable, 4 copies of grant application and/or secondary data agreement (include data security plan).

• Must be submitted by noon on the Friday 3 weeks prior to the next committee meeting.

Expedited Review• Submit one copy of complete application and

supporting documents at least two weeks prior to planned initial contact with participants or identifiable data. Protocols are reviewed as they are received and are not subject to the schedule for the full review protocols.

• When appropriate, include copy of grant application and/or secondary data agreement (include data security plan).

Decision Tree

• Developed to respond to needs of faculty, students, and staff

• Designed to help investigators determine what activities do not need IRB review & approval

Use of Secondary Data• Still considered human participant research if identifiers are

attached. Identifiers include:

Address Email address Telephone or fax #

Elements of dates (e.g., birth date)

Social Security # Medical record #

Health Insurance # Certificate or license #s Vehicle ID#

Account #s (e.g., credit card)

Internet protocol address Serial #s

Other unique ID #s Biometric identifiers (e.g., voice, fingerprint)

Device ID #s

Full face photos / images

Use of Secondary Data

• Confidentiality Concerns– Publications & Presentations– Online research– Identifiable by the investigator using the data

• Coded data• Combination of de-identified data sets

– Co-investigator holding links

Vulnerable Participants

• Regulations specify categories– Pregnant Women, Fetuses, Neonates– Prisoners– Children

• Others?– Individuals with diminished cognitive capacity

Informed Consent Process

• Types of Consent– Written– Information Sheet– Oral– Deferred Consent– Waiver