1. Intro to Projects – Research with Human Subjects
THE IRB

2. Definition of Human Subject
… a living individual person
about whom an investigator… conducting research obtains
Data through intervention or interaction with the individual, or
Identifiable private information
Code of Federal Regulations

3. Nuremberg Code 1947 Voluntary consent Anticipate scientific benefits
Benefits outweigh risks
Animal experiments first
Avoid suffering
Jeremy Sugarman, MD, MPH, MA, copyright

4. Nuremberg Code 1947 No intentional death or disability
Protection from harm
Subject free to stop
Qualified investigators
Investigator will stop if harm occurs
Jeremy Sugarman, MD, MPH, MA, copyright

5. Tuskegee Syphilis Study
Macon Co., AL
400 African- American men
Researchers tested the men for latent syphilis and studied its natural course
Enrolled without consent
Penicillin was discovered and widely available in 1940s
Jeremy Sugarman, MD, MPH, MA, copyright

6. Tuskegee Syphilis Study
Spinal taps
Recruited with promise of “special free treatment” for “bad blood”
Actually spinal taps without anesthesia, called “spinal shots”
Jeremy Sugarman, MD, MPH, MA, copyright

7. Tuskegee Syphilis Study
Denied antibiotic therapy in the 1940s and 1950s (although safe and effective)
Study halted in 1972: men died from advanced syphilis
Led to the development of the Office for Human Research Protections (OHRP)
federal laws and regulations requiring Institutional Review Boards (IRBs)
Jeremy Sugarman, MD, MPH, MA, copyright

8. Federal Regulations and IRBs 1974-Today
Sets a minimum standard
Based on the Belmont Principles
Applies to ALL research
Puts the responsibility on the institution
Through the establishment of a local IRB to review research with human subjects
IRB=Institutional Review Board

9. The Belmont Principles 1979
Respect for persons
individuals should be treated as autonomous agents
persons with diminished autonomy are entitled to protection
Beneficence
do not harm
maximize possible benefits and minimize possible harms
Justice
Who ought to receive the benefits of research and bear its burdens?

10. Special Populations found in sub-parts of the regulation
Vulnerable populations require a higher level of oversight
Children
Mentally Handicapped
Prisoners
Minorities
Women
Fetuses in utero
The Elderly
Employees, Students.

11. Activities that are not research with human subjects
Surveys or interviews done to inform institutional practice that stay within the institution
Journalism interviews for newspaper articles
Quality control, quality assurance
Classroom research at LTU required for completion of a class UNLESS you are presenting that research outside of the University
Even if your project is exempt, or not considered research with human subjects, you still have to follow ethical and legal principles

12. No need for IRB application @ LTU
Reviews and searches of existing literature and research involving a living individual, such as a biography, that is not generalizable beyond that individual.
Public archival data so long as the analysis of the data will not make the data individually identifiable.
Data collected for internal departmental, school, or other LTU administrative purposes (e.g. teaching evaluations, course evaluations, quality assurance).

13. No need for IRB application @ LTU
Class projects or term papers if all of the following are true:
The project is limited to surveys/questionnaires/ interviews/observations of public behavior directly related to topics being studied in an official college course so long as the assessment tools contain no sensitive personal questions or other personal information that could stigmatize an individual (e.g., questions about criminal activity, medical history, drug use, sexual behavior).

14. No need for IRB application @ LTU
Class projects or term papers if all of the following are true:
No identifying information is recorded to link a person with the data such that it could reasonably harm the individual's reputation, employability, financial standing, or place them at risk for criminal or civil liability.
The participants in the project are not from a vulnerable or special population (e.g., pregnant women, prisoners, children or adolescents under the age of 18, cognitively impaired individuals).

15. No need for IRB application @ LTU
Class projects or term papers if all of the following are true:
The collected data does not leave the classroom setting, or if the project involves collecting data on an organization, agency or company, the data are shared only with that entity.
No LTU employee or student is receiving financial compensation for collecting, organizing, analyzing, or reporting the data.

16. If you will do research with Human subjects
Research can begin only after the investigator receives a written approval from the IRB.
At LTU, submit forms electronically via to
More information about LTU IRB is at the provost’s website

17. Categories of review Exempt – 1 reviewer Expedited – 2 reviewers
anonymous AND minimal risk
IRB decides if exempt
no special populations
Most education research fits here – regular classroom procedures or educational tests
Reviewed by department representative on the IRB
Expedited – 2 reviewers
Oral history, interviews, surveys, focus groups
Minimal risk, but not anonymous
UNLESS children are involved
Full Board

18. What about my my study? IRB Review Criteria
There must be a benefit.
The protocol must minimize the risks.
There must be an equitable selection of subjects.
Participation must be informed and voluntary. No unfair inducements such as large cash payments.
Privacy and confidentiality of subjects and data must be protected.