Intro to Projects – Research with Human Subjects THE IRB

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 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

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

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

Tuskegee Syphilis Study Macon Co., AL 1932-1972 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

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

Tuskegee Syphilis Study Denied antibiotic therapy in the 1940s and 1950s (although safe and effective) Study halted in 1972: 28-100 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

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

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?

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.

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

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).

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).

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).

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.

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 email to IRB@ltu.edu More information about LTU IRB is at the provost’s website http://www.ltu.edu/provosts_office/irb.asp

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

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.