Protection of Human Subjects in Research
Whitworth UniversityInstitutional Review Board
The Board
Scientist Non-scientist Persons with expertise in the types
of special populations reviewed Person with expertise in
regulations Community member
Whitworth’s IRB
We review behavioral and educational research faculty research student research when it is a
requirement for graduation such as the psychology research projects or a master’s thesis.
research from off campus which uses our student body as subjects (occasionally)
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
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”
Enrolled without consent
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
Jeremy Sugarman, MD, MPH, MA, copyright
Willowbrook State School Hepatitis Experiments 1963-1966
Inoculation and injection of hepatitis
Mentally retarded, institutionalized children
Admission through the research unit
Jeremy Sugarman, MD, MPH, MA, copyright
Federal Regulations and IRBs1974-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
Beneficence Maximize benefit, minimize harm
Categories of Risk Minimal risk: The risks of harm are not
greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
More than minimal risk: Risks exceed, either in probability or magnitude, those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
Risks in Behavioral and Social Research
Invasion of privacy Breach of confidentiality Embarrassment Stigma Psychological Trauma
The Belmont Principles 1979
Respect for persons: dignity and autonomy Participation is informed and
voluntary Special protection of vulnerable
subjects
The Belmont Principles 1979
Justice Fair and equitable selection of
subjects Benefits and burdens of research is
distributed fairly among populations
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.
Informed Consent May be coercive if
Subjects are in a group when recruited and there is an unspoken expectation that they should participate because of their membership in the group, e.g. students, racial affiliation
Compared to the study subjects, the investigator has a position of socio-economic status and/or expertise, e.g. doctor or professor
The technical jargon makes subjects feel intimidated and/or prevents understanding
Elements of Written Consent
Purpose Procedures Voluntary Participation How the information will be used How to opt out at any point How to contact the researcher Signatures
IRB Review of Projects in Schools
Any research which looks at normal educational practices or educational testing is exempt – Fill out the exempt application, no parental consent is required by the IRB – check your schools’ policies and follow them
Projects in Schools
When doing research in schools, follow the individual school policy.
In many cases you do not need parental approval if your research is on regular educational practices
Protection of Pupil Rights Amendment (PPRA) Parental consent is required for Qs
about: Political affiliations Mental and psychological problems
potentially embarrassing Sex behavior and attitudes Illegal, anti-social, self-incriminating and
demeaning behavior Critical appraisals of others (close family) Legally recognized privileged relationships
such as lawyers, doctors Family income
Non-Exempt Educational Research
Those projects that would fall under PPRA
Any other survey or interview projects that are not part of the regular classroom procedure can be reviewed at the expedited level
Examples of when written consent can be waived
Phone interviews – keep a log
Surveys – introductory explanation either verbal or written (tacit consent)
On-line surveys – introductory explanation
What about my study? When is research taking place with human subjects?
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The knowledge is published or presented in a public forum.
Human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction, or 2) identifiable private information.
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 Whitworth required for completion of a class UNLESS you are presenting that research at the Spokane Intercollegiate Research Conference
However . . .
Even if your project is exempt, or not considered research with human subjects, you still have to follow ethical and legal principles
When can research begin?
Research can begin only after the investigator receives a written approval from the IRB.
If investigator is asked to make some changes prior to approval, research may not begin until the researcher submits a Protocol Change form and receives written approval from the IRB indicating that they have met the conditions required.
Can Deceit be used in Human Subjects Research? Yes, but . . . researcher must debrief
subjects afterwards
In a school setting this would not be exempt
A study without deceit may withhold some non-risk related procedural or outcome information if it might affect participant behavior (not participation) and, therefore, destroy or invalidate the results of the study
Categories of review Exempt – 1 reviewer
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.
Documentation of Informed Consent It is a process, not just a document
Provide a written statement/script whenever written consent is waived
Washington State requires written consent if a conversation is to be taped or recorded
Waiver of Written Consent Written consent can be waived by the IRB
if: the only record linking the subject and the
research would be the consent, AND
If their name were discovered they would be at risk of legal proceedings or their reputation, job or financial status would be at risk OR
it presents no more than minimal risk and it is anonymous
What a script should cover Purpose & subject matter Procedure Voluntary participation How to opt out at any point w/out penalty Your name, Lynn Noland’s info., and
contact information A template is available on the Sponsored
Programs website Academicaffairs/sponsoredprograms/
compliance
Street Kids
Need to have an advocate who works with street kids present
The board will also need to have an advocate present during review
Requires full board review
Prisoners Research done with prisoners cannot be
done by students unless a faculty member who is experienced in working with prisoners is involved and present
Research with prisoners cannot be approved by the IRB unless there is a prisoner advocate present – full board review
Research with juvenile prisoners must have approval from the court first
Navigating the Review Process Fill out application – Follow the
directions Exempt is first page only Attach survey sample Attach consent form, verbal consent
script, or written explanation Attach letters of approval from outside
agencies whose clients you propose to use as subjects
Common Problems Not enough detail to describe the study
procedures Letters from agencies outside Whitworth not
attached Consent form in language that is difficult to
understand – should be at 5th grade reading level. Unclear how to opt out once study begins No script or information if written consent is
waived Did not read directions on the application Studies which put students or the university at
legal risk, e.g. simulated shoplifting, carjacking
Autonomy of Board
If the board approves a project, it can be overturned by the Vice President for Academic Affairs if it is decided that it is not in the best interests of the college.
If the board disapproves a project, the college cannot overturn that ruling.
Brief History WWII and Nazi experiments- Nuremberg Trials
and Nuremberg Code - unsigned 1960s, 1970s in US – Willowbrook, Tuskegee 1974 Code of Federal Regulations mandates
IRB review of research 1979 – Belmont Commission Report 1990s – tightening of the regs because of
continued abuse 2007 – loosening of some interpretations when
applied to social, behavioral and educational research