Protection of Human Subjects in Research Whitworth University Institutional 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 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: men died from advanced syphilis Jeremy Sugarman, MD, MPH, MA, copyright

Willowbrook State School Hepatitis Experiments  Inoculation and injection of hepatitis  Mentally retarded, institutionalized children  Admission through the research unit 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  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 5 th 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