1. Conducting Human Subjects Research at CSUEB
A Roadmap

2. Examples of Human Subjects Research at CSUEB
History – Taking oral histories of prominent individuals
Psychology – Determining student attitudes through questionnaires
Teacher Education – Evaluating new teaching techniques in K-12 classrooms
Women’s Studies – Studying women’s health issues through surveys and interviews

3. More Examples
Kinesiology – Determine if video modeling can help improve volleyball serve
Entrepreneurship – Life histories of successful business leaders
Sociology – Attitudes of native employees of call center in India
Criminal Justice – Questionnaires used to determine traits of Good Samaritans

4. Even More
Computer Science – Gender-based and ethnicity-based attitudes in the computing sciences
Social Work – Encouraging cancer-prevention behaviors in traditional societies
Anthropology – Urban reactions to rural accents in Japan
Communicative Sciences – Computer-based interventions for Alzheimer's sufferers

5. Principles of Human Subjects Research
Belmont Report – 1979
Respect for Persons
Acknowledge autonomy
Protect those with diminished autonomy
Beneficence
Do no harm
Maximize benefits, minimize possible harm
Justice

6. When Things Go Wrong Tuskegee Syphilis Study – 1930s to 1972
400 African-American men with syphilis and 200 without.
Underwent unnecessary procedures
Despite many deaths, infected subjects were not treated once a cure was found (penicillin in the 40s).

7. Government Regulations
45 CFR 46 – The Common Rule
Applies to almost all federally funded research (FDA has own regulations)
Procedures for protecting human subjects
Establishment of Institutional Review Boards to enforce procedures
Regulations specify the minimum protections an institution must enforce

8. Definitions
Research – Systematic investigation designed to develop or contribute to generalizable knowledge
At CSUEB, research = anything published or presented outside the classroom
Unless published or presented, class projects need not be reviewed by IRB. Instructor responsible for ensuring policies are upheld, especially for sensitive topics

9. Definitions
Human Subject – a living individual about whom an investigator conducting research obtains:
Data obtained through intervention or interaction with the individual, or
Identifiable private information

10. What Is Not Human Subjects Research?
Journalism
Research using publicly available data
Research in which the data obtained is not about a person
Research on an individual who is no longer living
No interaction or identity determination

11. If It Is Human Subjects Research
P.I. submits research protocol to the IRB Coordinator, Anne Wing at or
Protocol is registered and forwarded to IRB Chair
Chair determines if research falls into a federal exemption category – if so, administratively reviewed by IRB chair
If not, protocol is reviewed by partial or complete membership of board (expedited or full review)
Note: Training is required for researchers doing non-exempt research

12. If It Is Human Subjects Research
Additional information or modifications may be requested prior to granting approval
An approval form is provided to P.I. Approval may be given for a maximum of one year
For multi-year projects, project is reviewed again at least once per year (via continuation review)

13. Exempt Research
1) Research conducted in established or commonly accepted educational settings, involving normal educational practices
2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
The subject may be identified and
Disclosure may result in risk of criminal or civil liability or damage to the subject’s standing or reputation

14. More Exemptions
3) Research not exempt under 2), but in which public officials are the subjects
4) Collection of data which is publicly available or if subjects are not identifiable
5) Research to study public benefit programs
6) Taste and food quality evaluation

15. Please remember
Even research which falls into an exemption category must be submitted to the IRB and approved.
The decision regarding exemption is made by the IRB, and is made based on the exemption definitions and considering the risks of possible harm to the subjects.
Also, there are some exceptions to the exemptions (for children, prisoners, etc.)

16. The Research Protocol
A description of the research to be done including:
Procedures to be conducted
Description of the subjects
Risks and mitigation
Consent mechanisms

17. Protocol Elements Section III - Starting and ending dates
IRB approval must be prospective, not retrospective
Provide 1-2 weeks for exempt research, 3-4 for expedited, and 4-5 for full review
Note that projects lasting over one year will require continuation review
Section IV - Qualifications
List pertinent training or certifications

18. Protocol Elements Section VI – Involvement of other organizations
Examples: testing K-12 students, college students at other universities, colleagues at work
Need evidence of permission from gatekeeper
Section VII - Hypothesis
Brief and understandable to people outside discipline
Value of research

19. Protocol Elements Section VIII – Research Method and Design
What procedures will be conducted?
Surveys, interviews, hearing tests
What setting?
K-12 school, workplace, hospital
Methodology?
Statistical analysis, oral history

20. Human Subjects Involvement
Section IX.A – Description
Chronological description in detail
What will subject be asked to do?
Engage in focus group, take survey, kick ball
Where will research take place?
In subject’s home, via telephone
How long will each element of subject participation take?
Example: 30 minute pre-test, 8 hour unit on driver safety, 30 minute post-test
Who conducts each part?
Student assistant, primary investigator

21. Human Subjects Involvement
Section IX.B – Subject Population
How many subjects will be used?
Characteristics?
Age
Gender
Race
Why chosen? Selection criteria
Vulnerable populations?
Children
Cognitively impaired

22. Human Subjects Involvement
Section IX.C – Research Material
Include any surveys, questionnaires, interview questions
Section IX.D – Recruitment Plan
How will subjects be approached?
In class by instructor, via , in front of clinic
Address possible coercion especially for vulnerable populations
Section IX.E – Potential Benefits
Direct benefits to subjects
Cash, prizes

23. Human Subjects Involvement
Section IX.F – Potential Risks
Section IX.G – Risk Reduction
A description of the possible risks to the participant and how each risk will be addressed
Emotional upset – Debriefing after interview completed, indicate availability of counseling
Loss of privacy – ensure confidentiality
Physical injury – use of trained personnel

24. Ensuring Confidentiality
Section IX.H – describe how confidentiality will be ensured
Store records in locked cabinets
Encrypt data files
Use codes to connect participant identification to collected data
Anonymous surveys
Certificate of Confidentiality
Some disclosures must be reported:
Child abuse
Risk of harm to others or self

25. Protocol Elements Section IX.I – Risk/Benefit
Shows that benefits outweigh risks

26. Consent Issues Section J.1
Describe how consent will be obtained from subjects, by whom, and include copy of consent and possibly assent forms

27. Requirements for Informed Consent
Be obtained from subject or representative
Provide subject time for consideration and no undue coercion
Be in understandable language
Not include exculpatory language
Be prospective (retroactive consent not permitted)

28. Consent Form (legally required)
Purpose of research, duration, what to expect
Description of risks
Description of benefits
Description of alternate procedures (if treatment is involved)
Description of how confidentiality will be maintained
A statement of whether compensation for harm is available

29. Consent Form (legally required)
Contact information – researcher, Office of Research and Sponsored Programs at (510)
Statement that participant is free to withdraw at any time without reprisal or penalty
Not required but reasonable additions
Sponsors of the project (if any)
Researcher’s association to participants

30. Exceptions to Informed Consent
Portions may be waived if necessary to research and research is no more than minimal risk
Written documentation of consent may be waived if privacy issues warrant or no way to conduct research otherwise (example: online or telephone survey)

31. Vulnerable Populations
Research with children
The assent of the child must be obtained using a form written at the child’s level
The consent of both parent’s must be obtained if possible (may be waived)
Some exemptions do not apply

32. Vulnerable Populations
Non-English speakers
Alzheimer’s sufferers
Prisoners
Pregnant women
Decisionally impaired – psychiatric issues, drug use, dementia, etc.
Terminally ill

33. Mid-course Changes
If changes need to be made to procedures, surveys, subject population, etc. – Researcher submits changes and Modification review is done by IRB

34. Continuation Review Approval may be given for a maximum of 1 year.
If study lasts more than a year, request continuation review before approval expires.

35. Required Training
Researchers doing non-exempt research must complete on-line training in human subjects issues (through CITI program) prior to beginning research
IRB chair will screen protocols and contact investigator to specify type of research

36. Available on the IRB Website
Protocol approval form and protocol template
Example consent and assent forms
Forms to request continuation or modification review
Example video or photo releases
IRB policies, FAQs, training links, and more

37. Resources CSUEB IRB site Office for Human Research Protections
Office for Human Research Protections
IRB Forum
Journal of Empirical Research on Human Research Ethics

38. Questions or Comments?
Contact IRB chair, Kevin Brown, at