Institutional Review Board and YOU!

1. Institutional Review Board and YOU! Choya Washington Division of Research Affairs Graduate & Research Affairs San Diego State University

2. Overview • What is the IRB/ Why is it needed? • Important Historical Events & how they apply to what you may be doing • The IRB and You

3. What is the IRB? • The IRB stands for the Institutional Review Board • A group that has been formally designated to review research to ensure the rights and welfare of human subjects involved in the research are adequately protected. • The IRB reviews all research with human subjects conducted at SDSU

4. SDSU’s Board • SDSU Faculty (7) • Psychology (2/2) • Exercise and Nutritional Sciences (1) • Public Health (2) (medical doctor) • Anthropology & Latin American Studies (1)-works closely with Cross-Cultural Education • Speech, Language and Hearing Sciences(1) • School of Public Affairs(1) • SDSU Student Representative (2) • Anthropology (grad) • School of Communication (undergrad) • Non-Affiliated Individuals (3) • SDSU Staff (Alternates) • Analysts(1/3) • We also invite outside experts to assist with the review of protocols as necessary • Advocates for certain classes of participants are invited to aid in the review of certain types of research

5. SDSU Education Research • Research Involving Autistic children and their social adjustment • Research exploring racial identity, racial relations and how it effects learning in higher education, elementary education and high school. • The effects of type of sexual education on safe sex behavior

6. The Willowbrook Study: Mid 1950’s – Early 1970’s • Vulnerable population: Involved infecting mentally disabled children with a Hepatitis virus to study the progression of the disease and to test new vaccinations. • Undue Influence: The study was extremely coercive as parents often had a difficult time getting their children admitted to any mental health care facilities. • Parents were manipulated by the researchers into allowing their children to participate and were told that their children could not enroll at Willowbrook unless they agreed to participate. • Risks outweigh Benefits: The nature of the experiments were extremely cruel and unjust.

7. Tea Room Study- • Researcher Role-A student was conducting research for his dissertation. • Deception-He would pose as a “look out” for police. • Privacy-However, he also took notes on the characteristics of the men and the behaviors they engaged in. • Risk Management Plan-He also recorded the license plate numbers of these men went to their homes and interviewed them and their families.

8. National Research Act(NRA)Belmont Report • NRA-Required informed consent for all government sponsored studies and established IRBs • Foundation of current federal regulations-outlines acceptable and ethical practices in research • Three basic tenets of the Belmont Report include: • Respect: -Informed Consent-Voluntary Participation-Privacy &Confidentiality • Beneficence:-Maximize benefits-Minimize risk-Qualifications of researcher to carry out the study in a safe and appropriate manner? • Justice: • Fair subject selection • Equitable distribution of risks & benefits

9. What is Reviewed by the IRB • What is research involving human subjects • [Research] • Defined by 45 CFR 46.102(d) as: YOU: A systematic investigation designed to develop or contribute to generalizable knowledge.. (hypothesis or research question to answer)_ • Generalizable knowledge: • YOU: publication (article, thesis or dissertation) • professional presentation

10. Are Human Subjects Involved? A few examples: • Reviewed by the IRB: (Helpful question for YOU, is the data to be collected specific to an individual) • Studies that use medical records, or case files, student records (this is individual information about subjects). Studies that will involve the opinions, feelings, experiences, or characteristics of individuals • Not reviewed by the IRB: • Studies concerning amount of people using a given health resource center (does not involve individual information about subjects; it is information about individual facilities). Also, aggregate data (e.g., census data, etc).

11. Benign Exempt Minimal Risk Expedited Greater than Full Committee Minimal Risk 1 >1 >6 Risk level Reviewers required Review level

12. You-Making a determination Full Committee: greater than minimal risk • deception • vulnerable subjects-depending on what the research tasks are • Tasks/questions being asked • Expedited- research involving no more than minimal risk* • *Minimal risk = probability of harm/discomfort in research is not greater than that encountered in daily life (You- explaining your populations and the tasks and why it is min risk) Deadline dates do not apply • Exempt Examples: Adults who complete a non-sensitive survey/interview • Observation of public behavior- • Non-anonymous data as long as no risk is posed if confidentiality is breached the study would not solicit informationfrom a participant that, if disclosed, would reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. • Analysis of existing data-may need to ck w/ IRB

13. Discussion Study inside of classrooms asking students to complete a survey that asks about family immigration status, dating violence, sexual assault, dating and sexual practices to determine the prevalence inside the school and the factors that lead to reporting. • Thoughts: Is this benign, Minimal Risk or Greater Than Minimal? • How can we apply the Belmont Report? Respect (informed consent, voluntary), Beneficence (Minimize Risks-Privacy, mandated reporting)

14. Children in Research • If research activities are not limited to educational tests, research activities directly related to current curriculum or observations of public behavior and the researcher does not participate in the activities being observed. An Expedited protocol must be submitted. • Per the CA Education Code Section 51513 written parental consent must be obtained prior to child participation in research involving tests, questionnaires, surveys, or examinations containing any questions about the student's or the student’s family’s personal beliefs or practices in sex, family life, morality, and religion. The SDSU IRB requires such research to be submitted through the Expedited template and will not be considered exempt.

15. Expedited and Exempt Examples Expedited Exempt Interviews with adult student teachers about current coursework to determine the impact of that coursework in your preparation as a teacher. Reported anonymously, interviews conducted privately • Survey of parents and high school students about recently introduced religious studies curriculum, thoughts on teachers, schools. Included questions about religious beliefs and family life.-SEE PREV SLIDE

16. Recruitment • Recruitment should be done in a neutral fashion; avoid persuasive language or situations. • -Things to think about?? When they are recruited. Who is doing the recruitment. • Access-How are teacher, students and parental information being accessed. You- Proper access to a person’s information for research purposes? Sending out research information on your behalf. FERPA Compliant-The Family Educational Rights and Privacy Act (FERPA). Generally, schools must have written permission from the parent or eligible student in order to release any information from a student's education record.

17. Types of Consent Forms: Informal Consent (Exempt) Formal Informed Consent (Full Committee and Expedited)- these can be modified- English as a 2nd language, low literacy, etc. Save yourself time and stress… use SDSU templates! You- These forms can be modified to fit your population (low literacy, international, online, etc..) Children in research Assent forms Parental Permission forms

18. Existing Data: Anonymous or will be made anonymous prior to being analyzed(Exempt) Apart of data collection, access to links, contains links(Expedited) Usually best to contact IRB prior to submitting

19. Additional IRB Review… If you have other affiliations… Joint Students Hospital University If you will be conducting a study through another institution, you must receive their IRB approval before submitting to the SDSU IRB.

20. Respect for Persons-Consent Not just a written form, but an on-going open discussion of participant rights and study details. Think about this especially with studies that include multiple data collection points (i.e. Pre and Post) Inadequate consent forms-Language should be understandable to the audience it is written for Inconsistent with protocol Adequate Details so they are clear about whether or not to participate.-Consistent with the protocol.

21. How to use vIRB Link to the tutorial Link to Guidebook Templates Faculty Assurance forms-You (Have your faculty sponsor READ and APPROVE your protocol and supporting documents before submitting!!!). Protocol cannot be reviewed without this signed form. Go to our website for tips http://www-rohan.sdsu.edu/~gra/grad/research/hrpp.html

22. Contact Information List yourself as the Principal Investigator (PI) Email address Phone number List your Thesis Chair (Masters) or Faculty Sponsor (Doctoral) as the Co-I Email address Office phone number

23. Upload Supporting Documents Upload all applicable documents: Letters of Authorization Recruitment Materials Informed Consent Forms Study Instruments Grant Narrative (if funded)

24. IRB Contact Information Phone: (619) 594-6622 Office: Gateway Center-3505 E-mail: irb@mail.sdsu.edu Good luck! • Amy McDaniel • amcdanie@mail.sdsu.edu • 619-594-0758 • Brianne Mongeon • blarsen@mail.sdsu.edu • 619-594-3380 Choya Washington cwashing@mail.sdsu.edu 619-594-3822