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? • Important Historical Events • The IRB and You

3. What is the IRB? • The IRB stands for the Institutional Review Board • IRBs are composed of individuals with the expertise and background needed to conduct a complete and adequate review of the research planned by an institution • The IRB reviews all research with human subjects conducted at SDSU

4. Who is on the Board • M.D.s • Faculty members from various colleges(including Psychology) • Community Member • Non Scientist • 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. Why Does the IRB exist? Important Historical Events • Willowbrook Study • Tea Room Study • 1974: National Research Act • 1979: The Belmont Report

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- • 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. • He also recorded the license plate numbers of these men went to their homes and interviewed them and their families.

8. 1974: National Research Act • Created the National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research • Required informed consent for all government sponsored studies • Established IRBs

9. 1979 Belmont Report • Belmont Report outlines acceptable ethical practices in research • Foundation of current federal regulations • 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

10. 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

11. Are Human Subjects Involved? A few examples: • Reviewed by the IRB: (Helpful question for YOU, are the data to be collected specific to an individual) • Studies that use medical records, or case files (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 resource center (does not involve individual information about subjects; it is information about individual facilities). Also, aggregate data (e.g., census data, etc).

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

13. You-Making a determination Full Committee: greater than minimal risk • deception • vulnerable subjects-depending on what the research tasks are. • Tasks/questions being asked • Deadline Dates apply • 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 • Analysis of existing data-may need to ck w/ IRB

14. Examples of Full Committee Research Study inside of classrooms asking students to complete a survey that asks about incest, dating violence, sexual assault, dating and sexual practices to determine the relation between molestation and/or violence and dating violence. • Privacy • Confidentiality • Risk Management

15. Expedited and Exempt Examples Expedited Exempt Asking school counselors their opinions on the needs (programs, resources that should be available) of teenagers who have experienced child molestation. • Adult anonymous online survey asking about childhood experiences (molestation, etc.) and dating practices from late adolescence into adulthood

16. Subject Selection/ Recruitment • Subjects should be chosen to participate because they best represent the population under study • Recruitment should be done in a neutral fashion; avoid persuasive language or situations. • -Things to think about?? Do you know potential participants outside of this research study (personal contacts, co –workers, your students, etc.) Example: Hello! I am your Language Arts teacher, I am also collecting data for my Masters thesis at San Diego State University. It would really help me out if you participate in a group discussion with me and some of your fellow classmates about what you’re learning in class. THERE WILL BE PIZZA! It will only take an hour of your time and it will get you out of P.E. Please see me after class and let me know if I can count you in! Participation is voluntary. What are some problems with this recruitment script?

17. You-What are some ways you may Recruit? (Discussion) • Who is doing the recruiting? You- Is it better for me or someone else to recruit? • Access You- Do you have access to a person’s information for research purposes? For example, you may have access to grades/contact information in your position at a school, but this does not automatically mean you can use this information for research purposes without proper permission. The Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99) is a Federal law that protects the privacy of student education records.

18. Types of Consent Forms: Informal Consent (Exempt) Formal Informed Consent (Full Committee and Expedited) 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

19. Respect for Persons-Consent Not just a written form, but an on-going open discussion of participant rights and study details. Inadequate consent forms-Language should be understandable to the audience it is written for Non -coercive Adequate Details so they are clear about whether or not to participate.

20. Consent Examples Description You will be asked to fill out a questionnaire and be in a focus group about the field of psychology and your attitudes about the major of psychology. Participation will take about one hour. Purpose The approach of the research is an exploratory qualitative discussion that will allow students the chance to ventilate how they feel budget cuts have effected their opportunities to learn. Revised The purpose of this study is to research the effects that California’s recent budget cuts to education might have had on student’s opportunities to learn. Adequate Details- Can participants skip ?’s, Recording-do they have to agree?, Will there be consequences if they tell you certain things?

21. Beneficence • Maximize benefits • To the individual, scientific knowledge, the population from which study participants are drawn • Minimize risks • Some risk in research is acceptable, but risks should be minimized to the greatest extent possible. • You- Think through your risk management plan. Know the possible repercussions and how you will protect subjects whether it is their safety, or from social risks, or illegal risks that may come from participation.

22. Be Consistent! Anonymity vs. Confidentiality example, the study is anonymous no identifying information will be collected example, the study is confidential, data will be stored in a locked cabinet, a code will be created between data and subject information, this link will be destroyed at the end of the study. Transportation of data.

23. Subjects and Research Activities: Complete and Consistent Protocol Document Respond to section directions for EACH subject group AND research activity. Use subheadings. E.G.: Subject Involvement Section Students/Patients: Will take 15 minute online survey Staff: Will take a 10 minute online survey and will participate in audiotaped 30-minute interview Administrators: Will participate in two consecutive audiotaped 60-minute interviews (for a total of 120 minutes spread over two days) Supporting Documents Upload recruitment materials, consent documents and study instruments for EACH subject group.

24. Inadequate responses to conditions-comments often have several parts ensure you respond to each part of the comment Common Inconsistency problem Response #1 This information is in the consent form. #2 I will also be conducting interviews • Subject Involvement section and Research design Involvement section: Participation in this study will last approximately 30-45 minutes for the focus group session. Research design section: I will conduct individual interviews with current sophomore students for 45 min

25. 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!!!) Go to our website for tips http://www-rohan.sdsu.edu/~gra/grad/research/hrpp.html

26. 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

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

28. 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.

29. Step 5: Protocol Maintenance Once you have approval, you are responsible for submitting requests for changes to your protocol in the form of a Modification request. Pay attention to expiration dates!!! You must renew your protocol to continue research activities before it expires by submitting a Report of Progress!!!

30. IRB Contact Information Phone: (619) 594-6622 Office: Student Services East, 1410 E-mail: irb@mail.sdsu.edu Good luck! • Amy McDaniel • amcdanie@mail.sdsu.edu • 619-594-0758 Choya Washington cwashing@mail.sdsu.edu 619-594-3822