Institutional Review Board Application Procedures ...and more!

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

2. Overview • What is the IRB? • Important Historical Events • What is reviewed by the IRB • How to submit a protocol to the IRB

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 • 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 • Tuskegee Study • 1974: National Research Act • 1979: The Belmont Report

6. The Willowbrook Study: Mid 1950’s – Early 1970’s • Vulnerable population: Involved infecting mentally retarded 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: The nature of the experiments were extremely cruel and unjust.

7. Tuskegee Study-200-300 Black men w/ syphilis were enrolled to document the effects of the disease untreated over time • This study exemplifies: • Unfair subject selection: syphilis can potentially affect all human beings not just African American men. • Denial of informed consent: subjects were not told of their disease or given the option to opt out of the study. • Excessive Risk: The risks far exceeded any potential benefits. 1943-Penicillin was discovered as a treatment, but was withheld from the subjects.

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 • Is it research? • Are human subjects involved? • Types of review and risk

11. What is Reviewed by the IRB • Research involving human subjects • Defined by 45 CFR 46.102(d) as: A systematic investigation designed to develop or contribute to generalizable knowledge • Generalizable knowledge: • publication (article, thesis or dissertation) • professional presentation

12. Are Human Subjects Involved? A few examples: • Reviewed by the IRB: • 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).  • Aggregate data (e.g., census data, etc)

13. Read the Guidebook

14. Pass the Tutorial

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

16. Full Committee Review • Research that involves: • an intervention or manipulation of the subject's environment (sometimes but not always-whether full committee review is required is dependant on risk involved) • deception • vulnerable subjects e.g. children, prisoners, mentally disabled, pregnant women (sometimes but not always-whether full committee review is required is dependant on risk involved) • greater than minimal risk

17. Full Committee: Example Research concerning factors that may lead to low school performance in a particular racial group Includes interviews about students’ sexual practices, illegal behaviors (drug use)

18. Full Committee: Deadline Dates Protocols due 2 weeks prior to meeting. Dates are listed on the web site Expect notification of review outcome within one-week of IRB meeting

19. Common Problems in Full Committee Research Adequately addressing risks and risk management plans for vulnerable subject populations and/or asking subjects to complete high-risk tasks. 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. • Undue Influence during recruitment • Vulnerable populations • Informed Consent Process

20. Expedited Review Expedited review includes certain kinds of research involving no more than minimal risk* Deadline dates do not apply *Minimal risk = probability of harm/discomfort in research is not greater than that encountered in daily life

21. Expedited: Example Using confidential methods like survey, focus group, interview to obtain information. Interviewing teachers in a focus group at their place of employment -Includes questions about what their feelings on administration, school policies and their peers.

22. Exempt Review • Children in a normal classroom setting • Adults who complete a non-sensitive survey • Observation of public behavior • Non-anonymous data as long as no risk is posed if confidentiality is breached • Food studies of wholesome foods without additives • Analysis of existing data-may need to ck w/ IRB

23. Exempt Prospective: Examples Anonymous survey of teachers opinions on current school policy and improvements needed. Non-anonymous, benign study in which parents are asked about which produce their children like to eat and how often they eat it.

24. Prior to Submission Access the templates on IRB website Submit a vIRB Questionnaire by following these steps: Login to the vIRB through the WebPortal; Choose “Yes” to access the Questionnaire; then You will receive a response within 5-7 days. Have your faculty sponsor READ and APPROVE of your protocol and supporting documents before submitting!!!

25. Access your WebPortal Account Click “Activate Research Role” Click “Launch IRB” All notifications are electronic You will receive an email when your submission is: received reviewed approved Step 4: Using the virtual IRB (vIRB)

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. 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

28. 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.

29. Common Issues Inadequate responses to conditions-comments often have several parts ensure you respond to each part of the comment Inadequate consent forms-Language should be understandable Non -coercive Not just a written form, but an on-going open discussion of participant’s rights and study details

30. Types of Consent Forms: Informal Consent (Exempt) Formal Informed Consent (Full Committee and Expedited) Children in research Assent forms Parental Permission forms Save yourself time and stress… use SDSU templates!

31. Beneficence/ FairSubject Selection • 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. • 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

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

33. 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.

34. 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!!!

35. 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 • Brianne Larsen • blarsen@mail.sdsu.edu • 619-594-3380 Choya Washington cwashing@mail.sdsu.edu 619-594-3822