1. Introduction to the IRB Application Process at Stony Brook University
Betsy Baron, BA
IRB Administrator
Office of Research Compliance
Stony Brook University

2. Is the activity Research?
Does the research involve Human Subjects?
Exempt from regulation
Expedited
Full

3. that involves human subjects…
(OHRP)
IRBs review research…
A systematic investigation including research development, testing and evaluation designed to contribute to generalizable knowledge
that involves human subjects…
The actual human being, and/or
Identifiable human tissue, and/or
Identifiable human data
Outside entities…sponsors (where there is one), federal auditors etc.
YOU’RE INVESTIGATING A HYPOTHESIS THAT IS CONDUCTED IN A WAY SO THAT THE FINDINGS WILL BE APPLICABLE TO MORE THAN THE POPULATION YOU TESTED IT ON.

4. What’s the difference between these two humans?
Clinical Research
Patient Subject

5. Which coat are you wearing?
White coat on!
Do no harm
Treat the individual patient
Convince the patient that the doctor knows ‘what’s best’
White coat off!
Do good (risk/benefit)
Follow the study protocol and
obtain data to answer the study
question
Convince the patient that you do
not know ‘what’s best’: EQUIPOISE

6. When is the activity NOT research involving human subjects?
Clinical Practice is not research
Case Reports are not research
Hospital-endorsed QA/QI activities are not research (as long as they do not meet the definition of research)

7. Institutional Review Boards
Federally mandated
Locally, called Committees on Research Involving Human Subjects (CORIHS)
Must
facilitate safe and ethical research
ensure that human subjects’ rights and welfare are protected
ensure compliance with federal regulations governing the protection of human subjects including 45 CFR 46 and 21 CFR 50, 56 etc.

8. 4 Possible Routes for IRB Review at SBU
SBU’s Committees on Research Involving Human Subjects (CORIHSa, CORIHSb)
Identical Charge (not ‘just SBS’ or ‘just ‘Biomed’)
Each has one deadline and meeting date per month
The Commercial (“Central”) IRB Option:
Chesapeake Research Review, Inc. (CRRI)
(Option is available only for Industry sponsored studies)
The National Cancer Institute Central IRB Option:
NCI’s Pediatric and Adult Central IRB’s
(available for certain oncology group trials: ECOG, GOG, COG, NSABP, etc)

9. The ‘application route’ you take depends on the level of risk and federally-determined review category
DEFINE RISK

10. If no foreseeable risk and fits into an exemption review category, the ‘exempt’ application is completed. Review conducted by the ‘Institution’ (ORC staff)

11. Review conducted by 1 IRB member.
If minimal risk, and fits into an expedited review category, the ‘full’ application is completed, but:
Review conducted by 1 IRB member.
DEFINE RISK

12. If the activity doesn’t fit into the exempt or expedited review categories, full committee review is required
DEFINE RISK

13. CORIHS Application Tool designed to facilitate review
IRB is charged with finding and documenting that protocol meets all federally mandated approval criteria

14. The first step in the consent process
Recruitment
(Truth in Advertising)

16. Even at this early stage, privacy is important
How are you recruiting?
“Hello? Is this Mrs. Jones’ husband?...”
Where are you recruiting? What is the setting in which the potential subject will be interacting with you/your study team?
Outside an ‘adult toy’ shop?
Liquor store?
A bathroom?
Planned Parenthood waiting room?

17. Informed Consent: Respect for Persons

18. Before you sit down to initiate the consent process with a prospective subject…
Do you know the protocol COLD, including the inclusion/exclusion criteria and recruitment parameters?
Do you have the time to consent the prospective subject properly? (the more risky or complicated the protocol, the more time needs to be taken for the consent process)
Do you speak the language of the prospective subject?

19. What information MUST be included to ensure informed consent?
Statement: The study involves research, not standard of care.
Purpose: Why is this study being done?
Duration: How long does the subject have to be in this study?
Procedures: What will the subject have to do that s/he wouldn’t otherwise have to do if s/he wasn’t a subject?

20. And…
What are the reasonably foreseeable risks or discomforts the subject may experience?
What are the benefits to the subject that s/he may reasonably expect from participation?

21. And…
If the person says no to being in this study, what other procedures or treatments are available to him/her?
Will the subject’s participation in this study be kept confidential? What steps will be taken to make sure his/her privacy will be preserved?

22. And… If the subject gets injured while on study…
Who does s/he tell?
Where should s/he go?
Who will pay for any treatment or hospitalization?
Who can the subject speak with if s/he has any questions about the study?
Who can the subject speak with if s/he has a question about his/her rights as a research subject?

23. And finally, the subject must be assured that…
New Information that is discovered during the course of the research which may relate to the subject's willingness to continue to be in the study will be provided to the subject

24. And finally, the best part…
The subject doesn’t have to be in this study if she doesn’t want to be.
S/he can say no, and there will be no penalty whatsoever.
S/he can say yes now, and then change his/her mind without penalty and without giving a reason.
If you come to a fork in the road, take it.

25. What information MAY be included to ensure informed consent?
risks to the subject which are currently unforeseeable (should be included when testing investigational drugs);
Why a subject's participation may be terminated by the investigator;
Costs to participation;
Consequences of withdrawal
the approximate number of subjects involved in the study.

26. The Informed Consent Process
Repeat after me: Your mother, your father, your aunt, your uncle…
Assess the capacity to consent of ALL individuals
Give the subject TIME to decide
‘I won’t be your doctor if you don’t consent to this’
Me falta práctica en Español!!!

27. Capacity to consent=a demonstrated appreciation:
1.    that the activity is research, not standard treatment
2.    of the risks and benefits of a study
3.    of the alternatives that are available if s/he does not participate
4.    that, if s/he chooses not to participate, this decision will be accepted without penalty, i.e., without jeopardizing e.g., status or clinical care

28. and…
…How do you know if the person in front of you is even capable of making the decision to participate in your research?

29. Capacity to consent…cont.
The potential subject needs to demonstrate an ability to use this information in a rational manner, applying these factors appropriately.
‘Yeah, whatever’
vs.
‘YES! YES! A THOUSAND TIMES, YES!’

30. Consent Form vs. Consent Process
Is the signing of the consent form a monumental event?

31. A signed consent form is proof that…a consent form was signed
A signed consent form is proof that…a consent form was signed. Big whoop.*
*but if the IRB approved documented consent, you better have them for every subject.

32. Ready? Adults consent for themselves
Parents give permission for their children
Children assent for themselves
And, where the IRB permits the inclusion of adult subjects who cannot consent for themselves,
Surrogates give permission for the subject, and whenever possible, the subject themselves assent.

33. IRB Mandate: Vulnerable Populations 45 CFR 46.111 (b)
When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children… additional safeguards have been included in the study to protect the rights and welfare of these subjects.
How do provide?
Parent permission
Minor assent
Certain categories of research
FOLKS WHO CAN’T CONSENT FOR THEMSELVES
-must they be in the research?
-if yes, certain categories of research

34. We don’t include kids in research unless the activity fits into a federally acceptable category…
§ (§ 50.51) …minimal risk...
§ (§ 50.52) …greater than minimal risk, possible direct benefit…
§ (§ 50.53) …(slightly) greater than minimal risk, no possible direct benefit…but likely to yield generalizable knowledge about the subject's disorder or condition.
§ (§ 50.54) Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. (Mandated review at the federal level)

35. We don’t include kids unless we get parental permission, except when…
…the IRB determines that parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children).
(an appropriate mechanism for protecting the children must be substituted, and will depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition)

36. We don’t include kids unless we get their assent, except when…
the capability of some or all of the children is so limited that they cannot reasonably be consulted Or
the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research,

37. If the IRB requires assent, it means:
Obtaining Obtaining
verbal assent documented assent
starting at age starting at age 11-12
AND:
If the child does not assent, the child is not enrolled in the study.

38. Other Vulnerable Populations
Prisoners
Pregnant Women
Fetuses
Questionably Viable Neonates
Non-Viable Neonates
Elderly
Economically/Educationally Disadvantaged
Students
Subordinates
Those who have just received a medical diagnosis…

39. If PHI is being used or generated…
IPAA Impacts Research Activities

40. HIPAA AUTHORIZATION
Authorization can be addressed in ONE of the following ways:
Signed consent document (must contain required HIPAA authorization language)
De-identified data
Limited Data Set (LDS)
HIPAA Waiver of Authorization

41. Once approval is granted:
It is granted for no longer than one year
The study must be conducted exactly as approved by the IRB. The only exception is where subject safety requires a change in protocol.
Informed consent must be obtained (unless waived by the IRB) using ONLY the consent document(s) approved by CORIHS (i.e., displaying the CORIHS approval stamp)
You must keep the IRB informed of:
Any proposed changes to any aspect of the protocol, and you must receive approval before implementing them
Anything that happens relative to the study that is unanticipated, and affects the risks to subjects or others

42. Researchers submit Proposals to IRBs…with best guesses as to…
Procedures they think will answer the research hypothesis
Populations they think were correctly selected
Benefits they think subjects may experience
Risks they think subjects may experience

43. Unanticipated Problems (UPs) involving risks to subjects or others must be reported to the IRB:
Refer to any problem, event, or new information that:
Is unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents, such as the CORIHS-approved research protocol and informed consent documents; and the characteristics of the subject population being studied; and
Related or possibly related (reasonable possibility) to participation in the research, and
Indicates that subjects or others are at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

44. IRBNet: www.irbnet.org Select a library – Human Subjects Instructions
Submission requirements
Registration form
Application forms
Consent form templates
Protocol template

45. IRBNet (con’t) Share with study team members
Obtain required signatures
Ensure all required materials are uploaded
Submit for review!

46. Review time
Allow 2-3 weeks for initial review