institutional review board application procedures...and more! choya washington division of research...
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Institutional Review Board Institutional Review Board Application ProceduresApplication Procedures
...and more!...and more!
Choya WashingtonChoya WashingtonDivision of Research AffairsDivision of Research AffairsGraduate & Research AffairsGraduate & Research AffairsSan Diego State UniversitySan Diego State University
OverviewOverview
What is the IRB?
Important Historical Events
What is reviewed by the IRB
How to submit a protocol to the IRB
What is the IRB?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
Who is on the BoardWho 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
Why Does the IRB exist? Why Does the IRB exist? Important Historical EventsImportant Historical Events
Willowbrook Study Tuskegee Study 1974: National Research Act 1979: The Belmont Report
The Willowbrook Study: The Willowbrook Study: Mid 1950’s – Early 1970’sMid 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.
Tuskegee Study-Tuskegee Study-200-300 Black men w/ syphilis were 200-300 Black men w/ syphilis were
enrolled to document the effects of the disease untreated over timeenrolled 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.
1974: National Research Act1974: 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
1979 Belmont Report1979 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
What is Reviewed by the IRBWhat is Reviewed by the IRB
Is it research?
Are human subjects involved?
Types of review and risk
What is Reviewed by the IRBWhat 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
Are Human Subjects Involved? A Are Human Subjects Involved? A few examples: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)
Read the Guidebook
Pass the Tutorial
Benign Exempt
Minimal Risk Expedited
Greater than Full Committee
Minimal Risk
1
>1
>6
Risk level Reviewers required Review level
Full Committee ReviewFull 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
Full Committee: Example 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)
Full Committee: Deadline DatesFull 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
Common Problems in Full Common Problems in Full Committee ResearchCommittee ResearchAdequately 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
Expedited ReviewExpedited 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
ExpeditedExpedited: 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.
Exempt ReviewExempt 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
Exempt Prospective: ExamplesExempt 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.
Prior to Submission
Access the templates on IRB websiteSubmit a vIRB Questionnaire by following
these steps:Login to the vIRB through the WebPortal;Choose “Yes” to access the Questionnaire; thenYou will receive a response within 5-7 days.
Have your faculty sponsor READ and APPROVE of your protocol and supporting documents before submitting!!!
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)
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
Be Consistent!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
Subjects and Research Activities: Subjects and Research Activities:
Complete and ConsistentComplete and ConsistentProtocol DocumentRespond to section directions for EACH subject
group AND research activity. Use subheadings.
E.G.: Subject Involvement SectionStudents/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 DocumentsUpload recruitment materials, consent documents and study instruments
for EACH subject group.
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
Types of Consent Forms: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!
Beneficence/ FairBeneficence/ Fair SubjectSubject Selection
Beneficence/ FairBeneficence/ Fair SubjectSubject 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
Upload Supporting Documents
Upload all applicable documents:
Letters of Authorization Recruitment Materials Informed Consent Forms Study Instruments Grant Narrative (if
funded)
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.
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!!!
IRB Contact InformationPhone: (619) 594-6622
Office: Student Services East, 1410
E-mail: [email protected]
Good luck!Good luck!
Amy [email protected] 619-594-0758
Brianne [email protected] 619-594-3380
Choya [email protected]
Choya [email protected]