IRB2010 Update

Elaine MajorDirector of Institutional Compliance215 Wannalancit, ext. 3452

www.uml.edu/ora/institutionalcompliance

Institutional Review Boards:

Protect rights and welfare of research subjects

Review research to ensure participants are protected and aware of any risks

Serve as interface between researchers & participants

Allow universities to stay eligible for federal funding

Brief History of IRBs

Early to mid-1900s, research not regulated 1948 Nuremberg Code (basic elements include voluntary and informed

consent, risk/benefit analysis, right to withdraw w/out penalty) resulted from Nazi physicians forcing prisoners to undergo horrifying procedures for research

1955 Wichita Jury Study (study by U of Chicago using deception- jurors were not notified they were being audio-taped)

1962 Thalidomide Experience (pregnant women treated w drug to reduce morning sickness. No informed consent to indicate drug was still experimental)

1973 Congressional Hearings (led by Sen. Edward Kennedy) re ethical problems w medical research;

Milgram Study (obedience to authority) San Antonio Contraception Study (not informed might get placebo) Tuskegee Syphilis Study (subjects not informed research was to study course

of disease and treatment not provided when discovered penicillin treated it) 1974 Current IRB System Established

IRB Authority

Institution signs agreement (FWA) to comply with regulations and protect human subjects

IO or Chancellor may not overturn an IRB disapproval – can override approval

ALL projects that involve human subjects need IRB review (funded or not!)

Federally funded projects require proposals also be submitted to the IRB for review

IRB Process Briefs

All submissions and approvals electronic Need hard copy of signatures only ALWAYS go to website

Training is required (every 3 years) Requirement for your class!

Meeting schedule posted on website PIs invited to attend IRB meetings Renewal notices sent electronically

CR must be within 30 days of expiration date

Education/Training Options

Collaborative IRB Training Initiative (CITI) www.citiprogram.org

NIH Protecting Human Research Participants

http://phrp.nihtraining.com/users/login.php

Research – Systematic investigation designed to develop or contribute to generalizable knowledge

Human Subject Research –data obtained through intervention or interaction with a living individual for generalizable knowledge

Evaluation – Systematic gathering of information but used to revise, alter, or provide feedback about an object or process. Not intended to contribute to generalizable knowledge

Minimal risk - Harm or discomfort no greater than ordinarily encountered in daily life of a normal, healthy person or during performance of routine physical or psychological examinations or tests

Key DefinitionsKey Definitions

Review Categories (45 CFR 46)

Exempt (NOT exempt from review) Expedited Full Review required when:

Greater than minimal risk Vulnerable populations (prisoners) Sensitive research topics PIs encouraged to attend the meeting

Considerations Does it involve living human subjects? WHAT is being obtained? Is it research or a course requirement? Risk- magnitude and probability Vulnerable populations Collaborating institutions Cannot do retroactive reviews!!!

Implications for graduate students and timing of data collection

Journals often require proof of IRB approval

Vulnerable Populations

ChildrenPregnant womenHuman fetuses and neonatesPrisoners- must be full reviewOther: economically disadvantaged,

elderly, terminally ill, employees, cognitively impaired

Review Categories (45 CFR 46)

Exempt (NOT exempt from review) Expedited Full Review required when:

Greater than minimal risk Vulnerable populations (prisoners) Sensitive research topics PIs encouraged to attend the meeting

Typical Exempt ResearchMust be anonymous and <minimal risk Conducted in established educational setting

and involves normal educational practices Use of educational tests, survey procedures,

interview procedures or observations of public behavior AND anonymous and no risk

Study of existing data- if publicly available and recorded so that subjects are anonymous

Taste and food quality evaluation and consumer studies

Characteristics for Exempt Must be minimal risk and no identifiers After IRB determination, no more oversight unless

amendment affects change in category If so, resubmit as new application for expedited or full review

File automatically closed out after one year, records retained for three years

Typical examples: ● Observational research in educational settings ● Anonymous surveys, interviews, or observations● Collection or use of existing data, records, specimens

Expedited CategoriesCan use identifiers but must be < minimal risk● Collection of blood samples (for healthy adults)● Noninvasive collection of specimens (hair, nail clippings,

deciduous teeth, sweat, saliva, placental tissue, dental plaque, mucosal cells)

● Collection of data through noninvasive procedures (physical sensors applied to body, ultrasound, MRI, EKG, moderate exercise, muscular strength testing, flexibility testing, etc. (not x-rays or microwaves)

● Existing data not collected for research (routine medical records or leftover specimens)

● Voice, video, digital, or image recordings for research purposes (requires special consent document)

● Research on group characteristics or behavior that involves no stress or employs survey, interview, oral history, focus group, etc.

Characteristics for ExpeditedCan collect identifiable data but no more

than minimal riskMinor changes in approved researchCan include vulnerable populations-

except prisonersExamples- educational research,

psychology studies, evaluating robotic computers, research on service learning practices, continuing review

Submitting an Application Submit all documents as Word files Student research must be submitted by PI

(faculty advisor) Application form and all supporting documents

Informed consent Letter of support Training certifications

PI Assurance and Signature Page-fax or mail If subjects speak language other than English:

submit Translation & Certification form after approval

Top Reasons for Delays Considerations with informed consent

Waivers Use easy to understand language Outline time commitment required Include any incentives and what must be completed to

receive Think about ALL potential risks Write in 3rd person (you are being asked to ...) Provide contact information for questions after the research

Missing support letters from collaborators Training certification information Application does not have enough detail to clearly

describe the project, all activities, and processes Funded project but proposal not submitted

Informed Consent Process Central protection for participants under regulations 3 key purposes

Discloses information to potential subjects to make informed decision Facilitates understanding of what is disclosed Promotes voluntary response as to whether or not to participate

Meant to be communicated to participants in ACTIVE sharing process:

Purpose of research and duration How data are to be used Procedures and any discomfort Any risks/benefits (including if confidentiality is broken) Disclosure of alternative treatments/procedures Voluntary and can withdraw from study at any time PI contact information For minors, may include assent or passive consent of parents

Communicate in language/terms subjects understand Where incentives are provided, include plan for early withdrawal

Waivers of Informed ConsentMust be specifically requested and approved!

Two types: Waiver of Documentation of IC

For research that is no more than minimal risk to subjects Only record linking subject to research is the document and it may

pose a risk to subjects Obtaining IC may diminish the scientific merit of the research Subject will still be consented and can have documentation if desired

Waiver of Informed Consent For research that is no more than minimal risk Waiver does not adversely affect rights and welfare of subjects Research could not be done w/o waiver Subjects provided additional information after participation

Implied and Passive Consent

Implied: Ex. Survey sent by mail or electronic Materials clearly state that by responding, the

subjects have agreed to participate IRB MUST approve the alteration to process Participants are still allowed to not answer

Passive: Collecting data from children at school (Opt Out procedure) Parents contacted and requested to return form if

do NOT want children to participate IRB MUST waive requirement for specific parental

permission

Data Retention

IRB records- retained for 3-5 years after completion of research (depends on sponsor and purpose for data)

Research data- same but may be longerTo retain data with Identifiers- must

submit form for annual renewalIf data de-identified, can keep indefinitely

but close protocol with Final Report Form

Collaborative Agreements

Used to reduce duplication of effortFor institutions with an IRB and FWA

onlyDefers authority to one IRB and is

reported to OHRPFWA updated annually to indicate

organizations UML relies uponInternational research activities

Miscellaneous ALWAYS go to the website to get the newest forms Submit applications to IRB@uml.edu If publishing images, separate release form required Research with children can receive exempt or

expedited review – depends on risk and identifiers Apply for waiver for any alteration to consent process Once assigned, always refer to IRB Protocol No. Amendments used for changes to personnel, protocol,

funding, survey tool, etc. Always report incidents or problems encountered during

the research to the IRB Compliance Office

For Information and Assistance

IRB AdministratorStephen_Moses@uml.edu, x4134

IRB AssistantAmy_Finneral@uml.edu, x4698

Website www.uml.edu/ora/institutionalcompliance References

DHHS http://www.dhhs.gov/ohrp/ DHHS 45 CFR Part 46 IRB Management and Function 2006 by Bankert and

Amdur (in Library)