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Joey Casanova, Education Coordinator Human Subject Research Office. IRB Overview and eProst Redesigned. What is an IRB?. Belmont Principles. Respect: individuals must be autonomous in their decisions of whether to participate in research (making informed decisions)
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Joey Casanova, Education Coordinator Human Subject Research Office IRB Overview and eProst Redesigned
Belmont Principles • Respect:individuals must be autonomous in their decisions of whether to participate in research (making informed decisions) • Beneficence:securing well-being of participants by reducing risks • Justice:considerations appropriate to avoid injustices that arise from social, racial, sexual, and cultural biases
Regulations Overview (HHS & FDA) • The mission of the OHRP is to monitor and promote compliance with regulations set forth from the Department of Health and Human Services (DHHS) that relate to the ethical standards of research involving human subjects (45 CFR 46). • Any research involving a drug, a biologic, or a medical device is subject to Food & Drug Administration (FDA) regulation (21 CFR 50, 56, respectively).
Definitions of “Human Subject” • HHS: A living individual about whom an investigator… conducting research obtains • Data through intervention or interaction with the individual, or • Identifiable private information • FDA: Recipient of test article or control
Definitions of Research • HHS: A systematic investigation designed to develop or contribute to generalizeable knowledge • FDA: Clinical Investigations of FDA Regulated Products – any experiment in which a drug, biologic or significant risk device is administered or dispensed to or used involving one or more human subjects
What are the types of review? *Level of risk helps determine route of review
What is Minimal Risk? • DHHS 45 CFR 46.102(i) & FDA 21 CFR 56: • The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during routine physical or psychological exams or tests • OHRP Guidance: • Minimal risk is relative to the daily life of a normal, healthy person. The risk threshold cannot increase because the person is sick and faces greater risk due to illness
Exempt Research • Six categories defined by 45 CFR 46 • Research must fall into one or more of the categories to be exempt • IRB has the responsibility to determine exemption, PI cannot make determination • May still require consent or other safeguards • How is data being collected? • Is there a code that links data to subjects (easily identifiable)?
Exemption Categories (1) Educational research (2-3) Tests, surveys, interviews or public observation (4) Research on existing public or anonymous data or specimens (5) Federal demonstration projects (6) Taste and food evaluation
Expedited Review • Expedited does not mean quicker • Rigor of review is the same, number of reviewers different • Review carried out by IRB chair or by one or more experienced reviewers • Reviewers may approve or modify, but may not disapprove
An IRB may use the expedited review procedure to review either of the following: • Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk • Minor changes in previously approved research during the period (of one year or less) for which approval is authorized
Eligible for Expedited Review:(Initial Review) (1) Clinical studies: IND/IDE not required (2) Blood sample collection (routine methods – small amounts) (3) Prospective collection of biological samples – noninvasive means (4) Data collected through noninvasive means (routinely practiced in clinical settings) (5) Materials (data, documents, specimens) have been collected or will be collected for non-research purposes (6) Collection of voice, video or digital data for research purposes (7) Individual or group behavior, surveys, interviews, oral histories
“It is not invasive so it must be minimal risk” This is not correct. The IRB must consider the risk of criminal/civil liability, financial risk, employment risk, risk of stigmatization, risk to insurability, and risk of embarrassment in addition to physical risk when deciding if risk is truly minimal.
Full Review means: • A full quorum is assembled (at least half of the members plus one, includes nonscientist) • All members participate in discussion and make comments (plenary review) • Decision is rendered by a majority of the assembled quorum • No member with a conflict of interest participates in the decision • Numerical vote is taken and recorded
Criteria for Approval • Minimized risks (not eliminated) • Reasonable risk/benefit assessment • Equitable subject selection • Informed consent process • Informed consent documentation • Data monitored for safety • Confidentiality/privacy maintained • Vulnerable populations protected
General Requirements: • Unless waived by the IRB, the investigator must obtain the legally effective informed consent of the subject or the subject’s legally authorized representative • Must provide the subject sufficient opportunity to consider participation and minimize undue influence • Information must be in language understandable to the subject • May not include exculpatory language
Informed Consent as a Process • Consent is a Process in which: • You disclose relevant information • The potential subject has the opportunity to ask questions • You answer questions • The consent form is a permanent record of… • The information you conveyed • The fact that the process occurred • The subject’s willingness to participate
Elements of Informed Consent • Research acknowledgement • Purpose of the study • Description of procedures • Description of potential risks • Description of potential benefits • Alternatives • Confidentiality • Compensation for Injury • Who will answer questions • Participation is voluntary
Other Elements as Necessary • The fact there may be unforeseeable risks • Involuntary termination of participation • Additional research costs • Consequences of subject withdrawal • Significant new finding will be reported to subject • Approximate number of subjects • Payments/Reimbursement
HSRO Assent Policy • Applies to children 7 through 17 years of age. • Failure to object is not assent • IRB determines whether and how it is documented • Assent is required except: • when child not capable: age, maturity, or psychological state; • Research presents direct benefit; important to the child’s well-being, and available only in context of research
HSRO Assent Policy • Assent can be waived if: • Research involves no more than minimal risk • Waiver will not adversely affect the rights and welfare • Research could not be practicably carried out without the waiver • Whenever appropriate the participants will be provided with additional pertinent information
eProst: Re-Designed http://hsro.miami.edu
eProst Background ElectronicPROtocolSubmission &Tracking system • Assists the HSRO in supporting and managing all biomedical and social behavioral research • Access via standard internet browser • Internet Explorer (PC Users) • Safari (Apple Users) • Captures information capture as required by federal regulations, state laws, and institutional policies
The Electronic Workflow • Full Re-deployment of the electronic workflow will be completed in February 2008 • Study teams will continue to complete protocol forms in eProst • All members of the Protocol Team need to Submit their Conflict of Interest disclosures individually • Principal Investigator will then be able to Submit Protocol • Study will now be traveling through the workflow
Benefits of Workflow • Accessible anywhere you have internet access • Faster turnaround time for submissions to the HSRO • Easier tracking of studies through review process • Incorporated audit trail • Improved interaction between study teams and Institutional Review Board staff • Back-ups performed regularly by both the HSRO and Med-IT • IRB-approved and watermarked documents available online
Western IRB • No new studies are being reviewed at WIRB • Many existing studies currently at WIRB are being reacquired at continuing review • WIRB submissions will still need to be printed for submission to the HSRO and subsequently WIRB • Only WIRB forms required for continuing report or amendment • Investigators asked to update smart form for amendments when necessary
Available Training • eProst User Guide available at http://hsro.miami.edu • Up-to-date information relayed via eProst and HSRO eNews
