Joey Casanova, Education Coordinator Human Subject Research Office

Joey Casanova, Education CoordinatorHuman Subject Research Office

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

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).

HHS:A living individual about whom an investigator… conducting research obtains1. Data through intervention or

interaction with the individual, or 2. Identifiable private information

FDA:Recipient of test article or control

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

*Level of risk helps determine route of review

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

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)?

(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 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

(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

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.

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

Minimized risks (not eliminated)Reasonable risk/benefit

assessmentEquitable subject selectionInformed consent processInformed consent documentationData monitored for safetyConfidentiality/privacy maintainedVulnerable populations protected

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

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

Research acknowledgementPurpose of the studyDescription of proceduresDescription of potential risksDescription of potential benefitsAlternativesConfidentialityCompensation for InjuryWho will answer questionsParticipation is voluntary

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

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

http://hsro.miami.edu

Electronic PROtocol Submission & 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

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

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

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

eProst User Guide available at http://hsro.miami.edu

Up-to-date information relayed via eProst and HSRO eNews

Average time for completion of review process/IRB

determination = 4-6 weeks

Study cannot begin until PI has received approval

notification from the IRB.

Submission arrives

At HSRO

Post-Board Review (Determination Letter)

IRB Regulatory Specialist

(Exempt & Expedited Review)

IRB Regulatory Analyst

(Full Board Review)

IRB Full Board IRB Chair/Designee (Exempt/Expedited)