Institutional Review Board for Human Subject Research: Does Your Research Need One? Merle Rosenzweig Michael Unsworth

OUTLINE IRB Background  Definitions & Concepts  History – matter of ethics  IRB process Case Studies

Definitions & Concepts

Institutional Review Board (IRB) A group that reviews and approves any type of research to protect the people who take part in it. IRBs check to see that the research is well designed, legal, ethical, does not involve unneccesary risks, and includes safeguards for people taking part.

AS DEFINED BY FEDERAL REGULATIONS

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Studies that involve interviews, follow-up contact to determine the effectiveness of a program. Marketing surveys and surveys to assess user satisfaction often do not require IRB review and approval because contracts with member groups specifically allow members to be contacted without such approval and because these surveys do not contribute to generalizable knowledge. If information from a project will be published in a scientific journal or presented at a scientific meeting, the project is considered research by the federal definition and requires IRB review and approval. Publication or presentation implies an intention to contribute to generalizable knowledge. Additionally, many medical journals require documentation of review by a human subjects committee as a condition of publication.

Human Subjects Research Involves Wide variety of biomedical and clinical research Behavioral research Survey research

A fundamental ethical requirement in connection with research involving human subjects A basic principle of respect for persons Respect for persons requires that subjects, to the degree they are capable, be given the opportunity to choose what shall or shall not happen to them

Most Research Receiving Federal Funding Must Follow “The Common Rule.“(45 CFR 46) Elements:  requirements for assuring compliance by research institutions;  requirements for researchers obtaining and documenting informed consent;  requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.  additional protections for certain vulnerable research subjects-- pregnant women, prisoners, and children

IRBs Are the Result of 20 th Century Research Misconduct or Dilemmas

The IRB Process

Title of the Study Principle Investigator,Study Team Members (Roles,Conflict of Interest information, & Credentials) Project Summary Estimated start and end dates Performance Site(s) and Details Research Design: Objective, Specific Aim(s)/Hypothesis, Background Information, Interactions (e.g., information gathering, survey, interview, focus groups), Statistical Design Benefits and Risks Subject participation (number and age) Recruitment (may include screening) Informed Consent Confidentiality/Security Retention of Data

An IRB then reviews the application to insure that: Risks to subjects are minimized. Risks to subjects are reasonable in relation to anticipated benefits, if any. Selection of subjects is equitable. Informed consent will be sought from each prospective subject. The possibility of coercion or undue influence is minimized. Require that additional information be given to subjects “when in the IRB's judgment the information would meaningfully add to protection of the rights and welfare of subjects”.

IRBs are also responsible for ensuring that members who review research have no conflicting interest.

Research that meets the categories set forth by the federal regulations (45 CFR 46) that expose participants to no more than minimal risk.

Research limited to the following activities may qualify for an exemption determination by an IRB: Studying educational methods Interviewing public figures Use of publicly available data sets Use of existing data and/or specimens stripped of identifiers

HOW AN IRB DETERMINES AN EXEMPTION:

TO GET AN IRB EXEMPTION, ONE MUST STILL DO A LOT OF PAPERWORK!

CONCLUSION: ACCEPT THE IRB PROCEDURES AS PART OF THE RESEARCH PROCESS AND FOLLOW THEM

Medical journals retract "unethical" research studies published by Boldt had so far been foundnot to have had approval from an ethics body known as the institutional review board (IRB).” “The editors of 16 international medical journals have retracted "unethical" research carried out by a German doctor on drugs known as colloids, which boost blood volume in patients having surgery. Joachim Boldt, an anesthesiologist at the center of an investigation into allegations that he may have forged up to 90 studies, was sacked from Klinikum Ludwigshafen, the German hospital where he worked, late last year. British surgeons' organizations said they were withdrawing and reviewing their guidelines on the use of colloids following the retractions, although experts said there was little risk to patients. In an open letter, 16 editors of various medical journals, including the U.S.-based Anesthesia & Analgesia, the European Journal of Anesthesiology and the British Journal of Anesthesia, said 89 of 102 studies published by Boldt had so far been found not to have had approval from an ethics body known as the institutional review board (IRB).”

When Our Library Does Research

Submitting an UM 45 steps to complete

Our Two IRBs Creating Health Information Connections for Persons with Disabilities Blumenthal Exempt Approved - Initial 2/6/2008 9:36 AM HUM Point-of-Care Resources Blumenthal Approved Application 6/28/2010 8:12 AM HUM

IRB for Point-of-Care Resources Submission in Approved state See Approval Letter

Risk Level No more than minimal risk

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