IRB Reviewer Worksheet for Reviewing Abbreviated Consent Forms

Project Name______

Protocol number ______

Reviewer’s Name ______

Date ______

Level of review requested by PI______

Note: An abbreviated consent form is only appropriate in circumstances where there is no chance of physical injury and minimal chance (or less) of psychological discomfort or loss of confidentiality. This type of consent form is appropriate for many types of surveys, interviews, and studies of standard educational practices. An abbreviated consent is not appropriate for any type of exercise or health-related testing or interventions.

CONSENT FORM

/ Yes / NO / NA / Comment
1. Is the consent form written in second –person language?
2.  Is the consent form written in lay language at the fifth grade level throughout?
3.  Is all technical jargon defined in lay terms?
4.  Is suggested standard wording used whenever appropriate?
REVIEWER ANALYSIS: Are the details of the consent form consistent with the IRB application form throughout?
INVITATION / Yes / NO / NA /

Comment

1. Does the invitation tell who is conducting the study, the affiliations of the investigators, and where the study is being conducted?
2. Does the invitation state that participation is voluntary?
3. Does the invitation suggest the subject read the entire consent and ask questions?

PURPOSE

/ Yes / NO / NA /

Comment

1. Is the purpose of the study clearly defined in lay terms?

DURATION AND LOCATION

/ Yes / NO / NA /

Comment

1. Is the projected time commitment for the subject clearly defined?
2. Is the location of the study identified?

PROCEDURES

/ Yes / NO / NA /

Comment

1. Are the procedures explained clearly and sequentially in lay language?

R REVIEWER ANALYSIS Are the procedures described in the informed consent consistent with procedures described in the IRB application form?

POTENTIAL RISKS & DISCOMFORTS / Yes / No / NA / Comment
1. Are the risks and discomforts described for each procedure? Are emotional, psychological and risks associated with loss of confidentiality considered?
2. Are measures taken to reduce risks explained?
CONFIDENTIALITY / Yes / No / NA / COMMENT
1. Are procedures to maintain confidentiality during data collection (if applicable) described?
2. Is there a description of where the data will be stored and how it will be protected from unauthorized access
3. Is there a description of how and when data will eventually be destroyed?
4. Are audio or video recordings included in the methodology? / PLEASE NOTE THAT AUDIO AND VIDEO RECORDING REQUIRES AN EXEMPTED LEVEL OF REVIEW AND A STANDARD (NOT ABBREVIATED) CONSENT FORM
7. Are safeguards taken to protect subject confidentiality during subsequent presentations and publications?

PARTICIPATION AND WITHDRAWAL

/ Yes / No / NA / COMMENT
1. Is the standard text used that outlines the right to not participate and to withdraw from the study?
RIGHTS OF RESEARCH SUBJECTS
1. Is standard wording used?
2. Is an individual’s name provided who is not associated with the study and who can provide subjects with information about their rights? This person should be knowledgeable about federal regulations involved in human research.
OFFER TO ANSWER QUESTIONS
1. Has someone been designated to answer questions who would be able to answer subjects’ questions about the study design and procedures (usually the PI)?
2. Has someone been designated as the contact person should a research-related injury occur? (Research-related injury POC is also usually the PI although in the case of student projects this person should be the faculty advisor) / A STANDARD CONSENT FORM RATHER THAN AN ABBREVIATED CONSENT FORM SHOULD BE USED IF THERE ARE ANY ASPECTS OF THE PROTOCOL IN WHICH AN INJURY COULD POSSIBLY OCCUR

SIGNATURES

1.  Is standard formatting and wording used? (Each subject must sign his or her own consent form.)
2. Subject signature and date
3. Witness signature and date
4. Investigator signature and date

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IRB/forms/Worksheet for abbreviated consent form review_8-14-05