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Common Pitfalls to Avoid when Completing an IRB Application .

Common Pitfalls to Avoid when Completing an IRB Application . . Debra Schneider, IRB Administrator (313) 593-5468; dschnei@umd.umich.edu. Part 1: Basic Information. This section contains basic information about the IRB application including:

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Common Pitfalls to Avoid when Completing an IRB Application .

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  1. Common Pitfalls to Avoid when Completing an IRB Application. Debra Schneider, IRB Administrator (313) 593-5468; dschnei@umd.umich.edu

  2. Part 1: Basic Information • This section contains basic information about the IRB application including: • Documents needed for application • System Requirements • Types of IRB Applications (these are dependent on the level of risk to the subjects and whether the subjects are vulnerable to coercion.) • Risk

  3. Documents Needed for Application • Resume or CV for each study team member. • Site Approval Letters from each organization where research activities will take place. Letters must be on organization letterhead and signed by the director or person in charge. • Protocol • Consent Forms • Copies of all survey instruments or questions that will be given to the subjects. • Copy of all recruitment materials • Sona Screenshot and URL (see section 8 of application)

  4. System Requirements • Uniqname and Kerberos password: These are required to access eResearch. • Browser: Your browser must allow cookies, Javascript, Java applets and pop-ups (for the eresearch.umich.edu site). • Tested and Supported systems: • Windows Windows 2000/XP Internet Explorer 6 • Apple: Macintosh OSX Safari browser • Other Recommendations for All Systems • Display capable of at least 1024x768 resolutionHigh-speed internet connection (128K or higher)

  5. Application Type • There are 4 application types. • Not regulated as human subject research. • Exempt • Expedited • Full Board Review

  6. Not Regulated as Human Subject Research • There is no intervention or interaction with the individual AND the identity of the individual is not known. • Research is done using publically available data sets with no individual identifiers attached to the data.

  7. Exempt Human Subject Research Research that exposes participants to minimal risk, or no risk at all, may be considered exempt from the need for ongoing IRB review. • The following types of studies may qualify for an exemption determination. • Studying educational methods • Interviewing public figures • Utilizing publicly available data sets • Utilizing specimens of human tissue stripped of identifiers. • Most common Exemption types here at UM - Dearborn • Exemption 1: Research conducted in educational settings involving normal educational practices. • Exemption 2: Research involving the use of educational tests, survey procedures, or observation of public behavior unless research is recorded in a way that subjects can be identified.

  8. Expedited Human Subject Research • Procedure must be no more than minimal risk. • Procedure must not put subjects at risk of criminal or civil liability or be socially or economically damaging. • Any research utilizing the UM-Dearborn Psychology Subject Pool will require Expedited Review. • Most student initiated studies are Standard, non-exempt research projects. Frequently, they are reviewed as Expedited Human Subject Research.

  9. Full Board Review • If research involves any of the following it will most likely require full board review: • Studies that include vulnerable populations such as: • Minors • Prisoners • Pregnant Women • Impaired Adults OR • Studies that present moderate or high risk to the subjects such as: • Illegal activities, such as drug use • Private activities such as sexual behavior • FDA approved drugs and devices presenting more than minimal risk • Non-FDA approved drugs and devices • Involving deception

  10. A Note about Vulnerable Populations • Vulnerable populations are those that face a high risk of coercion. If your study involves children, prisoners, pregnant women, or impaired adults the researcher will need to take extra precautions to prevent the subjects from unwilling participation in a research study. • For studies involving children, for example, the parents will complete a consent form allowing children to participate in the study and the children will complete an assent form agreeing to be in the study. The PI must include both forms on the IRB application. • The Dearborn IRB is not equipped to review studies that include prisoners in the subject population. These studies are reviewed by an Ann Arbor campus IRB. Contact IRB administrator if your study includes prisoners in the subject population.

  11. 4 levels of Risk • No more than minimal: generally, the magnitude of harm is not more than what you would experience in daily life. • Minor Increase Over Minimal: Risk to health, reputation, financial or legal standing slightly above that which is faced in everyday life. • Moderate Risk: Could cause unwanted emotions, sadness, temporary harm to social standing, temporary or moderate financial lost, temporary pain. • High Risk: Pronounced distress, severe long term harm to social reputation, severe or permanent harm to financial standing, severe pain or death.

  12. Links • Office of Research & Sponsored Programs Human Subjects Pages: • http://www.research.umd.umich.edu/irb/ • IRB Applications are completed through the eResearch Regulatory Management module: • http://www.umich.edu/~eresinfo/rm.html • All Principal Investigators who work with Human Subjects must have completed the PEERRS Human Subjects module related to their type of research. Most UM Dearborn PI’s must complete the “Human Subjects Social and Behavioral Sciences” Module. • http://my.research.umich.edu/peerrs/

  13. Part 2: Common Application Errors • Application is incomplete when submitted – these errors are usually found in section 1 • Application does not include all research locations and activities (section 3) • Application responses do not match attached documents. (section 5) • Misunderstanding application questions (section 6,7,9) • Consent Form issues (section 10)

  14. Section 1 Common Errors • 1.3 Study Team member does not accept role, complete COI questions and upload CV. • 1-2.3 Department is not entered. To search use the “%” (percent symbol) before and after the search term. For example, %Education%. Select Dearborn School of Education from the list.

  15. Section 3 - 5 • 3.1 Not all research activities are selected. Unless you are working with a data set you will need to select at least the following categories: recruitment, interaction, analysis, and storage. • 3-1.1 Not all sites where research activities will take place are listed. All locations where any research activity will take place must be listed and a Site Approval Letter must be attached. SITE APPROVAL LETTER: Must be on organization letterhead and signed by the director or someone in charge allowing you to conduct research activities at that organization.

  16. Section 5 • 5.1 The stand alone protocol does not say the same thing as the application questions. • Tip: if you are using a stand alone protocol; to avoid discrepancies between the stand alone document and the IRB application answers; please refer to the pages of the stand alone document and do not include any other information when answering the application questions.

  17. Section 6 • 6.1 This question is about benefits to society as a whole not benefits to the subjects. • 6.3 is about risks to the community, not risks to the subjects. • 6.5 Click the “Add” button to add the benefits and risks to the subjects as a result of participating in the study. • To go back to edit any questions higher than 6.4; click on the 6.4 “view” button to open that section of the application. A Direct Benefit is a benefit that each subject would receive as a result participating in your study that they would not otherwise be able to gain.

  18. 7-1.5 Data Collection • If you are not using a data set; answer “Yes” to this question.

  19. Common Errors: Section 9 • 9.1 This question contains a double negative so many people get confused. • If you are doing a study of the general adult population and none of the listed subcategories answer “YES” • If you are doing a study of any of the listed subcategories answer “No”. • If you are studying both the adult population and one or more of the listed subcategories answer “No”

  20. Common Pitfalls: Section 10 • 10-1 .1 Consent forms: • Form does not include all required elements of consent form. (Next slide) • Forms are not on the approved template. • Consent form template margins are changed. • Consent form lacks required signature lines; separate signature lines are required for: • Participating in study • Agree to being videotaped • Agree to being audiotaped IMPORTANT: If there are children in your study; parents must sign a consent form allowing the child to participate in study. Children will sign a separate Assent Form agreeing to participate.

  21. Consent form Elements • Statement that subject is participating in a research project. • Description of what the research is about, what the subject will be doing, the amount of time they can expect to spend. • Statement that the subject can skip any portion of the study or withdraw without penalty or loss of benefit. • Statement of benefits and risks. • Separate signature lines for participation in study, agreeing to be audiotaped, agreeing to be videotaped. • Contact information for PI and / or research team • Contact information for ORSP office (already on template). NOTE: This is mandatory language do not remove from consent form.

  22. Section 44, 45 • Do not upload study documents here they should all be uploaded in the application. Section 29 is the spot to upload all of the survey instruments.

  23. Questions? • Contact: • Dr. Drew Buchanan, Director Office of Research & Sponsored Programs. • 593-5468 • dbn-research@umd.umich.edu • Deb Schneider, IRB Administrator • 593-5468 • dschnei@umd.umich.edu

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