Investigators seeking exempt determination, expedited approval, or full board approval for their research must complete an on-line application using eResearch. For more information about the IRB or applying for approval, contact irb-dearborn or call Deb Schneider at 313-593-5468.
Make sure you are using internet Explorer to complete the eResearch application.
Ask all study team members to Login to eResearch and complete the access request. If a study team member is not affiliated with the University of Michigan they will need to obtain an eResearch Friends Account.
Ask all study team members to login to PEERRS and complete the Human Subjects: Behavioral Sciences module.
Assemble the following documents which will be attached to the application. All Attached documents should be in either .doc or .rtf format.
IV. eResearch Application Outline
A. Required Sections:
01. General Study Information
02. Sponsor Information
03. Performance Sites
04. Study Abstract See Section III, above
05. Research Design See Section II, above
06. Benefits and Risks See Section III, above
07. Special Considerations* Check only those that apply
09. Subject Populations
10. Informed Consent See Section III, above and
Help on Informed Consent
11. Confidentiality and Security
12. Exemption
B. Additional Sections as Applicable (depends on responses to #07*)
13. Subject Payments Or Other Incentives
15. Drug, Biologics, Etc.
16. Devices
17. Placebo
18. Biological Specimens
20. Genetic Analysis
22. Organ/Tissue/Cell Transfer
24. Secondary Data Analysis
25. Protected Health Information/HIPAA
26. Epidemiology
27. Deception Research
28. Internet/Email
29. Survey Research
30. International
31. Watching/Listening to Audiovisual Materials
32. Data Safety Monitoring Plan
33. Children
35. Pregnant Women and/or Fetuses
36. Lactating Women
37. Women of Child Bearing Potential
38. Prisoners
39. Cognitively Impaired Adults
40. College Students
41. Subjects Vulnerable to Coercion
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We recommend that you prepare the highlighted sections of your application (below) before you begin an eResearch application.
I. Main body of the application: the Research Design section contains most of the text description of the protocol; you should prepare this section ahead of time in MS Word and upload to the eResearch application. Use the order and heading identifiers shown below: the following sections and descriptions are exactly as they appear in eResearch.
Section 5. Research Design
This section covers the overall research design of the project. Later sections will ask more specific questions about benefits, risks, special review considerations, targeted populations, recruitment strategies, and experimental methodologies/procedures.
In this section, you will be able to answer the specific questions by:
- Attaching a protocol and indicating the relevant section for the requested information;
- Providing the explanation; or
- Attaching a protocol and augmenting with comments.
5.2 Objective: What is the overall purpose of this research study? (Limit response to 1-2 sentences. If covered in attached protocol, please indicate section.)
5.3 Specific Aim(s): What is (are) the specific aim(s) of this study and/or what hypothesis (hypotheses) is (are) to be tested? (If covered in attached protocol, please indicate section.)
5.4 Background: What prior information or knowledge exists to support the conduct of this study? (Limit response to no more than one additional page; not including references. If covered in attached protocol, please indicate section.)
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5.5 Study team Experience: Briefly outline the experience and competence of the study team to pursue the proposed study. (This will supplement information provided in study team CVs. If covered in attached protocol, please indicate section.)
5.6 Methodology: Describe the design and procedures to be used to accomplish the specific aims. Describe the advantages of any innovative methodologies. Include a sequence or timetable of research activities. (If covered in attached protocol, please indicate section.)
5.7 Statistical Design: Describe the statistical design of the research study, including methods used to analyze data. Include (as appropriate) statistical or interpretive analysis methods, study stopping rules, etc. (If covered in attached document, please indicate section.)
II. Cut and paste sections: these sections contain short descriptions and statements and may be drafted ahead of time; cut and paste into the appropriate sections of the eResearch application or enter the information directly on-line.
Section 4. Abstract
4.1 Study Abstract (400 words or less): Use non-technical language that someone without a scientific background could understand. Include a summary of the significance, scientific objective, and specific aims..
6. Benefits and Risks to Subjects
6.1 Are there potential direct benefits of this research to the subjects?
6.1.1 If yes, describe the potential direct benefits and indicate if all, or only certain, of the research subjects may derive this potential benefit.
6.2 Are there potential indirect benefits of this research to the public or others (e.g. potential improvement in management of a particular illness; health care cost reduction; increased knowledge; improved safety; better health; technological advancement.)?
6.2.1 If yes, describe the potential indirect benefits
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6.4 Describe any direct risks to the public or community, which could result from this research (e.g. potential dissemination to others of transferred genetic material, exposure of others to radiation from radioisotopes administered to a subject.)?
6.6 Discuss why the risks to the subjects are reasonable in relation to the anticipated benefits.
6.7 What specific criteria will be used to end a subject's participation in the study (i.e. subject stopping rules or endpoints)? If covered in attached protocol, please indicate section.
10. Informed Consent (Adults)
10.1.1 Describe the process to seek and obtain informed consent from adults (e.g., setting, timing, personnel involved, arrangements for answering subject questions before and after the consent is signed).
III. Documents to Upload: these documents should be uploaded to eResearch in the appropriate sections; if electronic versions are not available, a hard copy will need to be forwarded to the IRB administrator, Office of Research and Sponsored Programs.
A. Required: the Consent Form must be uploaded with the application!
· Informed Consent Form
B. Additional Documents as Applicable; any of these may be submitted in hard copy form separate from the application
• Research Design
• Grant Proposal (if applicable)
• Outcome of Previous IRB Review (if applicable)
• Subject Recruitment Materials (if applicable)
• Biographical Sketch or CV of PI and Other Investigators
• Management Plan for Conflicts of Interest (if applicable)
• Documentation of Approval for Use of Site (if applicable)
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Site Approval Letters must be obtained from all off-campus organizations where any research related activity will take place. This includes recruitment activities as well as actual research activities. The letter must be on organization letterhead and be signed by the person in charge of the organization. Letters must be scanned and saved on a computer so that they can be uploaded to the eResearch application. If you do not have a scanner; call Deb Schneider, IRB Administrator, (313) 593-5468 for assistance.
