M-Inform: Request Input from Discloser

Overview

COI Staff

In determining whether a potential conflict of interest exists during review of a Research Initiated Certification (RC), COI Staff may find it necessary to request additional information from the discloser. The Request Input activity is available for RCs in the states of Admin Review and Admin Review: Response Received.

Navigation

COI Staff Dashboard > My Inbox | or Unassigned tab

Step-by-Step Process

  1. Verify COI Staff under My Dashboards is selected.
  2. Click the name of the Research Initiated Certification.
  3. Click Request Input under Activities.
  4. Enter a Comment, if desired.
    Request Input
  5. Click the applicable checkbox(es) to select questions/question sets that will display in the notification sent to the discloser.
  6. Click OK.

Notes

  • Once the Request Input questions have been submitted, the RC transitions to the state of Response Required, and an email is sent to the investigator alerting them to go to M-Inform to respond to the questions.
  • Once the discloser submits their responses, the RC transitions to the state of Admin Review: Response Received.

Tip COI Staff can view the discloser’s responses by clicking Print View in the RC workspace, or they can click Edit Research Certification and then select the Additional Information section from the Jump To menu.
Research Certification workspace

Questions/Question Sets

SECTION SELECTION QUESTIONS RESPONSE
UM Role of Investigator on Project
  Request specific duties/work details 1. Describe your specific duties, deliverables and responsibilities on the research project: Text box
  Data collection/Analysis 1. Are you involved in data collection? [If yes, answer #3] Yes/No
2. Are you involved in data analysis? [If yes, answer #3] Yes/No
3. Is there a Data and Safety Monitoring Board (DSMB) or neutral third party or plan for reviewing the data? [If yes, answer #4] Yes/No
4. Please describe: Text box
  Income 1. Do you anticipate that income from your outside interest will exceed the $5,000 threshold in any 12-month period over the course of the research project? Yes/No
Sponsor Roles on Project
  Specify outside company’s duties/deliverables 1. Specify the outside company’s duties/deliverables: Text box
  Consulting work 1. Will you be working on the same research project in your consulting role? [If yes, answer #2] Yes/No
2. Describe how your consulting/speaking is the same or different from the scope of the research: Text box
Students on Project
  Request specifics on student/trainee involvement 1. Do you supervise any students/trainees assigned to the research project? [If yes, answer #2 and #3] Yes/No
2. List their names, uniqname, and academic rank Add
3. Are any of these students/trainees working directly with the outside company personnel? Yes/No
4. Do any students/trainees on the research project have employment with the outside company? [If yes, answer #5] Yes/No
5. List their names, uniqname, and the name of their supervisor at the company Add
6. Does any member of the graduate student's thesis committee have a financial relationship with the outside company? [If yes, answer #7] Yes/No
7. List their names and their uniqnames Add
Junior Faculty on Project
  Request specifics on junior faculty involvement 1. Do you supervise or mentor any junior faculty assigned to the research project? [If yes, answer #2] Yes/No
2. List their names and their uniqnames Add
3. Are you a member of the promotion/tenure committee for any junior faculty assigned to the research project? [If yes, answer #4] Yes/No
4. List their names and their uniqnames Add
Intellectual Property on Project
  Does the research use IP Optioned/licensed to the outside company 1. Does this research use or enhance IP that is optioned/licensed to the outside company? [If yes, answer #2 and #4] Yes/No
2. Is any of the IP optioned? [If yes, answer #3] Yes/No
3. Provide the file number(s) of the licensed IP (if known): Add
4. Is any of the IP licensed? [If yes, answer #5] Yes/No
5. Provide the file number(s) of the licensed IP (if known): Add
6. Do you receive royalties on IP used or involved in this research? Yes/No
7. Do you have any other current sponsored projects that use or enhance the UM technologies optioned/licensed to the outside company? Yes/No
SBIR/STTR
  Request specifics on SBIR/STTR 1. Please provide a copy of the full SBIR/STTR proposal package (including budget, budget justification, statement of work, etc.) Add
2. Provide the name of the PI who will conduct the work at the outside company. Indicate the PI's affiliation (e.g. faculty, staff, student) with UM (if any) Text box
3. Where will the outside company's portion of the work be conducted? Text box
Human Subjects Research
  Do you plan to obtain informed consent 1. Are you one of the people who will obtain informed consent? [If no, answer #2 and #3] Yes/No
2. If not, who will obtain informed consent? Text box
3. Do you supervise the above person(s)? Yes/No
  Are any of the subjects in this research project also your patients 1. Are any of the subjects in this research project also your patients? Yes/No
Additional Question(s)
  Select to present questions from the text box below Manually enter additional questions in the provided text box. Text box
Last Updated: 
Wednesday, July 1, 2020