A S S O C I A T E S I R B
Non-Coercion Statement Request Form
1. Submission information: Use this form to request a Non-Coercion Statement for use in consenting employees or family members to participate in a research study currently approved by Schulman IRB.2. Submission instructions: Submit via Secure eSubmission or email to .
SECTION 1.0: Study & Contact Information
1. IRB No.:
2. PI/QI Name:
3. Sponsor:
4. Protocol No.:
5. Contact information for this request:
Name: / Company:
Phone: / Email:
SECTION 2.0: Information & Safeguards for Enrolling Employees/Family Members
1. Do the protocol inclusion/exclusion criteria prohibit the enrollment of employees or family members of employees of the research site into this research study?
No / Yes The Non-Coercion Statement request cannot be approved. Contact Schulman IRB for questions or assistance.
2. Does the site plan to enroll employees/family members of employees of the research site into this research study?
No / Yes
3. Has the site already enrolled employees/family members of employees of the research site into this research study without having a Board approved Non-Coercion Statement signed at the time of initial consent?
No / Yes Submit a Non-Compliance Report.
4. Are subjects currently participating in this study at this site?
No / Yes
5. Are there plans to enroll new subjects in the future?
No / Yes
6. The following safeguards must be followed when enrolling employees/family members into a research study:
· Measures must be taken to ensure the confidentiality of an employee’s study-related medical records. Additionally, no action can be taken against an employee based on information to which an employer would not otherwise be entitled but obtains because of an employee’s participation in a study. An employee who participates in a research study must be treated as other subjects and must be able to decide not to participate or to discontinue study participation without any impact on his/her employment status. The Board requires that each employee sign a Non-Coercion Statement prior to the subject’s participation in the study. “Employee” refers to either an employee or an employee’s family member who is participating in a research study.
SECTION 3.0: Investigator Certification Signature
As the individual responsible for completing this form, my signature certifies that:
1. I am the Principal Investigator (PI) or Qualified Investigator (QI) or the PI/QI's designee authorized to submit on behalf of the PI/QI;
2. The PI/QI and all study personnel have reviewed the information regarding safeguards for vulnerable group(s) and agree to the appropriate safeguards;
3. All information provided in this form is true and accurate, has been reviewed by the PI/QI and communicated to all study personnel.
Principal Investigator [US] / Qualified Investigator [CAN] or Designee Signature / Signature Date (mm/dd/yyyy)
Principal Investigator [US] / Qualified Investigator [CAN] or Designee Name & Title
Version: April 17, 2015 / © 2015 Copyright SCHULMAN / Page 1 of 1