Human Research Protection Program Feedback

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Human Research Protection Program Feedback

The MaineHealth Human Research Protection Program (HRPP) recognizes that it is a privilege to work with human participants in research and welcomes any information that would support our efforts to assure the continuous quality and compliance of our program.

If you have feedback regarding research involving human participants at MaineHealth (MH), you may report it in one of several ways:

Speak with the Director, Research Compliance Office.
Speak with a Principal Investigator or Clinical Research Coordinator.
Call the MH IRB Office at (207) 661-4474.
Email the MH IRB Office at hrppirb@mainehealth.org.
Submit your feedback CONFIDENTIALLY by using this form.

This form is not intended for issues requiring immediate attention. If you have a concern that needs an urgent response, please contact us using one of the other methods listed above.

All feedback will remain confidential and without reprisal. IF you prefer total anonymity, please use this form and do not include your name.

THE PERSON MAKING THIS REPORT IS NOT REQUIRED TO PROVIDE HIS/HER NAME.

If you wish to remain anonymous, please do not disclose any information that would be identifying.

What is your role in research?

Research participant

Associated with research participant (e.g., family member)

Community member

PI / Sub-PI

Research team member (e.g., CRC)

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Please tell us about your questions/concerns:

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Would you like to be contacted by our office?

No Yes (please provide information)

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Your name

______'s primary email

______'s primary phone number

1. What is the IRB number and/or study title of the study you are/were involved?

2. Name of Principal Investigator (PI) and/or person(s) with whom you interacted:

3. How long have you been participating in this study?

4. Were you given enough time to consider whether or not to participate in the study?

Yes No (please explain)

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4a. If no, please explain:

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5. Were you given the opportunity to have all of your questions satisfactorily answered?

Yes No (please explain)

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5a. If no, please explain:

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6. Were you provided with a signed and dated copy of the Informed Consent Form?

Yes No (please explain)

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6a. If no, please explain:

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7. Is your doctor also the researcher?

Yes No

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7a. If yes, were you influenced or pressured to participate because of this relationship?

Yes (please explain) No

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7b. If yes, please explain:

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8. Were there any other things that influenced your decision to participate, for example payment for participation, free medication, etc.?

Yes (please explain) No

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8a. If yes, please explain:

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9. Were you made aware that participation is voluntary and that you are free to withdraw at any time?

Yes No

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9a. If no, please explain:

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10. If you have completed one or more study visits, do you feel you were fully informed about the study?

Yes No

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10a. If no, please explain:

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11. If you have completed one or more study visits, were you treated respectfully at those visits?

Yes No

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11a. If no, please explain:

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