H. PRINCIPAL INVESTIGATOR ASSURANCE AND SIGNATURE PAGE

Each box must be checked and submit original by fax or intercampus mail with PI and Co-PI signatures.

I have received and reviewed the UML IRB Policies and Procedures.

I have a current conflict of interest disclosure form on file at the ORA Office for Research.

I agree to conduct the study(s) in accordance with the relevant, approved protocol(s) and will only modify or revise a protocol after notifying and receiving approval from the sponsor and the IRB, except when necessary to protect the safety, rights, or welfare of subjects.

I agree to personally conduct or supervise the described investigation(s).

I agree to inform all research subjects of the investigational nature of this project as required in 21 CFR 50 and 45 CFR 46.

I will ensure that the requirements for obtaining informed consent are met per the regulations found at 21 CFR parts 50 and 45 and 45 CFR part 46.

I agree to report to the sponsor, IRB,FDA, OHRP, NIH, all site-responsible investigators and any other required sponsor or agency, the adverse experiences that occur in the course of the investigation(s).

I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study(s) are informed about their obligations in meeting the above commitments and confidentiality requirements.

I agree to maintain adequate and accurate records in accordance with the regulations and to make those records available for inspection in accordance with the regulations. (Records will be kept on file 3 years from the project completion date.)

I understand that UMass Lowell students will be recruited by public announcement and not by personal solicitation.

I am responsible for submitting the materials for continuing review in a timely manner.

I will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risks to humans or others.

I understand that any medical procedures or treatments of human subjects will be performed by or under the supervision of a person who is licensed or certified to perform that particular procedure.

I have completed the required human subject research training. Type: Date:

I understand that the research may not begin until I have received the official notice of approval and that my signature in Section I. has been received by the IRB Administrator.

I. SIGNATURE(S):

PI Signature:	Date:
Printed Name:	IRB Protocol/Version No.
Co-PI Signature:	Date:
Printed Name:
Co-PI Signature:	Date:
Printed Name:

Fax this page to 978-934-3018 or Send by intercampus mail to IRB Administrator, Office of Institutional Compliance, 200 Dugan Hall.