Download Addendum H: Informed Consent Waiver to Enroll Subjects

Addendum H
Jacksonville – IRB-03
Waiver or Modification of Informed
Consent for ENROLLING Subjects
Make sure your Microsoft Word program is set to display “Hidden Text”. This document contains helpful
information, examples, and instructions that are only visible (and will never print) when the “Hidden
Text” feature is enabled. “Hidden Text” will be displayed highlighted yellow, italics, and underlined. Go
to the “Tools” menu, “Options”, on the “View” tab make sure “Hidden Text” has a check mark, and click
“OK”.
Study Title:
1. Are you requesting a Full Waiver of Informed Consent to enroll subjects?
Yes - Answer Question 2.
No – go to Question 3.
2. Is this research project subject to FDA regulations?
Yes – FDA regulations do not permit Informed Consent to be waived for drugs or
devices being studied in support of an IND or IDE; any use of a drug, other than
the use of marketed drug in the course of medical practice; any evaluation of
the safety or effectiveness of a device; and/or the submission of data to FDA in
support of a marketing application for an FDA regulated test article other than a
drug or device. A FULL WAIVER CANNOT BE GRANTED.
No – go to Question 3.
3. Are you requesting a Modification of Informed Consent?
Yes - Describe:
No
.
4. Did you request a Full Waiver of Informed Consent or Modification of Informed Consent in
Questions 1 or 3 above?
No – Go to Question 5.
Yes - you must answer the following questions in order to qualify for a Full Waiver or
Modification of Informed Consent:
a. Describe and justify why the research could not practicably be carried out without the
waiver or modification:
b. Is this project:
(1) conducted by or subject to the approval of state or local government officials, and
(2) designed to study, evaluate, or otherwise examine: (i) public benefit or service
programs; (ii) procedures for obtaining benefits or services under those programs;
(iii) possible changes in or alternatives to those programs or procedures; or (iv)
possible changes in methods or levels of payment for benefits or services under
those programs?
Yes – Go to Question 5.
No – answer items (i) –(iii) below.
i. Is the protocol more than minimal risk to the subjects?
Yes
No
ii. Describe why the waiver or modification will not adversely affect the rights
and welfare of the subjects:
Addendum H: ICF Waiver to Enroll
IRB version: 11/24/2009
PI version:
Page 1 of 2
iii. Is it appropriate to give subjects additional pertinent information after
participation?
No
Yes – Describe:
5. Are you requesting a Waiver of Documentation of Informed Consent to enroll subjects?
No – Go to Question 6.
Yes – Answer items (a) and (b) below.
a. Select one of the following:
i. The only record linking the subject and the research would be the consent
document and the principal risk would be potential harm resulting from a
breach of confidentiality. Each subject will be asked whether the subject
wants documentation linking the subject with the research, and the subject’s
wishes will govern. EXCEPTION: this kind of waiver cannot be approved for
research involving FDA regulated test articles (e.g. drugs, devices, or
biologics).
ii. The research presents no more than minimal risk of harm to subjects and
involves no procedures for which written consent is normally required outside
of the research context. Provide protocol specific information to justify:
b. Do you intend on providing a written statement to the subject that describes the
research and their rights?
No. Justify why an explanatory document is not needed:
Yes. You must submit a copy of what you intend to use and receive IRB
approval before using it.
6. Does this study involve the development, collection, use, or sharing of personal health
information (PHI)?
No – You do not need a Waiver of HIPAA Authorization.
Yes – You must complete and submit a Waiver of HIPAA Authorization available at:
http://irb.ufl.edu/docs/HIPAA/authorization-waiver.doc
Addendum H: ICF Waiver to Enroll
IRB version: 11/24/2009
PI version:
Page 2 of 2