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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 250.100- Source Plasma - Guidelines for Informed Consent Forms

 

BACKGROUND AND POLICY:

Informed consent is the agreement obtained from a subject, or the subject's authorized representative, for the subject's participation in the specific program. Donors who are considering entering a plasmapheresis program must be made aware of the nature of the procedure and of all its risks. In addition to a verbal explanation which a licensed physician is required to provide, the individual should have the opportunity to read, as well as hear the details of the procedure so he/she is, indeed, informed. The agreements shall contain no exculpatory language through which the donor is made to waive, or appear to waive, any of his/her legal rights, or to release the corporate establishment or its agents from liability for negligence. Two separate consent forms should be available, one for the regular plasmapheresis procedure, and one for immunization.

A. Each form should include the following:

1. A clear explanation in non-medical terms, of the procedures to be followed, including maximum volumes of blood to be removed at one time, and the time limits between donations set forth in the Regulations.

2. A description of any donor's discomforts and the risks of the procedure including:

a. Possible return of another donor's red blood cells resulting in a hemolytic transfusion reaction;

b. Common systemic reactions which may ensue;

c. Changes in protein, hemoglobin, IgG levels which may necessitate deferment or removal from the program.

3. The necessity for a donor to actively participate in accurate identification of his/her red blood cells before they are returned to him/her.

4. The statement that the donor has been offered an opportunity to ask any questions concerning the procedures or an opportunity to refuse, before a consent form is signed.

5. An instruction that the donor is free to withdraw his/her consent and to discontinue participation in the plasmapheresis program at any time.

B. If plasmapheresis is to be accompanied by immunizing injections, the form shall also include:

1. A clear explanation of the immunization program including:

a. The nature of the antigen(s) which will be used. (Space should be provided on the form for the identification of each antigen to be administered);

b. Approximate duration of the immunization program;

c. Maximum number of injections and factors determining when injections will be administered.

2. If the immunizing agent is a human blood product, the donor should be made fully aware of the following:

a. The possible transmission of hepatitis viruses;

b. the increased risk of adverse reaction if incompatible blood is received by the donor at a later date;

c. women of childbearing age should not be immunized unless evidence of surgical sterility is presented;

d. the increased risk of rejecting an organ transplant, if such a transplant is needed at a later date.

*Material between asterisks is new or revised*

[] Indicates material has been deleted

Issued: 7/19/76
Revised: 10/1/80, 3/95