1. Blood Donor Written Statement of Understanding
Introduction
Orieji Illoh, MD
Office of Blood Research and Review
CBER/FDA
Blood Products Advisory Committee
April 29, 2011

2. Outline Introduction Issues to be considered
Donor consent: Current status
FDA requirements or recommendations
AABB standards
ACBSA recommendations
“Written statement of understanding” (WSU)
Elements as outlined in the 2007 proposed rule
Public comments to the proposed rule
Elements of the written statement of understanding
Educational material
Risks and hazards of blood donation
Questions for the committee
Speakers and topics

3. Introduction
About 10 million allogeneic donors provided ~17 million donations of Whole Blood and Red Blood Cells in 2008.
The blood donation process is highly safe but adverse reactions can occur.
FDA has regulations for donor consent in Source plasma, plateletpheresis and plasmapheresis donors.
The practice of donor consent for whole blood donors varies. 3

4. Blood donation process1 2 3 4
Registration
Donor provides identification and demographic information
Donor reads information about blood donation (Educational material)
Donor consents to blood donation
Health history and limited physical examination
Health history questions asked by blood center staff
Blood pressure, pulse and hemoglobin levels are checked
Donation
Arm is cleansed
Blood is drawn (6-10 minutes)
Needle is removed
Recovery
Rest ~ 15mins
Snacks
Average donation process takes just under one hour

5. Issues for consideration
Proposed “Written Statement of Understanding” for Whole Blood donors
Content
How to administer
When to administer
Does not include informed consent for research studies.
Including collection of repository samples.

6. Donor consent: Current status

7. FDA requirements or recommendations
Source Plasma
21CFR
“Guidance on Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs”
Plateletpheresis and plasmapheresis
21 CFR (c) and 21CFR (b)
“Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods”
Apheresis red blood cell donations
“Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods

8. AABB Standard for Donor Consent
Obtained on the day of donation and presented in understandable terms
Information provided regarding:
Risks of the procedure.
Tests performed to reduce the transmission of infectious diseases to the allogeneic recipient.
An opportunity provided to ask questions and to give or refuse consent for donation.
AABB. Standards for Blood Banks and Transfusion Services. 27th ed.

9. Advisory Committee for Blood Safety and Availability: December 2008
Donor consent is generally adequate but lacks consistency.
Include in consent forms
The effects of repeat donation on the donor population.
The gender specific effects of iron deficiency on donors.
The effects of collecting blood from anemic men using current donation thresholds.
The disproportionate prevalence of adverse events in the youngest donors.
Consider
The method and frequency of effective informed consent for repeat donations

10. FDA Proposed Rule: Written Statement of Understanding

11. “Written Statement of Understanding” - definition
The term “Written Statement of Understanding” is used as a general term to differentiate it from informed consent for research as defined in 21CFR 50.25

12. 2007 Proposed Rule: WSU
The donor has received and reviewed the educational material.
The donor agrees not to donate if the donation could result in a potential risk to the safety, purity, or potency of the blood supply.
A sample of the donor’s blood will be tested for specified relevant transfusion-transmitted infections and for syphilis.

13. 2007 Proposed Rule: WSU
If any of the tests is reactive, the sample of blood will be tested further.
If the donation is determined to be not suitable or if the donor is deferred from donation, the donor’s record must identify the donor as ineligible to donate and the donor must be notified.
The hazards and risks of the donation procedure are explained.
The donor has the opportunity to ask questions and withdraw consent at any time.

14. 2007 Proposed Rule: WSU
Blood establishments would need to provide and ensure that the written statement to the donor:
Is read and signed before each donation.
Is written in clear terminology.
Does not include language that would waive any of the donor's legal rights.
FDA rulemaking is not intended to preempt state laws regarding donor consent for minors.

15. Proposed Rule: WSU Representative comments from industry
Agreement that donors should be adequately informed about the blood donation process and that there should be documentation that the donor has been so informed.
Concern about how signature will be obtained.
Consider electronic acknowledgement.
Provide guidance that provides recommendations for compliance with this rule.

16. Proposed Rule: Written Statement of Understanding:
Selected elements
Educational materials
Risks and hazards of donation

17. WSU: Educational materials
AABB introduced educational materials in 1984.
Current FDA recommendations for HIV education published in the 1992 memorandum.
Incorporated into the AABB educational materials.
AABB educational material version 1.3

18. WSU: Educational materials
Information about the behaviors that increase risks of relevant transfusion-transmitted infections.
Signs and symptoms of such infections, and the consequent risk to the safety of the blood and blood component.
Instructions for donors to self-defer if they determine that they have participated in an increased-risk behavior for, or show signs or symptoms of that relevant transfusion-transmitted infection.

19. WSU: Educational materials
This information may be provided in oral, written, or multimedia form in a manner designed to be understood by the donor.
FDA may provide additional guidance in the future.

20. WSU: Risks and hazards of Blood donation
About 3 – 10% of blood donors will experience an adverse reaction
Eder A et al. Transfus Med Rev Jul;23(3):
Severe adverse donor reaction rate in 2008 = 0.09% collection procedures
Whitaker BI et al. The 2009 National Blood Collection and Utilization Survey (presented at the 2010 AABB meeting)

21. Risks and hazards of Whole Blood donation
Minor
Major
Long term
Dizziness
Presyncope
Bruises
Hematomas
Allergic
Syncope with loss of consciousness or injury
Nerve damage
Arterial puncture
Iron deficiency with or without anemia

22. Risks and hazards of blood donation
Study: Post donation interview of 1000 Whole Blood donors
% donor reaction rate
AEs = Adverse effects
Arm injuries
Systemic reactions
Total AEs
Bruise
Sore arm
Hematoma
Sensory changes
Fatigue
Vasovagal
Nausea
and vomiting
36.1
22.7
10.0
1.7
0.9
7.8
5.3
1.1
Newman et al. Transfusion May;43(5):

23. American Red Cross: 2006 hemovigilance data
Rates of complications associated with
allogeneic Whole Blood donation
~ 6 million whole blood donations
~ 349 complications/ 10,000 donations
Major reaction rate (7.4/10,000)
Most complications were minor
Hematomas (~75/10,000)
Presyncopal (~258/10,000)
Eder et al. Transfusion Sep;48(9):

24. Blood donor fatalities
FDA donor fatality reports: FY 2005 through FY 2009.
In 2009,
Whole blood fatalities
2 cases - donation ruled out
1 case - donation not ruled out but no causal relationship
Availability/ReportaProblem/TransfusionDonationFatalities

25. Questions for the committee
Please comment on the seven proposed elements of the written statement of understanding as listed in FDA’s 2007 proposed donor eligibility rule.
Does the Committee agree that the data support a need for minimum standards for the explanation of the risks and hazards of Whole Blood donation to the donor?
Please comment on what methods are acceptable for presenting the written statement of understanding to the donor, and how the donor should acknowledge receipt of this statement.

26. Questions for the committee
Please comment: When should blood establishments administer the written statement of understanding?
Before donor questions?
Before physical examination?
Before phlebotomy?
Please comment: How often should blood establishments administer the written statement of understanding to Whole Blood donors?

27. Speakers
Christine Grady, MSN, PhD : National Institutes of Health. Clinical Center
An overview of informed consent
Beth Shaz, M.D.: New York Blood Center
Evaluation of informed consent forms for adults and minors for whole blood donation used by United States blood centers.
Ronald Domen, M.D.: Penn State Milton S. Hershey Medical Center
The informed consent process in whole blood donation.