1 Donor’s Written Statement of Understanding Beth H. Shaz, MD Chief Medical Officer New York Blood Center Clinical Associate Professor Emory University School of Medicine

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3 Blood collection Is done under the supervision of a licensed physician Has known risks

4 What guidelines exist AMA Code of Ethics AABB Code of Ethics AABB Standards for Blood Banks and Transfusion Services CMS Guidelines for Informed Consent FDA CBER Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs FDA Guidance for Institutional Review Boards and Clinical Investigators: A Guide to Informed Consent

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6 Informed consent process Informed consent is more than simply getting a patient to sign a written consent form. It is a process of communication between a patient and physician that results in the patient's authorization or agreement to undergo a specific medical intervention. In the communications process, you, as the physician providing or performing the treatment and/or procedure (not a delegated representative), should disclose and discuss with your patient: The patient's diagnosis, if known; The nature and purpose of a proposed treatment or procedure; The risks and benefits of a proposed treatment or procedure; Alternatives (regardless of their cost or the extent to which the treatment options are covered by health insurance); The risks and benefits of the alternative treatment or procedure; and The risks and benefits of not receiving or undergoing a treatment or procedure. In turn, your patient should have an opportunity to ask questions to elicit a better understanding of the treatment or procedure, so that he or she can make an informed decision to proceed or to refuse a particular course of medical intervention. topics/informed-consent.page#

7 AABB Standards for Blood Banks and Transfusion Services, 27 th edition Standard 5.2 Information, Consents and Notifications –Elements of the donation procedure shall be explained to the prospective donor in understandable terms. The explanation shall include information about risks of the procedure, tests performed to reduce the risks of transmission of infectious diseases to the allogeneic recipient and requirements to report donor information, including test results, to state or local health departments. The donor shall have an opportunity to ask questions and have them answered and to give or refuse consent for donation. In the case of a minor or a legally incompetent adult, consent shall be addressed in accordance with applicable law.

8 Major elements of informed consent process Disclosure –Sharing material information Comprehension –Ability to understand information Voluntariness –Freedom to make decisions Competence –Ability to make decisions Consent – Decision and authorization Arch Pathol Lab Med 2008;132:

9 Four essential elements of informed consent 1. The reason for, the nature and purpose of, the risks and potential consequences of, the benefits from, and any feasible alternatives to the procedure; 2. The extent, limits, and mechanisms used to maintain confidentiality; 3. Who to contact with questions; and 4. That participation is voluntary and discontinuation is possible at any time without penalty.

10 What are the risks of whole blood donation TRANSFUSION 2008;48:

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13 Goal of study Investigate use, nature and content of informed consent and related materials for whole blood donation Transfusion Jun;49(6):

14 Materials and methods Collection of informed consents and related documents –Blood collection establishments were identified by the AABB and America’s Blood Centers’ Web sites as of 12/1/2007 –Random selection was used to contact establishments –Documents also obtained from the internet or requested Transfusion Jun;49(6):

15 Definitions Informed consent form (ICF): Paper document that was signed by the prospective donor prior to donation Parental consent form (PCF): Paper document the parent or guardian signed to establish proof of permission for the minor to donate General information forms (GIF): Any paper documents that were specifically referred to for reference purposes in the ICF or PCF Transfusion Jun;49(6):

16 Scoring of documents Based on guidance by the FDA and CMS on informed consent for surgical procedures, research subjects and source plasma donors, we determined which elements should be contained All forms were scored independently and differences were reconciled If a single blood establishment used the same forms in multiple states, the forms were only scored once Transfusion Jun;49(6):

17 Guidance and guidelines

18 Transfusion Jun;49(6): The four common essential elements to all consent forms included: 1) the reason for, the nature and purpose of (2 points), the risks and potential consequences of (4 points- 1 point for each of the four most common adverse events, including vasovagal reactions, hematoma and bruising, fatigue, and infection at the site of puncture), the benefits from (2 points), and any feasible alternatives to (as there are no alternatives for blood donation, this element was not scored, 0 points), the procedure; 2) the extent, limits and mechanisms used to maintain confidentiality (4 points total and only 2 points if confidentiality is solely mentioned in the context of infectious disease testing); 3) who to contact with questions (4 points), and 4) that participation is voluntary (2 points) and discontinuation is possible at any time without penalty (2 points). These elements were scored (total 20 points) on ICFs and PCFs and their related GIFs. Common essential elements

19 Transfusion Jun;49(6): An additional set of elements included: 1) description of the procedure: pre/post donation (1 point), donor eligibility/ donor screening (1 point), and estimated time for donation (1 point); 2) infectious disease testing: general statement regarding infection disease testing (1 point), testing for HIV/AIDS (1 point), testing for hepatitis B and C (1 point), reporting positive result to the donor and/or parent (1 point); 3) contact information to report injury (1 point); 4) information regarding donor deferral (1 point); 5) information regarding potential additional medical expenses and/or treatment (1 point); and 6) documentation of the consent by parent/guardian or donor signature on the consent (1 point). These elements were scored (total 11 points) on ICFs and PCFs and their related GIFs. Specific blood donation elements

20 Transfusion Jun;49(6): PCFs should have a number of related and likely important elements such as permission to allow outside medical treatment or emergency transport in the event of a serious reaction. Thus, the authors sought to determine if some of the standard elements of a school field trip consent form that could relate to the blood donation itself or the blood donation process were included in the PCFs under investigation. By identifying and reviewing a number of school field trip consent forms on the internet, a list of the critical components for PCFs was created by the authors. These specialized aspects, which are exclusive of the elements listed for scoring above, include 3 key elements: 1) explanation of the duration of consent (1 point if a consent included a statement such as “this consent is no longer required on your child’s 18th birthday”); 2) parent contact number at the time of donation (1 point), and 3) authorization for medical treatment in case of an emergency (1 point). Unique minor age donor elements

21 Transfusion Jun;49(6): different informed consents with related materials were included 21 ICFs and 37 PCFs 9 hospital-based, 39 community-based and 10 multistate blood collection centers ICFs and PCFs were collected from 48 states Blood establishment forms surveyed represented >90% collected in the US Results

22 Transfusion Jun;49(6): ElementDetailICF (n=21) PCF (n=37) Purpose of donationPurpose of the consent form100% Risks and potential consequences Light-headed/dizziness/ loss of conscience38%51% Bruising/ hematoma33%54% Weakness/fatigue0%5% Infection at site of puncture24%30% Description of any benefits Benefits of donating0%51% Statement describing the extent of confidentiality of records Confidentiality of donor records33%28% Explanation of whom to contact for answers to pertinent questions Contact number for questions/injuries14%62% Statement that participation is voluntaryParticipation is voluntary81%49% Statement that refusal to participate will involve no penalty or loss of benefits/ Statement that the subject may discontinue participation at any time without penalty Ability to withdraw and not continue with the donation process 29%11% Common essential elements

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24 Transfusion Jun;49(6): Specific blood donation elements ElementDetailICF (n=21) PCF (n=37) Description of the procedurePre/post donation process14%51% Pre-screening/eligibility10%38% Estimated time for donation0%24% Infection disease testingGeneral statement about ID testing95%62% Statement that blood will be tested for HIV/AIDS 81%68% Statement that blood will be tested for Hepatitis B and C 62%46% Discovery of a positive ID test reported to donor and/or parent 71%73% Explanation of whom to contact in the event of an injury Contact number in case of injury10%5% Anticipated circumstances under which participation may be terminated Causes of deferral (Permanent or temporary) 62%24% Any additional costs to that may resultAdverse events or positive ID test may result in additional expenses and physician examinations for outside treatment. 10%8% Written consent form approved by the IRB and signed and dated by subject or subject's legally authorized representative Signature on the consent form100%

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26 Transfusion Jun;49(6): Unique minor age elements ElementPCF (n=37) Length of period consent is valid100% Parent contact number documented on the consent form 54% Acknowledgement on the form consenting for medical treatment in case of an emergency by parent 3%

27 Study limitations A number of limitations include that: 1) the investigators were not blinded to the blood center name when evaluating ICFs and PCFs; 2) the scoring system used was subjective and not previously employed in others studies or validated; 3) the investigators could not evaluate the entire informed consent process; 4) some of the informed consents were downloaded from the internet and therefore may not be accurate or the most current version used at the blood center; and 5) the use of the research informed consent essential elements as the model for the essential elements for whole blood donation. Some of the elements of the research consent may not directly applicable to whole blood donation. These elements include the individual will not have direct benefit (which at times is true in the research setting), and there are not alternatives to whole blood donation (with the possible exception of blood component collection by apheresis). Nonetheless, the investigators believe that the data are important and timely, and that key conclusions can be drawn and recommendations made.

28 Study recommendations Most parental consent forms and informed consent forms with the related general information forms do not contain the majority of the common essential or specific blood donation elements Recommend an intervention to remedy this, such as nation-wide task force to make recommendations