The Informed Consent Process in Whole Blood Donation Lindsay A. Alaishuski, MD; Rodney D. Grim, MA; Ronald E. Domen, MD

● Context.—Informed consent in transfusion medicine has been an area lacking of significant research and it is unknown if donors fully comprehend the risks associated with whole blood donation. Objective.—To assess the adequacy of the informed consent process in whole blood donation. Design.—A brief questionnaire was constructed and distributed to whole blood donors visiting various fixed and mobile donor sites of the Central Pennsylvania Blood Bank. Questions consisted of demographic information; donor opinions of information content, length, and comprehension; and a short quiz pertaining to donor risks and eligibility. Results.—Analysis of 849 surveys demonstrated that donors comprehended a mean of 73.5% of the various donor eligibility and risks that were surveyed. Female and younger donors scored statistically higher on comprehension questions compared with male and older counterparts. Donors were most aware of (1) donor eligibility requirements

related to acquired immunodeficiency syndrome comprehension, (2) the risk of dizziness postdonation, and (3) having lived in a certain country (93.7%–95.6% comprehension, respectively). Donors were least aware of (1) the risk of a possible referral to a physician for outstanding medical conditions or positive test results, (2) the risk of a positive test result, and (3) West Nile virus testing information (22.4%–49.3% comprehension, respectively). Conclusions.—Whole blood donors believed that they were giving informed consent, but a significant percentage of donors were unaware of several of the risks associated with blood donation, including participation in West Nile virus research testing. Our data suggest that donors do not fully comprehend the risks of whole blood donation and that repetition of information to the donor, and in multiple formats, strengthens the level of comprehension and thus the informed consent process. (Arch Pathol Lab Med. 2008;132:947–951)

T

United States has a long history that dates back to 1914 with the legal case of Schloendorff v Society of New York Hospital.2,3 This case defined the right of competent adults to determine what can be done to their bodies. A number of subsequent legal cases further defined the concept of informed consent but it was not until 1957 in the case of Salgo v Leland Stanford, Jr University Board of Trustees that informed was connected to consent and that there was a duty to disclose alternatives to patients undergoing medical interventions.2,3 The legal and ethical duty to obtain informed consent from patients prior to medical treatments and interventions is a normal part of the practice of medicine today. The major elements of informed consent consist of disclosure (sharing material information), comprehension (ability to understand information), voluntariness (freedom to make decisions), competence (ability to make decisions), and consent (decision and authorization).3,4 The Code of Ethics of the American Association of Blood Banks does not explicitly mention ‘‘informed consent.’’ 5 The Code of Ethics of the International Society for Blood Transfusion does stipulate that the donor ‘‘should provide informed consent to the donation of blood or blood components’’ and, furthermore, that the donor ‘‘should be advised of the risks connected with the procedure.’’ 6 The Code of Ethics of the American Medical Association only addresses donor informed consent in the context of umbilical cord blood donation in which the parents of the infant should be ‘‘fully informed of the risks of the donation and written consent should be obtained.’’ 7 The AABB Standards8 requires that ‘‘the consent of all do-

he statement that a whole blood donor is required to sign prior to the collection of blood in the United States has evolved during the past 60 years from a ‘‘release’’ type of statement to something more like ‘‘consent’’ verbiage. The donor release statement developed by the American Red Cross at the inauguration of their blood program in 1941 was more of a legal document that stated that virtually no one involved in the collection process was ‘‘in any way responsible for any consequences to me resulting from the giving of such blood or from any of the tests, examinations or procedures incident thereto.’’ 1 The current donor consent is more likely to stipulate that donors have reviewed and understand the written materials presented to them and that they could be placed on a deferral registry should they test positive for an infectious disease marker. The donor is generally held accountable for comprehending the process. The concept of informed consent in medicine in the Accepted for publication December 5, 2007. From Penn State University College of Medicine, Hershey (Dr Alaishuski); the Emig Research Center, York Hospital, York, Pa (Mr Grim); and the Department of Pathology, Penn State University College of Medicine, Milton S. Hershey Medical Center, Hershey (Dr Domen). Dr Alaishuski is now with the Family Practice Center, Banner Good Samaritan Medical Center, Phoenix, Ariz. The authors have no relevant financial interest in the products or companies described in this article. Reprints: Ronald E. Domen, MD, Department of Pathology, H160, Penn State University College of Medicine, Milton S. Hershey Medical Center, 500 University Dr, Hershey, PA 17033 (e-mail: rdomen@psu. edu). Arch Pathol Lab Med—Vol 132, June 2008

Informed Consent in Blood Donation—Alaishuski et al

947

Table 1.

Donor Consent Statement*

I agree to WNV testing as described in the attached sheet (NRSIS). Yes No I, the undersigned, am voluntarily donating blood to be used by this Blood Bank as they decide. I certify that I have, to the best of my knowledge, truthfully answered questions regarding my health and medical history and understand that this information is important for my good health and that of the patient receiving my blood. I have reviewed and understand the information provided to me regarding the spread of communicable disease by blood or plasma. If I am potentially at risk for spreading disease, I agree not to donate blood or plasma for transfusion to another person or for further manufacture. I understand that my blood will be tested for antibodies to human immunodeficiency virus (HIV) and other disease markers. If this test indicates that I should no longer donate blood or plasma because of the risk of transmitting disease, my name will be entered on a list of permanently deferred donors and positive test results will be reported to me and appropriate health agencies as required by law. If instead, the result of testing is not clearly negative or positive, my blood will not be used and my name will be placed on a deferral list. My test results may be shared with other blood collection facilities.

Donor Signature Witness Date * WNV indicates West Nile virus; NRSIS, Nucleic Acid Amplification Technology Research Study Information Sheet.

nors shall be obtained before donation’’ and provides some guidance on the elements of the consent process. Blood collection by our regional blood center in south central Pennsylvania probably occurs similar to that in most other areas of the United States. Donors are given extensive written information regarding eligibility requirements and risks of donation and are asked to independently complete a form that asks specific medical history and other questions. In a private and confidential meeting with a staff member certain high-risk questions related to human immunodeficiency virus–acquired immunodeficiency syndrome are verbally asked of the donor. The donor may or may not be asked if he or she has any additional questions about the donation process. If there is a research test being investigated, for example West Nile virus (WNV) testing, the donor will be asked to read additional information specific to that research study. Most elements of the informed consent process would be expected to be addressed in the process outlined previously.3,4 Donors are given information about the donation process (disclosure), they are voluntarily making their donation (voluntariness), they are subjectively screened for their ability to make decisions (competence), and they give their written consent. Although whole blood donors give their ‘‘consent’’ for the collection of their blood, there are virtually no studies examining whether they understand the risks of donation, the eligibility criteria for whole blood donation, or other details of the donation process (ie, comprehension). This study was undertaken to primarily assess the level of comprehension of our whole blood donors with various aspects of the donation process. MATERIALS AND METHODS This study was approved by the institutional review board of the Penn State College of Medicine/Milton S. Hershey Medical Center. The Central Pennsylvania Blood Bank is the area’s regional blood center and collects blood at fixed and mobile donor sites in south central Pennsylvania for its member hospitals. Several member hospitals, including the Penn State Milton S. Hershey Medical Center (Hershey), also collect blood at their hospital-based donor centers in conjunction with the Central Pennsylvania Blood Bank. Approximately 5500 whole blood donations per month are made throughout the system; however, only those donors at the Central Pennsylvania Blood Bank’s fixed and mobile sites and the Penn State sites were asked to participate in the study. Donors at these sites participated in the customary screening process for whole blood donation. This entails reading 2 handouts, namely ‘‘Important Information for Blood Donors,’’ 948 Arch Pathol Lab Med—Vol 132, June 2008

and the ‘‘Nucleic Acid Amplification Technology Research Study Information Sheet’’ for WNV testing. The first handout outlines the donation process, the risks of donation, donor eligibility and exclusion criteria, postdonation events, information on human immunodeficiency virus transmission, and donor center contact information. A separate WNV research handout outlines study procedures, risks, benefits, confidentiality, and researcher contact information. Allogeneic donors are not permitted to donate unless they agree to undergo WNV research testing. After reading the handouts donors are asked to fill out the donor form, consisting of yes/no check-off questions, regarding their past and present medical conditions, prescription drug use, and habitation in certain countries. Donors then meet individually and privately with blood center staff for an assessment of vital signs and hematocrit testing. During this confidential session, donors are verbally asked questions related to high-risk activities related to sexually transmitted diseases and intravenous drug use. Donors are also verbally asked if they have ‘‘read and understood all of the donor information presented’’ to them and if their ‘‘questions [have] been answered.’’ Donors are then asked to sign the consent for donation and WNV testing. The consent in place at the time of this study is shown in Table 1. A brief, 1-page questionnaire (Table 2) was constructed with questions regarding demographic information (section 1), and donors were asked for their self-assessment on the content, length, and comprehension of the donor information presented to them (section 2). Section 3 of the donor survey consisted of a ‘‘quiz’’ to test the donor’s knowledge of factual information related to the donation process that had been provided in the written and verbal information. To ensure validity, the survey was constructed with the help of a statistician in the Department of Health Evaluation Services in the Penn State University College of Medicine. Surveys were randomly distributed during the course of approximately 8 to 10 months to donors during their donation and then collected at the completion of donation. Participation in the study was voluntary and donors had the option not to participate and still donate. No attempt was made to specifically target firsttime versus repeat donors. Surveys were collected by donor personnel without donor identifying information and returned to the principal investigator. Donors opting out of participating were not tracked. Survey data were scored and compiled using Microsoft Excel. Nonparametric tests, including chi-square, MannWhitney U, and Kruskal-Wallis and Spearman rho, were performed to analyze the data.

RESULTS A total of 851 surveys were returned and 849 were completed and able to be analyzed. The average donor age was 45.7 years (⫾15.1 years). Males comprised 54.4% of the donors and females 45.6%. First-time donors were Informed Consent in Blood Donation—Alaishuski et al

Table 2.

Donor Survey

Please checkmark answers or fill in blanks. Thank you! Section 1 1. Sex: □ Male 2. Age:

□ Female (please write in age)

3. Highest education completed: □ Less than high school

□ High school

□ College

4. First time donor? □ Yes □ No If ‘‘No,’’ number of times donated in past 2 years:

□ Graduate or more

(please write in number)

Section 2 1. The content of the donor information I was instructed to read before donation is □ Too easy □ Just right □ Too difficult 2. The length of the donor information I was instructed to read before donation is □ Too short □ Just right □ Too long

to read.

to read.

3. After reading the information provided to me and having any questions I had answered by staff members, I fully comprehend the risks and benefits of the blood donation process. □ Strongly disagree □ Disagree □ Agree □ Strongly agree Section 3 1. A person can donate blood every □ 45 □ 56 □ 65

days.

2. The following are reasons a person may not be eligible to donate (check all that apply): □ Too young □ Recent vaccination □ Too old □ Taking a certain medicine (such as Propecia) □ Too low blood count □ Weigh too much □ Blood pressure too high □ Weigh too little □ Blood pressure too low □ Lived in a certain country 3. If a person has the AIDS virus, he or she can give it to someone else even though he or she may feel well and have a negative HIV test. □ True □ False 4. If a person chooses not to participate in the West Nile virus testing today, he or she could still donate blood today at this center. □ True □ False 5. Possible risks of donating blood for a donor are: (check all that apply) □ Bruising □ Sore arm □ Fainting □ Obtaining a positive infectious disease (HIV, hepatitis) blood test □ Dizziness □ Referral to a physician for an outstanding medical condition □ Fatigue □ A person’s name placed on a blood donor deferral registry * AIDS indicates acquired immunodeficiency syndrome; HIV, human immunodeficiency virus.

6.7% of the total. In the past 2 years 10.4% donated 0 times; 24.3%, 1 to 3 times; 24.6%, 4 to 6 times; 10.6%, 7 to 9 times; and 13.5%, 10 to 12 times. Forty-seven percent of participating donors had a high school education, and 48.6% had college or higher education. Section 2 of the survey contained questions regarding the donor’s self-assessment and satisfaction of content, length, and comprehension of the donor information presented to him or her. Table 3 details the responses to section 2 of the survey. Donors were generally satisfied with the content and length of donor information and also indicated that they understood the material presented to them. Chi-square analysis comparing satisfaction levels between first-time and repeat donors’ opinions on content and comprehension was not statistically significant (P ⫽ .48 and P ⫽ .13, respectively). However, there was a significant difference between repeat donors and first-time donors in their assessment of the length of the donor information. Repeat donors felt that the length was too long as compared with first-time donors (P ⫽ .001). Questions 1 through 5 of section 3 of the survey were tallied to create a ‘‘quiz score’’ of comprehension. Each Arch Pathol Lab Med—Vol 132, June 2008

Table 3. Donor Opinions of Informed Consent Process (Table 2, Section 2, Questions 1 Through 3) Topic

Content Length Comprehension

Response

Percentage

Too easy Just right Too difficult Too short Just right Too long Strongly disagree Disagree Agree Strongly agree

1.8 97.5 0.7 0.1 81.3 18.6 2.3 1.2 56.7 39.8

correct response was awarded 1 point and there was a total of 21 possible points. The mean total quiz score for all donors was 15.3. The histogram of donor quiz scores revealed a non–bell-shaped curve with outliers on the left tail-end of the curve. The outliers contained questions that were left blank and caused the low scores, and it was assumed that donors chose not to answer these questions. Informed Consent in Blood Donation—Alaishuski et al

949

Table 4.

Topics of Donor Eligibility and Risks (Table 2, Section 3, Questions 1 Through 5)

Question Topic

Percent Correct

Lived in a certain country 95.6 Dizziness risk 95.3 AIDS* comprehension 93.7 Taking a certain medication 92.3 Fainting risk 90.1 Weigh too much 85.5 Bruising risk 84.0 Weigh too little 83.5 Sore arm risk 80.8 Recent vaccination 80.1 Too old 79.0 Blood pressure too low 77.6 Too low blood count 76.4 Blood pressure too high 76.3 Fatigue risk 73.5 Too young 71.5 Days between donation 62.3 West Nile comprehension 49.3 Deferral list risk 32.3 Positive test result risk 28.1 Referral to physician risk 22.4 * AIDS indicates acquired immunodeficiency syndrome.

These unanswered questions were scored as incorrect responses. Outliers were included and nonparametric statistical testing was performed. Mann-Whitney U tests demonstrated that female donors scored significantly better than male donors (median quiz score of 16 vs 15, respectively; U ⫽ ⫺2.36, P ⫽ .02). No significant difference between scores was observed between educational levels (P ⫽ .23). Spearman rho demonstrated a significant correlation between quiz score and age (r ⫽ ⫺0.226, P ⬍ .001), but no relationship was observed with the number of times donated (r ⫽ 0.054, P ⫽ .15). The Kruskal-Wallis test of the donors’ self-assessment of comprehension (Table 2, section 2) with their actual quiz score (ie, comprehension) demonstrated a significantly higher quiz score for those donors reporting that they ‘‘strongly agree’’ to understanding the risks and benefits of donation compared with those who reported ‘‘agree’’ (P ⫽ .003). Only 39.8% of our donors indicated that they ‘‘strongly agree’’ to comprehending the risks and benefits of donation. Each quiz question (Table 2, section 3) was analyzed individually to determine the percentage of correct responses by all survey participants (Table 4). The percentage of correct responses ranged from 22.4% to 95.6%. Greater than 90% of donors comprehended that dizziness or fainting are risks of donation, that certain medications affected donor eligibility, that having lived in certain countries can affect eligibility, and that acquired immunodeficiency syndrome could potentially be spread even if they felt well and had a negative human immunodeficiency virus test. Less than 50% of donors, however, seemed to not fully comprehend the WNV testing research study, that they could potentially be placed on a blood donor deferral registry, that they could obtain a positive infectious disease blood test, or that they could be referred to a physician for additional evaluation. COMMENT To our knowledge our study is the first to address multiple levels of comprehension of donor informed consent in a large cohort of whole blood donors. This study dem950 Arch Pathol Lab Med—Vol 132, June 2008

onstrates that a large proportion of survey respondents were incorrect with their comprehension of the risks and eligibility requirements of whole blood donation. This is especially concerning because the majority of those donors who completed the surveys were repeat donors. Most respondents were aware of risks such as dizziness, fainting, or bruising, but risks such as referral to a physician or placement on a deferral registry were understood by less than one third of donors. This suggests that donors are perhaps more aware of some of the immediate risks of donation but are not as aware of some of the more consequential risks that may have long-term effects or that may cause additional expense for physician follow-up and additional medical studies. No attempt was made to ‘‘rank order’’ the adverse consequences of donation because we consider all of the areas covered by the survey to be important components of the informed consent process for donation. Most, but not all, of the risks and eligibility requirements listed in Table 4 were presented to the donor in written or oral formats prior to donation and it is unclear why donors had better comprehension of some risks rather than others. Possible referral to a physician, for example, is not addressed in any of the written or oral formats presented to the donor prior to donation so it is understandable that donors scored low on this risk. The low score on ‘‘obtaining a positive infectious disease blood test’’ as a possible risk of donation may be because of a poorly worded question as donors are aware that their blood will be tested for certain infectious diseases. This question was meant to refer to obtaining a false-positive test but may have been interpreted differently by the survey respondents. However, obtaining a false-positive infectious disease test (and the possible related consequences) is not discussed in the materials presented to the donor prior to donation. Uncertainty about the WNV testing was somewhat of a surprise because donors are required to read a separate information sheet about this research study. Acquired immunodeficiency syndrome comprehension and living in certain countries are the only 2 areas that were surveyed that are mentioned in all 3 areas of the donor materials: the written information given to donors to read, the questionnaire or donor history form that donors independently fill out, and the oral questionnaire administered by donor center staff. This suggests that there is some strength in repetition and that donors may have better comprehension if topics and risks are presented multiple times using various methods of communication. Dizziness, taking certain prescription medications, and fainting are not presented in multiple formats but were correctly identified as potential risks by greater than 90% of donors. This could be because of its ‘‘clinical frequency’’ or because donors are aware of these risks through ‘‘experience’’ rather than through the donor information materials. How donor information and risks are organized and presented in written or oral formats may also be important in determining what donors comprehend, but presentation formats were not specifically addressed in this study. Only 2 previous studies have examined the informed consent process in donors. Sugarman and colleagues9 surveyed women who consented to umbilical cord blood donation by their infants. Those authors found a concerning lack of comprehension by participants in several areas of Informed Consent in Blood Donation—Alaishuski et al

the consent despite what appeared to be an optimal consent process. For example, one third of the participants in that study did not consider themselves to be participating in research, and many did not understand possible alternatives to donation or they misunderstood potential benefits.9 Another study by Lindstrøm and Røsvik10 focused on a few key areas of donor knowledge and found that how information is presented to donors can affect their level of understanding. They found that nearly 40% of blood donors were unaware of the term immunological window period in which they could be negative for the human immunodeficiency virus test, feel well, and still transmit the virus through blood donation.10 In our study, 93.7% of donors appeared to understand the underlying concept of the immunological window period although, in contrast to the study by Lindstrøm and Røsvik,10 that specific term was not used in our donor materials. Although our donors appear to be relatively satisfied with the current process of informed consent, it is evident that changes must be made in the current informative process to ensure that donors are indeed giving ‘‘informed’’ consent. Our study suggests that presenting information to the donor in multiple formats leads to greater comprehension of the donation process. We have also identified several areas in our consent process that could be improved: WNV testing information, the concept of falsepositive infectious disease tests and the potential associated ramifications, risks associated with being placed on a deferral list, and the potential referral to a physician for further medical or infectious disease test evaluations (and who bears the expense for such referrals), to name a few. Additional studies are needed from multiple centers to

Arch Pathol Lab Med—Vol 132, June 2008

further examine the informed consent process to optimize how, and what, information should be presented to donors to ensure that they fully comprehend what is being asked of them and what the potential risks are of the donation process.11,12 We thank Hung-Mo Lin, ScD, of the Penn State College of Medicine, Department of Health Evaluation Services for survey construction assistance and statistical planning and the staffs of the Central Pennsylvania Blood Bank and the Penn State Milton S. Hershey Medical Center Blood Bank for survey recruitment, distribution, and collection. References 1. Coates JB Jr, McFetridge EM, eds. Blood Program in World War II. Washington, DC: Department of the Army; 1964:139–141. 2. Sazama K. Practical issues in informed consent for transfusion. Am J Clin Pathol. 1997;107(suppl 1):S72–S74. 3. Domen RE. Medical ethics in transfusion medicine: a focus on the issue of informed consent. Blood Ther Med. 2000;1:11–16. 4. Domen RE, Smith ML. Confidentiality and informed consent issues in transfusion medicine. In: Macpherson CR, Domen RE, Perlin TM, eds. Ethical Issues in Transfusion Medicine. Bethesda, Md: AABB Press; 2000:39–54. 5. AABB code of ethics. Available at: http://www.aabb.org. Accessed on March 15, 2007. 6. Beal R. The International Society for Blood Transfusion and a code of ethics for blood donation and transfusion (2000). Vox Sang. 2002;82:165–166. 7. American Medical Association. Council on Ethical and Judicial Affairs: Code of Medical Ethics. Chicago, Ill: AMA Press; 2005:68. 8. Silva MA, ed. AABB Standards. 24th ed. Bethesda, Md: AABB Press; 2006: 16. 9. Sugarman J, Kurtzberg J, Box TL, Horner RD. Optimization of informed consent for umbilical cord blood banking. Am J Obstet Gynecol. 2002;187:1642– 1646. 10. Lindstrøm TC, Røsvik A. Ambiguity leads to uncertainty: ambiguous demands to blood donors. Scand J Caring Sci. 2003;17:74–77. 11. Domen RE. Ethical issues in transfusion medicine: the safety of blood and hematopoietic stem cell donation. Curr Hematol Rep. 2005;4:465–469. 12. Domen RE, Sazama K. Informed consent: the donor perspective. In: Stowell CP, Sazama K, eds. Informed Consent in Blood Transfusion and Cellular Therapies: Patients, Donors, and Research Subjects. Bethesda, Md: AABB Press; 2007: 113–137.

Informed Consent in Blood Donation—Alaishuski et al

951