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The Journal of Emergency Medicine, Vol. 34, No. 3, pp. 269–275, 2008Copyright © 2008 Elsevier Inc.

Printed in the USA. All rights reserved0736-4679/08 $–see front matter

doi:10.1016/j.jemermed.2007.06.026

OriginalContributions

IMPACT OF DETAILED INFORMED CONSENT ON RESEARCH SUBJECTS’PARTICIPATION: A PROSPECTIVE, RANDOMIZED TRIAL

Catherine A. Marco, MD

Department of Emergency Medicine, St. Vincent Mercy Medical Center, Toledo, OhioReprint Address: Catherine A. Marco, MD, Department of Emergency Medicine, St. Vincent Mercy Medical Center, 2213 Cherry St.,

Toledo, OH 43608-2691

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Abstract—This study was undertaken to measure poten-ial research subjects’ participation in a survey researchesign, based on level and type of informed consent re-uired before enrollment. In this prospective, randomizedrial, 300 eligible Emergency Department participants wereandomized to one of three groups: verbal consent (n �00), limited written consent (n � 100), and detailed writtenonsent with signature (n � 100). The consent was relatedo a self-administered patient satisfaction survey. The pri-ary outcome was level of participation, where participa-

ion was categorized as full, limited, or refusal. Ninety-fiveercent confidence intervals (CI) constructed about propor-ions were used to assess differences in participation ratesetween the three consent groups. Among 300 participants,o demographic differences were found between groups forge or gender. Participants who were randomized to com-lete the detailed written consent had a significantly lowerate of full participation (72%) when compared to thoseandomized to verbal consent (85%; mean difference be-ween groups 13%, 95% CI 2% to 24%) and to those withimited written consent (84%; mean difference betweenroups 12%, 95% CI 1% to 23%). Participants randomizedo detailed written consent also had a significantly higherefusal rate (23%) when compared to those in the limitedritten group (12%; mean difference between groups11%, 95% CI �21% to �1%). The length and type of

Presented in part at the Mercy Health Partners Researchymposium, Toledo, Ohio, February 2005.This study was supported in part by a grant from the Medical

ollege of Ohio, Toledo, Ohio.

ECEIVED: 17 October 2005; FINAL SUBMISSION RECEIVED:

CCEPTED: 11 February 2007

269

nformed consent required affected potential research sub-ect participation in a survey research design. Participantsho were asked to sign a detailed written informed consentocument had a lower rate of participation compared tohose with verbal or limited written consent. © 2008lsevier Inc.

Keywords—research; informed consent

INTRODUCTION

he doctrine of informed consent is a fundamental prin-iple of the US legal system, introduced by case law in957. The term delineates the relationship between thehysician and patient. Informed consent and refusal ofreatment are recognized as significant legal and ethicalights of patients (1). All adults with decisional capacityave the right to consent to, or refuse medical care (2).lthough physicians possess the ability to make diag-oses and recommend treatment, it is presumed that theatient is most capable of deciding whether the proposednterventions are compatible with his or her value sys-em. Informed consent represents one of the most fun-amental rights of patient autonomy in medical decision-aking (3–8). The doctrine of informed consent also is

n important component of autonomy among researcharticipants (9,10). A literature search did not identifyny publications regarding the ideal length of informedonsent to improve research subjects’ understanding and

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270 C. A. Marco

illingness to participate in studies (PubMed Nationalibrary of Medicine, keywords: consent, research).

This study was designed to directly measure the im-act of the length and type of informed consent for atandardized research survey, and to determine partici-ation of potential research subjects based on lengthlimited written, detailed written) and type (verbal, writ-en) of informed consent.

METHODS

tudy Design

his study was a prospective, randomized, controlledrial.

tudy Setting and Population

his study was conducted at St. Vincent Mercy Medicalenter (Toledo, Ohio), a university-affiliated institutionith an Emergency Department (ED) census of 59,000.he study was approved by the St. Vincent Mercy Med-

cal Center Institutional Review Board.Eligible participants included adult ED patients, aged

8 years and over, and those accompanying them. Par-icipants were recruited as a convenience sample, when aesearch assistant was available to enroll participants.xclusion criteria included patients who chose not toarticipate and those who could not complete the survey.dditionally, patients who were obviously ill, or in sig-ificant pain or other type of distress were excluded fromarticipation.

tudy Protocol

n this prospective, randomized trial, 300 eligible EDarticipants were randomly assigned (by computer-gen-rated randomization list) to one of three groups, eachith 100 per group: verbal consent, limited written con-

ent, and detailed written consent with signature. Forarticipants randomized to verbal consent, the followingerbal script was used by the research assistant: “We areoing a research study on patient satisfaction. Would youe willing to fill out a questionnaire?” For participantsandomized to limited written consent, they received aover letter including four brief paragraphs with infor-ation about the study, voluntary participation, and

ights as a research subject. No signature was requiredAppendix 1). For participants randomized to detailedritten consent with signature, they received a three-

age consent document including details regarding w

ights, risks, alternatives, and privacy; a witnessed sig-ature was required (Appendix 2). This study was pri-arily designed to measure the impact of length of

onsent on potential subjects’ participation. The associ-ted patient satisfaction survey was designed as a sec-ndary measurement.

Medical care of patients was not altered. If patientsere called to the treatment area, the study protocol was

esumed at a subsequent waiting time during the treat-ent period.

easurements

ata were collected by a single trained research assistant.articipants completed the consent, as well as a self-dministered survey entitled “Emergency Departmentatient Satisfaction Survey.”

Data collected included age, gender, ethnicity, con-ent group of randomization, and category of participa-ion (full participation, limited participation, or refusal toarticipate). The primary outcome measures were ratesf participation among the three groups. Additionally,uestions and comments from potential subjects wereecorded.

ata Analysis

reliminary power analysis demonstrated that with 100ubjects per group, there was at least 80% power, at 1.7%ype I error (adjusted for multiple comparisons), to detectoderate differences between groups (e.g., 75% vs.

3%, or 20% vs. 41%).Ninety-five percent confidence intervals (CI) con-

tructed around means and proportions were used tossess group differences. CIs are presented as loweround to upper bound. Statistical analyses were donesing SAS version 8.0 (SAS Institute Inc., Cary, NC).

RESULTS

he mean age of study participants was 40 years (range8–83 years). Sixty-one percent of participants wereomen; 52% of the participants were Caucasians. Sixty-

wo percent of participants were ED patients, and 38%ere accompanying an ED patient. No demographicifferences were found between groups for age or gen-er. There were more Caucasians in the detailed writtenonsent group (63%) compared to the verbal (44%) andhe limited written consent (50%) groups.

After initial agreement to participate, participants who

ere randomized to complete the detailed written con-

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Impact of Informed Consent 271

ent had a significantly lower rate of full participation72%) when compared to those randomized to verbalonsent (85%; mean difference between groups 13%,5% CI 2–24%) and to those with limited written con-ent (84%; mean difference between groups 12%, CI–23%). Participants randomized to detailed written con-ent also had a significantly higher refusal rate (23%)hen compared to those in the limited written group

12%; mean difference between groups �11%, CI �21o �1%) (Table 1).

DISCUSSION

articipation in research studies varies greatly. Severaltudies have previously identified factors that affect sub-ect participation, including physician rapport, physicianommunication skills, socioeconomic status, expectationf benefit, monetary payments, investigator conflict ofnterest, and privacy (11–15).

Informed consent for research is an important safe-uard to the rights of human subjects. Informed consentocuments should be appropriately worded, understand-ble, and should address multiple issues of importance tohe potential research subject, including an explanationf the purposes of research, duration of participation,escription of the study, risks, benefits, alternatives, con-dentiality, compensation, and information about volun-

ariness (16–25). In addition to the goals of making thenformed consent document understandable and com-lete, researchers also should strive to assist patients byriting documents that are understandable and manage-

ble to potential participants. The language of informedonsent is essential to ensuring the adequate informationelivery to potential research subjects. Informed consentocuments and discussion should be written and deliv-red at a reading level appropriate to the potential sub-ect. This may require some individual adaptation, par-icularly of the informed consent discussion.

Several recent reports indicate that a majority of pa-

able 1. Participation in a Research Study by Type of Inform

Study Group

Out

Full

erbal consent (group I) 85% (78–92%)imited written (group II) 84% (77–91%)etailed written (group III) 72% (63–81%)ifference group I–II 1% (�9–11)ifference group I–III 13% (2–24)*ifference group II–III 12% (1–23)*

Indicates significant difference between groups because CI do

ients prefer detailed information compared to abbrevi- h

ted information, when asked directly (26–28). Severalecent studies demonstrate that research subjects’ andatients’ understanding of detailed informed consent isoor (29–32). Many patients do not understand the pur-oses of informed consent documents for research (33).nother study demonstrates improved information reten-

ion with a short form, compared to a more detailed form34). Another recent study demonstrates that subjectsay be less willing to participate in a hypothetical studyhen explicit statistical information is presented, com-ared to abbreviated information (35). A similar studynds that patients are less willing to consent to radio-raphic procedures when written informed consent isequired (36).

There exist many unanswered questions about thedeal informed consent process, the ideal ways to appro-riately inform potential research subjects of risks andenefits in ways that improve understanding and reten-ion of information presented. A recent literature searchid not yield any previous publications addressing theirect impact of the type of consent required, and poten-ial research subjects’ participation.

imitations

his study has several important limitations. The dataresented are all collected from a single ED, and may note generalizable in other regions or other settings. Blind-ng of the research assistant was not feasible, and thisay have affected interpersonal interactions with partic-

pants. Literacy of participants was not assessed, and thisay have affected participants’ willingness to participateith written informed consent processes. Although the

tudy demonstrates that length and type of informedonsent does have an impact upon participation, this doesot have direct implications for change in the currentnformed consent process, which is designed to protect

nsent

Level of Participation % Participation (95% CI)

Limited Refused

1% (0–3%) 14% (8–21%)4% (0–8%) 12% (6–18%)5% (0–9%) 23% (15–31%)

�3% (�7–1) 2% (�7–11)�4% (�9–1) �9% (�20–2)�1% (�7–5) �11% (�21–�1)*

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272 C. A. Marco

CONCLUSIONS

he length and type of informed consent required af-ected potential research subject participation in a surveyesearch design. Participants who were asked to sign aetailed written informed consent document had a lowerate of participation compared to those with verbal orimited written consent.

cknowledgments—The author wishes to thank Nancy Fennuderer, MS, for her statistical expertise, and Jason Jones, BS,

or his assistance with data collection.

REFERENCES

1. Meisel A, Kuczewski M. Legal and ethical myths about informedconsent. Arch Intern Med 1996;156:2521–6.

2. In the Matter of Farrell, 108 N.J. 335, 529 A.2d 404 (1987).3. Prentice ED. Informed consent: the most important protector. Acad

Emerg Med 1999;6:774–5.4. Moskop JC. Informed consent in the emergency department.

Emerg Med Clin North Am 1999;17:327–40.5. Hansson MO. Balancing the quality of consent. J Med Ethics

1998;24:182–7.6. Young WF Jr. Informed consent. Ann Emerg Med 1997;30:350–1.7. Etchells E, Sharpe G, Walsh P, Williams JR, Singer PA. Bioethics

for clinicians: consent. CMAJ 1996;155:177–80.8. Faden RR, Beauchamp TL, King NMP. A history and theory of

informed consent. New York: Oxford University Press; 1998.9. National Commission for the Protection of Human Subjects of

Biomedical and Behavioral Research. The Belmont report. Avail-able at: http://hhs.gov/ohrp/humansubjects/guidance/belmont.htm.Accessed November 29, 2006.

0. Schmidt TA, Salo D, Hughes JA, et al.; SAEM Ethics Committee.Confronting the ethical challenges to informed consent in emer-gency medicine research. Acad Emerg Med 2004;11:1082–9.

1. Crotar D, Miller V, Willard V, Anthony K, Kodish E. Correlatedof parental participation during informed consent for randomizedclinical trials in the treatment of childhood leukemia. Ethics Behav2004;14:1–15.

2. Bentley JP, Thacker PG. The influence of risk and monetarypayment on the research participation decision making process.J Med Ethics 2004;30:293–8.

3. Kim SY, Millard RW, Nisbet P, Cox C, Caine ED. Potentialresearch participants’ views regarding researcher and institutionalfinancial conflicts of interest. J Med Ethics 2004;30:73–9.

4. Phipps E, Harris D, Brown N, et al. Investigation of ethnic differ-ences in willingness to enroll in a rehabilitation research registry:a study of the Northeast Cognitive Rehabilitation Research Net-work. Am J Phys Med Rehabil 2004;83:875–83.

5. Flory J, Emanuel E. Interventions to improve research participants’understanding in informed consent for research: a systematic re-view. JAMA 2004;292:1593–601.

6. Biros MH, Lewis RJ, Olson CM, et al. Informed consent in

emergency research. Consensus statement from the Coalition Con-

ference of Acute Resuscitation and Critical Care Researchers.JAMA 1995;273:1283–7.

7. Fish SS. Research ethics in emergency medicine. Emerg Med ClinNorth Am 1999;17:461–74.

8. Foex BA. The problem of informed consent in emergency medi-cine research. Emerg Med J 2001;18:198–204.

9. World Medical Association. Declaration of Helsinki. Ethical prin-ciples for medical research involving human subjects. Adopted bythe 18th WMA General Assembly, Helsinki, Finland, June 1964,and amended by the 52nd WMA General Assembly, Edinburgh,Scotland, October 2000.

0. Mader TJ, Playe SF. Emergency medicine research consent formreadability assessment. Ann Emerg Med 1997;29:534–9.

1. Food and Drug Administration. Protection of human subjects:informed consent—FDA final rule. Fed Regist 1996;61:51498–533.

2. US Department of Health, Education, and Welfare. Protection ofhuman subjects: Belmont report—ethical principles and guidelinesfor the protection of human subjects of research. Fed Regist1979;18:23192–7.

3. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability stan-dards for informed-consent forms as compared with actual read-ability. N Engl J Med 2003;348:721–6.

4. Schmidt TA, Salo D, Hughes JA, et al. Confronting the ethicalchallenges to informed consent in emergency medicine research.Acad Emerg Med 2004;11:1082–9.

5. Marco CA. The Society for Academic Emergency Medicine posi-tion on informed consent for emergency medicine research. AcadEmerg Med 2004;11:1090–1.

6. Madsen SM, Holm S, Riis P. The extent of written trial informa-tion: preferences among potential and actual trial subjects. BullMed Ethics 2000;159:13–8.

7. Kruse AY, Kjaergard LL, Krogsgaard K, et al. A randomized trialassessing the impact of written information on outpatients’ knowl-edge about and attitude toward randomized clinical trials. TheINFO trial group. Control Clin Trials 2000;21:223–40.

8. White DR, Muss HB, Michielutte R, et al. Informed consent:patient information forms in chemotherapy trials. Am J Clin Oncol1984;7:183–90.

9. White LJ, Jones JS, Felton CW, et al. Informed consent for medicalresearch: common discrepancies and readability. Acad Emerg Med1996;3:745–50.

0. Mader TJ, Playe SJ. Emergency medicine research consent formreadability assessment. Ann Emerg Med 1997;29:534–9.

1. David TC, Holcombe RF, Berkel HJ, Pramanik S, Divers SG.Informed consent for clinical trials: a comparative study of stan-dard versus simplified forms. J Natl Cancer Inst 1998;90:668–74.

2. Pesudovs K, Luscombe CK, Coster DJ. Recall from informedconsent counseling for cataract surgery. J Law Med 2006;13:496–504.

3. Akkad A, Jackson C, Kenyon S, et al. Patients’ perceptions ofwritten consent: questionnaire study. BMJ 2006;333:528.

4. Dresden GM, Levitt MA. Modifying a standard industry clinicaltrial consent form improves patient information retention as part ofthe informed consent process. Acad Emerg Med 2001;8:246–52.

5. Wragg JA, Robinson EJ, Lilford RJ. Information presentation anddecisions to enter clinical trials: a hypothetical trial of hormonereplacement therapy. Soc Sci Med 2000;51:453–62.

6. Hama Y, Sakurai Y, Kosuda S. Impact of written informationconsent on the number of intravenous contrast-enhanced CT and

MR studies. Acad Radiol 2006;13:258–61.

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Impact of Informed Consent 273

APPENDIX 1

rief Written Consent Document:

atient Satisfaction Survey

tudy Information: The following brief questions are part of a research survey about patient satisfaction. We are tryingo learn more about ER patients and what is important to them. The study is being conducted under the direction ofXXX.

onfidentiality: We are required by law to protect the privacy of your health information, and to use or disclose thenformation we obtain about you in connection with this research study only as authorized by you in this form. Theesults of this study will be kept anonymous and confidential. Your name and the date will not be on any part ofhe study. Do not put your name on the survey. The information that we will use or disclose includes your age, gender,thnicity, and whether you are a patient, or accompanying a patient, time and day of week.

oluntary Participation: Your participation is voluntary. Your participation, or lack of participation, will in no wayffect the care of you, your friends, or your family. If you decide to participate, please fill out the attached survey. Bylling out the survey, you indicate your consent to participate. You can change your mind at any time, and drop out of

he study. If you choose not to participate, simply return the paperwork to any of the staff treating you, or leave blank,n the room.

eneral Information: The study does not affect your medical care. The medical care you will get is determined by thehysician treating you, and is not in any way affected by your participation.

lease answer the following questions to the best of your ability. Thank-you for your participation.

f you have any questions about the study, you may contact XXXX. If you have any questions about your rights as aesearch subject, you may contact XXXX.

____________________________________________________________________________________________

APPENDIX 2

etailed Written Consent Document

onsent to Participate in a Research StudyPatient Satisfaction SurveyPurposes of an Informed Consent FormThe purposes of an Informed Consent Form are:

● to tell you what this research study is trying to find out;● to tell you what your part in this research study will be and whether any of the procedures, drugs or devices are

different from what would be used in standard medical practice;● to tell you about the frequent and/or important risks, side effects or discomforts that could happen to you during

this research;● to tell you if you can expect any benefit from participating and, if so, what the benefit might be;● to allow you to ask questions concerning this study, both before agreeing to be involved and during the course of

this study;

● to tell you the other choices you have and how they may be better or worse than being in this study;

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274 C. A. Marco

● to explain that you may refuse to participate at all or to change your mind about participating after this study is started;● to tell you that medical treatment is available if any complications arise;

1. Purpose of the Project

You have been asked to take part in a research project because we would like to know your opinions about medicalare in the Emergency Department (ER). There will be about 300 other persons in this project.

2. Procedures of the ProjectYou will be asked to complete a survey about various aspects of care, and to record your opinions about these issues.3. Risks of the ProjectWe do not anticipate any significant risks to you as a result of participation in this study. We estimate that the survey

ill take about 5 minutes of your time.4. Benefits of the ProjectThere may be a future benefit to others as a result of the findings of this study.5. ConfidentialityWe are required by law to protect the privacy of your health information, and to use or disclose the information we

btain about you in connection with this research study only as authorized by you in this form. The results of this studyill be kept anonymous and confidential. Your name and the date will not be on any part of the study. Do not put yourame on the survey. The information that we will use or disclose includes your age, gender, ethnicity, and whether youre a patient, or accompanying a patient, time and day of week. The results of the study may be published, but you willot be mentioned by name.

6. Information About the ProjectThis project has been explained to me by _____________________________________.He/she has offered to answer all of your questions. You may also contact XXXX, if you have additional questions

r concerns.7. Stopping the ProjectYou may choose to stop being in the project at any time. If you choose to stop participating, this decision will not

ffect your current or future medical care at XXXX or its affiliates. To discontinue your participation in the study, allou need do is notify your nurse or doctor while here in the emergency department, not return your survey.

8. Alternative to ParticipationIf you choose not to participate, this will not affect the medical care of you or your associates.9. Voluntary ParticipationYou do not have to be in this research study. If you refuse to be in the study, this decision will not affect your current

r future medical care by your physician(s) or at XXXX or its affiliates. If you decide not to participate in this researchr if you decide to stop being in the research after you have started, your medical care will not be affected.

10. Cost to the SubjectThere are no costs to you or your insurance company for participation in this study.11. Payments to the SubjectThere will be no payment to you for participating in this study.12. Financial Incentives for InvestigatorsThe investigators of this study have no financial incentives to disclose.13. Research-Related InjuriesIf physical injury occurs due to your involvement in this research, medical treatment is available, but you or your

nsurance company must pay the cost of treatment. XXXX has not set aside any funds for compensation for medicalxpenses or any other compensation for research-related injuries such as lost wages and/or direct or indirect losses.

14. Research Subject’s RightsBy signing this form you are not giving up any of your legal rights as a research subject If you have any questions

bout your rights as a research subject, you may contact XXXX.15. ConsentI have read this consent form and all of my questions have been answered to my satisfaction.By signing this form I do not give up any of my legal rights. My participation in this research study is voluntary. I

ay stop being in this project at any time. A copy of this consent form will be given to me.

I agree to be in this research project.

Impact of Informed Consent 275

Signatures___________________________________________________ __________________________AM/PMSignature of Subject Date TimePrint Name of Subject: ___________________________________________________________________________________________________ __________________________AM/PMSignature of Witness (only needed if patient is unable to sign name) Date Time___________________________________________________ __________________________AM/PMSignature of Person Obtaining Consent Date Time___________________________________________________ __________________________AM/PMSignature of Investigator Date Time