INFORMED CONSENT 1

1 Legal Nurse Consulting, Principles, 3rd Ed.

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12 Chapter 7
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14 Informed Consent
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17 Susan Mellott PhD, RN, CPHQ, FNAHQ

18 Mellott & Associates-

19 713-726-9919 (p)
20 713-726-9964 (f)
21 mellottandassociates.com (Contact Author)
22 (Contact Author)
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29 Chapter 7 - INFORMED CONSENT

30 Susan Mellott PhD, RN, CPHQ, FNAHQ

31 Contributors to previous editions of this chapter are

32

33 Objectives

34 Introduction

35 Informed Consent

36 When is Informed Consent Required?

37 Medical Informed Consent Process

38 Guiding Principles of Informed Consent

39 Documentation of Informed Consent

40 Exceptions to Informed Consent

41 Emergency situations

42 Therapeutic privilege

43 Compulsory Tests or Treatments

44 Who may sign the consent form?

45 Competent patient 18 years of age or older

46 Parent of a child under 18 years of age

47 Emancipated minors

48 Mentally Incompetent Persons

49 Legal Guardian
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50 Medical Power of Attorney

51 Specific Populations Informed Consent

52 Hospital Setting

53 Behavioral Health Setting

54 Long Term Care Setting

55 Home Health Setting

56 Hospice Setting

57 Department of Veteran Affairs Settings

58 Organ Recovery and Transplantation Settings

59 Research Informed Consent Process

60 Issues with Informed Consent and Research

61 Incomplete Disclosure

62 Informed Consent Procedure Forms

63 Competency

64 Comprehension and Understanding the Material

65 Proof in Court

66 Medical Negligence

67 Fraud, Deceit, Neglect, Misrepresentation and Breach of Contract

68 Viability of the Cause of Action

69 Summary

70 References

71 Test Questions

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74 Objectives

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76 o After reading this chapter, the reader will be able to:

77 Describe informed consent and the process of obtaining informed consent

78 Identify major issues related to informed consent

79 Describe the aspects of liability involved with informed consent

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81 Introduction

82

83 Elements of informed consent are part of the nurses' role regardless of the setting

84 that the nurse practices in. The rights of the patient to be well informed of the risks,

85 benefits, and alternatives to the prescribed elements of their care have become more

86 important than ever as technology evolves and patients are living longer with more

87 complicated diseases and co-morbidities.

88 The American Nurses Association (ANA)s , revised Code of Ethics for Nurses

89 has 17 provisions compared to the 2001 ANA which only had 11 provisions, (The first

90 provision of the 2008 version of the American Nurses Association Code of Ethics for

91 Nurses includes a discussion on self-determination as the foundation of informed consent

92 (ANA Code of Ethics for Nurses, 2008). The nurse's role is to assure that the patient

93 understands the information being presented. If the nurse feels that the patient does not

94 comprehend the information, the nurse must solicit the help of others to assure that there

95 is a complete understanding before the informed consent is obtained. The third provision

96 of the Code discusses the patient's rights regarding being informed about participation in
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97 research studies and addresses the new technologies that store personal information

98 concerning the patient. The nurse must also assure that the confidentiality of this

99 protected personal information is maintained according to the Health Insurance

100 Portability and Accountability Act (HIPAA). This chapter will discuss the concept and

101 process of informed consent, as well as limitations of the process. There will also be a

102 discussion concerning informed consent as a theory of liability that can be used in any

103 healthcare practice regardless of role or practice setting where the informed consent

104 process is a vital part of communicating with patients

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106 Informed Consent

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108 Informed consent is grounded in principles of respect for individuals and

109 individual autonomy. Each state has its own laws and requirements for what must be

110 included in the informed consent process. There are federal rules and regulations that

111 apply to certain types of institutions or procedures. Many professional organizations have

112 established ethic white papers that address the informed consent rights of an individual.

113 There are many examples of case law that are also applicable.

114 Consent to research is grounded in ethical codes, statutes, and administrative

115 regulations also. The informed consent for research has developed from history and the

116 need to protect the subjects of the research. However, patients often do not understand

117 what they are signing and often don't read the information before they sign. If they were

118 to read the document before signing it, research has shown that they frequently do not
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119 remember the information that they read (Turner, 2002). Informed consent leads to better

120 patient safety and more patient autonomy.

121 When is Informed Consent Required?

122 There is no inclusive source that lists all procedures and treatments that require

123 informed consent. The most common ideation is that any invasive test or procedure

124 should require informed consent to be obtained prior to the procedure or treatment. If

125 there are side effects of the treatment or procedure that could result in a temporary or

126 permanent loss of limb, function or life, informed consent must be obtained after

127 completely informing the patient of these potential side effects. To begin to determine

128 the procedures and treatments which require an informed consent prior to the start of the

129 procedure or treatment, the Emergency Care Research Institute (ECRI), a nonprofit

130 organization that uses applied science research to develop and identify safe and efficient

131 processes, suggests that organizations refer to state law and regulations, case law, high

132 risk procedures or low risk procedures such as are listed in Table 7.1, (ECRI, 2008).

133 The health code of a jurisdiction should be consulted for the applicable law in that

134 state. In some jurisdictions, specific language is required by statute for certain forms. In

135 Texas, for example, the legislature has determined what constitutes the inherent and

136 material risks for a large number of procedures, and these risks, specified in a list titled

137 List A, must be disclosed by the health care professional (Texas Medical Liability Trust,

138 2006). List A procedures require full disclosure of risks by the physician or health care

139 provider to the patient or person authorized to consent for the patient. If this form is used

140 for disclosure of risks, it is admissible in court and creates a rebuttable presumption that

141 the health care provider has complied with the statutory standard and is not negligent.
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142 They have also specified a list called List B which lists procedures that require no

143 disclosure. Examples include local anesthesia, hemorrhoidectomy, myringotomy, needle

144 biopsy or aspiration, lumbar puncture, many invasive radiological procedures, and others.

145 When a procedure is performed that does not fall in either List A or List B, the extent of

146 disclosure for that procedure is governed by the common law.

147 Federal law requires that patients who are to be transferred (or who have refused

148 recommended transfer) to another facility for health treatment under emergency

149 circumstances must be informed of the risks and benefits of transfer (42 U.S.C. 1395dd,

150 1996). This federal law also mandates that the hospital, and not the physician, take

151 responsible steps to obtain a patient's informed consent both for transfer under emergency

152 conditions and for refusal of transfer, if transfer is deemed medically necessary.

153 Courts have generally been reluctant to impose upon a referring physician a duty

154 to obtain informed consent for a procedure that is to be performed by a specialist who

155 presumably is most familiar with the procedure and its risks and alternatives. However,

156 several jurisdictions have held that a physician who actually prescribes the specific

157 diagnostic procedures to be performed by another physician could be held liable for

158 failure to obtain the patients informed consent (Bowers v. Talmage, 1963). These courts

159 reason that the patients personal physician bears primary responsibility for all phases of

160 treatment, including procedures performed by specialists to assist in the patients

161 diagnosis. This is not however, the general rule.

162 When a physician determines that a patient is not in need of medical treatment,

163 the physician is not required to inform the patient of possible risks and benefits of no

164 treatment. Courts have held that the informed consent doctrine cannot be extended to
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165 require disclosure of the risks of a recommendation of no treatment, when the physician,

166 in the exercise of his best judgment, believes no treatment is necessary. This has been

167 litigated in the context of alleged failure to diagnose certain conditions, where the

168 patient/plaintiff alleges that the physician should have performed further testing.(42

169 U.S.C. 11101 et seq., 2001)

170 Medical Informed Consent Process

171 Informed consent, as a process resulting from dialogue between the patient and

172 the physician or health care provider, does not refer simply to a signature at the bottom of

173 a form. The items listed in Table 7.2 are the elements that must be included in the

174 medical informed consent process (American Medical Association, 2008).

175 Guiding principles of informed consent.

176 The practitioner performing the procedure should be the one to obtain the consent,

177 The practitioner should have a complete understanding of the patient's medical condition

178 and history. The practitioner must assure that the patient is legally and mentally

179 competent to give consent for the procedure. The patient must give consent for a specific

180 procedure, and the practitioner may not perform any other procedure outside the scope of

181 the consented procedure. The practitioner must give the patient sufficient information at a

182 level that the patient can easily understand regarding the procedure, risks, benefit and

183 alternatives concerning the procedure. The patient must be given an opportunity to ask

184 questions concerning the procedure and its risks, benefits, and alternatives. The patient

185 must not be coerced into signing the consent form. The patient has the right to refuse

186 treatment or a procedure after the patient has been fully informed of the risks, benefits,

187 and alternatives to the treatment or procedure.

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188 Documentation of informed consent.

189 A consent form is the document reflecting the consent process, but it does not

190 replace the dialogue between the patient and the health care provider. In all cases where

191 informed consent is required, it should be documented that such consent was in fact

192 obtained by the person who had the duty to obtain it. Sometimes oral disclosure will be

193 sufficient, but the proof becomes problematic if the only witnesses to the conversation

194 were the doctor and the patient. If a form is not signed by the patient, then the healthcare

195 practitioner must document what was included in the discussion regarding the informed

196 consent process.

197 Executed consent forms should be a part of the patients permanent medical

198 record.

199 Consent forms can be general, such as consent to medical care and the release of

200 certain information on admission to a hospital, or specific to treatment or a procedure,

201 such as the consent form for the administration of blood or blood products. The forms

202 must be signed by the patient or authorized agent and witnessed, usually by a nurse or

203 other person who must ascertain that the patient has in fact had a discussion with the

204 physician and has given informed consent based on that discussion. If a patient does not

205 speak English, a translator must be involved in the process, and should also sign the

206 consent form. If no form is required or used in a particular facility, narrative chart notes

207 by the healthcare provider suffice.

208 There should be a witness to the signature of the individual giving consent for the

209 procedure and treatments. The witness is not responsible for giving the individual the

210 information required to have informed consent, but rather should ascertain that the
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211 individual has received this information from the physician and has no further questions

212 prior to the signature indicating consent. The person witnessing the individual's signature

213 should not be taking part in the treatment or procedure. For example, the same day

214 surgery nurse can witness the consent signature as long as that nurse is not involved with

215 the case in the operating room (McCorkle & Pietro, 2007). The witness should sign and

216 date the informed consent form while in the presence of the patient.

217 Exceptions to Informed Consent

218 Emergency situations

219 Consent is implied when a patient, who is unconscious or otherwise unable to

220 give express consent, needs immediate treatment necessary to save his life, and the harm

221 from failure to treat is imminent and outweighs the harm threatened by the proposed

222 treatment. In such cases, the physician is not held liable for failing to obtain informed

223 consent, even if complications occur that would be considered both inherent and material.

224 In this context, the rule requiring parental consent for a minor is suspended, if the minor

225 needs emergency treatment and the parents are not available to give consent.

226 Therapeutic privilege

227 In rare cases, i.e., where it is not medically feasible, a physician may withhold

228 information that he reasonably believes could hinder treatment or prove harmful to the

229 patient. This concept is employed by the defendant physician to justify nondisclosure on

230 the basis that it is in the best interests of the patient not to do so. For example, in a case

231 involving the psychotherapeutic drug that resulted in the side effect of tardive dyskinesia,

232 the doctor argued that the patients schizophrenia rendered him unable to have the

233 reactions of a reasonable person justifying nondisclosure of the risk. The court disagreed,
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234 holding that the patients right to disclosure was not negated just because his doctor did

235 not believe that his patient was reasonable (Barclay v & Campbell, 1986).

236 Compulsory tests or treatments.

237 Many states have laws regarding the blood tests that brides and grooms must

238 obtain in order to get a marriage license. Since the couple desire to obtain the marriage

239 license, they must have the blood tests and no informed consent is required.

240 Who May Sign The Consent Form?

241 Depending on each situation, the person giving consent is usually the patient

242 unless the patient is unable to do so for some reason. Each situation must be evaluated

243 and the facility's policy must be followed. Most facilities establish their consent policies

244 based on the laws and regulations of the state in which they are located.

245 Competent patient 18 years of age or older.

246 There is a legal presumption that any person who has reached the age of majority

247 (usually 18 years) is competent and may make decisions about medical care. For

248 informed consent, competence refers to decision-making capacity, or the patients ability

249 to engage in rational decision-making, rather than the patients clinical condition.

250 Parent of a child under 18 years of age.

251 In the case of minors, parents must give consent by proxy (Whitstone, 2004). If

252 the parents are divorced, or in a custody battle, the parent with custody of the child at that

253 time should be the one to consent for the child. If parents are unavailable in a given

254 situation, certain others, usually next of kin in a hierarchical fashion, may be authorized

255 under the jurisdictions family code. The parent must consent for neonatal treatment

256 before a baby is delivered. Many times the nurse in the labor and delivery area obtain the
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257 consent for the newborn's treatment at the time when the consent for the mother's

258 treatment is obtained.

259 Emancipated minors.

260 The state determines when a minor can consent for themselves. For example,

261 some family codes provide that a minor need not have parental consent in order to obtain

262 treatment for venereal disease, drug addiction, or pregnancy. In addition, emancipated

263 minors (e.g., minors who are married or have been legally adjudicated as emancipated)

264 can consent to treatment without parental participation. What constitutes an emancipated

265 minor differs from state to state, and each states family code should be consulted for

266 those laws. In 1979, the Supreme Court ruled in Parham v. J.R. and established a definite

267 standard for juvenile admissions for states and facilities to use. The parent may authorize

268 the admission of the juvenile, but that a neutral individual would need to determine if

269 statutory requirements for admission have been satisfied (Mohr, 2007).

270 Mentally incompetent persons.

271 The family codes or the mental health codes of a particular state may contain

272 provisions allowing procedures to be performed without the usual consent, when the

273 patient is mentally incompetent or committed to a mental institution and cannot give

274 informed consent because of that mental condition. In Texas, this exception allows for

275 the performance of surgery or other treatment in these circumstances under the advice

276 and consent of three licensed physicians, without consent of the patients guardian (Texas

277 Health & Safety Code 551.041, 2001).

278 Legal guardian.

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279 A legal guardian may be appointed by the legal system to handle the affairs of

280 another individual. This most often occurs when there is a physical or mental issue that

281 prevents the individual from making decisions and caring for themselves, when an

282 individual is in danger of substantial harm to themselves or from others, or when an

283 individual has no person already legally authorized to take responsibility of them, such as

284 when a child's parents are killed in a car accident, and there are no other family members

285 available.

286 The legal guardianship may be for a limited period of time or for an undetermined

287 period of time. The legal guardian then becomes responsible for the individual's

288 residence, healthcare, food, and social activity. The guardian should consider the wishes

289 of the individual in any decisions that are made regarding these items. The courts will

290 monitor the decisions made by the legal guardian to ensure that the individual is

291 benefiting from the services of the legal guardian. The courts may terminate a legal

292 guardianship at any time (Larson, n.d.).

293 Medical Power of Attorney

294 If a person lacks the decision making capacity, the physician(s) must determine if

295 there is another individual that can provide the consent or whom the patient had

296 previously identified to do so through a medical power of attorney. A medical power of

297 attorney, or sometimes called the Power of Attorney for Healthcare, is established by a

298 competent individual who identifies another person, known as the 'agent', to make

299 decisions regarding the individual's healthcare, should the individual become unable to

300 do so for whatever reason. The medical power of attorney becomes effective immediately

301 and remains in effect until it is revoked, replaced by a more recent version, or until the
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302 individual becomes competent to make clinical decisions. The agent may begin to make

303 healthcare decisions for the individual after a physician has certified in writing that the

304 individual is incompetent or unable to make such decisions. A copy of the medical power

305 of attorney must be maintained in the individual's permanent medical record (Texas

306 Medical Association, 1999).

307 The medical power of attorney may allow for the agent to make all healthcare

308 decisions, or it may limit the agent's decision making authority. Regardless of what is

309 stated in the medical power of attorney, states may have specific laws relating to what the

310 agent may consent to. For example, in the State of Texas, an agent named in a medical

311 power of attorney cannot consent for commitment to a mental institution, convulsive

312 treatment, psychosurgery, abortion, or the discontinuance of comfort care (Texas Medical

313 Association, 1999).

314 The medical power of attorney must be signed in the presence of two witnesses in

315 order for it to be valid. Each state defines who may or may not witness the signature. In

316 most states the following individuals are not allowed to witness the signatures: the agent,

317 a member of the individual's family, a person entitled to part of the individual's estate, an

318 individual's physician or an employee of the physician or healthcare facility in which the

319 individual is a patient (Texas Medical Association, 1999).

320

321 Specific Populations - Informed Consent

322

323 There are federal, state and facility regulations and policies regarding the extent

324 of informed consent required in different healthcare settings. Table 7.3 lists the Centers
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325 for Medicare and Medicaid Services (CMS) Conditions of Participation regulations

326 where specific information regarding each setting may be obtained.

327 Hospital Setting

328 In April 2007, CMS updated the 2004 version of the interpretive guidelines for

329 informed consent. The updates describe in detail what must be included in the informed

330 consent and the information given to the patient concerning the informed consent (CMS,

331 Interpretive Guidelines, n.d.).

332 The 2004 version of the interpretative guidelines, require a completed informed

333 consent form be in the patient's medical record prior to the surgery or procedure, unless it

334 is an emergency. It also required that there be included in the consent a list of the names

335 of all practitioners who will conduct specific and significant tasks during the procedure.

336 This requirement was changed to a recommendation in the 2007 version.

337 The 2007 version also detailed that the following information must be included on

338 the informed consent form (CMS, Conditions of Participation, 2007)

339 Name of the hospital;

340 Name of the procedure or other medical treatment;

341 Name of the practitioner performing the procedure or administering the medical

342 treatment;

343 Signature of the patient or legal guardian;

344 Date and time the consent is obtained;

345 Statement that the procedure and anticipated benefits, material risks, and available

346 alternative therapies were explained to the patient or guardian.

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347 The CMS goes on to recommend that organizations consider the following

348 elements to include in their informed consent forms: (CMS, 2007)

349 Statement that, if applicable, physicians other than the primary

350 surgeon/practitioner (e.g. residents) will conduct specific significant surgical

351 tasks. Significant surgical tasks include opening and closing harvesting grafts,

352 dissecting tissue, removing tissue, implementing devices, and altering tissues;

353 Statement, if applicable, that qualified medical practitioners who are not

354 physicians will perform important parts of the surgery or administration of

355 anesthesia;

356 Name of the practitioner who conducted the informed consent discussion with the

357 patient or guardian;

358 The date and time and the signature of the professional person witnessing the

359 consent;

360 A list of risks discussed with the patient or the patient's representative.

361 Behavioral Health Setting

362 There are several caveats to informed consent with individuals who are receiving

363 behavioral health services. When an individual seeks psychotherapy, it is unknown to the

364 therapist what the individual may reveal and what direction would be the best therapy to

365 pursue. In many cases, the individual receiving these services may not be able to consent

366 to the services, or the therapy may be court ordered. Also, many of these individuals will

367 undergo electroconvulsive therapy, which in and of itself requires an informed consent

368 every time the treatment is undertaken.

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369 When an individual is legally incapable of giving consent, the therapist must still

370 explain the process and obtain the individual's agreement to the therapy sessions. The

371 therapist must also become a patient advocate keeping the individual's preferences and

372 best interests in mind. Whenever possible, the therapist must obtain the permission for

373 the therapy from a legally authorized person, if one is available. When individuals are

374 receiving therapy due to a court order, the therapist must still explain the nature and

375 process to the individual, and inform the individual about their extent to which they may

376 refuse service (Zur, n.d.).

377 Electroconvulsive therapy has evolved into an acceptable therapy for certain

378 behavioral health patients; however, there is still a division of opinions concerning its

379 usefulness. The patient must be well aware of the risks, benefits, and alternatives of

380 receiving this therapy. The requirements for informed consent for electroconvulsive

381 therapy vary from state to state. In Texas, an informed consent form and a supplemental

382 statement ( 405.117) is required prior to each individual ECT treatment. The

383 requirements of the consent includes the following: (Texas Administrative Code, n.d.)

384 Indications for therapy for the patient

385 Description of the process

386 Anesthesia risks & side effects

387 Medical evaluation results

388 Results of psychiatric and other medical consultation(s) relevant to ECT

389 For patients 65 years of age or older, known medical conditions that may increase

390 the possibility of injury or death as a result of ECT and a statement signed by two

391 (2) physicians that the treatment is medically necessary.

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392 Contraindications to therapy

393 Risks of the therapy

394 Benefits of the therapy

395 Alternative therapies that are available

396 Long Term Care Setting

397 In Long Term Care, CMS addresses informed consent with information on

398 advance directives. In 42 CFR 483.10 Resident Rights, CMS states "These requirements

399 include provisions to inform and provide written information to all adult residents

400 concerning the right to accept or refuse medical or surgical treatment, and, at the

401 individual's option, formulate an advance directive". (CMS, Conditions of Participation -

402 Long Term Care, n.d.)

403 Home Health Setting

404 In the Home Health Setting, it is the nurse who usually must obtain the informed

405 consent from the patient. The Home Health nurse will be performing procedures ordered

406 by the physician, but the physician will not necessarily have seen the patient to explain

407 the risks, benefits, alternatives and right to refuse the procedure or treatment to the

408 patient. The nurse must document the discussion with the patient and the patient's consent

409 or refusal.

410 Hospice Setting

411 CMS does specifically address what must be in a general consent for treatment for

412 Hospice patients. In 42 CFR 418.62, CMS states that the hospice must include in the

413 informed consent the specifics of the type of care and services that may be provided as

414 hospice care (CMS, Conditions of Participation - Hospice, n.d.).

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415 Department of Veteran Affairs Settings

416 The Department of Veterans Affairs (VA) has its own federal regulations (38

417 CFR Part 17). Prior to March 8, 2007, only practitioners who were clinically privileged to

418 do so, and who where performing the procedure, could obtain informed consent from the

419 patient. This also included medical and dental residents who while not privileged, were

420 allowed to obtain informed consent. In the VA, this was limiting since a number of

421 advance practitioners performed procedures or treatment, but were not credentialed to do

422 this. These advance practitioners function under a "scope of practice" agreements or

423 formal delineations of their job which specified what these practitioners were allowed to

424 perform (Federal Register Rules and Regulations, 2007).

425 On March 8, 2007 the regulation was changed to extend privileges to medical or

426 dental resident, any healthcare professional, such as dentists, physician assistants and

427 advance practice nurses and others who are appropriately trained who has primary

428 responsibility for the patient or who performs the procedure or treatment, must obtain the

429 informed consent for the procedure/treatment. However, the practitioner must be

430 qualified and per this Federal Regulation, the VA had to establish national requirements

431 in policy and hold the local VA facilities accountable for the implementation of these

432 policies. (Federal Register Rules and Regulations, 2007).

433 The regulations state that the content in Table 7.4 must be included as elements of

434 the informed consent. The regulation further states that the documentation of the consent

435 must be in a written format, approved by the Institution Review Board (IRB) and signed

436 and dated by the subject at the time consent is given. If the information is given orally to

437 the subject, there must be a short form written consent document that states that the
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438 information was presented orally, which is signed by the subject. There must be a witness

439 to the oral presentation who will sign both the short form and the copy of the summary

440 that was presented to the subject. The IRB must approve the written summary of what is

441 to be said to the subject. The person obtaining the consent must also sign the summary

442 document. The patient must then receive a copy of the signed short form and the

443 summary form (Food and Drug Administration, 2008).

444 Organ Recovery and Transplantation Settings

445 In 42 CFR 482.45(a)(3), CMS discusses how to obtain consent from the family of

446 a potential donor. Basically, CMS requires that, in collaboration with an Organ

447 Procurement Organization (OPO), the hospital must identify an individual staff member

448 who will/has completed a course offered or approved by the OPO regarding how to

449 approach potential donor families and request the organ or tissue transplant. The OPO

450 will determine if the patient is a potential donor and then the specially trained hospital

451 staff member will approach the family for permission to donate. A member of the OPO

452 frequently joins the designated/trained staff member when the family is approached. The

453 staff member must inform the family member(s) of its options to donate organs, tissues,

454 or eyes, and their right to decline the donation (CMS, Conditions of Participation -

455 Hospital, 2007).

456 While the CMS regulations comment on informed consent for the donor, there is

457 currently no legislation or law which requires full consent for the recipient of the

458 transplant organ or tissue. In 2008, the United Network for Organ Sharing (UNOS) the

459 national clearing house for organ allocation, and the Organ Procurement and

460 Transplantation Network (OPTN) were in the process of developing a policy to address
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461 disclosure of the donator risk factors. The proposed policy would inform transplant

462 recipients of the known high risk behaviors of the donor at the time organs become

463 available. Utilizing Centers for Disease Control and Prevention (CDC) guidelines, the

464 high risk criteria would include behavior and history criteria, pediatric donor criteria, and

465 laboratory and other medical criteria. The recipient could at that time decide to accept or

466 decline those particular organs or tissue. Currently only the recipients of kidney donor

467 organs are permitted to accept or decline organs if they are obtained from an older donor

468 or from a donor who had hypertension or other such disorder (Organ Procurement

469 Transplantation Network and the United Network for Organ Sharing, n.d.).

470 A group of physicians from the University of Pennsylvania School of Medicine

471 are calling for the policy to be modified to require all transplant recipients to be made

472 aware of "all foreseeable risks" when the patient is placed on a waiting list for an organ or

473 tissue. The physicians identify the risks as those which could occur when the transplanted

474 organ or tissue comes from donors who are older, who have any infectious diseases (or

475 risks there of), or donors who suffered a cardiac arrest prior to their death. The physicians

476 further state that the recipient of the organ should not be allowed to accept or decline

477 transplantation at the time the transplant is to take place, but must determine when they

478 are placed on the waiting list that they are aware of the risks but still wish to receive a

479 donor organ. These physicians feel that if the recipient is allowed to reject a particular

480 donor's organ or tissue that the process could lead to "discrimination, inefficiency, and

481 inequity in how organs are allocated". (University of Pennsylvania, 2008)

482 The United Network for Organ Sharing and the Organ Procurement and

483 Transplantation Network has also developed a resource document regarding informed
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484 consent regarding the donation of organs by living donors. The document was developed

485 as a resource to transplant professionals to follow when obtaining informed consent from

486 living donors. The document discusses the risks, benefits and alternatives that the living

487 donor has as well as the fact that the transplant centers are required to report living donor

488 follow-up information for at least two (2) years after the donation takes place, as this is

489 the only method they have for collection of information regarding the long term effects of

490 donation on living donors. (Organ Procurement and Transplantation Network, n.d.)

491

492 Research Informed Consent Process and Research

493

494 Informed Consent for research studies and medical experimentation on humans

495 first gathered attention after a World War II military tribunal was held in 1947 in the case

496 of the USA vs. Karl Brandt, et al. As a result of the testimony and discussion during the

497 trail, the tribunal submitted a memorandum to the United States Council for War Crimes

498 which outlined six points, eventually becoming ten points, defining legitimate research.

499 The document became known as the Nuremberg Code, but it never became law in the

500 United States nor Germany (U.S. Holocaust Memorial Museum, 1953).

501 In 1981, the U.S. Food and Drug Administration enacted their regulations

502 regarding the Protection of Human Subjects. This regulation states "No investigator may

503 involve a human being as a subject in research covered by these regulations unless the

504 investigator has obtained the legally effective informed consent of the subject or the

505 subject's legally authorized representative" (Food and Drug Administration, 2008). The

506 regulations state that the consent must be in a language understandable to the subject or
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507 representative and that the subject may not waive their legal rights or relieve anyone

508 involved from liability for negligence. There are exceptions to this rule as stated in

509 Section 50.23 and 50.24 of the regulation.

510 There are individual state laws that govern the conduct of research and informed

511 consent process and that additional protections for vulnerable populations, such as

512 pregnant women, children and prisoners are required by institutional review boards or

513 human research review committees, Special rules for children participating in research

514 apply. The consent process is outlined in the Code of Federal Regulations at 45 CFR Part

515 46. The Office of Human Research is the federal agency charged with the consent

516 process during research.

517 Academy of Pediatrics on Bioethics has developed a policy regarding consent for

518 Pediatric research that states that parental permission may be given only for medical

519 necessitated treatments. If the treatment is non-essential, then the procedure should wait

520 until the child is at an age where they can consent for themselves (Van Howe, 1999).

521 The parent is in essence giving consent by proxy since the consent is for someone else.

522 The practitioners must be assured that the parent or guardian is acting in the best interest

523 of the child and not in the parents own interest. If the practitioner feels that the parent is

524 not capable of decision making, then the practitioner is obligated to act to have another

525 person, such as a guardian ad litem appointed by the courts to make medical decisions

526 for the child (Whitstone, 2004).

527 In Wisconsin v Yoder, the US Supreme Court deemed that parental decisions may

528 be limited if the decisions will jeopardize the health and safety of the child. In the Little v Formatted: Not Highlight

529 Little case, the courts maintained that the parents may consent only to the medically
 INFORMED CONSENT 24

530 necessary treatments. In this case, the guardian ad litem of a 14 year old mentally

531 incompetent girl, applied to the courts for the childs mother to have the girls healthy

532 kidney removed in order to have it transplanted into the mothers sons body since he was

533 suffering from end-stage renal disease. The courts refused to allow this procedure to be

534 done since it could harm the 14 year old girl and put her at unnecessary risk for potential

535 harm (Van Howe, 1999). According to Van Howe, a review of the literature on pediatric

536 consent supports the test for parental consent for a surgical intervention must have three

537 parts: 1) the intervention must be medically necessary; 2) the intervention must be in the

538 best interests of the child; and 3) it must not place the child at risk for unnecessary

539 suffering or injury.

540 Whenever possible, the older child or adolescent should be involved in the

541 decision making process to the extent possible based on their developmental level. It is

542 important that the child or adolescent gives assent to the procedure or treatment if they

543 are developmentally able to do so.

544

545

546 Issues with Informed Consent

547

548 Many articles have been written and research studies completed that identify

549 issues and limits with the informed consent process. According to Burns, et al, (2005)

550 More than 50 % of the study patients could not list any treatment-related risks at the time

551 of surgery, even though 90 % of the patients were satisfied with the informed consent

552 process and considered themselves well informed (Murphy, 2008). The main issues
 INFORMED CONSENT 25

553 identified in the literature revolve around the concepts of incomplete disclosure,

554 inadequate consent forms, comprehension, and mental competency.

555 Incomplete Disclosure

556 Incomplete disclosure is one of the most debated components of informed

557 consent. Clinicians and researchers have published many articles regarding what should

558 be disclosed to the patient regarding medical care and research informed consents, and

559 what may not need to be disclosed. The keystone case regarding informed consent is the

560 1914 case of Schloendorff v. New York Hospital. The judge in this case concluded "Every

561 human being of adult years and sound mind has a right to determine what should be done

562 with his own body" (Walker, 2006).

563 In the clinical arena, there is less discrepancy between what to disclose or not to

564 disclose. The main issue of disclosure is regarding what was known and when it was

565 known (Walker, 2006). The effects of asbestos fibers were not known for many years,

566 and as a result there has been a plethora of litigation against the manufacturers of this

567 product, even though the manufacturers were not aware of these effects when the product

568 was introduced.

569 In the research arena, there is a large amount of controversy between the views of

570 researchers regarding informed consent. One of the main discussion points is that if

571 research participants are given complete information about the study that either the

572 patients would refuse participation or that the results could be biased. In some research,

573 the complete set of risks may not be known until after the research has been completed

574 Informed Consent Procedure Forms

 INFORMED CONSENT 26

575 Melissa Bottrell, et al. conducted a study to determine if informed consent forms

576 met acceptable standards (Bottrell, 2000). These researchers gathered informed consent

577 forms from a random selection of hospitals from the 1994 American Hospital Association

578 (AHA) directory. Five Hundred-forty (540) informed consent forms were obtained from

579 157 hospitals nationwide. All of the forms were scored based on the six components

580 listed in Table 7.5.

581 The conclusion of this study was that the content of the forms did not meet

582 acceptable standards of informed consent or patient-physician interaction. (Bottrell,

583 2000) Of the 540 consent forms, 96% indicated the procedure, but only 26% of them

584 indicated the risks, benefits and alternatives in addition to the procedure(s) name. Figures

585 7.1 and 7.2 indicate the results of this study. The researchers also found that in states

586 where the basic elements of procedure, risks, benefits and alternatives are required by

587 law, the informed consent forms did no better than those without the state laws requiring

588 such.

589 Competency

590 There are many other reasons why a patient may not be competent to give

591 informed consent. Patients who may not give consent are those who are under the age of

592 18, or who are mentally impaired, demented, confused, unconscious, drug dependent, and

593 multiple other categories of patients. In the case of emergencies, it may be difficult for

594 any individual to process the information being given to them regarding informed

595 consent. In emergencies and at other stressful times, individuals are less able to process

596 information, and may in fact, be more susceptible to the persuasion of others (O'Neill,

597 2003).
 INFORMED CONSENT 27

598 Alzheimer's and other forms of dementia affect patients in varying degrees. It is

599 often difficult to determine if a patient with these diagnoses is competent. Alzheimer's is

600 a disease that takes many years to manifest itself to the furthest degree. There are many

601 individuals with mild Alzheimer's who remain competent, while others with the same

602 degree of illness who can function socially and express their abilities, are not competent

603 to give consent (Kim et al, 2001). A study developed to accurately measure the decision

604 making capacity of patients with an Alzheimer's found it would be difficult to indicate

605 whether a patient was capable or incapable to give informed consent (Kim et al, 2001)

606 A practitioner may have questions about a patient's decision making capabilities

607 when the patient refuses a course of treatment that goes against what the physician is

608 recommending. In such a case, the practitioner must document the decision making

609 capacity of the patient. Simply because the patient has the ability to consent to a

610 procedure or treatment does not mean that the patient has the capacity to make a decision

611 to refuse treatment. According to Derse (2005), "the concern for the patient's well being

612 must be balanced against the respect for the patient's self-determination" (Derse, 2005).

613 Derse maintains that if the consequences of the decision to refuse treatment may result in

614 a disability or death, the patient must have a higher level of decision making capability

615 than if the treatment would just be beneficial to the patient. This is one of the ethical

616 dilemmas that physicians must face in determining a course of action on behalf of the

617 patient.

618 Comprehension and Understanding of Material.

619 According to information published in 2004 from a survey conducted by a

620 Commonwealth Fund, 33% of sick patients who leave the physician's office after an
 INFORMED CONSENT 28

621 appointment do so without getting all their important questions answered (Woolf,

622 2005).A research study by Engel, et al. (2008) indicated 78% of discharged patients had

623 difficulty recalling their diagnosis and its cause, the care received in the ED, the post-

624 ED care instructions, and the instructions regarding returning to the ED if needed.

625 Cassileth (1980) identified three factors that were related to the lack of recall of

626 the information discussed during the informed consent process: education, medical status,

627 and the care with which patients felt that they had read the consent forms. Education and

628 cognitive function are a few reasons poor comprehension and retention of information

629 provided during the informed consent process. The elderly, those with a below average

630 IQ and those who had impaired cognitive functions had the most difficulty recalling the

631 information that was provided (Lavelle-Jones, 1993). According to the National Institute

632 on Deafness and Other Communication Disorders (NIDCD), the average reading level

633 throughout the United States is between the 8th and 9th grades. However, the average

634 reading age of individuals from low economic classes is at the 5th grade level. The

635 NIDCD also states that two thirds of individuals over the age of 65, and 25% of

636 immigrants have poor literacy skills. Language barriers also pose a significant barrier to

637 informed consent. Many facilities only have informed consent forms in the English, while

638 many of their patients are LEP. The use of translators is haphazard at best, many times

639 utilizing family, other patients, and staff to provide the translation. The quality of their

640 translation is unknown and suspect to being incomplete or incorrect (Betancourt &

641 Jacobs, 2000).

642 The physician may be held liable if a competent medical interpreter is not utilized

643 to obtain informed consent if the patient speaks a language other than the language
 INFORMED CONSENT 29

644 spoken by the physician. In the case of Quintero v. Encarnacion,(2000) the physician

645 obtained consent from a patient who was able to communicate minimally utilizing a few

646 Spanish words (All Language Alliance, 2007).

647 The court ruled that:

648 Informed consent cannot be obtained if the explanations were conducted

649 in a language the patient did not understand. If the patient's capacity to understand

650 is limited by a language barrier, and the physician proceeds without addressing

651 this barrierthe physician may be liable for failing to obtain informed consent

652 from the patient (All Language Alliance, 2007).

653

654 Proof in Court

655

656 Informed consent as a theory of liability on which the plaintiff tries to obtain a

657 monetary judgment is most frequently combined with a medical negligence theory rather

658 than being the sole theory in a claim. The elements of the plaintiffs case in an informed

659 consent action are the same as in general medical negligence: duty, breach of duty, and

660 proximate cause of the injury. In other cases, the plaintiff may base the case on battery or

661 fraud, neglect, deceit, misrepresentation and breach of contract. Medical negligence is the

662 most commonly utilized approach.

663 Medical Negligence

664 Medical negligence model is based on four criteria; duty, breach of duty,

665 causation and damages. The plaintiff must show harm occurred as a result of the

666 procedure at issue, or that the possible harm was not disclosed to the patient at the time of
 INFORMED CONSENT 30

667 giving the informed consent. Most of these cases include expert testimony that the injury

668 was caused by the performance of the procedure at issue (ECRI, 2008). Plaintiffs

669 asserting informed consent claims must prove (1) that the complication or condition in

670 question was a risk inherent in the procedure performed, (2) that a reasonable person

671 fully informed of all inherent risks would not have consented to the treatment in question

672 (decisional causation), and (3) that the patient/plaintiff was in fact injured by the

673 occurrence of this complication or condition about which he was not informed (physical

674 causation). The relationship between the failure to disclose a particular risk and the later

675 occurrence of that complication must be shown in order for the patient/plaintiff to prevail

676 in the lawsuit. Generally, expert medical testimony is necessary to prove the plaintiffs

677 case in a negligence action based on informed consent (and to defend a physicians

678 actions in this regard). The expert must testify regarding the inherency of the risk

679 complained of and all other facts concerning the risk that show that knowledge of the risk

680 could influence a reasonable person in making a decision to consent to the procedure

681 (ECRI, 2008).

682 Decisional causation must demonstrate that if the physician had disclosed the

683 potential risk from the procedure, that the patient would have never consented to having

684 the procedure done, and that other people would have made the same determination.

685 There are two aspects of decisional causation that may be utilized. The objective

686 finding, that a reasonable person would also have refused the procedure if the information

687 had been disclosed, is the method most typically utilized in court. The reasonable person

688 standard described here requires that one persons behavior is compared to what a

689 hypothetical person who is just like the patient would do given the information about the
 INFORMED CONSENT 31

690 procedure, its risks and alternatives. The plaintiff must prove that he would not have

691 consented to the procedure if told about the risks or alternatives. It is by utilizing this

692 objective standard that subjectivity is removed from the decision regarding the case

693 (Mehlman, 2008).

694 The reasonable physician standard is a variation of the reasonable person

695 standard. By utilizing the reasonable physician standard, the defense must demonstrate

696 that the physician presented to the patient the information that any reasonable physician

697 would have presented to another similar patient. This is where the physician experts are

698 utilized to support what the physician told the patient (Mehlman, 2008).

699 The second aspect, the subjective approach, the jury, or the judge if there is no

700 jury, must decide that the patient would not have had the procedure if additional

701 information regarding the risks and alternatives had been disclosed. In this situation, the

702 jury decides what they would have done in a similar situation. The subjective approach

703 has been adopted by only a small number of states as the way the jury must determine if

704 there was decisional causation (Mehlman, 2008)

705 Medical negligence informed consent law was established as an intentional tort of

706 battery of the patient. The law protects the patient from unwanted physical touching of a

707 patients body by someone without permission. For battery to be alleged, one of the

708 following actions had to occur:

709 Physician performs a procedure without the consent of the patient

710 Physician performs a procedure that is substantially different from the procedure

711 that was consented to

 INFORMED CONSENT 32

712 Physician exceeds the scope of the consent by expanding on the procedures

713 performed

714 A different physician performs the procedure other than the physician listed on

715 the consent form.

716 The plaintiff may be compensated with a monetary award even if there is no

717 injury as a result of the failure to obtain the consent (ECRI, 2008).

718 Fraud, Deceit, Neglect, Misrepresentation & Breach of Contract.

719 In breach of contract cases, the plaintiff may be able to recover as damages the

720 cost of the procedure, nursing care, medications, and other monetary expenses that result

721 from the breach of contract (ECRI, 2008). Add something more --A properly executed

722 informed consent may be found to be invalid if obtained by fraudulent misrepresentation,

723 non-disclosure of important information or concealment.

724 Include a brief paragraph on current trends involving informed consentvideos,

725 interactive media, web sites; the expectation that physicians reveal their experience level

726 or complication rate with a particular surgery/procedure; and the trend to analyse the

727 severity of the undisclosed risk in determining what the physician should or does not

728 have to reasonably disclose.

729 Viability of the Cause of Action.

730 Practically speaking, is often difficult to persuade a jury in informed consent

731 claims, especially if the procedure or treatment in question is lifesaving, curative, or

732 necessary for a serious medical condition. When lack of informed consent is raised as an

733 issue in a medical malpractice case, it is often difficult to prove what occurred during the

734 informed consent discussion. There are frequently discrepancies between the physicians
 INFORMED CONSENT 33

735 and patients version of the information exchanged during this conversation. At times, a

736 dispute between the patient and physician takes place regarding whether to discuss the

737 risk was actually held, even if there was documentation.. Some physicians specifically

738 document the conversation in physician progress notes as well as on an informed consent

739 form. This may occur more often when the physician is getting consent for high-risk

740 surgical procedures.

741 In cases where the defendant physician or health care provider has proven

742 compliance with a statutory or common law duty, and a properly executed consent form

743 is part of the record, the patient/plaintiff must resort to claiming that the scope of the

744 disclosure was inadequate, or that the validity of the consent is in question. In that regard,

745 the patient may claim that he did not have the capacity to give consent, or that he did not

746 sign the form. Contract defenses such as fraud, mutual mistake, accident, and undue

747 influence are typically employed in such situations.

748 On the other hand, the reasonable person standard increases the difficulty of a

749 physician obtaining summary judgment, because the defendant must counter the

750 argument that knowledge of a particular risk of injury could influence a reasonable

751 person in making a treatment decision. This is typically a question of fact for the jury

752 rather than a question of law for the court. This definition is in the glossary

753

754 Summary

755

756 The importance of the informed consent process is not fully understood by many

757 healthcare professionals. Too often the nurse or other designee has the patient sign the
 INFORMED CONSENT 34

758 informed consent form without really knowing what the physician has discussed with the

759 patient regarding the treatment or procedure.

760 Failure to carry out the informed consent prior to any treatment or procedure

761 requiring informed consent could result in litigation. There should be documentation in

762 the medical record that the informed consent was obtained appropriately, that the patient

763 was presented with the appropriate information and understood what was presented.

764 There should be documentation of the methods utilized to overcome any limitations of

765 the consent process that practitioners and staff discover, such as language barriers and

766 readability of the consent documents. It is only through this documentation of what

767 information was discussed with the patient/subject and how the information was

768 presented that the medical record can substantiate the informed consent process utilized if

769 a law suit should result.

770

771 References
772
773
774 42 U.S.C. 1395dd, 1996. Retrieved on October 10, 2008 from

775 http://assembler.law.cornell.edu/uscode/html/uscode42/usc_sec_42_00001395--

776 dd000-.html

777 42. U.S.C. 11101 et seq., 2001. Retrieved on October 10, 2008 from www.npdb-

778 hipdb.hrsa.gov/legislation/title4.html

779 All Language Alliance, Inc. Medical Interpreters, Foreign Language Barriers and

780 Informed Consent. Translation for Lawyers September 2007. Retrieved on July

781 7, 2008 from

782
 INFORMED CONSENT 35

783 http://www.translationforlawyers.com/2008/06/medical_interpreters_foreign_l.html#mor

784 e

785 American Cancer Society, Informed Consent. Retrieved on May 25, 2008 from

786 www.cancer.org/docroot/ETO/content/ETO_1_2X_Informed_Consent.asp

787 American Medical Association, Office of the General Council, Division of Health Law,

788 Informed Consent Legal Issues. March 20, 2008. Retrieved on August 28, 2008

789 from http://www.ama-assn.org/ama/pub/category/print/4608.html.

790 ANA Code of Ethics for Nurses, 2008. Retrieved on June 27, 2008 from

791 http://nursingworld.org/ethics/code/protected_nwcoe813.htm

792 Barclay v. Campbell, 704 S.W.2d 8 (Tex. 1986). Retrieved on October 10, 2008 from

793 http://bulk.resource.org/courts.gov/c/F2/884/884.F2d.196.88-5615.html

794 Betancourt, J. & Jacobs, E. (2000) Language Barriers to Informed Consent and

795 Confidentiality: The impact on women's health. Journal of American Medical

796 Women's Association,55(5), 294-295.

797 Bottrell, Melissa, et al. (2000) Hospital Informed Consent for Procedure Forms. Archives

798 of Surgery 135:26-33.

799 Bowers v. Talmage, 159 So. 2d 888 (Fla. Dist. Ct. App. 1963

800 Burns, Paul, et al.(2005). Informed consent: A patients perspective. Journal of

801 Laryngology & Otology, 119, 19-22.

802 Cassileth, BR, et al. (1980), Informed consent - Why are its goals imperfectly

803 realized? New England Journal of Medicine; 302(16), 896-900.

804 Centers for Medicare & Medicaid Services. Conditions of Participation - Hospice.

805 Retrieved on July 27, 2008 from

806 http://www.access.gpo.gov/nara/cfr/waisidx_04/42cfr418_04.html
 INFORMED CONSENT 36

807 Centers for Medicare & Medicaid Services. (2007) Conditions of participation -

808 Hospital. Retrieved on July 28, 2008 from

809 http://www.access.gpo.gov/nara/cfr/waisidx_04/42cfr482_04.html

810 Centers for Medicare & Medicaid Services. (April 13, 2007). Revisions to the hospital

811 interpretive guidelines for informed consent {memorandum online}.

812 Retrieved on July 26, 2008 from

813 www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter07-17.pdf.

814 Centers for Medicare & Medicaid Services, (n,d.). Conditions of participation - Long

815 term care. Retrieved on July 27, 2008 from

816 http://www.access.gpo.gov/nara/cfr/waisidx_01/42cfr483_01.html

817 Derse, Arthur R. (2005). "What Part of 'No' Don't You understand?". Mount Sinai

818 Journal of Medicine, 2005. 72(4). 221-227.

819 ECRI Institute.( January 2008). Informed consent. Healthcare risk control risk analysis,

820 Vol2, Laws, Regulations, and Standards 4.

821 https://members2.ecri.org/Components/HRC/Pages/LawReg4.aspx?pfm=true

822 Engel, Kristen, et al.(May 16, 2008). Patient comprehension of emergency department

823 care and instructions: Are patients aware of when they do not understand?

824 Annals of Emergency Medicine.

825 Federal Register Rules and Regulations. Department of Veterans Affairs 38 CFR Part

826 17. Federal Register, Vol. 72, No. 45 Thursday March 8, 2007, page 10365 -

827 10367.

828 Food & Drug Administration. Subpart B. Informed Consent of Human Subjects. Title 21
 INFORMED CONSENT 37

829 Food and Drugs. Federal Register 46 FR 8951, January 27, 1981, as amended at

830 64 FR 10942, March 8, 1999, revised as of April 1, 2007 (21CR50). Downloaded

831 on August 13, 2008 from

832 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart

833 =50&showFR=1&subpartNode=21:1.0.1.1.19.2

834 Kim, Scott Y.H., et al. (2001). Assessing competence of persons with Alzheimer's

835 Disease in providing informed consent for participation in research. American

836 Journal of Psychiatry, 158(5), 712-717.

837 Larson, Aaron. The legal guardianship Expert Law. Retrieved on August 29, 2008

838 from www.expertlaw.com/library/estate_planning/guardianship.html

839 Lavelle-Jones, Christine, et al. (1993). Factors affecting quality of informed consent.

840 British Medical Journal, 306:885-890.

841 McCorkle, D. and Pietro, J. (2007). Perioperative nursing malpractice issues. Nursing

842 Malpractice, 3rd ed. Tucson: Lawyers & Judges, p. 372.

843 Mehlman, Maxwell J. (2008). Informed consent. The doctor will see you now. Retrieved

844 on February 19, 2009 from

845 http://www.thedoctorwillseeyounow.com/articles/bioethics/consent_3/.

846 Mohr, W. (2007). Psychiatric nursing liability. In P. Iyer (Ed.) Nursing Malpractice, 3rd

847 Ed. Tucson: Lawyers & Judges, Tucson, p. 420.

848 Murphy, Joshua, Editorial, Mayo Clinic Proceedings. (March 8, 2008).Benefits and

849 Challenges of Informed Consent, 83(3):272-273.

850 O'Neill, O. (2003). Some limits of informed consent" Journal of Medical Ethics. 29:4-7.
 INFORMED CONSENT 38

851 Organ Procurement and Transplantation Network. Resource Document for Informed

852 Consent of Living Donors. Retrieved July 27, 2008 from

853 www.unos.org/SharedContentDocuments/Informed_Consent_Living_Donors.pdf

854 Organ Procurement and Transplantation Network & United Network for Organ

855 Sharing (UNOS). Proposal to Require Transplant Centers to Inform

856 Potential Recipients about Known High Risk Donor Behavior. Retrieved on

857 July 27, 2008 from

858 http://www.unos.org/news/newsDetail.asp?id=948

859 Texas Administrative Code. "Electroconvulsive Therapy (ECT)". Title 25, Part 1,

860 Chapter 405, Subchapter E, Rule 405.108.

861 Texas Health & Safety Code 551.041, 2001, downloaded on October 10, 2008 from

862 http://tlo2.tlc.state.tx.us/cgi-

863 bin/cqcgi?CQ_SESSION_KEY=WQFLKGMLUMDR&CQ_QUERY_HANDLE

864 =126986&CQ_CUR_DOCUMENT=9&CQ_TLO_DOC_TEXT=YES

865 Texas Medical Association. "Medical Power of Attorney: Patient and Health Care

866 Provider Information" 1999. Retrieved on August 15, 2008 from

867 www.texmed.org/Template.aspx?id=65.

868 Texas Medical Liability Trust. (2006). Informed consent, the third generation. (2006).

869 Retrieved on October 10, 2008 from

870 www.tmlt.org/publications/riskpubs/informedconsentbook.pdf

871 Turner, P. & Williams, C. (2002). Informed consent: patients listen and read, but what

872 information do they retain? Journal of New Zealand Medical Association,

873 115(1164).
 INFORMED CONSENT 39

874

875 U.S. Holocaust Memorial Museum. Trials of War Criminals before the Nuremberg

876 Military Tribunals under Control Council Law No. 10. Nuremberg, October

877 1946-April 1949. Washington D.C. U.S. F.P.O. 1949-1953.

878 University of Pennsylvania. Press Release: (June 26, 2008). Disclosure of organ

879 transplant risks: A question of when, not if June 26, 2008. Retrieved July 27, 2008

880 from www.uphs.upenn.edu/news/News_Releases/2008/06/organ-transplant-risk-

881 disclosure.html

882 Van Howe, R.S., et al. (1999). Involuntary circumcision: The legal issues, BJU Int

883 , 83, Suppl 1:63-73.

884 Walker, Joan M. (Summer 2006). Beyond informed consent. Journal of Legal Nurse

885 Consulting, 17(3), 8.

886 Whitstone, Beth Newbury. (2004). Medical decision making: Informed consent in

887 pediatrics and pediatric research. Retrieved on July 16, 2008 from

888 http://tchin.org/resource_room/c_art_18.htm

889 Woolf, Steven H., et al. (2005). Promoting informed choice: Transforming Health care

890 to dispense knowledge in decision making. Annals of Internal Medicine, 143(4),

891 293-301.

892 Zur, Ofer. (n.d.). Ethics codes on record keeping and informed consent in psychotherapy

893 and counseling. Zur Institute. Retrieved on July 24, 2008 from

894 www.zurinstitute.com/ethicsofrecordkeeping.html.

895
 INFORMED CONSENT 40

896 Table 7.1.

897 Some High Risk Low Volume Procedures and Treatments That Should Have Consents
898
Some High Risk, Low Volume Procedures & Treatments That Should Have
Consents
Tubal Ligation Surgery
Vasectomy Administration of Radiation
Administration of psychotropic Insertion of devices or medication
drugs Electroconvulsive therapy
Administration of Anesthesia Genetic testing
Chemotherapy Newborn screening
Blood Administration Insertion of central lines

899 Adapted from ECRI Institute. Informed Consent. Healthcare Risk Control Risk Analysis,
900 January 2008, Vol 2, Laws, Regulations and Standards 4.
901
902
 INFORMED CONSENT 41

903
904 Table 7.2
905 Informed Consent for Procedures and Treatments
906
Informed Consent for Procedures and Treatments Must Include:
Nature and purpose of the procedure
Risks, benefits, and alternatives
Availability of alternative treatments (including no treatment ) and the risks, benefits of
the alternative treatment
Risks and benefits of not having the procedure
Other items that are required based on the procedures and treatments to be performed
Other items that are defined by each state
An assessment of patient understanding
The acceptance of the intervention by the patient
907 Adapted from American Medical Association, Office of the General Council, Division of
908 Health Law, Informed Consent Legal Issues.
909
910
 INFORMED CONSENT 42

911
912 Table 7.3
913 CMS Conditions of Participation Regulations
914
Type of Facility CMS Regulation Number for
Conditions of Participation
Ambulatory Surgery 42 CFR 416.2, 416.40-49
Community Mental Health Center 42 CFR 410.172
Comprehensive Outpatient Rehabilitation 42 CFR 485.50-74
Critical Access Hospital 42 CFR 485.501-645
End Stage Renal Facility 42 CFR 405.2100-2184
Home Health 42 CFR 484.1-.55
Hospice 42 CFR 418.3, 418.50-116, 418.58
Hospital 42 CFR 482, 489.20-24
Inpatient Rehabilitation 42 CFR 412.20-30, 412.600-632, 482.1-66
Intermediate Care Facility for Mental 42 CFR 435.1009, 440.150-220, 442.118-
Retardation 119, 483.400-480
Long Term Care 42 CFR 483
Outpatient Rehabilitation 42 CFR 485.701-729
Psychiatric Hospital 42 CFR 482.60-62
Psychiatric Residential Treatment Facility 42 CFR 483.350-376
Religious Non-Medical Healthcare Facility 42 CFR 403.730-746
Rural Health Clinic 42 CFR 405, 491, 485.601
Transplantation 42 CFR 482.68-104
915
916
 INFORMED CONSENT 43

917
918 Table7 4
919 Elements of Informed Consent
920
Basic Elements of Research Informed Consent
1. Explanation of the research and the expected duration of the subject's participation, a
description of the procedures to be followed, and identification of any procedures that are
experimental
2. Description of any reasonably foreseeable risks or discomforts to the subject
3. Description of any benefits to the subject or to others which may reasonably be
expected from the research
4. Disclosure of appropriate alternative procedures or courses of treatment that might be
advantageous to the subject
5. Statement describing the extent to which confidentiality of records identifying the
subject will be maintained and that notes the possibility that the Food and Drug
Administration may inspect the records
6. For research involving more than minimal risk, an explanation as to whether any
compensation and an explanation as to whether any medical treatments are available if
injury occurs and, if so, what they consist of, or where further information can be
obtained
7. Explanation of whom to contact for answers to pertinent questions about the research
and research subject's rights, and whom to contact in the event of a research-related
injury to the subject
8. Statement that participation is voluntary, that refusal to participate will involve no
penalty or loss of benefits to which the subject is otherwise entitled, and that the subject
may discontinue participation at any time without penalty or loss of benefits to which the
subject is otherwise entitled
Additional Elements of Research Informed Consent
1. Statement that the particular treatment or procedure may involve risks to the subject
(or to the embryo or fetus, if the subject is or may become pregnant) which are currently
unforeseeable
2. Anticipated circumstances under which the subject's participation may be terminated
by the investigator without regard to the subject's consent
3. Any additional costs to the subject that may result from participation in the research
4. The consequences of a subject's decision to withdraw from the research and procedures
for orderly termination of participation by the subject
5. Statement that significant new findings developed during the course of research may
relate to the subject's willingness to continue participation will be provided to the subject
6. Approximate number of subjects involved in the study
921 Adapted from Food and Drug Administration. Subpart B. Informed Consent of Human
922 Subjects. Title 21 Food and Drugs. Federal Register 46 FR 8951, January 27, 1981, as
923 amended at 64 FR10942, March 8, 1999, revised as of April 1, 2007 (21CR50).
924
 INFORMED CONSENT 44

925
926 Table 7.5

927 Items Scored from Informed Consent Forms in Bottrell, et. al. Study

Items Scored from Informed Consent Forms in Bottrell, et. al. Study
Nature of the procedure
Risks
Benefits
Alternatives
Items that might enhance patient-physician interactions
Items that might encourage shared decision making
928 Adapted from Bottrell, Melissa, et al. Hospital Informed Consent for Procedure Forms.
929 Archives of Surgery (2000), 135:26-33.
930
931

932
 INFORMED CONSENT 45

933