valid informed consent in clinical and academic practice
VALID INFORMED CONSENT IN CLINICAL AND ACADEMIC PRACTICE Peter Lars Jacobson, MD, FAAN University of North Carolina Chapel Hill, NC Informed Consent- Patient Autonomy and Safety Informed consent is a process that tries to ensure a person’s autonomy and safety, both in clinical treatment and in research. A neurologist’s role in this process in patient care and/or research is a cornerstone of professionalism. The process of informed consent requires that the physician has the medical-legal skills and knowledge, yet this process also provides the opportunity to enhance communication and rapport among the patient/subject, their family or guardian, and physician. Informed consent had its origins in the legal realm, but the process within the medical profession takes on moral, ethical, and practical implications. In this syllabus, we will discuss the basic principles of the valid informed consent process, distinguish the differences in clinical care and research, and provide examples of both research and clinical applications. In practical ethics (normative ethics), the terms “informed consent” and “mutual decision-making” are synonymous (1). Valid informed consent is essentially respect for a person’s autonomy. Autonomy may be defined as self-rule or self-governance (1). To attain autonomy, two essential elements are required: liberty (independence from controlling influences) and agency (capacity for intentional action) (1). In autonomous action, the patient acts intentionally, with understanding, and without controlling influences (1,2). In the informed consent, three elements are necessary: threshold elements, information elements, and consent elements (1,3,4). The threshold elements involve capacity of the person (ability to understand and decide) and voluntariness in deciding (neither undue influence nor coercion). The information elements include disclosure of material information, recommendations of a plan, and the understanding of the disclosure and recommendations in the person’s(or their surrogate’s) own words. The consent elements are a decision for a course of action and the authorization of the selected plan (1,3). Unfortunately, problems may occur with any or all three elements. We will discuss the issues in general, but review more specifics in the separate discussions of practice and research requirements. Threshold Elements Capacity In the threshold elements, the capacity or competence of the person may be in question. Inability to express or communicate a preference or choice (e.g. coma or aphasia) compromises capacity (1). In addition, inability to understand the situation and its consequences, inability to give a reason, inability to give a rational reason, inability to give risk/benefit-related reasons, and the inability to reach a reasonable decision (based on a reasonable person standard) may require surrogate decision-making (1,2). The following case illustrates this issue. A 47 year old patient was admitted to the intensive care unit on a respirator in a coma after a massive cerebral hemorrhage extending into the ventricles. The mechanical support and medications maintained his blood pressure, heart rate, and renal output. His neurologic examination and testing were consistent with brain death. He had a history of hypertension and poor medication compliance and did not leave a heathcare power of attorney, written directives, nor had he expressed his choices to family, friends or his physician to delineate his wishes on aggressive therapy or organ donation in this extreme situation. Medical futility is used to remove support in a patient that is declared brain dead; however, good communication with his wife and children helped the process of withdrawal of medical treatment. The neurologist took another course of action in this case. After the family was shown a normal encephalogram to contrast with the patient’s flat line study and they participated in a detailed discussion of the CT/ MRI films, the wife and family acted as the surrogate decision maker and requested withdrawal of all support. The patient expired within an hour of the withdrawal of artificial support. The family was upset by the death of their loved one, but they felt comfortable with this decision and had emotional support from the intensive care unit staff, social service, their pastor, and their physician. When patients are healthy, advance directives should be discussed in detail on an annual basis to guide a patient’s family and physician in the patient’s wishes for end-of- life care. The patients can also adjust their choices at any time. In the event that a patient may lack legal competence, a psychiatry consult should be obtained for documentation in a court of law. The legal standard for competence requires the four skills of communicating a decision, appreciating the current medical situation and its consequences, understanding relevant information, and utilizing the information on a rational basis. When the patient/subject lacks capacity (or competence in legal terms), a surrogate decision maker is necessary. Documentation of the lack of capacity should be in the medical record prior to utilizing a surrogate. Surrogate decision makers are identified by the patient’s written health care power of attorney, written directives, statedirected lineage representative(wife, son or daughter, etc.), or court (social worker or other assigned representative). The surrogate decision maker then has to decide the standard to apply to their decision-making. The “substituted judgment” standard utilized by the surrogate for the incompetent patient attempts to make a decision that the incompetent patient would have made if competent (1,3). The “pure autonomy” standard is applied to a formerly autonomous but now incompetent patient who previously expressed their autonomous preference through oral directives, written advance directives, health proxy(relative or court appointed), or health power of attorney (1). With the “best interests” standard, the surrogate decision maker weighs the risks and benefits among the options with the surrogate’s obligation to maximize the benefit for the patient (1,3). Voluntariness Voluntariness may be compromised by undue influence or coercion. Coercion is essentially an overt threat of harm that is stated by one person to another to obtain compliance. Undue influence occurs a multitude of ways; the effect is that an offer of an excessive, unwarranted, inappropriate or improper reward or overture is given to obtain compliance (1-3). The doctor-patient relationship adds to the possibility of undue influence, but awareness by the clinician or researcher of this positive influence by physicians helps to reduce its impact on informed consent. Voluntariness is especially affected in vulnerable populations, and this issue will be reviewed in research informed consent and the necessary safeguards (2-4). The key is to avoid manipulation and excessive persuasion. The use of language by the physician is important and the statements should not be absolute. Instead of the neurologist saying “You must have this test”, the neurologist should explain: “This test is important to you and will help in the diagnosis and treatment of your problem.” The patient should not feel a potential risk of abandonment when their belief system is against a proposed treatment. Once the patient has a clear understanding of the benefits and possible risks of a test or treatment, the patient can make their decision without fear of reprisal. If the choice is against medical advice, the decision should be documented and signed by the patient and a witness. In addition, documentation of the discussion in the medical record by the physician would also be helpful. The following case exemplifies the standard of voluntariness. Despite dexamethasone and diuretics, a 52 year old patient with a very large frontal meningioma had marked findings of increased intracranial pressure including headache, nausea, vomiting, papilledema, and bilateral extensor plantar responses. Her MRI scan was suggestive of impending herniation. She was a Jehovah’s Witness and refused surgery if a blood transfusion may be required. The consulting neurosurgeon (and his colleagues) at the hospital did not feel comfortable with performing this extensive surgery without the option of transfusions if the bleeding became life-threatening. The patient was transferred to a neurosurgeon at another hospital who felt comfortable with the patient’s decision, and the neurosurgeon proceeded with the surgery with the signed informed consent that included the statement that the patient understood that she could die from extensive bleeding during the operation with her refusal of the possibility of a blood transfusion. Sadly, the meningioma was highly vascular and the patient died from excessive bleeding during the operation. Her family was appreciative of the surgical attempt in a dire situation and the honoring of the patient’s choices. Vulnerable Populations Safety of the individual is essential in treatment and research. Autonomy of the patient or research subject may be compromised by multiple factors ranging from effects of disease to financial need. Safeguards in the informed consent process are needed to protect particularly vulnerable populations of patients for treatment and subjects for research. The protections required for research subjects are essentially the same concerns for our patients undergoing diagnostic evaluation and treatment. The vulnerable populations that are specifically identified by government mandates include pregnant women, prisoners, and children (2,3). Mentally impaired persons, psychiatrically ill persons, demented persons, economically compromised persons, terminally ill persons, and paid research volunteer subjects are also potentially at risk for undue influence and possible if not definitive incapacity (2). Information Elements Disclosure of Information Disclosure of sufficient (or insufficient) information was the legal context that produced the initial civil litigation in informed consent cases (1,3,4). The question is always “how much information is enough?” This element is at the core of professionalism. Professionals are generally obligated to disclose a core set of information that includes: 1) facts or descriptions that patients or subjects usually consider material in making a decision to comply or refuse the proposed medical intervention or research 2) information that the professional believes to be material to a decision 3) professional’s recommendation 4) purpose of seeking consent 5) nature and limits of consent as an act of authorization 6) any outside conflict of interest including the professional’s source of funding (1-4) A standard of disclosure is selected from three possible choices, with the preferred choice being the professional practice standard (1). The “professional practice standard” is based on the physicians’ professional expertise and commitment to the patients’ welfare; this standard is defined by evidence-based medicine and specialty practice parameters whenever possible. The next choice is the “reasonable person standard” which is dictated by legal jurisdictions; ie, what would a reasonable person need to understand the procedure? The third is the “subjective standard” based on the specific informational needs of the individual person and is not the generic “reasonable person.” The professional practice standard should be utilized whenever possible. Fortunately, evidence-based medicine and practice parameters for many neurologic diseases are documented for the neurologist with the help of the American Academy of Neurology. The neurologist can provide the diagnosis, prognosis, and treatment possibilities with a better clarity for the patient or their surrogate decision maker which maximizes disclosure for valid informed consent. Disclosure also concerns health literacy. Patients need to understand benefits and risks in their own terms. Risks can be discussed in both numeric and non-numeric probabilities. For example, some patients are more comfortable with comparisons to more familiar risks like driving the automobile or the use of a power saw (1). Many patients are illiterate and are embarrassed to reveal this problem. The American Medical Association has a kit on health literacy that clearly documents the need for better communication if reading and comprehension are problems for the patient (www.ama-assn.org/ama/pub/category/print/9913.html), and the AAN has participated in efforts to promote physician awareness of this issue. The importance of health literacy is reflected in the Physician Insurers Association of America (PIAA) Neurology Report available on the AAN Patient Safety Web page (http://www.aan.com/professionals/patient/piaa_neu.pdf). The report, which reviews 300 paid indemnity claims by PIAA for neurologists, shows that low health literacy is a significant factor relating to patient delay in seeking treatment, and that cases involving delay in seeking treatment had a higher “claim severity score”, which is associated with higher case indemnity (i.e. payment). They recommend assessing patients’ health literacy status, tailoring communication to the patient’s ability to understanding, and avoiding medical jargon. When English is not the patient’s primary language, competent medical translators must be available to provide full disclosure for a valid informed consent. The translator should not be a family member due to emotional ties to the patient and the subsequent effect in the translation, and because the family member may not have sufficient knowledge to translate medical terms or concepts. Before a translator participates, the neurologist needs to have an understanding of the translator’s knowledge base as well as their ability to translate possible difficult emotional information to the patient. If there is no evidence-based treatment available, the use of placebos for a possible therapeutic response may be considered, but the valid informed consent must disclose to the patient that the treatment that they are receiving “may or may not” have physiological effects and may not be effective. The therapeutic use of placebos falls under the threshold element of disclosure. The use of placebos may involve intentional deception or incomplete disclosure; in this situation, a placebo should not be considered. The “placebo effect” is well-known and may be therapeutic in up to 30 percent of patients (2). I do not agree that the placebo effect should be discounted on an ethical basis when the placebo has a potential benefit without side-effects in an illness that has no evidencebased, effective treatment. The only caveat is the informed consent of the patient with full disclosure prior to the treatment. Once a successful evidence-based therapy is identified, the use of placebos becomes unethical for the patient with a treatable disease (1). In clinical trials, documented effective medication or therapy should be compared to the “new treatment” when possible. Intentional non-disclosure is ethical in specific circumstances. Rarely used, therapeutic privilege is the physician’s decision to override disclosure and informed consent in medical emergencies or if the patient waives the right of disclosure. The patient has the right to delegate decision-making authority to the physician or ask not to be informed. Patients with serious illnesses who have rapport with their physician may state “Do what you need to do. I do not want to know.” To protect physicians and patients in this day of documentation, physicians should have patients sign a witnessed statement that they waive the right to informed consent. An ethics consultation provided by the hospital ethics committee should be considered in this situation prior to finalization of the process when possible. With the assessment of capacity, the disclosure of the essential information, and the atmosphere of autonomy, the most basic test of the success of communication for informed consent is to ask the patient to repeat back their understanding of the treatment or procedure in their own words including the potential risks and benefits (1,6). This technique will validate the efforts to obtain informed consent. Consent Elements Patient Response Patients with and without capacity have the right to the elements of informed consent prior to treatment or a medical procedure, and a significant majority of patients with capacity expressed their desire to exercise this right of patient autonomy (1,6). A study was performed in 1971 by radiologists at the Cleveland Clinic to obtain informed consent for angiography (6). During the study, the wording of the consent form and its presentation were adjusted for better clarity. After a straightforward disclosure of possible risks, complications, and potential benefits to patients with capacity, 228 patients consented to the angiography with four patients declining the procedure for various reasons. When asked about the informed consent process and the information, greater than 90% appreciated and wanted the information and informed consent process despite 70% feeling “disturbed” by the knowledge of the procedure. Only 4-5% of the patients felt that the disclosure “changed their minds” in anyway (6). Clinical Research Clinical research is essential for the advancement of neurologic diagnosis and treatment. The National Research Act (Pub. L. 93-348) was signed in July 1974 and created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (2,3). By multiple discussions and meetings through the auspices of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Belmont Report was developed and has remained a foundation for ethical behavior in clinical research (3). The Belmont Report and its ethical principles and guidelines should be required reading for all medical students and physicians. At this juncture, the basic differences in informed consent in medical practice and clinical research need to be emphasized. Medical practice requires diagnostic tests and therapeutic interventions that are directed solely for the improvement of the health of the individual patient and that have a reasonable benefit/ risk ratio with this goal in mind (1). In contrast, clinical research involving human subjects is a systematic investigation that is designed to test a hypothesis leading to conclusions, and the ultimate aim is the advancement of medical knowledge (1). The individual subject may or may not benefit from their involvement in the clinical trial (1). The U.S. Food and Drug Administration presents specific requirements for informed consent in clinical research, and their website delineates the goals under Part 50- Protection of Human Subjects (4). The basic treatment elements of informed consent are described by the FDA in Section 50.27, and a review of the general requirements applied to clinical research is summarized in Table 1. Table 1. FDA Basic Elements of Informed Consent (4) 1. Statement that study involves research, the expected duration of subject’s participation, a description of procedures to be followed, and identification of any procedures or treatments which are experimental 2. Description of reasonably anticipated risks or discomforts to the subject 3. Description of benefits of research 4. Disclosure of appropriate alternative procedures or courses of treatment, if any may be advantageous to the subject 5. Statement on extent of confidentiality of records and potential of identifying the subject and should note the possibility the FDA may inspect the records 6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation whether medical treatment available if injury occurs, and if so, what they consist of and that further information may be obtained. 7. Statement that participation is voluntary, that refusal to participate will not involve any penalty loss of benefits to which the subject is entitled, and the subject may discontinue their participation at any time without penalty Section 50.24 introduces the Institutional Review Board (IRB) for the assessment of proposed clinical investigations. Section 56 describes in detail the Institutional Review Board and its goal in the protection of the human subjects including vulnerable populations (see Table 2). Table 2 Basic Requirements of an Institutional Review Board (4) 1. Board has at least five members 2. The members have varying backgrounds in science and non-science 3. Every nondiscriminatory effort to ensure that men and women are represented 4. Board has at least one member whose primary expertise is in the scientific area 5. Board has at least one member whose primary concerns are in the nonscientific area 6. Board has at least one member who is not otherwise affiliated with the institution, and who is not an immediate family member of an affiliated person 7. Board has no members who have a conflicting interest in the Board’s initial review (or continuing review) of any specific project 8. Board may invite persons with competence in special areas to assist in the analysis of a complex issue (these persons do not have voting privileges with the Board) 9. Board has a member with medical-legal knowledge Informed consent is a critical component of clinical research, regardless where it is conducted. In the past few years, several prominent university medical centers had to stop all clinical research studies funded by the National Institute of Health due to problems with their valid informed consent process. Once adjustments in the informed consent process for clinical research were made by the university medical center IRB, the clinical research could continue. Clinical research in private practice by neurologists should be reviewed by an IRB at their hospital or through an IRB at a local university medical center. Fortunately, our university medical center has a very active office that monitors and directs the several IRB’s, and our institution has avoided this problem. With permission of the University of North Carolina at Chapel Hill, the informed consent guidelines for adults are included in this syllabus. Separate informed consent forms with the appropriate additions for vulnerable populations are available for review (see website)(7). One clinical study published in the Journal of the American Medical Association in 1992 is an unfortunate example of flaws in the application of valid informed consent (1,5). The study assessed the unreliability of patient self-reporting of cocaine use. However, the subjects signed an informed consent for a study of sexually transmitted disease and were not informed that there was a “piggy-back” study of recent cocaine use (5). After the signed informed consents for a study of sexually transmitted disease were completed, the subjects gave a urine samples that were tested for the recent use of cocaine. The subjects were paid ten dollars for the “STD study.” Ninety-one percent of the subjects were African-American, and eight-nine percent were uninsured. The study was performed in an outpatient clinic at Grady Memorial Hospital. The study was funded by the Center for Disease Control (a federal agency) and the Emory Care Foundation (5). Based on our previous review of valid informed consent and the role of the IRB, this study did not comply with many of the baseline requirements. It did not meet the standards of subject capacity, of full disclosure, or of autonomy. Since many of the subjects tested positive for recent cocaine exposure, the capacity of the subjects was compromised (5). The full disclosure requirement was not evident in the informed consent because information on cocaine testing was not provided to the subjects. With over eighty percent without insurance (an indication of possible financial compromise), the need for special safeguards of a vulnerable population should be instituted by the IRB (5). This study demonstrates the importance of an active IRB review of the informed consent process. An example of the current informed consent form for adult subjects at the University of North Carolina at Chapel Hill demonstrates the ability to provide full disclosure for the subject (or possibly the patient) in an effective manner without the loss of the key elements (7). Hopefully the use of questions and an attempt to simplify the form while still covering essential information reaches the goal of autonomy and safety for the subject and possibly their surrogate decision maker. By using the “question” format, the subject feels free to ask more about their concerns. The form is on the UNC School of Medicine website and has been printed with the permission of the University (See Addendum 1). The IRB plans a few minor changes to this consent form in the near future (7). Neurologic Practice In neurologic practice, the physician’s goal is diagnosis, prognosis, and treatment of the individual patient’s neurologic illness. The informed consent is less complex in diagnostic procedures, but could require more detailed disclosure of benefits and risks depending on the procedure involved. For example, the informed consent for an MRI would be simpler due to the lower risk/benefit ratio than the informed consent requirements for a four vessel arteriogram in a patient with recurrent ischemic vascular events. This informed consent process is similiar to informed consent for clinical research in the basic requirements of capacity, disclosure of information, and voluntariness; the main difference is the specificity to the patient’s needs in order to provide appropriate therapy. Normative (or practical) ethics will be discussed in the context of informed consent in clinical treatment of patients. The example will be one of the more difficult neurologic conditions and treatment. Neurologists have perceived many barriers to the treatment of chronic noncancer pain (8-10). In this case, a 41 year old male was involved in a single motor vehicle accident when he fell asleep while driving. The roll-over of his SUV resulted in fractures of the cervical spine at the odontoid, C1-C2, C4, C5, and C6 with associated ligamentous laxity at several cervical levels. In addition, the seat-belt produced a compound fracture of the clavicle with a brachial plexus injury. The patient survived the accident and required pinning of the clavicle and reattachment of torn ligaments that resulted in a permanent, mild dislocation of the left clavicle. Subsequently, his denial of problems over several years allowed the cervical spine to fuse in several areas with healing of the fractured odontoid as well as the other cervical fractures. The patient developed increasing neuropathic left arm pain and weakness; his headaches also increased which brought him to the neurologist. His neurologic examination was pertinent for an absent left triceps reflex with hyperreflexia in all four extremities with neutral flexor-plantar responses, and decreased left hand grip with a non-dermatomal sensory loss. The x-rays, CT scans, and MRI of the cervical spine showed progressive cervical spine post-traumatic changes with significant post-traumatic degeneration at multiple levels. In addition, the flexion films demonstrated misalignment with motion at C3- 4 level, and the body of C3 approximately 2-3 mm anterior to C4. Similiarly, the odontoid space on the flexion view is slightly wider at 1-2 mm on extension suggesting ligamentous injury. EMG documented multiple levels of chronic left cervical radiculopathy and left brachial plexopathy. Eventually, the daily baseline pain was reduced on a daily regimen of gabapentin, fluoxetine, and ibuprofen. Intermittent attacks of pain were controlled with short-acting opioids two to three times a week. The patient became more functional and started to work in a job with less physical demands; his interactions with his family and friends also demonstrated improvement. He maintained regular follow-up visits. During the neurologic work-up and subsequent treatment, valid informed consent was necessary and helpful to regulate the use of opioids. A key issue of concern for the neurologist and patient in pain control is the use of opioids (8-10). The new guidelines of the Drug Enforcement Administration for opioids include documentation (medical history, physical exam, pain assessment and treatment plan) during the first visit and subsequent follow-up visits. Evaluation of the nature and effect of pain, previous treatment, and alcohol and drug history are required. Monitoring is essential. A valid informed consent combined with a treatment contract would help the patient and the neurologist if opioids are considered in the patient’s pain management. For this patient, patient autonomy is essential in valid informed consent by the patient or surrogate decision maker. In our case, the patient had the capacity to understand the benefits and risks of the procedures and subsequent medications. He received full disclosure and information on his testing and the medications including their risks and benefits. During the disclosure, the patient was provided with knowledge that regular follow-ups were required to receive opioids and a treatment contract would be necessary. The specific contract was given to the patient to review. The contract should: 1) contain valid informed consent by the patient or their surrogate decision maker; 2) require the name, address, and the telephone number of a single pharmacy; 3) describe (and the staff will show) the prescription flowchart that will be part of the patient’s medical record; 4) permit refills during office hours only; 5) indicate that only one physician or their partner will be prescribing controlled substances; 6) require follow-up visits to monitor therapeutic response and possible adjustment of the treatment plan; 7) require notification of the physician’s office by the patient when prescriptions of controlled substances by other physicians for acute situations takes place; and 8) require agreement by the patient for immediate referral to a drug treatment program or possible dismissal from the medical practice for violations of the contract (9,10). The patient or surrogate decision maker should have sufficient time to decide whether to consent to the contract without undue influence or coercion. If the decision is consent, two copies of the treatment contract are signed and witnessed; one copy retained by the patient/surrogate and one copy placed in the medical record (9,10). Informed consent is essential for patient autonomy and safety (11). Differences in requirements for informed consent occur in medical practice and clinical research. However, the fundamental elements involved in informed consent are evident in both situations. References 1. Beauchamp TL, Childress JF. Principles of Biomedical Ethics, 5th ed. Oxford: Oxford University Press, 2001. 2. Wichman A. Ethical and regulatory aspects of research involving human subjects. Continuum 2003; 9:3457. 3. National Institutes of Health. The Belmont Report ethical principles and guidelines for the protection of human subjects of research. Available at: http://ohsr.od.nih.gov/guidelines/Belmont.html. Accessed October 11, 2004. 4. U.S. Food and Drug Administration. Part 50, Part 56, Protection of human subjects [online]. Available at:www.accessdata.fda.gov. Accessed November 3, 2004. 5. McNagy SE, Parker RM. Cocaine use and the unreliability of patient self-report in an inner-city walk-in clinic. JAMA 1992;267:1106-1108. 6. Alfidi RJ. Informed consent: A study of patient reaction. JAMA 1971;216:1325-1329. 7. IRB Forms, University of North Carolina at Chapel Hill. Available at:www.med.unc.edu/irb/Frames.htm. Accessed November 20, 2004. 8. Consensus statement from the American Academy of Pain Medicine and the American Pain Society. The use of opioids for the treatment of chronic pain. Clin J Pain 1997;13:6-8. 9. Jacobson PL, Mann JD. Neurologist’s role in chronic noncancer pain. Mayo Clin Proc 2003;78:80-84. 10. Jacobson PL, Mann JD. The valid informed consent in chronic non-cancer pain: its role in reducing barriers to effective pain management. Comp Ther 2004;30:101-104. 11. Bernat, JL. Ethical Issues in Neurology, 2nd ed. Woburn,MA: Butterworth-Heinemann, 2002. INFORMED CONSENT – PATIENT SAFETY AND AUTONOMY KEY POINTS Threshold Elements: Capacity or Competence: Mental or physical ability to understand and to communicate information about medical treatment. 1. If in question, consult psychiatry for clarification and documentation 2. If a documented problem, utilize surrogate decision maker including healthcare power of attorney, written advanced directives, appropriate family member, or court-appointed guardian Voluntariness: No undue influence or coercion 1. Avoid excessive manipulation by your behavior 2. Avoid threat of abandonment of patient Vulnerable Populations: Protection of pregnant women, children, prisoners, mentally impaired patients, psychiatrically ill patients, demented patients, economically compromised patients, terminally ill patients, and paid volunteer subjects of research 1. Check for special informed consent forms 2. Check for guidelines and specific consent forms by IRB for subjects of research Information Elements: 1. Disclosure a. Provide complete information to patient b. Review significant risks and benefits c. Discuss purpose of test or treatment d. Discuss any conflict of interest 2. Check health literacy of patient 3. If English is not patient’s primary language, contact competent translator 4. Give your recommendation and possible alternatives 5. Avoid use of therapeutic privilege (proceeding without valid informed consent) unless medical emergency. Obtain ethics consult if possible in non-emergent situations. Consent Elements: 1. Understand that the patient wants to follow informed consent process 2. Utilize this opportunity for better doctor-patient communication and rapport ADDENDUM 1 University of North Carolina-Chapel Hill Consent to Participate in a Research Study Adult Subjects _____________________________________________________________________________ (DELETE THIS AND ALL OTHER INSTRUCTIONS IN ITALICS) Medical IRB Study #_____________________ (Leave blank if new submission) Consent Form Version Date: ______________ (Enter or update for all submissions) Title of Study: Principal Investigator: (name and degree) UNC-CH Department: Phone number: Co-Investigators: (names and degrees) Sponsor: (National Cancer Institute, Name of Pharmaceutical Company, etc) _____________________________________________________________________________ You are being asked to take part in a research study. The investigators listed above are in charge of the study; other professional persons may help them or act for them. What are some general things you should know about research studies? Research studies are designed to gain scientific knowledge that may help other people in the future. You may not receive any direct benefit from participating. There may also be risks associated with participating in research studies. Your participation is voluntary. You may refuse to participate, or may withdraw your consent to participate in any study at any time, and for any reason, without jeopardizing your future care at this institution or your relationship with your doctor. If you are a patient with an illness, you do not have to participate in research in order to receive treatment. Details about this particular study are discussed below. It is important that you understand this information so that you can decide in a free and informed manner whether you want to participate. You will be given a copy of this consent form. You are urged to ask the investigators named above, or staff members who may assist them, any questions you have about this study at any time. What is the purpose of this study? The purpose of this research study is ... (If applicable, include a statement that the study involves testing an investigational drug or device, or an approved drug or device whose use in this study is investigational. Bear in mind, in this section and all others, that you are describing complex concepts to laypeople.) How many subjects will participate in this study? (For single-center studies) If you decide to participate, you will be one of approximately (number) subjects in this research study. (For multi-center studies) A total of approximately (number) subjects at (number) institutions will take part in this study, including approximately (number) subjects from this institution. How long will your participation last? Your participation in this study will last for approximately ... (How long entire study is projected to run is less important than this individual subject’s participation, in hours, days, months or years. Include required follow-up) What will happen if you take part in the study? During the course of this study, the following will occur: (Describe in lay language, step-by-step, what will be required of, or done to, the research subject. This should include, but need not be limited to: Overall design. Methods and probability of assignment, randomization and placebos. If applicable, blinding procedure, and a statement that a research subject's treatment can be determined rapidly in case of emergencies. Procedures to be performed, including frequency and follow-up. Differentiate between procedures/test articles that are investigational or included solely for research purposes and those that are standard clinical care. Research medications to be administered and method, dose and frequency of administration. Number, frequency and duration of visits, if known. Specific requirements of the research subject, such as post-treatment follow-up, diary cards, questionnaires, etc. In research involving patients as subjects, provide the name of the physician responsible for the patient's welfare during the study. Specimens to be collected including frequency and size/amount. If specimens will be stored for as-yet-unknown tests, see “Stored Samples Policy and Consent Form Addenda.”) Are there any reasons you should not participate? You should not participate in this study if… (List only those exclusion criteria about which subjects will know, and that may be unknown to the investigator. Do not necessarily list all the exclusions shown in the Master Protocol, for which investigators will screen every subject.) What are the possible risks or discomforts? This study might involve the following risks and/or discomforts to you: (For each research procedure/intervention, describe immediate and long-term physical, psychological, social and reproductive risks/discomforts. If frequency of such risks or discomforts is known from previous studies, provide estimates of frequency. It may be more meaningful for subjects to see side effects grouped as Common, Uncommon, Rare, etc, as opposed to a long unbroken list of every side effect ever noted.) (If women of childbearing age are included as subjects and the research procedure/drug/device may cause harm to an unborn fetus or breast feeding child, state whether pregnancy or breast-feeding excludes participation, whether birth control is required (and if so, which method), and that the P.I. should be notified immediately if the subject becomes pregnant.) In addition, there may be uncommon or previously unrecognized risks that might occur. What are the possible benefits? The benefits to you of participating in this study may be… (Describe potential benefits that might reasonably be expected to result from this research. Identify those that might accrue to the individual subject as well as those that might benefit society in general. If the individual subject will receive no direct benefit, make a statement to that effect.) If you choose not to participate, what other options do you have? You do not have to participate in this research study in order to receive treatment. Other procedures/treatments that are available are… (For research that does not involve treatment, eliminate this section. For protocols involving treatment, describe any alternative procedures or courses of treatment that might be available to the subject. For some terminally ill patients considering a treatment trial, supportive care only may be an alternative.) What if we learn about new risks during the study? You will be given any new information gained during the course of the study that might affect your willingness to continue your participation. How will your privacy be protected? No subjects will be identified in any report or publication about this study. Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information. This is very unlikely, but if disclosure is ever required, UNC-CH will take all steps allowable by law to protect the privacy of personal information. (Indicate how privacy and confidentiality will be protected. How will records be secured? To whom will access be limited? Will names be used, or will there be ID numbers only, and a linkage file? Is any sensitive information being collected, and will it be treated differently?) (If reviewed or sponsored by a manufacturer or government agency, include a statement that the manufacturer or government agency may review all records. If the study involves products regulated by the Food and Drug Administration (FDA), add a statement that the FDA may inspect the records.) (Include the following if research is clinically relevant for these subjects. Delete for healthy volunteers.) Because this study could affect your medical care, a copy of this consent form will be placed in your medical record. This will allow the doctors caring for you to obtain information about what drugs or procedures you are receiving in the study and treat you appropriately, if you have other health problems or needs during the study. Will you be paid for participating? You will receive (amount) for your participation in this study. (Or, “You will not be paid for your participation in this study.” if that is the case.) (If payment will be made, address how payments will be prorated in the event the subject withdraws, or is withdrawn by the investigator, from the study prior to completion.) Will it cost you anything to participate? The costs of this research will be... (e.g. “… billed to you and/or your insurance.” Or “… paid by the sponsor. There will be no costs to you for participating.” Elaborate as necessary, to describe specific items or procedures that may/may not be covered.) Who is sponsoring this study? This research is funded by (name of Drug Company, the National Institutes of Health, etc.). This means that the research team is being compensated by the sponsor for conducting the study. The researchers do not, however, hold a direct financial interest in the sponsor or in the outcome of the study. (Or, when appropriate, the last sentence should be modified/expanded to disclose the nature of any potential conflicts of interest relating to this study, financial or otherwise.) What will happen if you are injured by this research? All types of research involve possible risk, some including the risk of personal injury. In spite of all precautions, you might develop complications from participating in this study. If such complications arise, the researchers will assist you in obtaining appropriate medical treatment, but any costs associated with the treatment will be billed to you and/or your insurance company. The University of North Carolina at Chapel Hill has not set aside funds to compensate you for any such complications or injuries, or for related medical care. However, by signing this form, you do not waive any of your legal rights. (The above statement may be omitted if the study involves only minimal risk. "Minimal risk" means that the risks of harm anticipated in the proposed research are not greater, considering both probability and magnitude, than those encountered in daily life or during the performance of routine physical or psychological examinations.) (If applicable, add a separate paragraph about any compensation for injury that will be provided by the study sponsor.) What if you want to stop before your part in the study is complete? You can withdraw from this study at any time, without penalty. The investigators also have the right to stop your participation at any time. This could be because you have had an unexpected reaction, or have failed to follow instructions, or because the entire study has been stopped. (Modify the above paragraph, if necessary, to fit the study.) What if you have questions about this study? You have the right to ask, and have answered, any questions you may have about this research. If you have further questions, or if a research-related injury occurs, you should call (name and degree of investigator) at (phone number) . What if you have questions about your rights as a subject? This research has been reviewed and approved by the Committee on the Protection of the Rights of Human Subjects (Medical IRB) at the University of North Carolina at Chapel Hill. If you have any questions or concerns regarding your rights as a research subject, you may contact the Chairman of the Committee at (919) 966-1344. ----------------------------------------------------------------Subject’s Agreement: I have read the information provided above. I voluntarily agree to participate in this study. _________________________________________ Signature of Research Subject _________________ Date _________________________________________ Printed Name of Research Subject _________________________________________ Signature of Person Obtaining Consent _________________________________________ Printed Name of Person Obtaining Consent _________________ Date VALID INFORMED CONSENT IN CLINICAL AND ACADEMIC PRACTICE Peter Lars Jacobson, MD, FAAN University of North Carolina Chapel Hill, NC Informed consent is a process that tries to ensure: • A person’s autonomy • A person’s safety • Communication between person and neurologist • Rapport between person and neurologist Autonomy • Liberty (independence from controlling influences • Agency (capacity for intentional action) Informed Consent Elements • Threshold elements-ability to understand and decide (capacity) • Information elements- disclosure of material information and recommendations • Voluntariness-decision without undue influence or coercion Threshold Elements- Capacity • Inability to express or communicate choice • Inability to understand the situation and its consequences • Inability to give a reason • Inability to give risk/benefit reasons • Inability to reach a reasonable decision based on a “reasonable person” standard Surrogate Decision Maker • • • • Heath care power of attorney Written directives State definited family member Court appointed representative Case Study • 47 y/o male in a coma admitted to the ICU on a respirator and pressor agents • Massive intracerebral hemorrhage extending into ventricles from uncontrolled hypertension • Neuro exam and testing were consistent with brain death Case Study • No healthcare power of attorney, written directives, or expressed choices to family, friends, or physician • Medical futility can be considered to remove support • Good communication with wife and children for withdrawal of medical treatment Advance Directives • After age 18, never too early • Should be a part of routine follow-ups • Directives can always be changed by the patient • Easier and less stressful discussion when the patient is healthy • Provides more time for the patient to reflect on decisions Voluntariness Voluntariness may be compromised by - Coercion- overt threat of harm that is stated by one person to another to obtain compliance - Undue influence – offer of an excessive, unwarranted , inappropriate or improper reward or overture is given to obtain compliance Voluntariness (cont.) • Medicine is an art as well as a science • Doctor-patient relationship adds the possibility of undue influence, however awareness by the clinician/researcher can reduce its influence • Vulnerable populations are especially affected Disclosure • Facts or descriptions that patients or subjects consider important in making a decision to comply or refuse proposed medical intervention or research • Information that the physician believes to be important to the decision • Physician’s recommendation • Purpose for seeking consent Disclosure (cont.) • Nature and limits of consent as an act of authorization • Any outside conflict of interest including the physician’s source of funding Disclosure • Disclosure concerns medical literacy • Concerns patient’s literacy skills and comprehension • Concerns the use of a medical translator if English is not the patient’s primary language • Family members cannot be the translator • Translator’s knowledge and skills Disclosures • Placebos and ethics • Intentional non-disclosure in specific circumstances • Patient or surrogate decision maker repeats back their understanding in their own words Vulnerable Populations • Autonomy may be compromised by many factors- safeguards • Children, pregnant women, and prisoners • Mentally impaired, psychiatrically ill, demented, economically compromised, terminally ill persons and paid research volunteer subjects Patient Response • Patients with and without capacity have the right to the elements of informed consent • A significant majority of patients with capacity expressed their desire to exercise their right of patient autonomy despite the possible “bad news” Research and Informed Consent • The Belmont Report- a classic • US Food and Drug Administration requirements for informed consent in clinical research- see website • Part 50 delineates the goals- Protection of Human Subjects • Part 56 describes the Institutional Review Board IRB Informed Consent Forms • The University of North Carolina at Chapel Hill adult consent form in syllabus • Check website for example of informed consent form for children and other vulnerable populations Case Study • Admirable goals, but flawed informed consent • “Piggy back” study • Payment to vulnerable population • Compromised subjects without capacity • Importance of IRB monitoring for assistance and protection Research Informed Consent • • • • Voluntary Possibility of no benefit to subject Possibility of risks to subject May withdraw at any time from study without penalty Neurologic Practice and Informed Consent • Goal is diagnosis, prognosis, and treatment of the individual patient’s illness • Informed consent is for tests and treatment that will be helpful to patient’s specific needs • Informed consent may be less complex for diagnostic procedure with reduced risk/benefit to the patient Case Study • 4l y/o male injured in a roll-over accident in SUV and waited 5 years after L clavicle surgery to present with increasing L arm pain, increasing headache, and slowly progressive L hand weakness • Neurologic exam pertinent for chronic dislocation of L clavicle, absent L triceps reflex, hyperreflexia in all four extremities except L triceps with flexor-plantar responses, decreased hand grip, and sensory loss in C5-C6 distribution Case Study (cont.) • X-rays, CT, and MRI of cervical spineprogressive c-spine post-traumatic changes and degeneration at multiple levels. Healed C1-C2 including odontoid fractures, evidence of old fractures at C4, C5, and C6 with ligamentous laxity • On flexion films, misalignment with motion at C3C4, and the body of C3 approximately 2-3 mm anterior to C4 with the odontoid space wider by 1-2 mm on extension views Case Study (cont.) • EMG documents multiple levels of chronic L cervical radiculopathy and L brachial radiculopathy • Valid informed consent was necessary and helpful to regulate the use of shortacting opioids used 2-3x per week for acute attacks. • Daily baseline pain reduced with gabapentin, fluoxetine, and ibuprofen Opioids and Chronic Noncancer pain • Valid informed consent by the patient was beneficial for the patient and neurologist • Informed consent included a treatment contract to monitor the patient’s status • The essential components of the treatment contract are delineated in the syllabus • The patient had sufficient time and autonomy, information, and voluntariness prior to signing with a witness Informed Consent • Informed consent is essential for patient autonomy and safety • Differences in requirements for informed consent occur in medical practice and clinical research • The fundamental elements involved in informed consent are evident in both situations
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