DR IDARA

Informed consent, confidentiality and medical

records

INFORMED CONSENT

Requirements for Informed Consent

The legal duty of informed consent requires that physicians disclose:

a.The nature of the procedure or testb.The benefits, risks, and consequences of the

intervention c.Alternatives and their benefits, risks, and

consequencesA narrow vision of informed consent, while

meeting legal standards, may result in suboptimal patient care decisions.

Informed Refusal

Another view of informed consent is that patients have an ethical and legal right to be free of unwanted medical interventions and bodily invasions.

Competent patients must be informed of the risks of the proposed plan of care and have the power to reject their physicians’ recommendations.

This right to refuse is now extended to noninvasive care, such as diagnostic tests and medications.

In a broader view, patients have the right to choose among medically feasible options, in addition to the negative right to refuse unwanted interventions.

Obstacles To Informed Consent

Patients do not understand the medical information

Patients are compromised by illness, anxiety, etc.

Some patients do not want to make decisions

Language of probabilities is unfamiliar to lay-persons

Takes too much time

Some patients just don't want to know

Justification For Informed Consent• Respects autonomy/persons

autonomy as a value

autonomy as a goal

• Respects the right to control what happens to one's body

• Promotes trust between doctor and patient

• Reduces liability and malpractice claims

• Can be justified at least on utilitarian, deontological, and rights grounds, also on virtue ethics grounds.

Note

Ethically and legally, informed consent requires discussions of pertinent information, obtaining the patient’s agreement to the plan of care, and freedom from coercion.

In particular, the alternative of no intervention needs to be discussed.

The Competence of the doctor, team, institution should also be discussed because increased volume is associated with significantly better outcomes.

Consent should be given by the person performing the procedure

Discussions about the proposed test or treatment and the alternatives should be conducted by the attending physician or by the physician performing the intervention. Such discussions should not be delegated to nurses, medical students, or house officers.

Consent is required for each specific procedure.

Informed consent for those lacking the capacity

When patients lack the capacity to make informed decisions, Advanced directives or appropriate surrogates should guide decisions.

Oral directives are valid if they can be provenConsent obtained over the phone is valid .For

consent obtained over the phone, the physician may need to use another member of the healthcare team ( e.g. a nurse ) to act as a witness as it may be difficult to prove.

Pregnant women

The general consensus is that fetus is not considered a person until birth.

A pregnant woman has a right to informed consent as well as informed refusal even if the life of the fetus may be at risk.

The father of the fetus can’t give consent.

Exceptions To Seeking Informed Consent

1.1. EmergenciesEmergencies- if the patient is not competent and no surrogate is available and his or her advance wishes are unknown and there is danger to life or danger of serious impairment to health, and immediate treatment is necessary to avert these dangers, then the obligation to seek informed consent is waived ( AMA code,8.08)

2.2. Therapeutic privilegeTherapeutic privilege- If there is a reason to believe that information given to a specific patient will result in an adverse effect on the patient’s condition or health, the information may be withheld pending evaluation of the patient.

Case 1

Ms. B was a 58- year old woman who was found to have a small breast cancer, stage T1N0M0. Her surgeon recommends mastectomy and informs her of the benefits and risks of the operation, including side effects such as lymphedema of the arm. The surgeon says that a less extensive operation may not remove all the tumor. Ms. B’s daughter searched the internet for information about breast cancer and learned that her mother’s cancer could be treated with lumpectomy plus radiation therapy, which would avoid disfiguration and lymphedema.

Case 2

• A 52 year old man sees you in follow-up after a radical prostatectomy. He had been fully informed about the risk of the procedure such as incontinence and impotence. Neither of these adverse effects occurs. While searching on the web he finds that there is treatment without surgery involving the implantation of radioactive seeds or pellets in the prostate. He files suit against you because of an improper informed consent.

• What will be the most likely outcome of the suit?• A. he will lose cos there was no adverse effect.• B. he will lose cos all the risks of the surgery were explained to

him before he signed consent.• C. he will lose cos radical prostatectomy is a standard

procedure• D. he will win cos radioactive seeds are the superior form of

therapy.• E. he will win cos you did not inform him of the risks and

benefits of alternative therapy to surgery.

Case 3

A 54-YEAR OLD Spanish-speaking woman has arrived for the first of a clinical trial of chemotherapy for breast cancer. You suddenly remember the need for signing a consent form. You ask a medical student to “get the consent”. He walks up to the pt and says in English, “sign this”, and she signs. She completes the trial but her hair falls out and she files suits against you for an improper informed consent.

Why will this lawsuit be successful?A. the risk of the treatment were not explained.B. she experienced harm from the study medication.C. the explanation was not in a language you were sure

she could understand.D. someone who didn’t understand the study obtained

the consent.E. all of the above.

Confidentiality and Medical Records

Patients reveal to physicians sensitive personal information about their medical and emotional problems, alcohol and drug use, and sexual activities. The presumption is that physicians should keep patient information confidential unless the patient gives the permission to disclose it.

However, exceptions to confidentiality might be warranted to prevent serious harm to third parties or to the patient.

In 2003 the federal government issued health privacy regulations, commonly known as HIPAA regulations, because the Health Insurance and Accountability Act mandated them.

Reasons for confidentiality

1. It shows respect for patients2. It also has beneficial consequences for the

Doctor- Patient Relationship.- it encourages people to seek medical care and discuss sensitive issues candidly. In turn, treatment for these conditions benefits both the individual patient and public health.

3. It prevents harmful consequences to patients, such as stigmatization and discrimination.

Confidentiality vs. Privacy

Privacy- loss occurs if others enter “ Zones of secrecy, anonymity, seclusion, or solitude”, causing someone “ to be observed, touched, or intruded upon” against his or her wishes.

Privacy is also violated if others obtain information about a person that he or she wants to keep inaccessible.

Confidentiality refers to limits on the dissemination of information disclosed by a person within the Doctor- Patient relationship or participant – researcher relationship.

Exceptions to Confidentiality

A.A. Exceptions to protect third partiesExceptions to protect third parties1. Reporting to public officials

a. Infectious diseasesb. Impaired drivers

2. Injuries caused by weapons or crimes3. Partner notification by public health officials4. Warnings by physicians to persons at risk5. Violence by psychiatric patients – Tarasoff

Decision

B.B. Exceptions to Protect patientsExceptions to Protect patientsa. Child abuseb. Elder abusec. Domestic Violence

When Is Overriding Confidentiality Warranted?

a. The potential harm to identifiable third parties is serious

b. The likelihood of harm is highc. There is no less invasive, alternative means for

warning or protecting those at riskd. Breaching confidentiality allows the person at

risk to take steps to prevent harme. Harm to the patient resulting from the breach

of confidentiality is minimized and acceptable.Disclosure should be limited to information essential for the intended purpose, and only those persons with a need to know should receive information.

Disclosing Patient Information to others

The HIPPA privacy regulations requires that health care providers need to notify patients that relatives will be informed unless the patient requests that they not be.

5.

• You are working at the desk in your hospital when another employee of the hospital asks for information about a patient who was admitted last night with a pulmonary embolus secondary to cancer. You know the details of the case, the person requesting the information states that he is a close friend and co-worker of your patient. He shows you proper identification proving he really is a co-worker of your patient who also works in the hospital.

• Which of the following is the most appropriate response to this request?

• A. “ I will give you the information on the patient”.• B.” I give you the information only if you the patient’s

relative”.• C. “I am not at liberty to give details regarding the patient

without the patient’s permission”.• D. “ sign a release or consent form before I reveal the

information”.

6.

• You are seeing a patient in clinic who has developed TB. He is an illegal immigrant. His family will need to be screened for TB with PPD skin testing. He is frightened of being deported if the department of Health learns of his immigration status.

• What should you tell him?• A. “don’t worry, the department of health does not ask or

report immigration status”.• B. “only people who are noncompliant with medications

are reported to the government”.• C.” don’t worry, I will fully treat you before we deport

you”.• D. “I am sorry but there is nothing we can do about it;

there is mandatory reporting to the government”.

7.

• You are a psychiatrist in session with a patient who tells you he thinks his boss at work is persecuting him. The patient has had mild schizophrenia. The patient asks you if you can keep a secret and then tells you that he is planning to kill his boss” when the time is right”. You say, “ of course, everything you tell me during the session will always be confidential”.

• What should you do?• A. keep the pt’s session confidential but make attempts to

discourage the patient from his plan.• B. inform your medical director and let him handle it.• C. inform law enforcement agencies of the threat to the pt’s

boss.• D. inform the pt’s boss that he is in danger.• E. inform both the pt’s boss and law enforcement of the

threat.

8.

• You are discussing the care of an elderly woman with her family. Although she is awake and alert, the patient is very ill and physically fragile. You are awaiting the results of a biopsy for what will likely be cancer, which has already metastasized throughout the body. The family ask that you inform them first about the results of the biopsy. They are very loving and constantly surrounding the patient.

• What should you tell them?• A. “ what do you fear most about telling your mother

her diagnosis?”• B. “ I advise that we involve the ethics committee of the

hospital”• C.” I am sorry, this decision can only be made by the

health care proxy”• D.”It’s my duty to inform the patient of all the findings”.

Medical Records

Although the Hospital or Health- Care facility owns the medical record, the information contained within is the property of the patient.

The patient has an absolute right to access the information contained within the medical record.

The information contained within the medical record can’t be released to third parties without the patient’s approval.

Patients can make photocopies of the information contained within the medical record but they can’t take the records home.

9.A patient of yours has gone to the hospital to obtain a

copy of her medical record for her own review. The hospital refuses to release them to her on the grounds that she must provide an adequate reason for wishing to see the records. She has come to see you to ask if this is true and how can she get her records. What should you tell her?

A. you, as the physician, can get the records for yourself to view, but she cannot.

B. the hospital will give her the records as long as you ask

C. she has the right to have her own records as long as she has legitimate reason.

D. she has the right to her own records even without giving a reason.

E. she can have the records as long as she has fully paid her hospital bills.

F. Only another physician, hospital, or insurance company can have free access to her records.

10.

• You are seeing patients in clinic when two men in dark suits and dark glasses come in and show you badges marking them as members of a law enforcement agency. The identification is legitimate. These men inform you that they are making a minor investigation of one of your patients. They ask to look at the patient’s chart for a few minutes saying “ you wouldn’t want to interfere with a federal investigation, would you?”.

• What should you do?• A. give them the chart• B. give them the chart but watch what they do with it• C. tell them you cannot show them the chart unless

there is a signed release from the patient.• D. ask them to sign a release for the chart so you are

absolved of responsibility.

11.A man comes to the emergency department after

a stab wound. Your notes document a 500ml loss of blood. Later that night the patient develops a heart attack and dies. You find the loss of blood was originally really 3000ml, which was not recorded by you.

What should you do to correct the documentation?A. use correction fluid to eliminate the original

noteB. erase the original noteC. remove the original note from the chartD. write a new note timing and dating it at the

same time as the original note.E. write a new note with the current date and

time.

References

1. Principles of medical Ethics by Beauchamp and Childress 7th Edition

2. Resolving Ethical Dilemmas Bernard Lo 5th Edition

3. American Medical Association code of Medical Ethics, 1996

4. Medical Law Ethics and Bioethics for the Health professionals 6th Edition.