1. Revised Informed Consent policy: What’s new?

2. VHA HANDBOOK 1004.01 INFORMED CONSENT FOR CLINICAL TREATMENTS AND PROCEDURES
A new, revised version of the informed consent policy has just been released. Note that the policy has been re-numbered, and is now VHA Handbook instead of It can be downloaded off the Ethics Center website. Go to vaww.ethics.va.gov. On the left navigation bar click “Policy” to view all policies administered by the Ethics Center.

3. Major changes Signature consent iMedConsent HIV testing
Home telehealth
Who may obtain informed consent
The policy outlines major changes in several areas including signature consent, the mandatory use of iMedConsent, changes in consent for HIV testing, home telehealth, and who may obtain informed consent from patients . . .

4. Clarified procedures for:
obtaining consent for forensic or evidentiary exams
informed consent and disclosure of PHI related to 7332-protected info (i.e., HIV, alcohol/substance abuse
Informed consent when testing patients following an occupational exposure to bodily fluids
In addition, the policy clarifies procedures for obtaining informed consent for forensic examinations, evidentiary examinations, disclosure of 7332-rprotected information, and testing patients after an employee has experienced an occupational exposure to bodily fluids.

5. Who can obtain informed consent?
Any physician, dentist, or health care professional granted specific clinical privileges to perform the treatment or procedure.
Medical and dental residents, regardless of whether they have been granted specific clinical privileges.
Other health care professionals whose scope of practice agreement or other formal delineation of job responsibility specifically permits them to obtain informed consent, and who are appropriately trained and authorized to perform the procedure or provide the treatment for which consent is being obtained.
Before discussing the changes related to signature consent, let’s address a change in the types of health care professionals who are authorized to obtain informed consent.
What types of practitioners can obtain informed consent?
a. Any physician, dentist, or health care professional granted specific clinical privileges to perform the treatment or procedure. b. Medical and dental residents, regardless of whether they have been granted specific clinical privileges. c. Other health care professionals whose scope of practice agreement or other formal delineation of job responsibility specifically permits them to obtain informed consent, and who are appropriately trained and authorized to perform the procedure or provide the treatment for which consent is being obtained.

6. Who can obtain informed consent?
“other health care professional”
Who falls under the category of “other health care professionals?”
There are many different titles for health care professionals who practice under scopes of practice agreements or job delineation agreements including nurse practitioners, advance practice nurses, physician assistants, and medical technicians.
It is the responsibility of the Office of Nursing Services and Patient care Services to establish national policy directing scope of practice agreements.
It is the facilities’ responsibility to ensure scope of practice agreements are revised and accurately reflect the practitioner’s authority to both obtain consent and perform the procedure.

7. Signature consent
A properly executed VA authorized consent form is valid for a period of 60 calendar days from the date signed, instead of 30 days.
One major change is in the shelf life of a signed consent form. A properly executed VA authorized consent form is valid for a period of 60 calendar days from the date signed, instead of 30 days.
If you have held an informed consent conversation and obtained signature consent for a treatment or procedure, you do not have to re-consent an individual if less than 60 calendar days have elapsed since the consent form was signed.

8. Signature consent
Exception – where there is a significant change in the patient’s condition that would reasonably be expected to alter the diagnosis or therapeutic decision
But, if there is a significant change in the patient’s condition during that 60 days the consent is automatically rescinded and the informed consent process must be repeated for subsequent treatment. Rescission of consent must be documented in the patient’s health record.

9. Signature consent - witnesses
Witness signatures are no longer required for signature consent except in limited circumstances.
Signature consent is valid without a witness signature except in two circumstances

10. Signature consent - witnesses
Exception - when the patient’s or surrogate’s signature is indicated on the VA authorized consent form by an “X.”
Exception - when an individual cannot physically document consent.
Two exceptions:
a. when the patient’s or surrogate’s signature is indicated on the VA authorized consent form by an “X.” In this case two adult witnesses (not including the practitioner) are required to sign the form. The signatures of these witnesses on the form attests only to the fact that the witnesses saw the patient or surrogate and the practitioner sign the form.
b. when an individual cannot physically document consent. A member of the treatment team may sign on the patient’s behalf and document the circumstances of the signature in a progress note. The signing health professional’s signature must be witnessed by two adults.

11. Signature consent – HIV testing
Signature consent is no longer required for Human Immunodeficiency Virus (HIV) testing.
Instead – specific oral informed consent
Practitioners may perform HIV testing of individuals after obtaining specific oral informed consent. Signature consent is no longer required.
What does “specific informed consent” mean?

12. Signature consent – HIV testing
specific oral informed consent applies to tests for:
illicit drug use,
ETOH,
HIV,
Hepatitis B and C,
MRSA,
STDs,
inheritable genetic abnormalities
For tests that provide information that is particularly sensitive or may have significant consequences for the patient, the patient's oral consent to each test must be explicitly documented.
During the informed consent process, the practitioner must provide information that a patient, in similar circumstances, would reasonably want to know.
Information about certain tests must be considered “information that a patient in similar circumstances would reasonably want to know” because these tests are particularly sensitive and may have consequences that the patient might reasonably want to avoid. These tests include, but are not limited to, specific tests to identify illicit drug use, alcohol intoxication, HIV, Hepatitis C, Hepatitis B, Methicillin-Resistant Staphylococcus Aureus (MRSA), sexually-transmitted diseases, and inheritable genetic abnormalities. For these tests, practitioners must obtain specific consent and follow the informed consent process as outlined in the informed consent policy

13. Signature consent – HIV testing
specific oral informed consent
For tests that provide information that is particularly sensitive or may have significant consequences for the patient, the patient's oral consent to each test must be explicitly documented.
“Specific oral consent” means that the patient consents to have a particular, named laboratory test performed. This is distinguished from situations where the practitioner obtains consent to perform a battery of unspecified laboratory tests. It involves discussing with the patient the specific test that is being recommended, as well as the risks and benefits, providing educational information focused on that test, and obtaining consent from the patient to perform that test.

14. Specific oral informed consent - HIV
Mandatory – includes written educational material which includes a description of:
HIV disease, HIV testing
expected benefits/known risks associated with HIV testing
reasonable alternatives to HIV testing, consequences of choosing no HIV testing, availability of anonymous testing.
meaning of a positive and a negative HIV test;
how HIV is transmitted; and
measures to be taken for prevention of HIV transmission.
The informed consent discussion must include providing written educational information on HIV disease must include all of the following elements: Note – this material is available in the iMedConsent library
a. A description of HIV disease;
b. A description of HIV testing;
c. A description of the expected benefits and known risks associated with HIV testing, including the possibility that VA may disclose test results to the public health authorities and to the patient’s spouse or sexual partner;
d. A description of the reasonable alternatives to HIV testing, the anticipated consequences of choosing no HIV testing, and the availability of anonymous testing. NOTE: Anonymous testing is not available everywhere in the United States;
e. A description of the meaning of a positive and a negative HIV test;
f. A description of how HIV is transmitted; and
g. A description of measures to be taken for prevention of HIV transmission.

15. iMedConsent ™
The iMedConsent™ software program must be used to document the informed consent process except in specific circumstances
iMedConsent™ must be used to document patient consent for treatments or procedures that require signature consent (See VHA Handbook ), unless . . .

16. iMedConsent ™ - Exceptions
a. The patient declines to sign using the electronic signature pad;
b. There is a temporary system failure that prohibits proper use of the program;
c. The patient (or surrogate) is giving consent over the telephone or by fax; or
d. Use of the equipment that supports the iMedConsent software program would present introduce infection control issues
a. The patient declines to sign using the electronic signature pad; b. There is a temporary system failure that prohibits proper use of the program; c. The patient (or surrogate) is giving consent over the telephone or by fax; or d. Use of the equipment that supports the iMedConsent software program would present introduce infection control issues (e.g., inability to adequately disinfect the signature pad used for a patient who is in isolation precautions)

17. iMedConsent ™ - Exceptions
Documenting informed consent
Form OF-522 is obsolete
Use - VA Form a or b
When iMedConsent™ is not used due to one of the exceptions noted above, signature consent must be documented on the appropriate printed VA Form: a, b. Copies are available on the intranet at
VA Form OF 522 can no longer be used to document informed consent.

18. Signature consent – home telehealth
Signature consent is not required
Exception - unless the medical care delivered meets the usual requirements for signature consent.
For most treatments or procedures that are delivered via telehealth, oral informed consent is sufficient. Signature consent is required for treatments or procedures delivered via telehealth if and only if the treatment or procedure meets one or more of the criteria listed for requiring signature consent.

19. Signature consent – when is it required?
Signature consent must be obtained for treatments and procedures that:
Can be reasonably expected to produce significant pain or discomfort to the patient;
Can be reasonably expected to produce pain or discomfort to the patient that is substantial enough to require sedation, anesthesia, or narcotic analgesia;
Can be reasonably considered to have a significant risk of complication or morbidity;
To refresh everyone’s memory, the patient’s signature consent must be obtained for treatments and procedures that: a. Can be reasonably expected to produce significant pain or discomfort to the patient;
b. Can be reasonably expected to produce pain or discomfort to the patient that is substantial enough to require sedation, anesthesia, or narcotic analgesia;
c. Can be reasonably considered to have a significant risk of complication or morbidity; or -

20. Signature consent – when is it required?
Signature consent must be obtained for treatments and procedures that:
Require injections of any substance into a joint space or body cavity (excluding the intravascular space); or
Are listed in Appendix A of the informed consent policy.
d. Require injections of any substance into a joint space or body cavity
(excluding the intravascular space); or
e. Are listed in Appendix A of the informed consent policy.

21. Consent – home telehealth
The practitioner must ensure that the patient is informed about:
a. The likely differences between receiving care delivered using telehealth technologies and face-to-face care, and
b. That patients are free to choose among available comparable treatments or procedures that use telehealth and those that do not.
Even though signature consent for home telehealth is not required except in specific circumstances, the practitioner is still required to ensure that the patient is informed about:
The likely differences between receiving care delivered using telehealth technologies and face-to-face care, and
b. That patients are free to choose among available comparable treatments or procedures that use telehealth and those that do not.

22. Collecting and releasing evidentiary materials / signature consent for forensic examinations
If a patient is suspected of criminal wrongdoing or is the victim of a suspected crime presents for medical care at a VHA facility, the patient may undergo two types of treatments or procedures:
treatments or procedures that are designed to address the patient’s specific medical and mental health needs, and
a forensic examination to obtain all possible historical and physical evidence
If a patient is suspected of criminal wrongdoing or is the victim of a suspected crime presents for medical care at a VHA facility, the patient may undergo two types of treatments or procedures: (a) treatments or procedures that are designed to address the patient’s specific medical and mental health needs, and (b) a forensic examination to obtain all possible historical and physical evidence related to the suspected or alleged criminal wrongdoing. These examinations differ in purpose, risks and benefits, and informed consent must be obtained and documented separately for the medical evaluation and the forensic examination.

23. Collecting and releasing evidentiary materials / signature consent for forensic examinations
Follow the regular procedures for obtaining informed consent for treatments or procedures
Informed consent for medical treatments and procedures must be obtained according to the informed consent process delineated in paragraph 13 of the informed consent policy.

24. Collecting and releasing evidentiary materials / signature consent for forensic examinations
A separate signature informed consent is required to perform a forensic exam on a patient.
A separate signature informed consent is required to perform a forensic exam on a patient. Forensic examination includes collection of information and materials for the purpose of gathering legal evidence (e.g., rape kit). Evidentiary information or materials may be procured through history taking, physical examination, lab or diagnostic studies, medical assessment and care plan documentation, prescriptions and follow-up to care related to the initial forensic evaluation.

25. Collecting and releasing evidentiary materials / signature consent for forensic examinations
A separate signature informed consent is required to perform a forensic exam on a patient.
A separate signature informed consent is required to perform a forensic exam on a patient. Forensic examination includes collection of information and materials for the purpose of gathering legal evidence (e.g., rape kit). Evidentiary information or materials may be procured through history taking, physical examination, lab or diagnostic studies, medical assessment and care plan documentation, prescriptions and follow-up to care related to the initial forensic evaluation.

26. trained in conducting forensic evidentiary examinations.
Collecting and releasing evidentiary materials / signature consent for forensic examinations
Informed consent to an examination for evidentiary collection needs to be obtained by a practitioner
trained in conducting forensic evidentiary examinations.
Informed consent to an examination for evidentiary collection needs to be obtained by a practitioner trained in conducting forensic evidentiary examinations. NOTE: State law may limit the confidentiality of a suspected criminal’s or alleged victim’s health record. Patients suspected of criminal wrongdoing or alleged victims must, as part of the informed consent discussion, be made aware of the applicable limits to confidentiality in their state. Consult with Regional Counsel as appropriate.

27. The emergency exception does not apply to forensic examination.
Collecting and releasing evidentiary materials / signature consent for forensic examinations
The emergency exception does not apply to forensic examination.
Because forensic examination is not necessary to preserve a patient’s life or avert serious impairment to the patient’s health, the practitioner must always obtain signature informed consent for the forensic examination. The emergency exception does not apply to forensic examination.
If the patient is unable to provide signature informed consent because the patient lacks decision making capacity, procedures to identify an authorized surrogate and appropriate procedures for obtaining signature informed consent for patients without decision making capacity must be followed

28. Collecting and releasing evidentiary materials / signature consent for forensic examinations
The patient has the right
to refuse an examination
The patient has the right to accept or refuse any aspect of the medical treatment or forensic evidentiary examination which may include: a. Examination for the presence of injuries; b. Evidence of assault, evidence of sexual assault, and collection of physical evidence; c. Photographs of injuries. VA Form must be used if the pictures are not being used for treatment purposes; and d. Further examination and collection as provided for by state law.
What if the patient refuses a forensic examination? Refusal of the forensic examination for evidence is not grounds for denial of medical treatment for injuries or appropriate testing for medical care. Refusal of any recommended treatment or procedure must be documented in the health record and those treatments or procedures must not be provided. NOTE: Patients may opt to have forensic evidence collected anonymously and decide at a later date whether or not to cooperate with law enforcement. Consult with Regional Counsel regarding state laws.

29. Collecting and releasing evidentiary materials / signature consent for forensic examinations
Disclosure
Evidentiary information or materials can be disclosed with the patient’s or surrogate’s consent for use in legal proceedings if specific conditions are met, which are outlined in VHA Handbook NOTE: Requirements may differ depending on whether the information was obtained for treatment purposes, or as part of a forensic examination. Consult with Regional Counsel regarding state laws.
Evidentiary material must be collected, retained, and safeguarded. Follow VA Handbook 0730.

30. Includes VA-generated records related to:
Informed consent requirements and procedures for disclosure of 7332-protected information
Includes VA-generated records related to:
drug abuse,
alcoholism or alcohol abuse,
infection with HIV infection, or
sickle cell anemia
VA-generated records that reveal the identity, diagnosis, prognosis, or treatment of VA patients related to drug abuse, alcoholism or alcohol abuse, infection with HIV infection, or sickle cell anemia (information protected under Title 38 U.S.C Section 7332) must be kept confidential (including the fact that an HIV test was conducted or the negative results of HIV testing).

31. Informed consent requirements and procedures for disclosure of 7332-protected information
Special written consent for disclosure:
VA Form
Request For and Authorization to Release Medical Records
This information may not be released without the patient’s special written consent, unless the disclosure is otherwise authorized by law. VA Form Request For and Authorization to Release Medical Records must be signed if the patient wishes to have this information shared with his or her surrogate in the event that the patient loses decision-making capacity. Unauthorized release of any confidential information, such as HIV test results, may result in criminal penalties or substantial fines.

32. Includes VA-generated records related to:
Informed consent requirements and procedures for disclosure of 7332-protected information
Includes VA-generated records related to:
drug abuse,
alcoholism or alcohol abuse,
infection with HIV infection, or
sickle cell anemia
VA-generated records that reveal the identity, diagnosis, prognosis, or treatment of VA patients related to drug abuse, alcoholism or alcohol abuse, infection with HIV infection, or sickle cell anemia (information protected under Title 38 U.S.C Section 7332) must be kept confidential (including the fact that an HIV test was conducted or the negative results of HIV testing).

33. Obtaining consent for testing a source patient after an occupational exposure
When an employee is inadvertently exposed to a patient’s bodily fluids, tissues, or excretions (e.g., blood, urine, sweat, saliva, pus, fecal matter) there may be transmission of infectious pathogens (e.g., HIV, Hepatitis C, Hepatitis B, MRSA), contaminants (e.g., radiated isotopes), toxins, or other agents.
What situations are covered? When an employee is inadvertently exposed to a patient’s bodily fluids, tissues, or excretions (e.g., blood, urine, sweat, saliva, pus, fecal matter) there may be transmission of infectious pathogens (e.g., HIV, Hepatitis C, Hepatitis B, MRSA), contaminants (e.g., radiated isotopes), toxins, or other agents. When such an occupational exposure occurs, optimal treatment for the employee may depend upon the source patient’s medical condition(s).
Testing to determine the source patient’s medical condition(s) may be performed ONLY with the source patient’s (or surrogate’s) explicit informed consent and that consent must be documented according to procedures as outlined in subparagraph 13.c of the informed consent policy.

34. The patient has the right to refuse testing
Obtaining consent for testing a source patient after an occupational exposure
The patient has the right to refuse testing
Source patients have the right to refuse testing or procedures requested for the purposes of diagnosis or treatment of employees who have experienced an occupational exposure.

35. Obtaining consent for testing a source patient after an occupational exposure
Informed consent for source patient testing may only be obtained after the occupational exposure has occurred.
Informed consent for source patient testing may only be obtained after the occupational exposure has occurred. Consent may not be obtained prospectively, i.e., in case of a hypothetical or potential occupational exposure. For example, prior to a surgical procedure, patients may not be asked to provide consent to undergo Hepatitis C testing that might be needed if a member of the surgical team experiences a needlestick injury during the upcoming surgical procedure.

36. Who can obtain informed consent?
Obtaining consent for testing a source patient after an occupational exposure
Who can obtain informed consent?
an employee who does not have a personal relationship with the exposed employee (e.g., friend, family member, former spouse) and,
whenever possible, by an employee who is not professionally related to the employee or the patient.
To prevent coercion or undue influence on the source patient, informed consent for testing of a source patient after an occupational exposure must be performed by an employee who does not have a personal relationship with the exposed employee (e.g., friend, family member, former spouse) and, whenever possible, by an employee who is not professionally related to the employee or the patient. The exposed employee may never seek consent from the source patient.

37. Other issues “Blanket consent”
VHA does not recognize “general” or “blanket” consent for medical treatment, but requires the patient’s separate consent for each treatment, procedure, therapeutic course of treatment for a particular problem or condition (e.g., inpatient or outpatient treatment for diabetes), or series of treatments (e.g., cycles of chemotherapy).

38. multiple or recurrent treatments or procedures
Other issues
multiple or recurrent treatments or procedures
When the proposed treatment plan involves multiple or recurrent treatments and procedures, it is generally not necessary to repeat the informed consent discussion for each new treatment or procedure, provided that the original consent encompassed the treatments or procedures to be performed. However, two circumstances exist where the informed consent discussion must be repeated and a new consent must be obtained, they are:
(1) If there is a significant deviation from the treatment plan to which the patient originally consented; or
(2) If there is a change in the patient's condition or diagnosis that would reasonably be expected to alter the original informed consent.

39. Other issues “gurney consent”
Patients must not, as part of the routine practice of obtaining informed consent, be asked to sign consent forms “on the gurney” or after they have been sedated in preparation for a procedure. Exceptions may occur when there is an urgent clinical need.

40. Other issues oral consent
Treatments and procedures that are low risk and within broadly-accepted standards of medical practice (e.g., administration of most drugs, vaccines, or for the performance of minor procedures, such as routine X-rays) require oral informed consent, but do not require signature consent. Both oral informed consent and signature consent must be documented in the patient’s electronic health record. In accordance with VHA policy on documentation of patient records, documentation must be sufficient to serve as a basis to plan patient care, support diagnoses, and warrant treatment (see VHA Handbook ). In most cases, a brief statement such as “patient consented to treatment plan” is sufficient for these purposes.

41. separate consent for anesthesia
Other issues
separate consent for anesthesia
When sedation or anesthesia is administered in conjunction with a treatment or procedure, a single consent form that includes general information on anesthesia, along with information on the primary procedure or treatment, is sufficient. However, if sedation or anesthesia is administered in conjunction with a separate or secondary procedure or treatment (such as a lumbar puncture) a separate signature consent is required

42. consent for prescribing chronic narcotics
Other issues
consent for prescribing chronic narcotics
The patient’s signature consent is not required for prescribing chronic narcotic. Signature consent is required only for treatments and procedures that:
1. Can be reasonably expected to produce significant pain or discomfort to the patient;
2. Can be reasonably expected to produce pain or discomfort to the patient that is substantial enough to require sedation, anesthesia, or narcotic analgesia;
3. Can be reasonably considered to have a significant risk of complication or morbidity;
4. Require injections of any substance into a joint space or body cavity (excluding the intravascular space); or
5. Are listed in Appendix A of the informed consent policy.

43. ?