The following guidelines have been prepared to assist institutions in reviewing policies, procedures and forms relative to obtaining and documenting informed consent. The guidelines are based in part on opinions and advice of malpractice defense attorneys in Massachusetts. The Risk Management Foundation recognizes that institutions should continue to have the flexibility to respond to such recommendations in a manner that will least disrupt the orderly provision of health care at the facility.

1. Written policies and procedures should be developed by each institution designed to address all aspects of the informed consent process. At a minimum, policies should address:

1. medical procedures and treatments for which informed consent is required,
2. persons responsible for obtaining the consent of the patient,
3. manner of documentation of consent,
   appropriate persons, other than the patient, from whom consent may be obtained.



2. Consent should be obtained for all major therapeutic and diagnostic procedures where disclosure of significant medical information, including major risks involved, would assist a patient in making an intelligent decision whether to undergo the proposed procedure. Such procedures include:

   1. All surgical procedures performed under general/spinal anesthesia and selected procedures under local anesthesia
   2. Selected biopsies and excisions (including bone marrow)
   3. Cardiac catheterization and angiography
   4. All major endoscopies
   5. Bronchograms, lymphangiograms, myelograms, pneumoencephalograms, splenograms, ventriculograms, and radiation therapy
   6. Extracorporeal and peritoneal dialysis
   7. Cancer chemotherapy
   8. Electroconvulsive therapy
   9. Testing for human immunodeficiency virus (HIV)
   10. Blood and blood product use (including blood donation and autologous and other blood transfusions)
   11. Major radiologic and/or imaging procedures involving the use of contrast media (as per specific recommendations anticipated from the Loss Control Committee's Radiology Advisory Committee)
   12. Medications and/or other therapeutics with the potential for particularly severe side effects

3. A separate written consent should be obtained for the use of general, spinal and/or epidural anesthesia by the clinician administering and/or responsible for the anesthesia.

4. It is the physician's responsibility to obtain the informed consent of his patient, and to discuss sufficient medical information to enable the patient to decide whether to submit to treatment. Although the physician is responsible for informing the patient, hospital personnel may assist in the completion of documentation.

5. The type of information to be disclosed and discussed with the patient includes:

1. Nature of patient's condition and procedures to be performed
2. Nature and probability of material risks involved
3. Benefits to be reasonably expected of the procedure
4. Inability of the physician to predict results
5. Irreversibility of the procedure, if that is the case
6. The likely result of no treatment or procedure
7. Available alternatives, including their risks and benefits



6. The type and the number of risks to be disclosed should depend on the significance the doctor's patient would attach to such risks in deciding whether to consent to the procedure or treatment. (The court recognizes that such disclosure does not apply to all "remotely possibly risks of proposed treatment" which may be "almost without limit.")

7. A patient's consent should be documented with sufficient clarity and detail so as to satisfy the reader that the patient was given and understood the medical information listed in Item 5 above. Such documentation should include:

1. A statement that the information listed in Item 5 above was imparted to the patient
2. A specific listing of some of the more major material risks disclosed including, but not limited to, loss of life, loss of limb function, brain damage, paralysis, hemorrhage, allergic reactions, nerve injury and blood clots
3. General information such as the patient's name, contemplated procedure, and provision for the disposal and/or use of tissue necessarily removed during surgery
4. The date the patient expressly gave his/her consent
5. The date the documentation was recorded (if different than the date of consent)
6. Signature of the physician disclosing the information and obtaining consent
7. Signature of the patient
   



8. The patient's informed refusal of recommended diagnostic and therapeutic interventions, particularly when the decisions involve potentially life-threatening conditions, should also be documented.

9. Institutional policies should delineate the process to be followed, including required documentation, when it appears likely that tissue obtained by a procedure will be used in commercial development.

10. The potential use of tissue obtained by a procedure in research (of a non-commercial nature) and/or training should be documented on consent forms, as applicable.

11. Consent forms should contain language addressing the participation of physicians-in-training and/or other allied health practitioners in the procedure, as applicable.

12. Medical services and departments should develop brief lists of procedures, performed frequently within the specialty involved, which require written informed consent. Additionally, major material risks for each procedure should be identified. These lists should be appended to the institutional informed consent policy to provide clearer guidance for physicians on institutional requirements for informed consent.

13. Institutional informed consent policy and forms should undergo periodic review and update by the institution, as indicated, and should be submitted as requested to the Loss Control Committee of the CRICO shareholders for endorsement.