General consent is an umbrella consent taken for conducting those patient care processes which do not pose any significant risk of harm to patient. For example, physical examination, collection of blood sample, Intravenous administration of fluids etc. are less risky processes when compared to surgery, anaesthesia etc. and can be done by taking a general consent from patient. The reason it is called as a general consent is because under one consent, the hospital can do multiple patient care processes that are within the scope of general consent. Even though it is called as general consent, it has to be informed to the patient about the scope its scope, before he/she gives consent.
In OPD patients, general consent can be considered as implied for all non-risky OPD based procedures and written consent may not be required. However, in patients being admitted, general consent must be documented with patients’ signature. A standard general consent form can be used for this purpose. The scope can cover consent for…
· Admitting the patients in an intermediate care ward/room (Scope does not cover admission of patient to ICU for which a separate informed consent should be taken)
· Physical examination and clinical assessment
· Conduction of routine laboratory tests, as per doctor’s order.
· Conduction of imaging tests such as X-ray, Echo, ECG etc. For
· Minor surgical procedures such as abscess draining, wound cleaning, stiches etc.
· Fracture reduction closed and cast application
· Any other investigation or procedure that are considered to be less risky as per the current knowledge in medical science
· Disclosing medical information and basic details of patient to healthcare providers
· Disclosing patients’ information, diagnosis, treatment and bills to insurance companies or to payer of bills, if required, on behalf of the patient. Patient will be informed before this.
Following points must be ensured with regard to general consent
2. The consent should be taken before admitting the patient.
3. Scope of general consent must be explained to patient. It should also be informed that in case of clinical procedure that is not covered under general consent, a separate informed consent will be taken
4. It should also be informed that patient may withdraw consent
Informed consent on the other hand is required for conducting clinical processes that can have significant risk of patient harm, such as surgery, blood transfusion, radiation therapy etc. Informed consent should be specific to the clinical process that is required to be done and patient must be informed about the risks, benefits and alternatives of the clinical process, before he/she gives consent. As informed consent is taken for risky processes, it is extremely important to provide brief the patient thoroughly before he/she makes a decision. Standard informed consent forms may be used for documenting the consent of patient/family. However, as informed consent is generally specific to the clinical procedure, separate informed consent forms may be required for different procedures. Informed consent stands as the most important document in case of medical lawsuits.
Hospitals must list out the clinical procedures for which ‘Informed Consent’ should mandatorily be obtained. A sample list of procedures for which informed consent should be taken is given below.
1. Abdominal, pleural or pericardial drainage and drainage tube insertion
2. Administration of investigational drugs
3. Advanced directives for ‘Do Not Resuscitate (DNR)’
4. Any surgical procedure
5. Ascites tapping / Abdominal paracentesis
6. Blood transfusions (physician only)
7. Bone marrow biopsy and /or aspiration
8. Central line placement
9. Chemotherapy – any route
10. CT guided or US guided FNAC
11. CT scan with contrast
12. Fine Needle Aspiration for Cytological studies (FNAC)
13. Foley’s catheterization
14. HIV testing
15. Immune therapy, intravenous or sub-cutaneous
16. Incisional, excisional, punch or shave biopsy
17. Intubation
18. Lumbar puncture
19. Major or minor surgery which involves an entry into the body either through an incision or through the use of natural openings
20. Nasogastric tube insertion
21. Non-operative procedures which involve more than a slight risk of harm to patients, or which involve the risk of a change in patient's body structures
22. OCD / Direct Laryngoscopy / Bronchoscopy / Cystoscopy / Colonoscopy / Sigmoidoscopy
23. Participation in clinical research protocols
24. Procedures involving general anaesthesia, or moderate or deep sedation, whether or not entry into the body is involved
25. Procedures utilizing radium, x-rays, or isotopes
26. Sterilization
27. Thoracentesis
28. Transfusion of blood or any other blood products
Consent taking process – It’s important that the informed consent is valid and hence following things must be ensured before taking consent from patient (or family)
1. Ensure that the patient is in right frame of mind to understand and interpret the information and able to make decision regarding consent. Patient should be conscious, not intoxicated, not in unsound state of mind and is 12 years or above
2. Ask if he/she would like to incorporate family members in decision making. This is the right of every patient
3. Explain the medical procedure for which consent is being required. Give as much information as required for the patient to be able to make decision. Following should necessarily be explained to patient
a. Name of the procedure
b. Purpose of the procedure or expected benefits of it
c. Probability of expected result
d. Name of the person who will perform the procedure
e. Possible complication that may result due to the procedure
f. Alternative treatments and their probable effects
g. Prognosis of the disease if procedure not performed
h. Risks involved in the procedure
i. Any other relevant information
4. Patient and/or family should be explained in a language and manner that they can understand
5. Consent should be taken by the person who is going to perform the procedure or a member of his/her team
6. Consent should be taken before procedure is performed and within a reasonable time limit (either on the same day or on previous day). It should also be explained to patient that he/she may withdraw the consent any time before the procedure is initiated
7. If for some reason, the procedure could not be performed after taking consent, and is postponed to a later date, a fresh consent should be obtained from patient on the day or a day prior to the actual performance of procedure
8. If the patient has to undergo the procedure multiple time for lifelong or long time, for eg. Blood transfusion in Thalassemia patient, Haemodialysis, a fresh consent should be taken every time. However, this consent could be verbal. Once in six months (at a minimum) or whenever there is fresh information to be provided to the patient a fresh written consent shall be taken.
9. Consent should be taken in written by asking patient to sign the consent form which consist necessary information pertaining to the procedure, risks, benefits, alternatives and who will perform procedure
10. At-least one independent witness should be there when consent is being taken from the patient and his/her signature should also be taken on consent form
11. If the patient is illiterate his/her thumb impression should be taken along with the signature of two independent witnesses.
12. In case the patient is less than 18 years but above 12 years of age, signature of a parent/guardian should also be taken along with the signature of the child
13. Person taking the consent should also sign on the consent form
Consent forms – This is the most important document for informed consent is the consent form. Separate forms may be required for separate clinical procedure. The form must contain sufficient details about the procedure to be performed, risks, benefit expected, alternatives available, risk if procedure not performed and likely complications if any. The form must also have place for identifiers, dates and signature of relevant parties. Click on the links below to get sample consent forms
7. Informed consent form for Dialysis
