Informed Consent
Informed Consent
By Rachel
Health Care Systems Administrations 202
April 21st 2013
Table of Contents
Various ways to gain informed consent…………………………….Page 3
Factors that play into gaining informed consent……………………Page 4
Clinical Research……………………………………………………Page 5
United States Government Guidelines………………...……………Page 6
Timing of Consent…………………………………………………..Page 7
Consequences……………………………………….......…………..Page 7
Conclusion ………………………………………………………….Page 8
References…………………………………………………………. Page 10
Various ways to gain informed consent
There are various different ways to gain informed consent such as written, orally, or even a waiver. Written consent is when the patient or guardian has carefully read the risks, side effects, and procedure and then signed the paper for consent to precede. It is suggested that the patient read over the materials carefully in order to fully understand the entire procedure so the patient should be given the time to think about every option they have and every risk that may come up.
Oral consent is when the patient is given the risks, side effects and procedure verbally and then will have to sign a short form stating that they clearly understand everything they have been informed of. Oral consent is not typically used for planned out surgeries but more so in emergency situations that do not have the time for the paper to be consigned. There must always be a witness for the oral consent because there is not any visible proof for the hospital that the consent was given.
A waiver is used to gain consent when “the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context. ((OHRP), 1998)” Before any procedure takes place, informed consent must be given.
Factors that play into gaining informed consent
In order to go on with a procedure, the physician must gain informed consent. Many factors play into gaining
By Rachel
Health Care Systems Administrations 202
April 21st 2013
Table of Contents
Various ways to gain informed consent…………………………….Page 3
Factors that play into gaining informed consent……………………Page 4
Clinical Research……………………………………………………Page 5
United States Government Guidelines………………...……………Page 6
Timing of Consent…………………………………………………..Page 7
Consequences……………………………………….......…………..Page 7
Conclusion ………………………………………………………….Page 8
References…………………………………………………………. Page 10
Various ways to gain informed consent
There are various different ways to gain informed consent such as written, orally, or even a waiver. Written consent is when the patient or guardian has carefully read the risks, side effects, and procedure and then signed the paper for consent to precede. It is suggested that the patient read over the materials carefully in order to fully understand the entire procedure so the patient should be given the time to think about every option they have and every risk that may come up.
Oral consent is when the patient is given the risks, side effects and procedure verbally and then will have to sign a short form stating that they clearly understand everything they have been informed of. Oral consent is not typically used for planned out surgeries but more so in emergency situations that do not have the time for the paper to be consigned. There must always be a witness for the oral consent because there is not any visible proof for the hospital that the consent was given.
A waiver is used to gain consent when “the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context. ((OHRP), 1998)” Before any procedure takes place, informed consent must be given.
Factors that play into gaining informed consent
In order to go on with a procedure, the physician must gain informed consent. Many factors play into gaining
References: Office Department for Human Health Services. 1998. Office for Human Research Protections (OHRP) U.S. Department of Human and Health Services. 2013. Risk Management. Retrieved April 13th, 2013 from, http://www.ihs.gov/riskmanagement/index.cfm?module=part06 Medical Malpractice. 2012. Informed Consent. Retrieved April 14th, 2013 from, http://www.medicalmalpracticehelp.com/legal/informed-consent Applied Clinical Trials. 2003. Guidelines for Obtaining Informed Consent for Clinical Research Social Psychology Network. 1996. United States Government Guidelines. Retrieved April 15th, 2013 from, http://www.socialpsychology.org/consent.htm Legal Guardians. University of Illinois at Chicago College of Medicine. 2013. Retrieved April 16th, 2013 from, http://www.uic.edu/depts/mcam/ethics/ic.htm#legal