CORRESPONDENCE
Informed
Consent:
An Unresolved
Issue
To the Editor: In Reply:
The article "Informed Consent for Clinical Research" [July 1989;18:766-771] by Spivey addresses issues of importance to all investigators in emergency m e d i c i n e w h o perform clinical research. T h e a u t h o r states t h a t " t h e c o n s e n t form s h o u l d include a s t a t e m e n t that the i n s t i t u t i o n is responsible for any damages that occur." This is not accurate. T h e instit u t i o n at w h i c h the research is performed is not responsible for damages that occur, nor is it duty-bound to provide c o m p e n s a t i o n for such research-related injury. According to F D A - i n f o r m e d c o n s e n t r e g u l a t i o n s (21 CFR 50.25 [a] [6]), the research subject m u s t be told whether any comp e n s a t i o n a n d / o r m e d i c a l t r e a t m e n t is a v a i l a b l e if res e a r c h - r e l a t e d i n j u r y occurs, w h a t it c o n s i s t s of, and w h e r e f u r t h e r i n f o r m a t i o n m a y be o b t a i n e d . W h e t h e r c o m p e n s a t i o n and m e d i c a l t r e a t m e n t will be offered, as well as any stipulations regarding eligibility for such compensation or t r e a t m e n t , is solely up to the i n s t i t u t i o n and the sponsor of the project. As long as the research subject is informed of the existence of c o m p e n s a t i o n or lack of it, he m a y render an i n f o r m e d decision as to w h e t h e r to participate. As one w h o wears both the hat of the clinical researcher in e m e r g e n c y m e d i c i n e and t h a t of t h e c h a i r m a n of an IRB, I did appreciate the author's sensitive t r e a t m e n t of the " i n f o r m e d c o n s e n t " as a process to w h i c h the investigator should be c o m m i t t e d as distinct from having someone obtain a signature on a "consent form." A n y camouflaging or trivializing research risk in the obtaining of consent is unethical, as is any a t t e m p t at coercing the p a t i e n t to enroll in the study. It is a responsibility of all clinical researchers to police ourselves. W h e n we strictly adhere to our individual IRB policies, we will be m u c h m o r e consistent w i t h local standards of conduct t h a n if we only had guidelines from the bureaucrats in Washington. The issue of informed consent in resuscitation research is n o t yet resolved. D u e to the y o u t h of our specialty, we in emergency m e d i c i n e have not m a d e our voices heard by the authors of regulations and guidelines that pertain to clinical research using patients who are vulnerable by virtue of an u n s t a b l e m e d i c a l condition. M y appreciation goes out to the editors of Annals for their willingness to p u b l i s h articles such as Dr Spivey's so t h a t the dialogue on these issues m a y continue.
I thank Dr Runge for his c o m m e n t s regarding informed consent and clarify the issue he raises regarding responsibility for damages that occur during research. In the article, r e q u i r e m e n t s of the A m e r i c a n Code of Federal Regulations for the P r o t e c t i o n of H u m a n Subjects are clearly spelled out. After that is a section of additional e l e m e n t s of informed consent that, w h e n applicable, m a y be added to the consent form. The statement, "the consent form should include a s t a t e m e n t t h a t the i n s t i t u t i o n is responsible for any damages that occur" was i n t e n d e d as part of this section. W h e n applicable, a s t a t e m e n t regarding responsibility for damages should be included. Dr Runge is correct that the decision regarding c o m p e n s a t i o n of a pat i e n t is optional for the investigator and i n s t i t u t i o n . A l t h o u g h the responsibility for c o m p e n s a t i o n of a patient is optional, I feel strongly that the p h y s i c i a n and the i n s t i t u t i o n are responsible for the damages that a p a t i e n t m a y have suffered because of a research study. For moral and ethical reasons, t h e y should provide necessary medical t r e a t m e n t for an i n j u r y and a s s u m e costs of t h o s e treatments. Dr Runge refers to FDA regulations in his letter. It is i m p o r t a n t to note that there are two governing bodies that have t h e i r o w n r e g u l a t i o n s for c o n d u c t i n g r e s e a r c h and obtaining informed consent. The Federal Drug A d m i n i s t r a t i o n and the D e p a r t m e n t of H e a l t h and H u m a n Services have s i m i l a r g u i d e l i n e s for i n f o r m e d consent, b u t their guidelines for conducting an IRB differ. It is important that an investigator be familiar w i t h his IRB and the rules by w h i c h it is governed. Drugs and n e w m e d i c a l devices are m o r e l i k e l y to fall under FDA rules and regulations than are research protocols that do n o t involve drugs or n e w devices. As a n e w s p e c i a l t y that f r e q u e n t l y m u s t c o n d u c t research on patients w h o are o b t u n d e d or in cardiac arrest, it is i m p o r t a n t t h a t we develop n e w w a y s of o b t a i n i n g consent in these difficult situations. I applaud the efforts of Dr Runge and others who have taken the t i m e to participate as m e m b e r s of IRBs. A c t i v i t i e s like this not only increase the credibility of research in e m e r g e n c y medicine, b u t a l l o w us t h e o p p o r t u n i t y to b e t t e r u n d e r s t a n d t h e workings of an IRB and learn h o w we m i g h t better approach the difficult issue of i n f o r m e d consent.
Jeffrey W Runge, MD, FACEP Department of Emergency Medicine Research and Human Subjects Protection Committee Charlotte Memorial Hospital and Medical Center Charlotte, North Carolina
William H Spivey, MD, FACEP Department of Emergency Medicine Division of Research Medical College of Permsylvania Philadelphia
Unreliable
Effect of Nifedipine
in R e l i e v i n g
Renal Colic
To the Editor:
In their article "Nifedipine for the Relief of Renal Colic: A Double-Blind, Placebo-Controlled Trial" [April 1989;
158/841
18:352-354], Caravati et al presented a double-blind, placebo controlled study that evaluated the efficacy of nif-
Annals of Emergency Medicine
t9:7 July1990
Informed
Consent:
An Unresolved
Issue
To the Editor: In Reply:
The article "Informed Consent for Clinical Research" [July 1989;18:766-771] by Spivey addresses issues of importance to all investigators in emergency m e d i c i n e w h o perform clinical research. T h e a u t h o r states t h a t " t h e c o n s e n t form s h o u l d include a s t a t e m e n t that the i n s t i t u t i o n is responsible for any damages that occur." This is not accurate. T h e instit u t i o n at w h i c h the research is performed is not responsible for damages that occur, nor is it duty-bound to provide c o m p e n s a t i o n for such research-related injury. According to F D A - i n f o r m e d c o n s e n t r e g u l a t i o n s (21 CFR 50.25 [a] [6]), the research subject m u s t be told whether any comp e n s a t i o n a n d / o r m e d i c a l t r e a t m e n t is a v a i l a b l e if res e a r c h - r e l a t e d i n j u r y occurs, w h a t it c o n s i s t s of, and w h e r e f u r t h e r i n f o r m a t i o n m a y be o b t a i n e d . W h e t h e r c o m p e n s a t i o n and m e d i c a l t r e a t m e n t will be offered, as well as any stipulations regarding eligibility for such compensation or t r e a t m e n t , is solely up to the i n s t i t u t i o n and the sponsor of the project. As long as the research subject is informed of the existence of c o m p e n s a t i o n or lack of it, he m a y render an i n f o r m e d decision as to w h e t h e r to participate. As one w h o wears both the hat of the clinical researcher in e m e r g e n c y m e d i c i n e and t h a t of t h e c h a i r m a n of an IRB, I did appreciate the author's sensitive t r e a t m e n t of the " i n f o r m e d c o n s e n t " as a process to w h i c h the investigator should be c o m m i t t e d as distinct from having someone obtain a signature on a "consent form." A n y camouflaging or trivializing research risk in the obtaining of consent is unethical, as is any a t t e m p t at coercing the p a t i e n t to enroll in the study. It is a responsibility of all clinical researchers to police ourselves. W h e n we strictly adhere to our individual IRB policies, we will be m u c h m o r e consistent w i t h local standards of conduct t h a n if we only had guidelines from the bureaucrats in Washington. The issue of informed consent in resuscitation research is n o t yet resolved. D u e to the y o u t h of our specialty, we in emergency m e d i c i n e have not m a d e our voices heard by the authors of regulations and guidelines that pertain to clinical research using patients who are vulnerable by virtue of an u n s t a b l e m e d i c a l condition. M y appreciation goes out to the editors of Annals for their willingness to p u b l i s h articles such as Dr Spivey's so t h a t the dialogue on these issues m a y continue.
I thank Dr Runge for his c o m m e n t s regarding informed consent and clarify the issue he raises regarding responsibility for damages that occur during research. In the article, r e q u i r e m e n t s of the A m e r i c a n Code of Federal Regulations for the P r o t e c t i o n of H u m a n Subjects are clearly spelled out. After that is a section of additional e l e m e n t s of informed consent that, w h e n applicable, m a y be added to the consent form. The statement, "the consent form should include a s t a t e m e n t t h a t the i n s t i t u t i o n is responsible for any damages that occur" was i n t e n d e d as part of this section. W h e n applicable, a s t a t e m e n t regarding responsibility for damages should be included. Dr Runge is correct that the decision regarding c o m p e n s a t i o n of a pat i e n t is optional for the investigator and i n s t i t u t i o n . A l t h o u g h the responsibility for c o m p e n s a t i o n of a patient is optional, I feel strongly that the p h y s i c i a n and the i n s t i t u t i o n are responsible for the damages that a p a t i e n t m a y have suffered because of a research study. For moral and ethical reasons, t h e y should provide necessary medical t r e a t m e n t for an i n j u r y and a s s u m e costs of t h o s e treatments. Dr Runge refers to FDA regulations in his letter. It is i m p o r t a n t to note that there are two governing bodies that have t h e i r o w n r e g u l a t i o n s for c o n d u c t i n g r e s e a r c h and obtaining informed consent. The Federal Drug A d m i n i s t r a t i o n and the D e p a r t m e n t of H e a l t h and H u m a n Services have s i m i l a r g u i d e l i n e s for i n f o r m e d consent, b u t their guidelines for conducting an IRB differ. It is important that an investigator be familiar w i t h his IRB and the rules by w h i c h it is governed. Drugs and n e w m e d i c a l devices are m o r e l i k e l y to fall under FDA rules and regulations than are research protocols that do n o t involve drugs or n e w devices. As a n e w s p e c i a l t y that f r e q u e n t l y m u s t c o n d u c t research on patients w h o are o b t u n d e d or in cardiac arrest, it is i m p o r t a n t t h a t we develop n e w w a y s of o b t a i n i n g consent in these difficult situations. I applaud the efforts of Dr Runge and others who have taken the t i m e to participate as m e m b e r s of IRBs. A c t i v i t i e s like this not only increase the credibility of research in e m e r g e n c y medicine, b u t a l l o w us t h e o p p o r t u n i t y to b e t t e r u n d e r s t a n d t h e workings of an IRB and learn h o w we m i g h t better approach the difficult issue of i n f o r m e d consent.
Jeffrey W Runge, MD, FACEP Department of Emergency Medicine Research and Human Subjects Protection Committee Charlotte Memorial Hospital and Medical Center Charlotte, North Carolina
William H Spivey, MD, FACEP Department of Emergency Medicine Division of Research Medical College of Permsylvania Philadelphia
Unreliable
Effect of Nifedipine
in R e l i e v i n g
Renal Colic
To the Editor:
In their article "Nifedipine for the Relief of Renal Colic: A Double-Blind, Placebo-Controlled Trial" [April 1989;
158/841
18:352-354], Caravati et al presented a double-blind, placebo controlled study that evaluated the efficacy of nif-
Annals of Emergency Medicine
t9:7 July1990
