EmailEmail    |   Bookmark Page Bookmark  |   RSS Feeds RSS  |   Print Page Print  

Community Consultation Information

Community consultation involves the identification of a surrogate community that represents the population from which potential research candidates would be drawn. This community must be actively informed of the research activity and understand the nature of the research project, its goals and objectives and the protocols involved. The community must have the opportunity to ask questions and raise concerns about the project itself. Hospital style ID bracelets will be made available to persons who do not want to be enrolled in the study, but would rather opt-out.  Prehospital personnel will be trained to check for these bracelets prior to enrolling any patients.

Community Consultation is currently is progress.

For those who want an opt-out study bracelet, please call 414-805-6493.

ROC CCC COMMUNITY CONSULTATION SURVEY
Medical College of Wisconsin - Exception to Informed CONSENT RESEARCH

Questionnaire - August, 2011

 

Hello, my name is ________________________. I am calling on behalf of the Medical College of Wisconsin about a medical research study that may be conducted in your community.

[IF SPEAKING TO A CHILD] May I speak to someone in your household who is at least 18 years of age? Thank you.

[IF NECESSARY, REINTRODUCE YOURSELF]

This call does not involve sales or fundraising of any kind.

The Medical College of Wisconsin and several other universities across the United States and Canada are planning on conducting a medical research study in your community that may affect you or someone you know. We need to find out ahead of time what people think about this study which is trying to find better ways to help victims of severe traumatic injury to survive.

S1. I would like to tell you a little bit about this research and ask you a few questions about it. Would that be okay?

  1. Yes
  2. No [THANK AND POLITELY DISCONTINUE]
  3. Uncertain, Don’t Know, Refused [THANK AND POLITELY DISCONTINUE]

[READ THE FOLLOWING PRIOR TO ASKING SURVEY QUESTIONS]

Thank you.

Traumatic injuries, such as the injuries suffered in a car accident, are the leading cause of death in persons aged 15 to 44. Over half the deaths occur in the first 12 hours, frequently from bleeding. The physicians in the study I will be describing to you are trying to find more effective medical treatments for bleeding trauma victims to save more lives.

Paramedics who arrive at the scene to treat a patient with life-threatening trauma injuries typically begin by giving the patient intravenous fluids to replace those that have been lost. The standard fluid given is called the normal saline solution. It is made up of water and a very small amount of salt. What is not known is whether more lives can be saved by giving the standard amount of fluid or by giving a smaller amount of fluid. In this study, patients will be randomly assigned to receive either the standard amount of the normal saline solution or a smaller amount until bleeding has been controlled or 2 hours has passed after admission to the hospital. The study will determine which approach is best for promoting survival. Both groups of patients will receive the best care available in all other respects. The only procedure that will be varied is the amount of fluid patients receive prior to arriving at the hospital and during the first 2 hours in the hospital. As is the case in all medical treatment, every procedure contains potential benefits and potential risks. Both levels of fluid may help the patient to survive. But, giving the standard amount of fluid may raise the patient’s blood pressure and increase bleeding. Giving less fluid may result in decreased blood flow to vital organs.

Usually, researchers ask patients for consent before admitting them to a medical study. In the case of life-threatening traumatic injury, however, it is rarely possible to get consent. Patients are usually confused, unconscious or in shock and unable to communicate. Family members may not be available to speak for them. Also, treatment must be started immediately to save the individual’s life. For these reasons, this study must be conducted without first receiving the patient’s consent.

Once the patient arrives in the hospital emergency department, researchers will describe the research study to the patient or a family member, if available, who will be asked to provide informed consent. The patient or the patient’s family member will be given the option to withdraw from this study at that time. The study physicians will keep track of the patient’s recovery to determine if one level of fluid is superior to the other in saving lives or if there is no difference in survival.

It is legally allowable to carry out research studies without consent in emergency situations such as I have just described. This study has been examined in detail by the United States Food and Drug Administration, Health Canada Therapeutic Products Directorate and other special boards to ensure the science is accurate and the study is safe to perform. A research ethics board will review the study in depth before and during its conduct in order to keep it as safe as possible. Part of the ethics board review is to receive input from community members like you to see how you feel about this study. The board will use your feedback to help determine whether the study will be done in your community.

Now I would like to ask you a few questions.

1.  Based on the information I just read to you, do you understand what this study is about?

  1. Yes [SKIP TO Q3]
  2. No [READ BELOW SECTION OR REPEAT ABOVE SECTION]
  3. Not sure [READ BELOW SECTION OR REPEAT ABOVE SECTION]
  4. Refused to answer [READ BELOW SECTION OR REPEAT ABOVE SECTION]

The important points are these. Severe injuries such as those that happen in car accidents are the leading cause of death in individuals aged 15 to 44. This study will determine if giving the standard amount of normal saline solution or a smaller amount is more effective in promoting survival. Patients will be randomly assigned to receive more or less of the saline solution which is made up of water and a small amount of salt. Since patients are usually unable to communicate after a traumatic injury and treatment must be started immediately, the study must be conducted without the patient’s consent to participate or the consent of a family member. Once in the hospital, patients or family members will be asked to provide informed consent to continue in the study. All patients will receive the same standard of care except for the amount of fluid they receive. Regulations in the United States and Canada allow medical studies to be conducted without the patient’s consent if the study meets certain conditions. This study meets these conditions.

 

2. Based on this information, do you understand what this study is about?

  1. Yes
  2. No [FIND OUT WHAT THEY DON’T UNDERSTAND AND CLARIFY BASED ON ABOVE DESCRIPTIONS]
  3. Not sure [FIND OUT WHAT THEY DON’T UNDERSTAND AND CLARIFY BASED ON ABOVE DESCRIPTIONS]
  4. Refused to answer

 

3. If you were severely injured and had a one in three chance of dying would you be willing to be part of this study without first providing consent?

  1. Yes [SKIP TO Q5]
  2. No
  3. Don’t know, Refused

 

4. What is the reason for your concern?

  1. Fear about possible side effects
  2. Patients should not lose the right to provide consent for themselves
  3. Other [SPECIFY]
  4. Don’t know
  5. Refused

 

5. If you were severely injured and later learned that you had been put into this study without your consent, would you be upset?

  1. Yes
  2. No
  3. Don’t know, Refused

IF Q5 > 1, SKIP TO Q7 

 

6.  Why would you be upset? [VERBATIM]

 

7. Researchers will attempt to obtain consent from the patient or the patient's family member during the first two hours after arrival at the hospital. If one of your family members was severely injured as described, would you be willing to give consent for this individual to participate in this study?

  1. Yes [SKIP TO Q9]
  2. No
  3. Don’t know
  4. Question refused [SKIP TO Q9]
  5. Not applicable (respondent doesn’t have family members) [SKIP TO Q9]

 

8. What is the reason for your concern?

  1. Do not want to take responsibility for their life
  2. Patients should not lose the right to provide consent for themselves
  3. Other [SPECIFY]
  4. Don’t know, Refused

 

We will tell the community about this study before it begins. Which of the following would be a good way to inform you?

Response categories:

  1. Yes
  2. No
  3. Don’t know, Refused
    1. Newspaper
    2. Neighborhood Association
    3. Church
    4. Radio
    5. Television
    6. Other [SPECIFY]

 

17. Do you have any additional comments you would like to tell the researchers about this study? [VERBATIM]

 

I have just a few more questions to ask to make sure that we have a representative sampling of your community’s opinions. Your answers will be kept anonymous.

18. What is your age? [RECORD NUMBER]

 

19. Are you Hispanic or Latino? [RECORD ONE RESPONSE]

  1. Yes
  2. No
  3. Not Sure/Don’t Know
  4. Refused

 

20. What is your race? [ACCEPT ALL THAT APPLY]

  1. White
  2. Black or African American
  3. Alaskan Native or American Indian
  4. Asian
  5. Native Hawaiian or other Pacific Islander
  6. Some other race [SPECIFY]
  7. Not Sure/Don’t Know
  8. Refused

 

21. What is the highest level of education you have completed?

  1. Less than 9th grade
  2. 9th to 12th grade, no diploma
  3. High school graduate (including equivalency)
  4. Some college credit up to one or more years of college, no degree
  5. Associate, Technical or Vocational degree (2-year)
  6. Bachelor's degree
  7. Graduate or professional degree
  8. Refused/Don’t Know

 

If you would like more information on this study, I can give you the name and phone number of the study coordinator. Would you like this information?

Study Coordinator: Joe Brandt
Phone Number: 414-805-6493


THAT CONCLUDES OUR SURVEY. THANK YOU VERY MUCH FOR YOUR TIME AND COOPERATION.

 

POSTCODE GENDER:

  1. MALE
  2. FEMALE