MODEL INFORMED CONSENT FORM by OQ4WiL

VIEWS: 21 PAGES: 6

									APPROVED INFORMED CONSENT                                        Original Version:
Arnold Palmer Medical Center IRB                    Revised and Amended Version:
APMC IRB# _ _._ _ _._ _




                                     <Insert Full Protocol Title Here>

                                       INFORMED CONSENT FORM
                                              th                                            nd
             <Note: Consent should be at 6 grade reading level and written in the 2              person>

Good medical care includes obtaining informed consent before beginning any experimental procedure. The
patient or subject should be told the nature, purpose, alternative and possible side effects of the therapy. This
research study is being conducted by <insert Principal Investigator(s) name here>.

PLEASE MAKE SURE TO INSERT INFORMATION BELOW:
List principal investigator(s), sub-Investigators, sponsors and Orlando Health, Inc. if any of its employees or
facilities will be used.

Principal Investigator(s): XXXXXXX, MD

Sub-Investigator(s):       XXXXXX, MD              XXXXXX, ARNP
                           XXXXXX, MD              XXXXXX, MD
                           XXXXXX, MD              XXXXXX, MD

Sponsor:                   XXXXXX Pharmaceutical Company

Investigational Site(s):   Orlando Health, Inc.
                           Arnold Palmer Hospital
                           Lucerne Hospital…..etc

This consent form gives detailed information about the research study. Your doctor will discuss this information
with you. Once you understand the study, you will be asked to sign this form if you wish to participate.

1.     PURPOSE OF RESEARCH STUDY:
The purpose of the research study is ______________.

2.     EXPECTED DURATION:
You can expect to be part of this research study for __________.

3.      PROCEDURES TO BE FOLLOWED:
                                                      th
Describe clearly, using non-medical language (at a 6 grade reading level), all procedures to be followed. Use
charts or diagrams if helpful. Explain what will be done to the subject and when.
For randomized studies
      Participants in Arm / Group ___ will receive _______.
      Participants in Arm / Group ___ will receive ______
When you are found to be eligible to be in this study, you will be assigned by chance (like flipping a coin) to ____
of ____ study groups called Arm ___ or Group ___. You have a _____ chance of being in either/any of the
group(s). It is not known if any group will be better for you.

4.       IDENTIFICATION OF EXPERIMENTAL PROCEDURES:
Identify which of the above procedures are experimental OR not standard of care. Example: 4 CBCs may be
part of the standard procedure, but the drug used is the experimental part of the procedure.

5.       POTENTIAL RISKS AND DISCOMFORTS:
Describe any reasonable, foreseeable risks or discomforts to the subject for the procedures required by the
study, including such things as drawing blood. Include the following statement or words to that effect.


07/2011                                                  1                 V:/aph/irb/irb/data/forms/InformedConsent
APPROVED INFORMED CONSENT                                          Original Version:
Arnold Palmer Medical Center IRB                      Revised and Amended Version:
APMC IRB# _ _._ _ _._ _


For example: The treatment used in this program may cause some or none of the side effects listed. In addition,
there is always the risk of very uncommon or unknown side effects occurring. The doctor may prescribe
medication to keep the side effects under control. The use of medication could result in added costs. Neither
Orlando Health, Inc., nor the Investigator(s) are financially responsible for these costs.

6.        POTENTIAL BENEFIT TO SUBJECT OR OTHERS:
Examples:
It is not possible to predict whether or not any personal benefit will result from participation in this research study.
It is hoped that you will benefit from this therapy, but it is not to be considered a cure.

Or

It is hoped that you participation in this research study will lead to knowledge that may help others who have
similar conditions.

7.        ALTERNATIVE PROCEDURES OR TREATMENTS:
Describe appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the
patient or explain if there is no alternative other than not to treat, with an explanation of the possible effect of
failure to treat.

8a.      CONFIDENTIALITY OF RECORDS:
Describe the extent, if any, to which confidentiality of records identifying the subject will be maintained and note
the possibility that the Food and Drug Administration, Arnold Palmer Medical Center Institutional Review Board,
as well as any other organization specific to this study, may inspect the records.

Example:
Your study record will be kept in a confidential form at <insert site here>. The confidentiality of your record is
carefully guarded. No information by which you can be identified will be published in any publication. No
information by which you can be identified will be released to any third party except as provided herein or as
required by law. Representatives of the Food and Drug Administration (FDA) and the sponsor and their agents
may have access to the study record, as well as your medical record, which may contain your name, and the
FDA may be required by law in certain circumstances to release information in its possession.
If applicable:
Specimens, including tissue, blood samples and slides, may be sent to a central office for review, but your name
will be removed.

8b.     AUTHORIZATION TO USE OR DISCLOSE PROTECTED HEALTH INFORMATION (PHI) FOR
RESEARCH:
The Federal Privacy Regulations explain how your personal health information will be used and to whom it will be
disclosed (given to) for this research study. You will be provided with a copy of the Notice of Privacy Practices,
which describes the Orlando Health, Inc. privacy practices. Your protected health information may be used or
disclosed for research purposes.

What protected health information is collected in the study?
The following protected health information will be collected during this study:
Note to person preparing form: list all PHI to be collected for the study. The following are examples of
PHI that may be collecting during the research. There can be more items or less items depending on
each study. ALL PHI IS NOT LISTED HERE. REFER TO THE APPLICATION FOR ADDITIONAL ITEMS.
                Name
                Address
                Telephone
                Birth date
                Personal medical history
                Current and past medications, therapies, surgeries, procedures


07/2011                                                   2                  V:/aph/irb/irb/data/forms/InformedConsent
APPROVED INFORMED CONSENT                                        Original Version:
Arnold Palmer Medical Center IRB                    Revised and Amended Version:
APMC IRB# _ _._ _ _._ _


                Current and past hospitalizations
                Information from current and past physical examinations
                Results of tests noted in the “Procedure” section of the informed consent

Who may Use or Disclose your Protected Health Information?
The following individuals / organizations may use or disclose your protected health information for this research
study:
                 Study doctor and the study staff
                 Arnold Palmer Medical Center Institutional Review Board

To whom may your Protected Health Information be Disclosed?
As part of the study, the study doctor and the study staff may disclose the results of study-related tests and
procedures that may identify you to the following:
                 <Insert Sponsor’s name here>
                 Arnold Palmer Medical Center Institutional Review Board
                 Food and Drug Administration (FDA)
                 Office for Human Research Protection (OHRP)

In addition to the list of individuals and organizations to whom your Protected Health Information may be
disclosed, others may receive the information that is not currently known. If information from your records is
given to any of these people, they might give it to someone else. If this happens, the information will no longer
be protected. Someone Orlando Health, Inc. gives the information to is supposed to protect it, but Orlando
Health, Inc. cannot always keep that person from giving it to someone else. Your PHI may no longer be
protected by the Federal Privacy Rule once it is disclosed by the study doctor to these other parties.

By agreeing to participate in this research study and signing this informed consent, you are authorizing Orlando
Health, Inc., <insert name of site>, and <insert PI name> to use and disclose your protected health information
for the purpose of research related to this study. Only the smallest amount of protected health information
necessary will be used. <If applicable to the study, add “Portions of your medical information may be
transmitted over the Internet, but will be encrypted (scrambled) to maintain confidentiality.”> There is no
expiration date for the use of your health information for this research study. It may be used until all follow-up
procedures and all research/data collection has been completed. It may also be used until <NAME OF
SPONSOR> and the federal regulatory agency check that the data requirements have been met. Your health
information may be used in future additional re-checking of data accuracy (correctness). At the time that your
records no longer need to be checked, the <NAME OF SPONSOR>, and Orlando Health, Inc. will destroy
(shred) your research records.

Additional information about confidentiality of and access to your protected health information while you
participate in this research study:
 If your doctor wishes to use your identifiable information for any other reason than this research study,
    he/she must get your permission for that purpose.
 You may withdraw your permission to use your protected health information by talking with your doctor or
    research staff and making a request in writing. Use and release of information that was already gathered
    may continue when necessary in checking and reporting important events (such as accounting for your
    withdrawal from the study, adverse events reported to the FDA to monitor safety of participants, or federal
    regulatory agency audits (reviews).
 If you withdraw your permission to use your health information, neither Orlando Health, Inc. nor <insert PI
    name here> will release information collected after your withdrawal to <NAME OF SPONSOR> or any other
    third party.
 If you withdraw your permission to use and release your health information, you will no longer be able to
    participate in the study. However, if you decide to withdraw from the study, you will not be penalized or lose
    benefits to which you are otherwise entitled.




07/2011                                                  3                V:/aph/irb/irb/data/forms/InformedConsent
APPROVED INFORMED CONSENT                                         Original Version:
Arnold Palmer Medical Center IRB                     Revised and Amended Version:
APMC IRB# _ _._ _ _._ _


   Your doctor may discuss other research projects with you if he/she thinks the other projects relate to your
    condition. However, your health information cannot be given to another doctor or sponsor for the reason of
    asking you to enroll in another research study.

If applicable, modify the following paragraph to fit this study…
You have the right to inspect (look over) and obtain a copy of your health information that is kept for research
purposes for as long as this information is held by your study doctor or Orlando Health, Inc. However, to ensure
the integrity of the research, you will not be able to review some of the study information until the end of the
study.

9.     COMPENSATION:
Describe any free treatment, medical care, drug, device or money paid directly to the subject. If money, include
amount and timing of payment. State the reason for payment i.e., travel, etc.

10.      RESEARCH RELATED INJURY:
In the event that injury occurs as a result of this research, treatment will be available. However, you will not be
reimbursed by Orlando Health, Inc. or the investigator for these costs. <Insert any wording from the sponsor
as to their responsibility in the event of injury or harm or state that the subject will be responsible for
costs> For more information about your rights as a research subject, you may call the Institutional Review
Board Office, at (321) 841-5895. The study doctor involved in your care is available to answer any questions you
have concerning participation in this research program. You are free to call <insert name of PI here> at <insert
phone number here> with any questions concerning this research study that you have now or in the future.

11.      VOLUNTARY PARTICIPATION:
You are free to refuse or stop participation in this research study at any time without penalty or loss of benefits to
which you are otherwise entitled. You are free to seek care from a physician of your choice at any time. If you
do not take part in or withdraw from the study, you may continue to receive care for which you will be financially
responsible.
<Include any special instructions for the subject in the event that they wish to drop from the study>

12.      ADDITIONAL RISKS:
Participation in this study may involve risks to you which are currently unforeseeable.
<If applicable, include “Participation in this study may be harmful to an unborn baby.” Discuss birth control,
acceptable to the study doctor/study protocol, or any pregnancy tests if they are required by the
protocol>

13.     INVOLUNTARY TERMINATION:
Your participation in this study may be stopped by the study doctor or sponsor under the following
circumstances: not following protocol, failure to keep follow up appointments and/or administrative reasons.

14.      PROCEDURES FOR WITHDRAWAL:
When you complete the study or should you for any reason stop participating in the study, you should complete
the end of the study assessments. For example: During this visit, the following assessments will be done: a
physical exam, height, weight, an evaluation of any HIV associated symptoms, and problems and all medications
currently being used or blood products received. A blood test (about 2-3 teaspoons) will be done at this visit.
Also explain if the patient will be followed after the completion of or withdrawal from the study.

15.      NEW FINDINGS:
Significant new findings developed during the course of the research which may relate to your willingness to
continue your participation will be provided to you.

16.     NUMBER OF PARTICIPANTS:
The approximate number of subjects involved in the study at this site will be <insert number>; and at other sites
<insert number> subjects.


07/2011                                                   4                 V:/aph/irb/irb/data/forms/InformedConsent
APPROVED INFORMED CONSENT                                           Original Version:
Arnold Palmer Medical Center IRB                       Revised and Amended Version:
APMC IRB# _ _._ _ _._ _



17.     ADDITIONAL COST:
Describe any additional cost to the subject that may result from participation in the research study. Any costs not
explained clearly to the subject in this section will be charged to the research study.

Examples:
Some procedures involved in this study may result in added costs and some of these costs may not be covered
by insurance. You understand that you are responsible for all costs of participation in this study, whether or not
you are reimbursed by your insurance. This may include                    . For questions about your insurance
coverage you may call the Patient Business Department (321) 841-1576.

OR

Some procedures involved in this study may result in added costs and some of these costs may not by covered
by insurance. The sponsoring agency, <NAME OF SPONSOR> will be responsible for these costs.

OR

For MEDICARE Patients Receiving Research Devices:
Medicare may not pay for any Category A device that has not been approved by the Food and Drug
Administration. This includes the device and any services used because of the device, such as operating room
time, surgeon’s fees and x-rays. The entire hospital stay may not be paid by Medicare if the purpose of
admission was solely to place the research device. You (or the sponsor) will be responsible for these costs.

18. FINANCIAL DISCLOSURE:
This clinical research study is paid for by the sponsor, which makes one or more of the drugs/devices being
tested. Research monies may help support the research and educational programs of the hospital including
salaries of the doctors and nurses who conduct the study.

19. ADDITIONAL INFORMATION:
If this study is listed on clinicaltrials.gov, include the following:
A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most, the Web site will include a summary of the
results. You can search this Web site at any time.

If not:
There is no additional information at this time.




07/2011                                                    5                  V:/aph/irb/irb/data/forms/InformedConsent
APPROVED INFORMED CONSENT                                       Original Version:
Arnold Palmer Medical Center IRB                   Revised and Amended Version:
APMC IRB# _ _._ _ _._ _


                           <INSERT TITLE OF STUDY AS HEADER ON THIS PAGE>

THE FOLLOWING SIGNATURE PARAGRAPHS MUST BE VERBATIM. IF THIS STUDY DOES NOT INVOLVE
  PARTICIPATION BY Orlando Health, Inc. OR ITS EMPLOYEES, PLEASE DELETE ANY REFERENCE TO
                                         Orlando Health, Inc.
                   **ALL SIGNATURE PAGES MUST REMAIN ON ONE PAGE**

20.     SIGNATURES: My signature indicates that I consent and authorize                              and
whomever he (she) may designate as his (her) assistant(s) including Orlando Health, Inc., its employees and its
agents to perform upon                     (name of patient or “myself”) the research described above. If any
unforeseen conditions arise in the course of the research calling in the Doctor’s judgment for procedures in
addition to or different from those planned, I (we) further request and authorize the Doctor to do whatever he
(she) deems advisable.

I AM MAKING A DECISION WHETHER OR NOT TO PARTICIPATE IN THIS STUDY. I HAVE READ, OR HAD
READ TO ME IN A LANGUAGE THAT I UNDERSTAND, ALL OF THE ABOVE, ASKED QUESTIONS,
RECEIVED ANSWERS CONCERNING AREAS I DID NOT UNDERSTAND, AND WILLINGLY GIVE MY
CONSENT TO PARTICIPATE IN THIS STUDY. UPON SIGNING THIS FORM I WILL BE GIVEN A COPY.



Signature of Subject, Parent or Legal Representative                              Date



Signature of Witness                                                              Date

I have explained and defined in detail the research procedure in which the patient has consented to
participate.


Investigator’s Signature                                                          Date


Translator/Interpreter

Name__________________________________                     Phone#___________________________

Address_______________________________________________________________________________



For Signatures by Parent, Guardian, or Legal Representative, please describe the authority to act on behalf of
the participant below:




07/2011                                                6                V:/aph/irb/irb/data/forms/InformedConsent

								
To top