INSTRUCTIONS FOR WRITING A
HIPAA COMPLIANT HUMAN SUBJECTS CONSENT FORM
AT MONTANA STATE UNIVERSITY

Revised 01/24/08
I. Principles
  
A. The consent form has two (2) major parts: the description (Items II.A-N) and the authorization (Item II.P).
  
B. The description should be written with the subject identified in the second person singular. It should read like a transcript of the investigator telling the subject about the subject's role in the research. The description should be complete. It should be couched in simple, non-technical language that the subject can understand.
  
C. It is the investigator's responsibility to explain the research to the subject and to make sure that the subject understands the risks. The consent form verifies that this has been done.
  
II. Outline
  
A. Title:
                SUBJECT CONSENT FORM
                                  FOR
PARTICIPATION IN HUMAN RESEARCH AT
           MONTANA STATE UNIVERSITY
  
This is the approved Title (Heading) for all Consent Forms.
  
B. Project Title:
  
C. Opening sentence: "You are being asked to participate in a study ... (give a brief phrase/sentence such as:)
... of pain."
... of a new treatment for heart failure."
... of liver disease."
  
D. Rationale of research: briefly state the reason for the research and the potential significance of the expected results, for example:
  
"This may help us obtain a better understanding of high blood pressure."
  
E. Why/how subject was identified as a possible subject. Also explain any randomization of subjects into experimental and control groups if that is involved.
  
F. Procedures involved:
 
1. Begin with, "If you agree to participate ... "
 
2. Give a clear outline of what the subject will experience including time for study, total period, frequency of testing for long range studies, etc.
 
3. Describe each procedure in detail. Specific guidelines with standardized statements have been prepared by the Institutional Review Board for some of the common procedures such as blood drawing. They are available on request from the Institutional Review Board. Please use them if appropriate.
  
G. Risks: state all risks involved in the study and do your best to indicate the probability of occurrence of adverse effects of the research.
  
H. Benefits: benefit to the patient/subject, if any, should be given. Benefit with regard to science and future patients is not relevant. From our experience we suggest that very few studies have direct benefit to patients other than cash payments or services that they otherwise would not receive. Most consent forms, therefore, should state, "The study is of no benefit to you." DO NOT LIST FINANCIAL COMPENSATION AS A BENEFIT. Financial compensation can be listed elsewhere or under its own section heading if applicable.
  
I. Alternatives available: what happens if subject declines to participate?
  
J. Source of funding of project.
  
K. Cost to subject, if any.
  
L. Ask/encourage patient/subject to ask questions.
  
M. Explain status regarding confidentiality of records.
  
Describe the extent to which confidentiality of records identifying the subject will be maintained. Describe the way in which confidentiality will be maintained.

For research involving FDA regulated products, a statement that the FDA may inspect study records must be included. The following statement may be used for such studies:

"YOUR PHYSICIAN/INVESTIGATOR (AND THE DRUG COMPANY) WILL TREAT YOUR IDENTITY WITH PROFESSIONAL STANDARDS OF CONFIDENTIALITY. HOWEVER, THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (AND THE DRUG COMPANY) HAVE THE RIGHT TO INSPECT ALL OF YOUR MEDICAL RECORDS FOR THE PURPOSE OF VERIFYING DATA. THE INFORMATION OBTAINED IN THIS STUDY MAY BE PUBLISHED IN MEDICAL JOURNALS, BUT YOUR IDENTITY WILL NOT BE REVEALED."

  
N. Injury and compensation statement: the patient needs to be informed of what would happen if something went wrong. You can state that you will refer them to a trained caregiver, however, there is no compensation available from MSU for injury.
  
Statements of compensation:
 
1. Compensation for physical damage resulting from human research in grant supported research:
"In the event your participation in this research supported by ___________________________________ results in injury to you, medical treatment consisting of _______________________________________ will be available, but there is no compensation for such injury available. Further information about this treatment may be obtained by calling _______________________________________________ (researcher's name) at ______________________________________ (researcher's phone number) ."
 
2. Compensation for physical damage resulting from human research not supported by grants:
"In the event your participation in this research directly results in injury to you, medical treatment consisting of ________________________________________________ will be available, but there is no compensation for such injury available. Further information about this treatment may be obtained by calling _______________________________________ (researcher's name) at _____________________________________ (researcher's phone number)."

The two possible statements have been used frequently. Use the one which applies to your research, or use these as a model. Include it in the body of the consent form. Do not attach it separately.
       
  O.   AUTHORIZATION TO SHARE PERSONAL HEALTH INFORMATION IN RESEARCH

We are asking you to take part in the research described in the attached consent form.  To do this research, we need to collect health information that identifies you.  We may collect the results of tests, questionnaires and interviews.  We may also collect information from your medical record.  We will only collect information that is needed for the research.  This information is described in the attached consent form.  For you to be in this research, we need your permission to collect and share this information.

We will share your health information with people at the hospital who help with the research. We may share your information with other researchers outside of the hospital. We may also share your information with people outside of the hospital who are in charge of the research, pay for or work with us on the research. Some of these people make sure we do the research properly. The “confidentiality” section of the consent form says who these people are. Some of these people may share your health information with someone else. If they do, the same laws that the hospital must obey may not protect your health information.

If you sign this form, we will collect your health information until the end of the research. We may collect some information from your medical records even after your direct participation in the research project ends. We will keep all the information forever, in case we need to look at it again. We will protect the information and keep it confidential.

Your information may also be useful for other studies. We can only use your information again if the Institutional Review Board gives us permission. This committee may ask us to talk to you again before doing the research. But the committee may also let us do the research without talking to you again if we keep your health information private.

If you sign this form, you are giving us permission to collect, use and share your health information. You do not need to sign this form. If you decide not to sign this form, you cannot be in the research study. You need to sign this form and the attached consent form if you want to be in the research study. We cannot do the research if we cannot collect, use and share your health information.

If you change your mind later and do not want us to collect or share your health information, you need to send a letter to the researcher listed on the attached consent form. The letter needs to say that you have changed your mind and do not want the researcher to collect and share your health information. You may also need to leave the research study if we cannot collect any more health information. We may still use the information we have already collected. We need to know what happens to everyone who starts a research study, not just those people who stay in it.
 
P. The consent form should state that additional questions about the rights of human subjects can be answered by the Chairman of the Institutional Review Board, Mark Quinn, (406) 994-5721.
(A typed solid line or dashed line should separate the above descriptive aspects of the consent form from the authorization statement. Use one of the statements below or write one of your own using these as a model.)
  
Q. Standard authorization statements
 
1. For one's own participation:
 
"AUTHORIZATION: I have read the above and understand the discomforts, inconvenience and risk of this study. I, _____________________________ (name of subject), agree to participate in this research.  I also agree that my health information can be collected and used by the researchers and staff for the research study described in this consent form.  I understand that I may later refuse to participate, and that   may withdraw from the study at any time. I have received a copy of this consent form for my own records.

Signed: _________________________________________________

Witness: _________________________________________________

Investigator: ______________________________________________

Date: ____________________________________________________ ."

 
2. For the participation of a child or other person not able to give consent for themselves (e.g., someone who cannot read or is otherwise incompetent):
 
"AUTHORIZATION:  I have read the above and understand the discomforts, inconveniences and risks of this study.  I, ___________________________________ (name of parent or guardian), related to the subject as ______________________________________ relationship, agree to the participation of _________________________________________  (name of subject) in this research.  I also agree that their health information can be collected and used by the researchers and staff for the research study described in this consent form.  I understand that the subject or I may later refuse participation in this research and that the subject, through his/her own action or mine, may withdraw from the research at any time.  I have received a copy of this consent form for my own records.

Signed: _______________________________________________________

Witness: ______________________________________________________

Investigator: ___________________________________________________

Date: _________________________________________________________ ."

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