HIPAA Compliant Consent Form
|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.|
|SUBJECT CONSENT FORM
PARTICIPATION IN HUMAN RESEARCH
ON THE FORT PECK RESERVATION
|This is the approved Title (Heading) for all Consent Forms.|
|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 and anticipated benefits 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.|
|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 are available for some of the common procedures such as blood drawing. They are available on request from the Institutional Review Board or on this website. See links on the right. 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.|
|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.
|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, Zara Berg.|
|(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.
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.
Date: _________________________________________________________ ."