ceremony of research project

Writing a Consent Form

NOTE: Leave a 1.5" x 1.5" blank space at the bottom of each page of your consent form to allow for the IRB approval stamp. The stamped approved consent form is the one you need to use when gathering signatures.
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
Your consent form does not need to be in outline form; paragraph style is preferred with headings that are relevant to your research project.
A. Title (required on all consent forms):
SUBJECT CONSENT FORM
FOR
PARTICIPATION IN HUMAN RESEARCH
ON THE FORT PECK RESERVATION
This is the approved Title (Heading) for all Consent Forms.
B. Project Title:
C. Opening sentence: "You are being asked to participate in a research 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.
F. Procedures involved:
1. Begin with, "Participation is voluntary. If you agree to participate you will be asked to ... " [If the research project involves a survey or questionnaire, include the following: Participation is voluntary and you can choose to not answer any questions you do not want to answer and/or you can stop at anytime. If the subjects are students, indicate that participation or non-participation will not affect the student's grade or class standing.]
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 the 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. DO NOT STATE: "NONE" as there is always the unknown. If you cannot think of any possible risks, simply state: "There are no foreseen risks."
H. Benefits: benefit to the participant/subject, if any, should be given. Benefit with regard to science and future persons who may require medical care is not relevant. From our experience we suggest that very few studies have direct benefit to participants other than 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. If research project not funded, state: NA.
K. Cost to subject, if any. If no cost to participant, state: None.
L. Ask/encourage participant/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. 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. 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. The consent form should state that should the participant have questions about the research, they can contact ____________ (give your name and contact information). If they have additional questions about the rights of human subjects they can contact the Chair of the Institutional Review Board, Zara Berg, (406) 768-6367 [zberg@fpcc.edu]
(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.)
P. Standard authorization statements
1. For one's own participation (required wording):

"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 understand that I may later refuse to participate, and that I may withdraw from the study at any time. I have received a copy of this consent form for my own records.

Signed: _________________________________________________

Witness: _________________________________________________ (optional)

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] (required wording):

"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 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.

Parent or Guardian Signature: __________________________________________

Child's Assent Signature: _____________________________________________ (if applicable)

Witness: __________________________________________________________ (optional)

Investigator: _______________________________________________________

Date: ____________________________________________________________ ."

Q. NOTE: If your subjects are students in either grade school or middle school, you need to include a signed statement/agreement from the principal authorizing you to conduct the research project in the school. This should be a separate document.

Questions and Comments: irb@fpcc.edu.