INSTRUCTIONS FOR WRITING AN
INSTITUTIONAL REVIEW BOARD 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. 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 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.)



P. 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 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: _________________________________________________
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 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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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. 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 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.)

	P.	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 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: _________________________________________________ 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 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: _________________________________________________________ ."

INSTRUCTIONS FOR WRITING AN INSTITUTIONAL REVIEW BOARD CONSENT FORM AT MONTANA STATE UNIVERSITY Revised 01/24/08

INSTRUCTIONS FOR WRITING AN
INSTITUTIONAL REVIEW BOARD CONSENT FORM
AT MONTANA STATE UNIVERSITY
Revised 01/24/08