The following basic elements appear in a consent form. Creative energy should not be spent in re-arranging these elements but in composing the consent information in lay language appropriate to the reader and understandable at about the 8th grade level. Avoid technical jargon and abbreviations. A Glossary of Lay Terms for Use in Consent Forms is also available. The consent form must be prepared in the subject's primary language. The text should be written in second person, i.e., "You will be ...", except for the final consent statement which must be in the first person "I."
The following serves as a checklist to assure that the preparer includes all appropriate elements:
FORMAT
First page should be on LLU department letterhead whenever possible or type "Loma Linda University" as the heading. Label the document "Informed Consent." Indicate if joint VA/LLU research. The headings for items 1 through 12 constitute appropriate headings to be used in the actual consent form. A margin of at least 1-1/2 inches is needed at the bottom of each page for the IRB approval stamp in the right-hand corner. This becomes your official consent form for the dates specified and must be used as the master in generating copies of the consent form for use in enrolling subjects. In the lower left corner, provide 2 short lines on each page where subjects may initial and date to indicate they have read it. If more than one page is used, show the pages numbered as "page 1 of 3, 2 of 3, etc."
TITLE OF PROTOCOL
State the title of study. The title should be included at the top of each page of the consent form.
1. PURPOSE AND PROCEDURES
a. State why the individual has been asked to participate in the research activity: "You are invited to participate in a research study because..."
b. Give an explanation of the purpose(s) of the research study. "The (purpose, objective, aim) of this research study is..."
c. State the expected duration of the subject's participation. "Participation in this study will take _____ (minutes,days, months, etc.)"
d. Identify any experimental medications or procedures. "Participation in this study involves..." Make clear those procedures which are part of the research portion of the study as opposed to routine patient care.
e. Note that participant is to be referred to as "subject," not "patient" throughout the consent form.
REMINDER: Use lay language throughout, including diseases (i.e., "high blood pressure" not "hypertension.") Describe amount of blood drawing in tsps. or tbs.
2. RISKS
State the nature and degree of any reasonable potential risks, stress, discomfort, or invasion of privacy. "The risk(s) to you are..." [The following is suggested wording for venipuncture: "Pain and minor bruising at the site of the needle insertion and possible lightheadedness upon arising after the blood is drawn, are possible complications of blood drawing."] Include "The committee at Loma Linda University that reviews human studies (Institutional Review Board) has determined that participating in this study exposes you to ______ (minimal, moderate, high) risk." However, if study includes therapies which have more than minimal risk but are determined by the IRB to constitute only "minimal additional risk" over standard therapy due to medical status of participant, change the wording to read "...has determined that the study poses minimal additional risk. The therapy you are undergoing may have other risks which your physician will explain to you separately."
3. BENEFITS
Describe the potential personal AND societal benefits which may reasonably be expected from the research study; "The benefits to you are...; to your child are...; to humanity are..." For some studies, the following statement may be needed: "Because of the experimental nature of this study, it is possible that these benefits may not occur, and that complications and undesirable side effects which are unknown at this time, including worsening of your condition, may result." It is perfectly acceptable to have no personal benefit, in which case appropriate wording may read, "While you will not benefit personally, ..."
4. PARTICIPANTS' RIGHTS
Describe the voluntary nature of participation, the freedom to withdraw at any time without penalty or jeopardizing medical care, and the conditions of termination. "Participation in this study is voluntary. Your decision whether or not to participate or terminate at any time will not affect your present or future medical care."
5. SIGNIFICANT NEW FINDINGS
Depending on the type of study, the following statement may be needed. "Should your disease become worse, should side effects become severe or new scientific developments occur indicating this experimental treatment is not in your best interest or should your physician feel that participating in the study is no longer in your best interest, then this treatment would be stopped and other options would be discussed."
6. ALTERNATIVE TREATMENTS
State the appropriate alternative procedures or courses of treatment that might be advantageous or available to the subject. If no standard treatment exists, state that the subjects have the option of no treatment.
7. CONFIDENTIALITY
Indicate the extent to which confidentiality will be maintained. For FDA or other government-sponsored studies: "Any published document resulting from this study will not disclose your identity without your permission. The U.S. Food and Drug Administration, the Department of Health and Human Services, and/or their designee(s) may inspect the records relating to your (your child's) participation in this study."
8. ADDITIONAL COSTS
State any additional costs to the subject or a third party that may result from participation in the research. If costs are considered part of routine care, state: "You and your insurance company are responsible for the costs related to routine medical treatment. If in doubt about reimbursement, you should contact your third party payor." If none, state: "There is no cost to you for participating in this study."
9. REIMBURSEMENT
Explain if costs will be reimbursed or other inducements offered. "You will be paid the sum of $________ for participating in this study." If there is an inducement, state any restrictions or conditions that may limit the amount, i.e., premature withdrawal from the study. Generally, the amount should be pro-rated if subject leaves the study for any reason.
10. RESEARCH RELATED INJURY
For research involving more than minimal risk, state: (a) plan for handling injury, (b) nature of compensation, if any, (c) name, address and phone numbers of persons to contact. "In the event of physical injury resulting from this research, appropriate emergency medical treatment will be provided. If you should sustain injury as a result of this research, no other provision has been made for financial payments or other forms of compensation."
11. IMPARTIAL THIRD PARTY CONTACT
The following statement should be included in all consent forms: "If you wish to contact an impartial third party not associated with this study regarding any question or complaint you may have about the study, you may contact the Office of Patient Relations, Loma Linda University Medical Center, Loma Linda, CA 92354, phone 909-558-4647 for information and assistance." If the study is from an institution that has its own patient representative, substitute the appropriate name, address and phone number.
12. INFORMED CONSENT STATEMENT
The final paragraph should be in the first person and contain the following elements:
a. Opportunity for the subject to ask questions before consenting. "I have read the contents of the consent form and have listened to the verbal explanation given by the investigator. My questions concerning this study have been answered to my satisfaction. I hereby give voluntary consent to participate in this study (or for my child to participate in this study). Signing this consent document does not waive my rights nor does it release the investigators, institution or sponsors from their responsibilities. I may call (investigator) during routine office hours at (phone no.) or during non-office hours at (909) ____________ and ask for the (specialty) on call (e.g., ask for cardiologist) if I have additional questions or concerns." (State highest degree of investigator -- John Day, M.D. or D.D.S., etc.; not Dr. John Day.)
b. Each person signing the consent form should be given a copy. "I have been given a copy of this consent form."
c. If the protocol is an experimental clinical procedure, subjects must be given the CALIFORNIA EXPERIMENTAL SUBJECT'S BILL OF RIGHTS. A sample is attached with the IRB application, which may be copied as is. The consent form must state "I have received a copy of the California Experimental Subject's Bill of Rights and have had these rights explained to me."
d. Optional, to be used only if needed for your particular study. "I have/have not participated in any research study within the past 3 months. My participation occurred on (day/month/year) and involved..."
13. SIGNATURES
Provide a signature and date line for subject, parent or legal guardian ( include relationship), witness, and investigator as applicable.
a. For adult subjects and minors over 12 years old:
b. If subject is a minor, add signature set below (In addition, provide separate Assent Form for minors between the ages of 5-12 years):
"This protocol has been explained to my child at a level that he/she can comprehend and I give my consent for my child to participate in the study."
c. If subject is unable to sign:
Subject is unable to sign because ____________________
d. For all studies, provide signature of investigator:
"I have reviewed the contents of the California Experimental Subject's Bill of Rights and this consent form with the person signing above. I have explained potential risks and benefits of the study."
14. INPATIENT STUDIES
For all inpatient studies, to insure that patients receive coordinated care, an opportunity must be provided for the primary physician to sign.
As the primary physician responsible for the care of the patient, I indicate having knowledge of this research participation."