ADULT CONSENT FORM TO BE IN RESEARCH
[Please insert a lay language study title that is in simple language, but is descriptive of the research study]
Section / PageA.Who is conducting this research study?......
B.What is the purpose of this research study?......
C.Why are you invited to take part in this study?......
D.How many people will take part in the study?......
E.What will you be asked to do?......
F.Can you stop being in this study?......
G.What are the possible risks, side effects, or discomforts of being in this study?......
H.What are the benefits of taking part in this research study?......
I.What options are there to being in this study......
J.Are there potential conflicts of interest?......
K.What about your privacy? What about confidentiality of your private health information?
L.What are the costs of your being in this research study?......
M.Will you be paid for being in this study?......
N.What if you have an illness or injury related to being in this study?......
O.What are your rights as a human research subject?......
P.Whom do you call if you have questions or problems?......
Q.Consenting to be in this study:......
[Please provide information in lay terminology (i.e., 8th grade reading level).
Please use this template as it applies to your study.
After completing each section and answering the questions, please delete the words in blue and red, as well as the sections not applicable to your study.]
You are being asked to take part in a research study. This form describes the study. Research studies include only people who choose to take part. Please read it carefully and discuss it with your friends, family and or the investigator before you agree to take part in by signing the form. Remember that your participation is completely voluntary.
ADULT CONSENT FORM TO BE IN RESEARCH
[Please insert a lay language study title that is in simple language, but is descriptive of the research study. You may also include the formal study title in addition to the lay study title.Note, this template is to be used for studies that are more than minimal risk.]
A. Who is conducting this research study?
[Please use the term “Main Study Doctor” (if thestudy is clinical and medical in nature) or “Main Researcher” (if the study is not clinical andmedical in nature.) Please include a business phone number and afterhours phone number, if applicable to your study design.]
[Main Study Doctor/Main Researcher]:[name and degree(s)] [phone number(s)]
[Co-Study Doctor/Co-Researcher]:[name and degree(s)] [phone number(s)]
[name and degree(s)] [phone number(s)]
etc.
Study Site(s): ______[For example, Texas Health Presbyterian Hospital of Dallas, main study doctor’s/physician’s office.]
This research study is sponsored or paid for by [Insert name the sponsor or remove this sentence if this study is investigator-initiated or is not sponsored.] [Describe whether the study main doctor/main researcher and institution will be paid and if so by whom.]
B.What is the purpose of this research study?
The purpose of this study is [In no more than a few sentences, please explain in lay language the purpose of the study and why the research is being done and what is hoped to be learned from this study, e.g., what gaps in knowledge the research is trying to fill, or how the experimental procedures compare to the standard treatment provided for the health problem or disease under study. Examples are: “We do not know which of these two commonly-used treatments is better.” Use the lay language description from your IRB application.]
This study is research because [Insert lay language information that clearly and succinctly describes the investigational or experimental portion/procedures of the study.]
[If the study involves an investigational drug/device or the investigational use of anFDA-approved drug/device, please choose one of the following options:]
Option 1.
This research study is meant to test if [insert name of the drug or device] is safe and/or how well itworks for [explain the way the drug or device is being tested in the study]. [Drug or device]has not yet been approved by the U.S. Food and Drug Administration (FDA).
Option 2.
This research study is meant to test the safety and/or how well the [drug or device][insert name of drug or device] being tested(works. It has been approved by the U.S Food and Drug Administration (FDA). The [drug or device] used in the study is FDA-approved for [explain for what the drug or device is approved]. It is not yet approved for [explain the way the drug or device is being tested in the study].
C.Why are you invited to take part in this study?
[Insert one or both of the following two options:]
Option 1. Study subjects: You are being asked to take part in this study because [Insert the basic reason why the subject is selected to take part in this study, e.g., you have breast cancer that has not responded to standard treatment; you are a Mexican-American adult with diabetes; you are a family member of someone diagnosed with depression].
Option 2. Normal controls: You are being asked to take part in this study as a “normal” control research subject. That means that you do not have the health problemor disease that is being studied. You are being asked to be part of a group that will be compared to people with the health problem or disease.
D.How many people will take part in the study?
You will be one of about [insert number]people taking part in this study at this study site. [For multi-center studies: ]A total ofabout [insert number]people around the country or world will take part in this study.
E.What will you be asked to do?
Procedures
[If the research involves a mixture of conventional, research, and/or investigational procedures, please insert the following language:]
The procedures in this research study may be conventional or research-related, [insert if applicable: or investigational]. “Conventional Procedures” would be done even if you did not take part in this study. “Research-Related Procedures” are done only for research purposes and would not be done if you were not taking part in the study. [Insert if applicable: “Investigational Procedures” are procedures, drugs, or devices that are being tested or evaluated as part of the study and would not be done if you were not taking part in the study. [Insert if applicable: For a clear breakdown, please refer to the study procedures table. If you use the table, be sure to break down the procedures in the way described above. If you use a protocol schedule of events, be sure you break the items in it, into the categories above.]
The following research procedures will be done during this study:
[Please provide descriptions of the procedures involved in this study, including describing what data will be accessed, used and or disclosed from these procedures.
List procedures in bulleted format.
Please use lay language and short sentences in describing the procedures (click here for assistance).
If blood samples will be drawn, indicate how much blood will be drawn in cc’s AND tablespoons and how often the blood will be drawn.
If drugs will be administered, indicate the amount and route of administration.
If research procedures involve off-label use of conventional procedures (e.g., frequency/dose, method of administration, or an experimental combination of FDA-approved drugs), please describe how the proposed use compares to the standard use.
If the research involves subject follow-up to collect research data, describe the duration and nature of follow-up procedures, e.g., “Once you have stopped taking the study drug we will call you once every year for 5 years to see how you are doing.”
Specify if subjects will be asked to stop taking any non-research related medications while taking part in the study or during a washout period and, if appropriate, advise subjects that they should consult with the main and/or co-study doctors/main and/ or co-researcher before taking any non-study medications.
If there are Conventional procedures that all subjects will not receive as a result of participating in the study, please discuss this in the consent form.
Include any long-term follow-up
For studies with multiple procedures and/or visits, you may include in this section a table of procedures. (Sample table provided within this section.).]
[Recommendations for language have been provided below.]
[If research includes the use of placebo, include the following paragraph in the Procedures section].This is a placebo-controlled study. It will compare the effects (good or bad) of [insert drug name]with placebo (an inactive substance) on the health problem or diseasebeing studied in this research.
[If subjects randomized (see below verbiage) to placebo will not receive Conventional, please communicate this and discuss how their disease/health problem or disease will be managed.]
[If applicable, discuss and define randomization, double-blind, and cross-over trial.]
[If applicable, discuss if placebo (inactive substance) or control group will be used.]
[For randomized/double blind studies, please briefly describe the study design by including the following paragraphs in the Procedures section.]
This is a randomized, double-blind research study.
“Randomized” means that you will be placed into a study group by chance, like [insert method of randomization, i.e., flipping a coin, drawing straws]. You will be randomized into one of [insert number] study groups, and will have a [e.g., equal, one in three, etc.] chance of being placed in (either/any) of the [insert number] groups.
“Double-blind” means you will not know and the the [main and/or co-study doctor or main and/or co-researcher] will not know what group you are placed into. . This is to make sure that the study results are not affected by what you or the [main and/or co-study doctor or main and/or co-researcher] may expect to happen.
- The first research study group will[state what first group will receive or undergo, e.g., study drug XX, dosage and frequency]
- The second research study group will [state what second group will receive or undergo.]
- The third research study group….(etc.)
[If research procedures are limited to the comparison of two or more approved treatments without any off-label or investigational use of the approved drugs, devices, or procedures, include the following paragraph in the Procedures section.]
All procedures described in this section are Conventional for subjects with your health problem or disease. The research part of this study is that the treatment you receive will be decided by randomization, while normally you and your doctor would choose which treatment to use. [If not already noted above, state the following:]“Randomization” means that you will be put into a treatment group by chance, [insert method of randomization, i.e., flipping a coin, drawing straws].
[If the research involves having the subject complete a questionnaire or survey that will include subject identifiers, please include the following paragraph.]
You will be asked to complete a survey. You will be asked questions to evaluate [explain the purpose of the doing the survey]. It should take about [insert the amount of time to complete the survey] to complete the survey. You will be asked to complete the survey [insert the number of times; e.g., only once, twice, etc.]. If you are not comfortable answering any question, you are not required to answer it. The survey will contain information that can be used to identify you,[Select one: such as a code number that can be linked to your name OR such as your name, Social Security Number, medical record number, address, and more.]
[When the questionnaire or survey will not involve any identifiers.]
You will be asked to complete a survey. You will be asked questions to evaluate [explain the purpose of the doing the survey]. It should take about [insert the amount of time to complete the survey] to complete the survey. You will be asked to complete the survey[insert the number of times; e.g., only once, twice, etc.]. If you are not comfortable answering any question, you are not required to answer it. The survey will not contain any information that could be used to identify you.
[For clinical studies that include an optional tissue collection or genetic component, please include the following:]
The main purpose of this research study is described in Section B. We are also interested in collecting [name type of specimen, e.g., tumor, bone marrow, blood samples, etc.] to [e.g., study genetic material (genes), store for future studies, etc.]. Details of the [tissue collection or genetic] sub-study (a study within a larger study) are described in the attached [human specimens or genetic] consent form. You don’t have to take part in thesub-studyto be in the main part of the research study.
Initial below if you want to take part in the sub-study:
Yes, you would like to know more about the [tissue collection or
Please Initial genetic] sub-study. If you decide to take part in the sub-study, you will
sign a separate consent form.
No, you do not want to take part in the [tissue collection or genetic]
PleaseInitial sub-study.
How Long Will You Be In This Study[Please include in the Procedures section a statement regarding the duration of the study:]
You will be in the study for about [insert length of time including follow-up period, e.g., 4 months, 3 years, etc.]. [If the research involves subject follow-up to collect research data, describe the duration and nature of follow-up procedures.]
Table of Procedures
[If the study involves multiple procedures and/or visits (i.e., more than 3 procedures and/or visits), a tablemay be (not required) included that clearly shows the timeline for procedures and visits.
Procedures must be clearly distinguished as research-related, investigational, or Conventional, according to the definitions listed in the table.
The table text must be in at least 12 pt. font.
If necessary, the table may span over multiple pages, but please note that it must remain embedded in the consent document.
The sample table is presented in portrait orientation. Feel free to change it to landscape orientation if you feel it is more appropriate for the presentation of the procedures involved in this study.]
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[Study Site Consent Form: Version [insert number/date]
[IRB Template Revised: 22Feb16]
Sample Table:
Procedure / Initial Visit / Visit #2 / Visit #3 / Visit #4 / Annual Visits up to XX yrsConventionalProcedures: Procedures that are part of regular care and would be done even if you did not take part in this research study
[Insert procedure(s) in concise, lay terminology] / X
Research Related Procedures:Research-Related Procedures are done only for research purposes and would not be done if you were not taking part in the study
[Insert procedure(s) in concise, lay terminology] / X / X
Investigational Procedures: are procedures, drugs, or devices that are being tested or evaluated as part of the study and would not be done if you were not taking part in the study.
[Insert procedure(s) in concise, lay terminology] / X / X / X
Page 1 of 31
[Study Site Consent Form: Version [insert number/date]
[IRB Template Revised: 22Feb16]
F.Can you stop being in this study?
Taking part in this study is up to you. You may decide not to be in the study or you may stop being in this study at any time. If you decide not to take part, or you withdraw, you will not have any penalty or loss of benefits to which you are entitled[if applicable, insert the following verbiage] and this will not affect your future medical care.
[If THR employees are a specific target group for this study include the following:] Your participation is completely voluntary and your decision to take part in this study will not negatively impact or affect your current or future employment status or relationship with Texas Health Resources (THR).
If you withdraw your consent you will no longer be allowed to take part in the study. However, the information already obtained by the study staff and [if applicable: insert sponsor name] may be used and disclosed as permitted by this consent form.
[Describe any serious consequences of sudden withdrawal from the study and procedures for orderly termination if applicable. Include any instructions for recommended follow-up visits after withdrawal.]
The [main and/or co-study doctor or main and/or co-researcher] may decide to take you off this research study, even if you would like to continue. Some examples of why the [main and/or co-study doctor or main and/or co-researcher] might take you off the study are: