Instructions for Developing an Informed Consent Form (ICF)
Delete this page and the page break before finalizing the consent form.
The regulations require that the consent form be written in language understandable to the subject. The CHOP IRB interprets this to mean grade 6 – 8. If the language in the consent form is written at too high a level, the IRB will request revisions.
Readability tools are available for free at http://StoryToolz.com
The IRB website has several pages which provide advice for developing an informed consent form. See https://irb.research.chop.edu/informed-consent
IRB Consent Templates
Our consent form templates use Microsoft Word Style Sheets.
· Use the styles in the Quick Style list to format the text and headings instead of manually formatting the text.
· Use “Paste Special” command instead of “Paste” to insert text from other documents. Select “Unformatted Text” instead of formatted text.
· There is a link to a tutorial about Style Sheets on the IRB’s website at: https://irb.research.chop.edu/preparation-study-submission
Tips for Creating Readable ICFs (from the IRB website):
· Keep the column width to no more than 6-6.5 inches (1.5 inch margins). Columns that are too wide are hard to read;
· Use a 12 point or larger serif typeface such as Times or Times New Roman for body text;
· Use of a sans serif typeface such as Helvetica or Arial for headings;
· Avoid the use of all UPPERCASE; it is hard to read;
· Use bold, italic, or bold italic for emphasis; minimize the use of underlining;
· Use bullet points with short phrases or sentences rather than long paragraphs for explanations;
· Double space or add additional spacing between paragraphs;
· Write in the second person, using 'you' throughout. Using the first person has been shown to be coercive.
· When children are subjects of the research, and most will be capable of assenting to participation, use 'you' to refer to the child.
· When most or all of the subjects will not be capable of providing assent (e.g. because they are under the age of 7, have cognitive deficits, will be sedated, etc.), you may use 'you' to refer to the parent or guardian and 'your child' to refer to the child.
Informed Consent Form and HIPAA Authorization
Study Title: Insert Full Title of the Protocol
Version Date: Month, Day, 20XX
Consent Name: OPTIONAL Consent Identifier if there is more than one consent for the study (e.g. Control Consent)
Principal Investigator: / Investigator Name / Telephone: (xxx) xxx-xxxxEmergency Contact: / Name / Telephone: (xxx) xxx-xxxx
Omit if minimal risk / [should be a phone number accessible 24 hours (i.e. pager, cell) and answered by someone knowledgeable about the study]
You, or your child (as applicable), may be eligible to take part in a research study. This form gives you important information about the study. It describes the purpose of this research study, and the risks and possible benefits of participating.
If there is anything in this form you do not understand, please ask questions. Please take your time. You do not have to take part in this study if you do not want to. If you take part, you can leave the study at any time.
In the sections that follow, the word “we” means the study doctor and other research staff. If you are a parent or legal guardian who is giving permission for a child, please note that the word “you” refers to your child.
Why are you being asked to take part in this study?
You are being asked to take part in this research study because you have XXXX.
What is the purpose of this research study?
The purpose of this research study is to XXXX.
How many people will take part? (this section is optional and may be deleted if not informative)
(For single center studies:) About XXXX individuals/people/children etc. will take part in this study.
(For multicenter studies:) About XXXX people will take part in the study, including approximately XXXX participants from CHOP.
What is involved in the study?
Provide a brief overview of the study. Keep this as simple as possible and at an 8th grade level. Also include the probability of random assignment to each study group (if applicable).
How long will you be in this study?
If you agree to take part, your participation will last for XXXX and will involve XXXX study visits.
What are the study procedures?
Some of the procedures in this study will be repeated several times. Tests that are part of your regular, routine medical care will continue to be performed. Additional tests may be performed if any of your initial test results are not normal. The study involves the following tests and procedures.
Interviews: A team member will take your medical history, along with a listing of any medications you are taking. Throughout the study you will be asked to report if you think that anything bad has happened as a result of the study.
Physical Examination: Exams will be conducted before and during the study including measurements of weight, height, blood pressure, heart rate and respiratory rate, etc.
Blood Draw: Brief description
Urine Collection: Brief description
Procedure/Test: Brief description
Pregnancy Test: If you are pregnant or nursing, you will not be allowed to participate in this study. If you are eleven years old or older or have already started having periods, you will be asked to take a pregnancy test before starting this study. The results will be shared with you and not with your parent(s). We strongly encourage you to share the results with your parents. If you are found to be pregnant, you will not be able to continue participation in the study. About XXXX teaspoons of blood (or urine if urine test) will be needed.
Birth Control: For female subjects: You will need to take safety measures to prevent pregnancy (such as not having sexual intercourse, or using a medically accepted form of contraception) for a minimum of XXXX(time period before, during and after the study). If you have questions about how to avoid pregnancy, talk to your doctor or the researcher and they will provide you with information on contraceptive choices. You should contact Dr. XXXXX at once if you become pregnant during this research study.
For Male Subjects: You should not father a baby for a minimum of XXXX after administration of XXXX. You need to take safety measures to prevent pregnancy (such as not having sexual intercourse or using contraception) for a minimum of XXXX after administration of XXXX. If you have questions about how to prevent pregnancy, talk to your doctor or the researcher and they will provide you with information on contraceptive choices.
Study Drug/Intervention: You will need to take study drug by mouth twice a day for XXXX weeks.
(If the study involves recording/filming subjects or sharing images/videos/recordings as a research procedure, the investigators can either include this in the research consent or use CHOP’s “Consent and Release for Recording or Filming (OR-102)”, available at https://intranet.chop.edu/sites/privacy/recording-and-filming-patients/)
Wording for studies involving the collection of samples:
During the study, we will collect blood [urine, tissue etc., include as applicable] samples from you. By agreeing to participate in the study, you
[if stored at CHOP] agree to give these samples to CHOP for research purposes.
[if collected for a sponsor, include the language relevant to the sponsor’s storage and use]
Visit Schedule
The table below provides a brief description of the purpose and duration of each study visit. If there are multiple visits that involve different procedures using a table can help provide a clearer overview of the study. If there is just a single visit or the procedures are simple, the table is usually unnecessary.
Visit / Purpose / Main Procedures / DurationVisit 1 / Screening visit / Blood tests, MRI scan / 2 hours
Visit 2, Day 0 / Start study drug / Distribute study drug / 30 minutes
Visit 3, Day 28 / Routine Visit / Lab tests, distribute study drug / 1 hour
Visit 4, Day 56 / End of Study / Return unused drug and Quality-of-Life Survey / 1 hour
What are the risks of this study?
Taking part in a research study involves inconveniences and risks. If you have any questions about any of the possible risks listed below, you should talk to your study doctor or your regular doctor.
While in this study, you are at risk for the following side effects:
Risks associated with study drug, device or other intervention (XXXX):
The main risks of the XYZ are A, B, and C. Use bullet lists as appropriate.
· Most severe risks
· Less severe risks
· Etc.
Reproductive Risks: (Only insert when applicable. These risk belong as a sub-heading under the intervention or procedure that is associated with the risk to the pregnant woman or fetus. Pregnancy testing and birth control are procedures not risks and belong with the study procedures.)
Describe the potential risks to the fetus, pregnant woman or to the breast-fed infant. (All procedures to prevent pregnancy belongs in the procedures section.)
Other Potential Risks
(Include only if applicable) Because this drug/device/intervention is experimental there may be other side effects we do not know about yet. We can give you other medicines to make any side effects less serious or to make you feel better.
Risks associated with procedure 1:
The main risks of the XYZ are A, B, and C. Use bullet lists or paragraphs, whichever is appropriate.
· Most severe risks
· Less severe risks
· Etc.
Risks associated with procedure 2:
The main risks of the XYZ are A, B, and C. Use bullet lists or paragraphs, whichever is appropriate.
· Most severe risks
· Less severe risks
· Etc.
The following two sections are for genetic research studies and for sharing with NIH Repositories if applicable (NIH-funded research). These sections will need to be edited depending on the nature of the coding of samples and plans for future sharing.
Risks of Genetic Studies:
The risks related to genetic analyses can be to individuals or to groups. These harms include stigmatization and insurability. To reduce this risk, only coded samples will be stored and used for future research. Information about this study will not be recorded in your medical record.
The Genetic Information Nondiscrimination Act is a Federal law that makes it illegal for some groups to discriminate against you based on genetic information. This law applies to all health insurance companies, group health plans, and employers with 15 or more employees. This law does not apply to companies that sell life insurance, disability insurance, or long-term care insurance.
Are there any benefits to taking part in this study?
Study with prospect of direct benefit
You might benefit by XXXX (state the ways in subjects might benefit directly from this research). However, we cannot guarantee or promise that you will receive any direct benefit by participating in this study. The knowledge gained from this research may help doctors determine XXXX (whatever it is you hope to learn).
OR study without any prospect of direct benefit use this statement.
There will be no direct benefit to you from taking part in this study. The knowledge gained from this study may help doctors determine XXXX.
Do you need to give your consent in order to participate?
If you decide to participate in this study, you must sign this form. A copy will be given to you to keep as a record.
What are your responsibilities?
Please consider the study time commitments and responsibilities as a research subject when making your decision about participating in this study. (If applicable add) You will need to follow the study doctor’s instructions, keep all study appointments and take the study drug as directed (include “study drug” or add other intervention only if applicable).
What happens if you decide not to take part in this study?
Participation in this study is voluntary. You do not have to take part in order to receive care at CHOP.
If you decide not to take part or if you change your mind later there will be no penalties or loss of any benefits to which you are otherwise entitled.
Can you stop your participation in the study early?
You can stop being in the study at any time. You do not have to give a reason.
If there are consequences of early withdrawal describe them here.
Can the study doctor take you out of the study early?
The study doctor may take you off of the study if: (Do not include items that don’t apply. If the study is brief and/or is minimal risk, this section may not be applicable. For example, a study with a single visit cannot be stopped after the subject consents. )
· Your condition worsens.
· The study is stopped.
· The study drug is no longer available.
· You cannot meet all the requirements of the study.
· New information suggests taking part in the study may not be in your best interests.
What choices do you have other than this study?
There are options for you other than this study including: (Only include realistic options. If there are no other studies, don’t offer another study.)
· Participation in another study (be specific).
· Receiving XXXX care outside this study.