Consent Template: Combined HIPAA

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-xxxx

Emergency 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]

Almost all consent forms submitted to the IRB require extensive revision and delay the approval. Dont just cut and paste. Avoid delays by (1) following the advice and formatting of this template and (2) by reviewing the information on the IRBs website at https://irb.research.chop.edu/informed-consent before preparing the consent document. These steps will minimize the need for revision. Consent forms that are not written at grade appropriate level (Grade 6 8) will be returned with a request for revisions. A few key items from the Guidance are listed below.

NOTE: This consent template uses MS Word Style sheets. When cutting and pasting you must use the Paste Special function and paste as unformatted text in order to preserve the formatting of this template. DO NOT MODIFY THE FOOTER OF THE DOCUMENT.

Formatting:

1) The entire consent form should be written in the second person, using you throughout. If you are only going to enroll children who are unable to assent (e.g. because they are too young, have cognitive deficits, will be sedated, etc.), you may use "you" throughout the consent form to refer to the parent or guardian and "your child" to refer to the child participant.

2) Do not use the word patient; use subject or participant.

3) Modify the words treatment, therapy or device to investigational treatment/therapy/device or research treatment/therapy/device. This avoids therapeutic misconception.

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.

If the study only involves adults, the last sentence can be deleted.

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. Briefly include the major reasons why the subject is being approached to participate. For example, you have been diagnosed with sickle cell disease and are scheduled to have an MRI.

What is the purpose of this research study?

The purpose of this research study is to XXXX [insert applicable statement(s)]

Example: The purpose of the research is to see if XXXX improves the health of children with sickle cell disease.

Describe the purpose of the research in lay language. Provide the information that a reasonable and responsible parent would want to know before allowing their child to enroll in the study (i.e. focus on the major concepts rather than including detailed explanations of the science behind the research).

Dont include every single detail about the study. The consent form should include an explanation that is sufficient for most and offer the opportunity for the parent/subject to discuss any aspect of the study in more detail with the investigator.

If the study involves an experimental intervention, agent, device or diagnostic, provide a concise description that includes whether or not it is approved by the FDA. If it is approved, discuss whether it is approved for use for children.

How many people will take part?

(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.

Examples:

If you agree to take part, your participation will last for 1 hour.

If you agree to take part, your participation will last for 18 months and will involve 6 study visits and 3 telephone calls.

What are the study procedures?

The study involves the following tests and procedures.

It is not mandated that standard of care procedure be listed. If they are listed, the consent must explain which standard of care procedures (1) would be part of usual medical care (would occur even if the subject did not participate in the study), (2) which are standard procedures that will take place during the research and (3) which are the procedures/interventions being tested as part of the study (the research procedures).

List and explain the research procedures ONCE and follow with a TABLE that lists when the procedures happen. DO NOT repeatedly list the same procedures over and over again (e.g., screening procedures, treatment procedures, follow up procedures if it can be avoided. See the examples listed below.

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. Try to be brief and consolidate similar things. Examples, vital signs can be included with physical exam, interviews can include a wide range of research procedures.

Blood Test: Brief description

Urine Test: Brief description

Test: Brief description

Pregnancy Test: 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. Use this language if applicable. The risks of pregnancy, if any, for the study must appear in the Risk section.

Study Medication/Intervention: You will need to take study medication by mouth twice a day for XXXX weeks.

(Include this statement if applicable) 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.

Visit Schedule

For studies with several visits, a table can be helpful. The table below provides a brief description of the purpose and duration of each study visit.

This table is an example. Create a table that makes sense for your study. Very briefly list the visits and most important procedures. Do not simply list every procedure. Keep it as simple as possible.

The subjects/parents are not study coordinators; they just need a basic overview, not the detailed plan. Do not simply attach or paste the study table from the protocol; these are too detailed for subjects. For example, dont list all the blood tests, just blood tests, dont list each individual questionnaire, just list questionnaires. The table should not aim to be a complete listing; it should give subjects the general idea of the purpose of the visit and any special procedures for that day.

Visit

Purpose

Main Procedures

Duration

Visit 1

Screening visit

Blood tests, MRI scan

2 hours

Visit 2, Day 0

Start study drug

Distribute medication

30 minutes

Visit 3, Day 28

Routine Visit

Lab tests, distribute medication

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?

For each study procedure, there should be a corresponding risk description. See the IRB website for standard risk language: https://intranet.research.chop.edu/display/cmtirb/ICF+Standard+Language

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 medication, device or other intervention (XXXX):

Put the risks in descending order of importance. The intervention, if there is one, should go first. Risks to the developing fetus belong with the intervention that is responsible for that potential harm.

The main risks of the XYZ are A, B, and C. Use bulle