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
Department/Division
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. Don’t just cut and paste. Avoid delays by following this template and by reviewing the Guidance: Writing Readable Consent Forms (on IRB website) before preparing the consent document. This will minimize the need for revision. Consent forms that are not written at grade appropriate level 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, 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 lastsentence 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 _____. 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 ______[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. Providethe 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).

Don’t 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?

Single center: About ____ individuals/people/children etc. will take part in this study.

Multicenter: About ____ people will take part in the study, including approximately ____ 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 ______and will involve ______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.

Explain which procedures would be part of usual medical care (would occur even if the subject did not participate in the study) and which will take place only because of research participation.

List research procedures just one time and then include a table. Do NOT repeatedly list the 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.

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 _____ 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.

Blood Test: Brief description

Urine Test: Brief description

Test: Brief description

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

(Include 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 as it is often too detailed for subjects. For example, don’t list all the blood tests, just “blood tests”, don’t list each individual questionnaire, just “questionnaires”. The table doesn’t have to be complete; it should give an idea of the purpose of the visit and any painful or stressful procedures.

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:

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 (______):

The main risks of the XYZ are A, B, and C. Use bullet lists as appropriate.

  • Most severe risks
  • Less severe risks
  • Etc.

(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 as 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 as appropriate.

  • Most severe risks
  • Less severe risks
  • Etc.

Reproductive Risks (include only if applicable and include as a part of the procedure that engenders risk to pregnancy)

For female subjects:

If you are pregnant or nursing, you will not be allowed to participate in this study. 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 ____(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 _____ after administration of ______. You need to take safety measures to prevent pregnancy (such as not having sexual intercourse or using contraception) for a minimum of ____ after administration of ____. 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.

Are there any benefits to taking part in this study?

In this section summarize the potential direct benefits (to the person as a result of participation) and indirect benefits (new knowledge, improved care for future patients with the same condition, etc.). You should never promise or guarantee benefit. Two examples are included below. Use or alter one of these statements to meet the requirements of your study.

Study with prospect of direct benefit

You might benefit by (list the ways in subjects may 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 ______(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 ______

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. 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:(ONLY include those items that apply. If the study is brief and/or is minimal risk, this section may not be applicable. This section only applies for studies with multiple visits. )

  • 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?

ONLY use if this is an intervention study. Do not include for observational study designs. If alternative modes of care exist include this statement and list the options as bullet points – always include at least one option for care outside this study (not participating).

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 ______care outside this study.
  • Alternative therapy ______.
  • Not participation in this study.
  • You may discuss other options available to you with your doctor.

What about privacy, authorization for use of Personal Health Information (PHI) and confidentiality?

As part of this research, healthinformation about you will be collected. This will include information from (include all that apply) medical records, procedures, interviews and tests, etc.. Laboratory testresults will appear in your medical recordwith the exception of (list any exceptions, e.g. genetic tests, non-CLIA approved test results, confidential data which must be protected) which are performed only for this research study. We will do our best to keep your personal information private and confidential. However, we cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law.

The results of this study may be shown at meetings and published in journals to inform other doctors and health professionals. We will keep youridentity private in any publication or presentation.

Several people and organizations may review or receive your identifiable information. They will need this information to conduct the research, to assure the quality of the data,or to analyze the data or samples. These groupsinclude:

  • Members of the research team and other authorized staff at CHOPand UPenn(include UPenn if applicable);
  • People from agencies and organizations that perform independent accreditation and/or oversight of research; such as the Department of Health and Human Services, Office for Human Research Protections.

Include the following ONLY if applicable

  • Representatives of XXXX who is the study sponsor funding this research.
  • XXXX, who is testing your blood/urine/tissue sample(s).List lab names who receive identifiable specimens.
  • The Data Coordinating Center at ______(multi-center research studies)
  • Groups monitoring the safety of this study (e.g. DSMB)
  • The National Institutes of Health (or other funding agencies) who is sponsoring this research;
  • The Food and Drug Administration (if applicable)
  • Public health authorities that are required by law to receive information for the prevention or control of disease, injury or disability. (if applicable: sexually transmitted diseases, HIV, AIDS, child abuse, etc. )

By law, CHOP is required to protect your health information. The research staff will only allow access to your health information to the groups listed above. By signing this document, you are authorizing CHOP to use and/or release your health information for this research. Some of the organizations listed above may not be required to protect your information under Federal privacy laws. If permitted by law, they may be allowed to share it with others without your permission.

CHOOSE one of the first 2 statements, whichever applies. Note: Consent forms must be maintained for 6 years for HIPAA. FDA has separate requirements for maintenance of data. There is no set time for destroying the information that will be collected for this study. OR The identifiable information from this study will be destroyed XXXX years after the study is completed. Your permission to use and share the information and data from this study will continue until the research study ends and will not expire. Researchers continue to analyze data for many years and it is not possible to know when they will be completely done.