Research Informed Consent Form

Study Title:
Principal Investigator:
Study Sponsor:

“You” refers to the subject. (Include only if adult study)

“You” refers to you and your child. (Include only if pediatric study)

“We” refers to ______. (Include organizations affiliated with the research, e.g. Mercy Health, Mercy Health Physician Partners)

1. Introduction

Include the following language verbatim:

You are being asked to participate in a clinical research study. Clinical research is the study of human diseases in an attempt to improve diagnosis and treatment. In order to decide whether or not you should agree to be part of this research study, you should receive enough information about its risks and benefits to make a judgment. This process is called informed consent.

This consent form gives detailed information about the research study, which will be discussed with you. If you wish to participate in this study you will be asked to sign this form.

2. Purpose of This Research Study

(e.g. You are being asked to be part of this study because…….

This study is being done to find out…..)

  • Explain the purpose of your study, including procedures, in easily understood language.
  • Explain what you hope to learn (state what the study is designed to discover or establish).
  • Include special conditions of participation, including inclusion or exclusion criteria.
  • Clearly state why the participant is being asked to participate.

3. Registering Your Study on ClinicalTrials.gov(Omit this section if it does not apply to your study.)

Under the new 21 CFR 50.25©, the following statement must be included verbatim(for applicable clinical trials only):

“A description of this clinical trial will be available on , as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search with Web site at any time.”

For applicable clinical trials, refer to the attached guidance sheet at the end of this template for additional information.

 ATTENTION: Investigator or Sponsor enters version date of ICF in footer. 

Version Date 00/00/0000Page 1 of 11 Pt. Initials ______

4. Length of Your Participation

  • Explain the expected length of time of the subject’s participation. Include the number of required study visits.

5. Where the Study is Being Done and Number of People Participating

  • Explain where the study will be conducted and total number of subjects expected to be recruited overall. Specify expected number of subjects to be recruited for your site only.

6. Study Procedures

(e.g. If you agree to be part of this study, you will…..)

  • Include all study procedures, clearly explaining which procedures are considered standard of care versus those that are being conducted solely for the purpose of this study (experimental).
  • Provide explanation, in easily understood language, for:
  • Screening
  • Randomization (if applicable)
  • Blinding (if applicable)
  • Placebo (if applicable)
  • If specimens are required, describe:
  • Type
  • How and when obtained
  • If drawing blood, specify amount of blood required in tablespoons or teaspoons
  • If specimens are required for future research, explain how, where and length of time they will be stored, and who owns them.
  • If there are social behavioral consequences, identify potential risk and a plan to manage event issues.
  • If the research involves photographs, video or audiotaping, describe how subject’s identity will be protected.

7. What Will Happen When You Complete the Study

  • Provide an explanation (e.g. When your participation in the study ends, you will no longer have access to (the study medication/device).

8. Possible Risks or Side Effects of Taking Part in this Study

  • If there are no known side effects or risks, state as such.
  • Include a statement describing how participation may involve unforeseeable risks. If the study drug is still being tested, inform subjects they may experience other side effects that have not yet been reported (e.g. In addition to these risks, this research may hurt you in ways that are unknown. If we learn of new risks that we think might affect your desire to stay in the research, we will tell you. It is possible, if major risks are discovered after the study is finished, the sponsor may attempt to contact you.)
  • Include all known and potential risks or inconveniences of the study and any procedures required solely for the purposes of this study (e.g. psychological risks, genetic, financial).
  • If a blood draw is required, include a statement explaining there may be possible bruising, minor discomfort, bleeding or infection at the site
  • Describe each of the following risks/discomforts, if appropriate:
  • Physical risks (e.g. medical side effect)
  • Psychological risks/discomforts (e.g. embarrassment, fear or guilt)
  • Privacy risks (e.g. potential loss of confidentiality)
  • Legal risks (e.g. legal prosecution or being reported for child abuse)
  • Social risks (e.g. social ostracism or discrimination)
  • Economic risks (e.g. having to pay money out of pocket for research or medical expenses. Should you lose your health insurance during your involvement in this clinical trial, you may have to pay money out of pocket.)
  • If specimens are retained for future genetic research, explain what is meant by genetic information, how and where the specimens and genetic information will be stored, and who owns the specimens and related genetic information (e.g. “Like all tissues and cells in your body, these tissues/cells have genes. A ‘gene’ is the basic ‘instruction book’ for how to build a cell. Your genes determine your physical characteristics, such as your height and hair and eye color. Your genes can also help determine whether you have a chance of developing a certain illness or medical condition.”) Describe the risks of this information being collected or misused.(Refer to the Sample Genetic Research Informed Consent Language and Guidance for additional information.)
  • At the end of this section, the following language must be included(for those studies collecting specimens or bodily fluids):
  • In accordance with Michigan Public Health Code MCL 333.5133, an HIV and hepatitis test may be performed without written consent if a healthcare worker is exposed to your or your child’s blood or other bodily fluids. If the test results indicate you or your child are HIV or hepatitis positive, you or your child will be informed of these results and given appropriate counseling.

9. Acceptable Birth Control Language

  • Include one of the following sample statements (exactly as written) if applicable to your study. These choices are accepted within the Ethical and Religious Directives for Catholic Health Care Services (Directives 38-54).
  • "If you are pregnant or breastfeeding, you cannot take part in this study. You may be required to have a blood and/or urine test to see if you are pregnant before you begin this study treatment. If you are sexually active, it is important that you not become pregnant because this medication may be harmful to your unborn child. You must discuss your pregnancy plans with your doctor before enrolling in this study; you must also agree to use the type and duration of precautions approved by your doctor for the entire time you receive this study treatment. For women, if you become pregnant or have reason to believe you might be pregnant, please inform your doctor immediately. Once you are no longer receiving this study treatment, discuss with your doctor when it might be safe to become pregnant or become a new father."
  • "If you are pregnant or breastfeeding, you cannot take part in this study. You may be required to have a blood and/or urine test to see if you are pregnant before you begin this study treatment. If you are sexually active, it is important that you not become pregnant for this medication may be harmful to your unborn child. You must discuss your pregnancy plans with your doctor before enrolling in this study and agree that you will take the appropriate precautions not to become pregnant while enrolled in the study. For women, if you become pregnant or have reason to believe you might be pregnant, please inform your doctor immediately. Once you are no longer receiving this study treatment, discuss with your doctor when it might be safe to become pregnant or become a new father."

10. Costs for Taking Part in this Study

  • Explain any additional costs to the participant or their insurance that may be incurred by their participation in the study. If the study treatment is provided free of charge, state as such(e.g. There is no cost to you for participation in this clinical trial). Clearly differentiate those procedures considered standard of care and those that are solely for the purpose of the study.

Following is sample language you may use:

The study drug/device will be supplied free of charge.

Use the following language verbatim:

(The following information regarding patient care and research costs is reproduced language originating from the National Cancer Institute, )

As you think about taking part in this research study, you will need to consider how to cover the costs of your care. Even if you have health insurance, your plan may not cover all of the costs related to receiving treatment in a clinical trial. Some health plans will not pay these costs for people taking part in research studies. You may want to verify this with your health plan or insurance company to find out what they will pay for (your medical social worker may be able to help you with this, if needed).

There are two types of costs associated with a clinical trial: patient care costs and research costs.

Patient care costs are the costs related to treating your disease or medical issue even if you don't participate in a clinical trial. These costs are often covered by health insurance. They include:

  • Doctor Visits
  • Hospital Stays
  • Lab Tests
  • X-Rays and other Imaging Tests

Research costs are those specifically related to taking part in a clinical trial. Often these costs are not covered by health insurance, but they may be covered by the sponsor of the clinical trial. Examples include:

  • The study drug or device
  • Lab tests performed solely for research purposes
  • Additional x-rays and imaging tests performed solely for this clinical trial
  • You should also consider that you may have extra doctor visits that you would not have

with standard treatment. These extra visits can add costs for transportation and child care.

If you are injured as a result of your participation in this research project, Mercy Health will assist you in obtaining emergency care, if necessary, for your research related injuries. If you have insurance for medical care, your insurance carrier will be billed in the ordinary manner. As with any medical insurance, any costs that are not covered or are in excess of what are paid by your insurance, including deductibles, will be your responsibility. Mercy Health's policy is not to provide financial compensation for lost wages, disability, pain or discomfort, unless required by law to do so. This does not mean that you are giving up any legal rights you may have. You maycontact [insert Principal Investigator’s name and phone number] with any questions or to report an injury.

11. Payment for Taking Part in this Study

  • Explain any compensation the participant may receive, including the amount and any conditions of payment. Please state that “Payment will be in the form of a store card to a local retailer.” If no compensation will be given, please state as such.

12. Possible Benefits to You for Taking Part in the Study

  • Describe any potential benefits to the participant that may be reasonably expected.
  • If no direct benefit, state as such. (e.g. You will not directly benefit from your participation in the study. However, your participation in this study may contribute to the understanding of…..)

13. About Participating in this Study

Following is sample language to be included in this section:

Your health care provider may be an investigator of this research protocol and, as an investigator, is interested both in your clinical welfare and in the conduct of this study. Before entering this study, or at any time during the research, you may ask for a second opinion about your care from another doctor who is in no way associated with this research study. You will be responsible for any costs associated with obtaining a second opinion. You are not under any obligation to participate in any research project offered by your doctor.

Your participation in this study is voluntary. You may stop participating in this study at any time. Your decision not to take part in this study or to stop your participation, will not affect your medical care or any benefits to which you are entitled. If you decide to stop taking part in this study, you should tell the investigator. (Provide alternatives to study participation, if this is a clinical trial. Instead of being in this study, you may also…..)

Your doctor, the investigator and/or the Sponsor may stop your participation in the study at any time if they decide that it is in your best interest. They may also do this if you do not follow instructions. If you have other medical problems or side effects, the doctor and/or nurse will decide if you may continue in the research study.

If you wish to take part in this study, we expect that you will:

  • Keep your study appointments. If you cannot keep an appointment, contact theinvestigator or research study staff to reschedule as soon as you know that you will miss the appointment.
  • Tell theinvestigator or research study staff about any medications you are taking so they can check how the drug being studied and your medications may interact. If you need to start on any new medications while you are in the study, please check with theinvestigator before you do so.
  • Tell theinvestigator or research study staff about any side effects, doctor visits, or hospitalization that you may have whether or not you think they are related to the study therapy.

If you decide to leave the research, the consequences of your decision are (describe the adverse consequences – e.g. participants on a drug may experience worsening of their disease or withdrawal problems without substituting another drug or tapering the study drug.). If you decide to leave the research, contact the investigator so that the investigator can (describe the procedures for orderly termination by the participant.)

14. Compensation for Injury

  • If sponsor agrees to pay for expenses resulting from research related injury or illness, include the sponsor’s statement.
  • If no compensation is available from any source, insert the following statement:

If you are injured as a result of your participation in this research project, medical care and/or hospitalization will be provided, if necessary. If you have health insurance, your insurance carrier will be billed in the ordinary manner. As with any health insurance, any costs that are not covered or are in excess of what is paid by your insurance, including deductibles, will be your responsibility. No funds have been set aside to pay you in the event of a study related injury.

By signing this consent form, you will not waive any of your legal rights or release the parties involved in this study from liability for negligence.

15. Confidentiality of Study Records and Medical Records

Explain how the study records will be kept and controlled in order to maintain participant confidentiality.

  • If data for this project is being collected anonymously and researchers nor anyone else can link the data to the participant, state as such.
  • If data is being coded and a key maintained separately, inform participants of the process.

Sample statement:

Information collected for this study is confidential. However, the investigator and his/her study staff, delegated representatives of Mercy Health and Mercy Health Regional Institutional Review Board (IRB), the sponsor and/or their representatives, the Food and Drug Administration (FDA) and other government agencies involved in keeping research safe for people may look at your medical records when necessary, either in person, by mail, fax or electronically.

  • Discuss how you will keep the participant’s information confidential
  • Where will the data be stored and how will it be protected
  • Who will have access to the data?
  • Researchers and research staff
  • Institutional Review Board (IRB)
  • Sponsor
  • Government agencies (e.g. FDA)

16. Release of Personal Information

Include the following statement:

We will do our best to ensure that your personal information is kept confidential and private to the maximum extent required by law. We cannot guarantee absolute confidentiality and privacy. Your personal information may be disclosed if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

17. Financial Conflict of Interest (Omit this section if there is no conflict to disclose.)

  • If there is a conflict of interest, the researcher should disclose this on the consent form.
  • Significant financial interest
  • Affiliation with study sponsor

18. HIPAA Authorization (This section is required if protected health information is being accessed

and collected. Omit this section if no PHI is being accessed.)

Include all of the language in this section verbatim:

As part of this research study, you are being asked to release your health information. The Health Insurance Portability and Accountability Act (HIPAA) permits a hospital or doctor’s office to use or release protected health information (PHI) for the purposes of treatment, payment or health care operations. A HIPAA authorization gives permission from you to use or release PHI for research purposes, and is in addition to your consent to participate in this research study.