Content / Yes / No
Consistent
  • The content is consistent with the study protocol

Concise
  • Be brief and to the point, express more with fewer words

Comprehendible
  • Use simple language equivalent to an 8th grade reading level
  • Written in second person so as to not be interpreted as suggestive or coercive
  • Write out (define) abbreviations and acronyms with the first use
  • Explain medical terms

Compliant
  • Include all elements required by federal regulations
  • Include any additional elements that apply to the study in appendices after signature page

Clear
  • Proof read the document for accuracy and completeness
  • Ask “would this make sense to a potential subject?” and “is information presented in a logical order?”

Format & Style / Yes / No
  • Remove all non-applicable section headings and re-number them

  • Page orientation is portrait

  • Justification is left aligned

  • Text size is at least 12 point

  • Tables (If used) should be in portrait orientation

  • Replace green text for investigator use with language to the subject as described

  • Populate yellow highlighted data fields as described

Informed consent is a process, not just a form. Information must be presented to enable persons to decide voluntarily whether or not to participate as a research subject. It is a fundamental mechanism to ensure respect for persons who may be willing to offer their bodies and experiences to assist investigators in research without promise or benefit.

The informed consent document provides a summary of the clinical study and the individual’s rights as a participant. The document acts as a starting point for the necessary exchange of information between the investigator and the potential research participant. In addition, the consent form may be used as an information resource and reference for the participant throughout the research trial. The document is not a risk management tool for the investigator and/or the institution.

BASIC ELEMENTS:

Any information that is not a part of the required basic elements must be placed in an appendix at the end of the form after the signature page.The consent form should includethe following statements or concepts:

Research Participant Informed Consent and Authorization to Disclose Protected Health Information for Research-Related Activities and Treatment Form

Study Title:

Researcher and Title:

Department and Institution:

Address and Contact Information:

Sponsor:

Introduction

This document is designed to provide you with information about the risks and benefits of this clinical trial as well as what might happen if you choose to participate. In addition, your study doctor will explain the clinical trial to you. After you read this document and have all of your questions answered, you will be asked to make a decision whether or not you agree to be part of this research study. This process is known as informed consent.

Take your time to decide. Feel free to discuss the study with your family, friends and healthcare provider before you make your decision.

To help you decide if you want to take part in this study, you should know:

  • Taking part in this study is completely voluntary
  • You can choose not to participate
  • You are free to change your mind at any time if you choose to participate
  • Your decision will not cause any penalties or loss of benefits to which you are otherwise entitled
  • Your decision will not change the access to medical care you receive at Sparrow Health System now or in the future if you choose not to participate or discontinue your participation

Contact Information

You can contact… / At… / If you have questions about…
Principal Investigator(s):
Study Team Contact: / Phone:
Phone:
Address: /
  • Study tests and procedures
  • Research-related injuries or emergencies
  • Any research-related concerns or complaints
  • Withdrawing from the research study
  • Materials you receive
  • Research-related appointments

Sparrow Health System Institutional Review Board (IRB) / Phone:
517.364.2157
Email:
/
  • Rights of a research participant
  • Any research-related concerns or complaints
  • Use of your Protected Health Information (PHI)
  • Stopping your authorization to use your Protected Health Information

Why is this study being done?

Points to include:

  • Description of the study drug or procedure being done
  • “You are being asked to take part in this medical research study because…”
  • State what the Investigators hope to learn from this study
  • State whether or not the Patients will be randomized and what it means (if applicable) and state whether or not the Physician will know which drugs or treatment the Patient will receive

How many people will take part in the study?

“A total of ____ people will take part in this research study around the world. About ____Patients will take part in this study at your institution.”

What will happen if I take part in the research study?

Describe the procedures to be undergone by the Patient in the study. If you are randomizing subjects, be sure to explain your randomization process. Use as much detail as necessary to ensure that all study procedures and visits are spelled out clearly for the Patient. Clearly identify which of these procedures is experimental and which is part of the standard therapy. Indicate the approximate amount of time the Patient will need to devote to study procedures. In complicated protocols it is very helpful to have a chart to explain the procedures in more detail.

How long will I be in the study?

State clearly how long the Patient will be expected to participate in the study, including follow up once they have completed their study treatment (if applicable).

What are the risks/side effects?

List the discomforts and risks that will or may result from participation in the study. Include not the only the risks from individual drugs and treatments but the overall effect of the combined drugs or treatments. If there is a risk to an unborn or nursing child, these risks should be addressed in this section.

The consent form should indicate to the participant that any new information that bears on the risks and/or benefits of the study would be made available to the participant.

  • Qualitative and numerical descriptors must be included with each category of risk. Please be advised if this is not incorporated into the consent form it will delay your research project approval. Examples of common definitions include:
  • Likely (occurs in more than 25% of people – more than 25 out of 100 people)
  • Common (occurs in 10-25% of people – 10 to 25 out of 100 people)
  • Infrequent (occurs in 1-10% of people – 1 to 10 out of 100 people)
  • Rare (occurs in less than 1% of people – less than 1 out of 100)

Note: If the level of specificity is not feasible, explain why in the application form.

What are the benefits of taking part in the study?

State the potential benefits of the study to the Patient, where appropriate, and to others who may benefit from the research.

What other choices do I have if I do not take part in the study?

State all alternative treatments available to the Patient and indicate, where appropriate, which treatments are currently the standards of care for the Patient’s problem. Where appropriate, tell the Patient that no additional treatment is also an option.

What are the costs of taking part in this study?

In the case that there are likely to be additional costs to the Patient, investigators must incorporate a statement specifying the nature of these costs in their consent forms. A statement should be included to the effect that either: (Select only one option that applies)

Option 1

All doctors’ visits, tests, ______that are required during the study are similar to those you would receive during standard treatments of your disease and will be billed to you or your medical insurance. Your health insurance company may or may not pay for these charges. Unless otherwise stated in this consent form, you will be responsible for all of the costs linked with this study that are not covered by other payers (HMO, health insurance company, etc.) Procedures that are done only for the study will be paid by ______.However, you or your insurance carrier must provide payment for hospital, clinical and other medical costs related to this study and associated with standard medical care provided to you during your participation in this study.

Option 2

The participation of the subject in this research project will not involve any additional costs to the subject or the subject's healthcare insurer.

Option 3

Your participation in the research project may involve additional costs to you(specify the additional procedures, tests, etc. that occasion the costs). Your health insurance will not cover all of the additional costs. An estimate of total costs is $______. If actual costs exceed the estimate, you will remain responsible for the costs.

What happens if I am injured because I took part in this study?

Specify that if an injury occurs as a direct result of the research study, emergency medical care required to treat the injury will be provided by (indicate the payee). The statement should also specify whether reimbursement would be sought from the Patient’s insurance company for the emergency care and any other medical expenses incurred as a result of the injury.

The following injury clauses have been provided as suggested language to incorporate in the informed consent form (select only the appropriate clause):

Option 1 - No costs will be paid

If you are injured as a result of your participation in this research project, Sparrow Hospital 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 in excess of what are paid by your insurance, including deductibles, will be your responsibility. The Hospital’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 may contact [insert Principal Investigator’s name and phone number]with any questions or to report an injury.

Option 2 - Third party will pay

If you are injured as a result of your participation in this research project, Sparrow Hospital 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. Any costs that are not covered or in excess of what are paid by your insurance, including deductibles, shall be paid by[name of payee].The Hospital’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 may contact[insert Principal Investigator’s name and phone number] with any questions or to report an injury.

Option 3 - Used forcContracts with the Army or where Army personnel are involved and the research study is funded by the Department of Defense

If you are hurt or get sick because of this research study, you can receive medical care at an Army hospital or clinic free of charge. You will only be treated for injuries that are directly caused by the research study. The Army will not pay for your transportation to and from the hospital or clinic. If you have questions about this medical care, talk to the Principal Investigator. If the issue cannot be resolved, contact the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of the Staff Judge Advocate (legal office) at 301.619.7663/2221.

Termination of the study

Indicate the circumstances under which the investigator or Patient’s doctor may terminate the study without the consent of the patient.

What are my rights if I take part in this study?

It is up to you to decide whether or not being on this study is the right choice for you, and if you decide to participate you can change your mind at any time.

You have the right to say no and the right not to sign this form. If you do not sign the form, you cannot take part in this research study. However, this decision will not affect your relationship with the hospital, it will not affect your present or future healthcare, nor will it cause any penalty or loss of benefits to which you are otherwise entitled.

Will my medical information be kept confidential?

Sparrow Health System is committed to protecting the confidentiality of information obtained about you in connection with this research study.

  • Describe methods used to safeguard the confidentiality of subjects’ data (e.g. coding data or samples with numbers, storing data in encrypted sparrow.box.com cloud application, etc.

During this research, information about your health will be collected. Under Federal law, called the HIPAA and HITECH Rule, health information is private. However, there are exceptions to this rule and you should know who may be able to see, use, and share your health information for research and why they may need to do so. Information about you and your health cannot be used in this study without your written permission. By signing this form, you are providing that permission.

Health information may be collected about you from:

  • Past, present, and future medical records
  • Research procedures, including research office visits, tests, interviews and questionnaires

Why will this information be used and/or given to others?

  • To do the research
  • To report the results
  • To see if the research was done correctly

If the results of this study are made public, information that identifies you will not be used.

Who may use or share your health information?

  • Sparrow Health System research staff involved in this study
  • Other (please list Sponsor’s name if applicable)

With whom may your health information be shared?

  • The Sparrow Institutional Review Board that oversees the research
  • Other Sparrow Health System Physicians involved in your clinical care (Omit if research test results will NOT be put in medical records)
  • Researchers involved in this study at other institutions
  • Federal and State Agencies (such as the Food and Drug Administration, the Department of Health and Human Services, the National Institutes of Health and other United States agencies)or government agencies in other countries that oversee or review research
  • The Sponsor(s) of this study and the people or groups it hires to help perform this research
  • A group that oversees the data (study information) and safety of this research

Information disclosed may contain mental healthcare records (except psychotherapy notes that are not kept within the medical records) alcohol/substance abuse treatment records, and any AIDS/HIV status. Limited data gathered could imply this type of treatment; such as a medication list with medications used to treat the above conditions. (This sensitive information has special protections under title 42 of the Code of Federal Regulations Part II and the 1989 Public Act 174)

Is your health information protected after it has been shared with others?

Sparrow Health System asks anyone who receives your health information from us to protect your privacy; however, once your information is shared outside Sparrow Health System, we cannot promise that it will remain private and it may no longer be protected by the Privacy Rule.

Your Privacy Rights

You do not have to sign this form, but if you do not, you cannot take part in this research study.

If you cancel your permission to use or share your health information, your participation in this study will end and no more information about you will be collected; however, information already collected about you in the study may continue to be used.

If you chose not to take part or if you withdraw from this study, it will not harm your relationship with your own doctors or with Sparrow Health System.

The following statement must be added to the Informed Consent if your study is an FDA regulated Clinical Trial.

A description of this clinical trial will be available on as

required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.

Enrollment and Permission Signature

Before signing this form below, make sure that you:

  • Have read the entire consent form
  • Know that your participation is voluntary
  • Know that you may choose to discontinue your participation at any time
  • Have taken your time to think about your decision to participate
  • Have had all of your questions answered by your study doctor

Special provisions apply in the case of cognitively impaired persons. For a discussion of these provisions, please contact the IRB office 517.364.2157.

If the subject is a minor, provisions should be made for obtaining parent or guardian's informed consent (signature) and the minor's assent. An assent form must be written in language that can be read and understood by the child based on their age, maturity, and degree of literacy. For additional guidance contact the IRB office.

Your Signature documents your permission to take part in this research.

/ / : a.m./p.m.