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Lay Summary/Consent Form Guidance

Click here for a Sample Lay Summary & Consent Form

NOTE:

  • For studies involving children relevant sections of this document should refer to “you or your child” as appropriate
  • Reading level, formatting and descriptions should be clear and simple
  • The participant should be given a copy of the summary for their own files
  • Unless waived by the IRB, no investigator may involve a living human being as a subject in research covered by policy 9.03 revised without obtaining informed consent of the participant or the participant’s legally authorized representative.

The following elements must be included in all consent forms

1. Header

This should include:

Title of Research Project: The title should be the same as submitted in your IRB proposal; in some cases where titles are complicated the IRB will allow simplification in this lay summary

Project Leader/Principal Investigator: Include name

2. Introduction & Voluntary Participation

Participants should understand: why they qualify to participate and that their participation is voluntary; they should understand that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled. They should understand who is conducting the project and what their affiliation is to the AHS; additionally, they should understand who is funding or sponsoring the project.

Sample Language:

You are being invited to take part in this research study because (explain how/why the participant qualifies or may qualify for the study). ( If the study is being conducted under a grant or special funding explain what it is) This study is being conducted by the Agency of Human Services (add the member department/division or office that is affiliated with the study, in the _______ (use the program or organization name that the participant would recognize).

We encourage you to ask questions and take the opportunity to discuss the study with anybody you think can help you make a decision whether or not to participate.

3. Why is This Research Study Being Conducted?

Participants need to understand WHY this research is being conducted, Include, easy-to-understand terms, some background and specific goals of the study.

4. What Is Involved In The Study?

  • Briefly explain the study design
  • For treatment and non-treatment studies, describe all procedures. Indicate the time commitment involved for participants, specifying number of visits, where the visits will occur (e.g., whether procedures are done on an inpatient or outpatient basis), etc. and the approximate time duration per visit. Discuss anticipated duration of participation including treatment and follow-up.
  • If this is a treatment study, discuss the study treatments and the probability for random assignment to each treatment including the use of placebo if any; explain the randomization process (if applicable).
  • For treatment trials, clearly state which are experimental/research related procedures and which procedures are standard care.

5. What Are The Risks and Discomforts Of The Study?

Participants should be able to gain a realistic idea of the known risks that they are taking and of discomforts or inconveniences they might experience as a result of participating in the study.

  • When necessary, include not only physical risks but also potential legal, economic or psychological risks that are relevant.
  • List risks in order of likelihood of occurrence from common to uncommon and provide a measure of the likelihood of occurrence (such as 1 in 10, 1 in 100) when available.
  • For all women of childbearing potential who are enrolled in a treatment trial, note potential risks to an embryo, fetus, or nursing infant.
  • State that the particular treatment or procedure may involve risks that are currently unforeseeable.
  • If there are no known risks, so state.

6. What Are The Benefits of Participating In The Study?

This should include an unbiased statement

  • If none, so state.
  • Both personal and societal benefits should be stated.
  • Note: money provided as compensation is not considered a benefit and should not be listed here.

7. What Other Options Are There?

The participants should clearly understand any alternative procedures or courses of treatment, if any, that might be advantageous to them. For treatment studies, describe options open to participants if they do not participate.

  • Discuss appropriate treatment alternatives and their potential risks/benefit.
  • Discuss if the same treatment is available outside of the research study.

8. What About Confidentiality?

Detail how confidentiality will be maintained. The greater the risk to the participant of a breach of confidentiality, the more detailed the discussion should be. Please note ,if the study uses, creates or discloses protected health information, you must have a separate HIPAA authorization form in addition to the consent. The consent form should include a statement about the disposition of all information collected, and any video, audio or photographic documentation following the study.

9. What Happens If You Are Injured?

For treatment studies and/or research studies involving more than minimal risk, participants should understand what procedure to follow should they become injured as a result of their participation.

10. Can You Withdraw from the Study?

Participants should understand their right to withdraw at any time and the consequences, if any, of a decision to withdraw from the study. Procedures for terminating participation should be clear and stated here.

11.Contact Information

The following language must be in all informed consent forms:

You may contact _____________ , the Investigator in charge of this study, at _________for more information about this study. If you have any questions about your rights as a participant in a research project or for more information on how to proceed should you believe that you have been injured as a result of your participation in this study you should contact the Secretary of the Agency of Human Services Office and ask to speak with the Institutional Review Board Chair at 802-241-2244.

12. Statement of Consent & Signatures

Sample sign-off language is below:

“You have been given and have read or have had read to you a summary of this research study. Should you have any further questions about the research, you may contact the person conducting the study at the address and telephone number given below. Your participation is voluntary and you may refuse to participate or withdraw at any time without penalty or prejudice to your present and/or future care.

You agree to participate in this study and you understand that you will receive a signed copy of this form.”

_______________________________________________________________
Signature of Participant Date

_______________________________________________________________
Name of Participant Printed

_______________________________________________________________________
Minor Providing Assent Date
(applicable for children 11 years of age or older dependent upon their understanding)

_______________________________________________________________________
Name of Minor Providing Assent Printed

_______________________________________________________________________
Signature of Legal Guardian or Legally Authorized Representative Date
(applicable for children and participants unable to provide consent)

_______________________________________________________________________
Name of Legal Guardian or Legally Authorized Representative Printed

_______________________________________________________________
Signature of Principal Investigator or Designee Date

_______________________________________________________________
Name of Principal Investigator or Designee Printed

Name of Principal Investigator:

Address:

Telephone Number:

When relevant to the study design and procedures the consent form should also contain the following elements:

1. How Many People Will Take Part In The Study?

If this is a national study include both national and local numbers.

2. Are There Any Costs?

State all additional costs to participants as a result of participating in the research. For treatment studies, if applicable, clarify that standard testing/treatment will be billed to participants or their insurance and not all expenses may be covered by their insurance, which would leave them responsible for payment.

3. What Is the Compensation?

State the level of compensation and detail the point(s) at which compensation is given, e.g., only at the end of study or at after each completed visit.

  • State the mechanism for proration.
  • Avoid using the word "pay".
  • Compensation is only offered to cover expenses, time lost or inconveniences. Specify what the compensation is for.
  • Payment is not made for inducing participants to assume any risks.
  • If applicable, state “You will not receive payment for participation in this study.”

4. Can You Be Withdrawn From This Study?

If a treatment study and an adverse or unexpected event occurs the participant should understand that the researcher may withdraw them from the study. Sample text may include

“Should your disease become worse, should side effects become very severe, should new scientific developments occur that indicate the treatment is not in your best interest, or should your physician feels that this treatment is no longer in your best interest, the treatment will be stopped.”

5. Are their unforeseeable risks?

When more than minimal risk is involved, include a statement that the particular treatment or procedures may involve risks to the participant (or embryo or fetus, if the participant is or may become pregnant) which are currently unforeseeable.

6. What if significant new findings are developed in the course of the study?

A statement that any significant new findings that may develop in the course of the research, which may relate to the participant’s willingness to continue in the project will be provided to the participants.