Dec 03, 2024  
2022 IRB Handbook 
    
2022 IRB Handbook [ARCHIVED CATALOG]

Guidelines for Informed Consent for Research Participation


Directions for the Participant 

Project Information

Introduction

Purpose of the Research

Brief Description of Methodology

Participant Selection

Voluntary Participation

Procedures

Duration

 

Risks

Benefits

Reimbursements

Confidentiality

Sharing the Results

Right to Refuse or Withdraw

Who to Contact

Certificate of Consent

Participants Under the Age of 18

 

 

 


 

The sections below include direction for the informed consent form that all research participants must sign. Researchers must create an Informed Consent Form that includes this information.  

Directions for the Participant 

This section needs to provide guidance to the individual completing the form for why they are completing it.

Example: Please Read this consent form carefully and ask as many questions as you like before you decide whether or not you want to participate in this research study. You are free to ask questions at any time before, during, or after your participation in this research.

Project Information

Information about the research project needs to be included on this form. The information that should be included here is as follows:

  • Project title
  • Researcher(s) names
  • Contact information (phone and email) for researchers 
  • Organization names for researchers

Introduction

Briefly state who you are and that you are inviting them to participate in research.

Example: “I am X, working for the Y organization. I am doing research on________. [If you are a student, use the following introductory sentence: “I am X, and I am a student at Y organization. I am doing research under the guidance and supervision of [mentor/chair’s name and position]. I will give you some information about the project and invite you to be part of this research. Before you decide, you can talk to anyone you feel comfortable with about the research. This consent form may contain words that you do not understand. Please ask me to stop as we go through the information and I will explain. If you have questions later, you can ask them then.

Purpose of the Research

Explain the research question in lay terms which will clarify rather than confuse. Use simplified words rather than scientific terms or professional jargon. Aim for 6-8th grade reading level.

Brief Description of Methodology

Briefly state the method of data collection.

Example: “This research will involve your participation in a group discussion that will take about one and a half hours and a one-hour interview.”

Participant Selection

Indicate why you have chosen this person to participate in this research.

Example: “You are being invited to take part in this research because your experience as a teacher (or as an administrator, or as a parent) can contribute much to our understanding of children’s reading.”

Voluntary Participation

Indicate clearly that they can choose to participate or not. State that they will still receive all the services they usually do if they choose not to participate.

Example: “Your participation in this research is entirely voluntary. It is your choice whether or not to participate. If you choose not to participate, all the services you receive at this program will continue.” OR “The choice that you make will have no bearing on your job or on any work-related evaluations or reports. You may change your mind later and stop participating even if you agreed earlier.)”

Procedures

Provide a brief introduction to the format of the research study.

Example: “We are asking you to help us learn more about dropouts in your community. We are inviting you to take part in this research project. If you accept, you will be asked to…)”

Explain the type of questions likely to be asked. If the research involves questions which may be sensitive or potentially cause embarrassment, inform the participant of this.

Duration

Describe the time commitments for the participant, including both the duration of the research any follow-up.

Example: “The research takes place over ______ (number of) days/or ______ (number of) months. During that time, I will visit you three times for interviewing you at one-month intervals; each interview will last for about one hour.”

Risks

Explain any risks that you anticipate or that are possible.

Example: If the research focuses on sensitive or personal issues, you might say, “We are asking you to share personal and confidential information, and you may feel uncomfortable talking about some of the topics. You do not have to answer any question or take part in the discussion if you don’t wish to do so. You do not have to give any reason for not responding to any question.”

Benefits

Benefits may be divided into benefits to the individual, benefits to the community in which the individual resides and benefits to society as a whole.

Example: “While there will be no direct financial benefit to you, your participation is likely to help us find out more about how to prevent dropouts in your community.”

Reimbursements

State clearly what you will provide the participants as a result of their participation.

Example: “You will be provided a $20 gift card to take part in the research. Babysitting or child care will be available for free while we are having our focus group discussion. There will also be free pizza provided for all participants.”

Confidentiality

Explain how the researcher will maintain the confidentiality of data.

Example: “I will not share information about you or anything you say to anyone outside of the research team. The information that we collect will be kept in a locked file cabinet or encrypted computer file. Any information about you will have a number on it instead of your name. Only I will know what your number is and I will secure that information.”

Sharing the Results

Describe your plan for sharing the findings with the participants. Inform the participant that the research findings may be shared more broadly through publications and conferences.

Example: “Each participant will receive a summary of the research findings. I hope to publish the results so that other interested people may learn from the research.”

Right to Refuse or Withdraw

Reconfirm that participation is voluntary and includes the right to withdraw at any time.

Who to Contact

Provide the name and contact information of the Lead Researcher. State the name (and contact details) of the IRB that has approved the proposal.

Example: “If you have any questions, you can ask them now or later. If you wish to ask questions later, you may contact [name, address/telephone number/e-mail]. This research plan has been reviewed and approved by the Institutional Review Board of American College of Education. This is a committee whose role is to make sure that research participants are protected from harm. If you wish to ask questions of this group, email [email protected].”

Certificate of Consent

This section should be written in the first person. It should include a few brief statements about the research and be followed by a statement similar to the one in below. If the participant is illiterate but gives oral consent, a witness must sign. A lead researcher or the person going over the informed consent must sign each consent form.

Example: I have read the information about this study, or it has been read to me. I have had the opportunity to ask questions about the study, and any questions have been answered to my satisfaction. I consent voluntarily to be a participant in this study.

Participants need to print or type their name, sign, and date the form. 

Participants Under the Age of 18

If research participants are minors, ask for assent from the participants and consent of parent or guardian. The parent/guardian will also need to sign the form and attest to the statement like the one below.  

Example: I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.