PARTICIPANT INFORMATION STATEMENT

PARTICIPANT INFORMATION STATEMENT

Invitation

You are invited to participate in a research study on …..

Before you decide whether or not you wish to participate in this study, it is important for you to understand why the research is being done and what it will involve. Please take the time to read the following

information carefully and discuss it with others if you wish.

What is the purpose of this study?

[In simple language state the aims of the project and why you consider it worth doing]

If appropriate put the research into context in relation to other research on the topic, eg previous

research has shown that …

Why have I been invited to participate in this study?

[State who is being invited to participate, ie the category or group, and how they have been identified to receive the invitation]

Eg We are seeking males aged 18-­40 years to participate in this research. Your name was selected at

random from the Electoral Roll.

If applicable, identify and include exclusion criteria for potential participants who should not, or cannot, participate eg:

  • If you are not currently in a management position, then, unfortunately, you are not eligible to participate…
  • Claustrophobic people should not participate as the research procedures require participants to be in a small confined space.
  • If you are taking medications for … then, unfortunately, you cannot participate.

What does this study involve?

If you agree to participate, you will be asked to [using simple language give a clear and explicit explanation of what participants will be asked to do or what will be done to them.]

This should:

  • Identify all procedures, examinations, medication, interviews, focus groups, questionnaires, observations, etc and where and when they will take place and whether interviews etc will be recorded ( audio or video)
  • Explain what information you will be obtaining from or about the participant. If access to participants’ records.eg medical records, is being sought, state what information will be extracted ( explicit consent is required)
  • Identify who will have contact with the participants to conduct the research procedures, eg perform tests or conduct interviews, focus groups etc. For specialist procedures, provide advice on the qualifications or expertise of the investigator performing the procedure.
  • Where a participant has the option of participating in one, or more than one, component of a project, this must be made clear with a statement like, If you choose to participate by returning the questionnaire, you are not obligated to agree to an interview.
  • Make it clear which aspects, if any, of the project are experimental.

Are there risks and benefits to me in taking part in this study?

[Provide an objective description of the known and potential risks/discomforts and benefits.]

Any benefits to the participants should be identified, but not exaggerated. If there is no reasonable chance of a benefit then this needs to be stated, eg There will be no benefit to you in participating in this research, or We cannot promise you any benefit from participating in this research.

This section should deal with benefits to the individual participant, not general benefits such as those for future generations, society, or the advancement of knowledge.

Any risks to participants should be identified and if an injury occurs what procedures are in place to assist

participants and who will pay for any treatment required.

How will my confidentiality be protected?

[State how the research data will be kept secure, who will have access to it, and how long it will be

retained.] 

In many research projects, but not necessarily all, names and identifying information will be kept confidential. Explain how this will be managed.

There are limits on assurances of confidentiality as the law may subpoena research data/records. For example, any information collected by the researchers that might identify you will be stored securely and only accessed by the researchers unless you consent otherwise, except as required by law. Suppose no identifying information is to be collected, eg anonymous questionnaires. In that case, the statement could be The questionnaire is anonymous, and it will not be possible to identify you from your answers.

If data are identifiable, how will confidentiality be ensured, eg replacing names with numerical codes. When will identifiers be permanently removed?

The information that might identify participants is not disclosed without their prior consent. This is particularly important for interview, oral history, focus groups, imagery or performance data, where individuals might be quoted or directly or indirectly identified. Explicit consent is required in this case, and participants must understand the intended use of their material before granting consent.

Focus Groups Discussions. A request should be made to the focus group participants to maintain the confidentiality of the group discussion and not divulge the specific content to outside parties.

Illegal behaviour. Suppose there is a possibility that participants could report incidences of criminal behavior during their participation, eg in a survey or during an interview. In that case, there should be a warning in the information statement that if they provide specific details about an incident (Eg date, place, perpetrators), the researcher may be obliged to report the information to the police.

of withdrawing their data; however, this is not possible in some cases, such as focus group discussion. Anonymously collected data cannot be withdrawn.

How will my confidentiality be protected?

[State how the research data will be kept secure, who will have access to it, and how long it will be

retained.] 

In many research projects, but not necessarily all, names and identifying information will be kept confidential. Explain how this will be managed.

There are limits on assurances of confidentiality as the law may subpoena research data/records. For example, any information collected by the researchers that might identify you will be stored securely and only accessed by the researchers unless you consent otherwise, except as required by law. Suppose no identifying information is to be collected, eg anonymous questionnaires. In that case, the statement could be The questionnaire is anonymous, and it will not be possible to identify you from your answers.

If data are identifiable, how will confidentiality be ensured, eg replacing names with numerical codes. When will identifiers be permanently removed?

The information that might identify participants is not disclosed without their prior consent. This is particularly important for interview, oral history, focus groups, imagery or performance data, where individuals might be quoted or directly or indirectly identified. Explicit consent is required in this case, and participants must understand the intended use of their material before granting consent.

Focus Groups Discussions. A request should be made to the focus group participants to maintain the confidentiality of the group discussion and not divulge the specific content to outside parties.

Illegal behaviour. Suppose there is a possibility that participants could report incidences of criminal behavior during their participation, eg in a survey or during an interview. In that case, there should be a warning in the information statement that if they provide specific details about an incident (Eg date, place, perpetrators), the researcher may be obliged to report the information to the police.

What will happen to the information that I give you? 

[Explain how and where the data will be reported or presented]

For example, in papers in scientific journals, in a thesis to be submitted for Ms X’s degree; at a public exhibition. Please note that in some circumstances, participants may agree to be identified or their comments accredited to them.

[Explain what information about the participants will be reported],

For example, individual participants will not be identified in any reports arising from the project.

Audio and Videotaping. If audio and videotaping are to be used, include whether participants will be given an opportunity to review the recording, eg You will be able to review the recording to edit or erase your contribution. Where audio tapes are to be transcribed, it should extend to recording and/or transcripts.

[Explain what feedback will be available to participants about the results of the study.] 

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