Participant Rights and Information
If you have taken part in a research study and would like to submit a complaint, please download and complete the following form, and submit it to the IRB via email, firstname.lastname@example.org:
As a participant, you should have received consent information. Consent information should include specific information about the study:
- A statement that the study involves research
- Explanation of the purposes of the research
- Expected duration of the participation
- Description of the procedures
- Whether any procedures are experimental
Risks, Benefits, & Alternatives
- Any foreseeable risks or discomforts
- Any benefits to the subject or to others
- Any alternative procedures or treatments that might be advantageous
- The extent, if any, to which confidentiality of records identifying the subject will be maintained
Compensation & Treatment
- If a study is greater than minimal risk:
- Whether any compensation will be provided
- Whether any medical treatments are available if injury occurs
- If so, what they consist of, or where further information may be obtained
- Whom to contact for answers to questions about the research and research subjects’ rights
- Whom to contact in the event of a research-related injury to the subject
Ability to Withdraw
- Participation is voluntary
- Refusal to participate will involve no penalty or loss of benefits
- May discontinue participation at any time without penalty or loss of benefits
Exceptions to Informed Consent
Signing the Consent Document
You may not have had to sign a consent form. Signed consent is not required if:
- The research is no greater than minimal risk to participants
- A breach in confidentiality would constitute the primary risk
- A signed consent form would be the only record linking the participant to the research
- The research does not include any activities that would require signed consent in non-research settings
Receipt of the Consent Document
For research studies that do not require the informed consent documents to be signed:
- It is not necessary for researchers to provide hard copies of the informed consent document to potential participants.
- The researcher may post the document online or send it via email
- Information should still be provided to you.
At times it is necessary for a researcher to temporarily deceive participants. An example of this would be a project in which providing the complete purpose of the research would serve to discourage participants from taking part or influence how they respond to survey questions.
- Research that qualifies for a deceptive consent document and debriefing statement can pose no greater than minimal risk (equal to the risk involved in performing everyday activities) to participants.
Altered Informed Consent Information
If deception is used, the researcher will create an ‘altered’ consent document.
- The researcher will present the altered consent document to participants prior to their taking part in the study.
Once the study has concluded, the researcher may use a debriefing statement.
- Debriefing statements disclose the deceptive aspects of a study and explain the reason(s) for the deception and the study’s true purpose.