Informed Consent
An informed consent letter is essential in research involving human subjects, as it ensures participants understand the study and their rights.
Standard Informed Consent
The following elements should be included:
- Study Title and Purpose:
- A clear explanation of the research’s purpose and objectives, including what the study aims to achieve.
- Researcher Information:
- Names and contact information of the principal investigator(s) and any relevant research staff.
- Description of Procedures:
- A detailed explanation of what participation will involve (e.g., interviews, surveys, experiments), including the duration, frequency, and location of the procedures.
- Potential Risks and Discomforts:
- A transparent outline of any foreseeable risks, discomforts, or adverse effects that may occur as a result of participation. Even if no more risk than would be encountered in everyday life is anticipated, it is impossible to predict how any individual will react to some questions. Participants should always be advised to withdraw from the study if any adverse reaction is felt. Students can be directed to on-campus counseling services.
- Potential Benefits:
- A description of any potential benefits to participants or to society from the research, while emphasizing that personal benefits are not guaranteed.
- Voluntary Participation Statement:
- A clear statement that participation is voluntary, with no penalty for declining to participate or withdrawing from the study at any time without consequences.
- Confidentiality and Data Privacy:
- An explanation of how personal data and responses will be handled, stored, and kept confidential, including any limitations to confidentiality (e.g., mandatory reporting or data sharing agreements).
- Compensation (if applicable):
- Information about any compensation or reimbursement for participation (e.g., monetary payment, gift cards) and any conditions tied to receiving it.
- Right to Withdraw:
- A statement confirming the participant’s right to withdraw from the study at any point, without providing a reason or facing any penalties.
- Contact Information for Questions or Concerns:
- Contact information for someone participants can reach out to if they have questions about the study or their rights (usually the principal investigator and the IRB office).
- Consent to Publication/Use of Data:
- If applicable, a section explaining how the data will be used (e.g., in publications or presentations) and whether it will be anonymized.
- Signatures:
- A space for the participant’s signature and date, indicating their agreement to participate after reading and understanding the letter.
- If necessary, a section for the researcher’s signature or that of a witness.
- Statement on Alternative Procedures (if applicable):
- If there are alternative ways the participant can receive similar services or outcomes without participating in the study, this should be clearly stated.
- Disclosure of Conflicts of Interest (if applicable):
- Any potential conflicts of interest (e.g., funding from organizations with a stake in the outcomes) should be disclosed.
These elements ensure that participants are fully informed and can make a voluntary and educated decision about joining the study.
Download Informed Consent Template
PARENTAL CONSENT
For research studies involving minors, parental consent and minor assent is required. Parental consent forms are similar to informed consent for adults in that they both include elements like the study's purpose, procedures, risks, benefits, and confidentiality measures. However, the language of the parental consent form is tailored to addresses the concerns and responsibilities of a third party (parents/guardians) and typically adds:
- Parental Responsibilities: Explicitly outlines the parent’s role in the process, such as transporting the child or ensuring they attend study sessions.
- Added Explanations: Addresses concerns parents might have about their child’s participation and details procedures to minimize discomfort, ensure comprehension, and to manage data to protect minors.
- Consent from One or Both Parents: For minimal risk or greater-than-minimal-risk with direct benefit, the consent from one parent is sufficient. For studies involving greater risk without direct benefit, the consent from both parents is required.
Download Parental Consent Template
ASSENT FROM CHILDREN
Researchers must obtain assent from children capable of understanding the research, as determined by the IRB. Assent requirements may vary based on the child’s age, maturity, and psychological state. Typically, children aged 7 and older are asked for assent, though this can vary depending on the child and the study. Younger children or children with limited cognitive abilities may not be able to provide meaningful assent, in which case the IRB may waive this requirement.
Assent should include the following elements in age-appropriate language:
- A description of the study and its purpose.
- What will happen to the participant during the study.
- An explanation of any potential risks or discomforts.
- An outline of any possible benefits to the child or others.
- A clear statement that participation is voluntary, and the child can withdraw at any time without penalty.
For older children capable of reading, assent may be documented using a written form, which should be brief, simple, and easily understandable. For younger children, verbal assent is typically sufficient and can be documented in the researcher's notes or as the researcher’s signature on the parental consent form as an additional assurance that assent was provided.
Tips for Researchers:
- Use clear, simple language appropriate for the child’s age and understanding level.
- Avoid coercive language or undue influence when seeking assent.
- Create a welcoming environment where children feel comfortable asking questions.
- Allow sufficient time for the child to consider participation.
Download Assent Template
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