CITI Informed Consent SBE FAQ

 This page will answer the most popular questions of the CITI Informed Consent SBE.

There is general consensus on the importance of informed consent in research for treating individuals with respect, autonomy, and the right to decide.

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However, obtaining and documenting consent can be a complex process, with certain challenges like potential subjects not being literate in the language of the study or the need to deceive to obtain valid data.

The federal regulations provide flexibility for cases with minimal risk of harm, allowing waivers or alterations to the requirements for consent and documentation processes.

The Process

Informed consent is a process that begins with recruitment and screening and continues throughout the subject’s involvement in the research. It involves providing specific information about the study in an understandable way, answering questions to ensure understanding, giving subjects time to consider their decision, and obtaining voluntary agreement to enter the study (subjects may withdraw or decline to answer at any time).

Popular Questions

Question 1: A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?

Answer: The parents of the children might feel pressure to give permission to the therapist to use their children’s data so that she will continue to provide services to their children. [Quizzma]

In this case, the researcher must make sure to provide additional information about the research to balance out any potential benefit of participation against any risks or harms. The parent should also be informed that there is an option for their child not to participate in the study, and all reasonable efforts should be made to ensure that the parent’s permission is voluntary.

Question 2: A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it not be appropriate to provide subjects with information about missing elements of consent?

Answer: A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

In this case, providing additional information after the study would potentially cause greater harm than good and is likely inappropriate. The research team should ensure that subjects are fully informed of all elements of the consent process prior to the study.

Question 3: A researcher leaves a research file in her car while she attends a concert, and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?

Answer: There was neither a violation of privacy nor a breach of confidentiality.

In this case, since no identifying information was retained and all data was stored in an aggregated form, there is likely no violation of privacy or breach of confidentiality. However, the researcher should still take appropriate steps to investigate the theft and file a police report if necessary.

Question 4: When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?

Answer: The researcher cannot control what participants repeat about others outside the group.

In this case, the researcher should make clear to participants that confidentiality is expected and enforced within the focus group.

The researcher should also do their best to ensure that all information shared remains confidential by setting ground rules for discussion and by limiting access to the recordings or transcripts of the group discussion. However, it is ultimately up to each participant to keep any shared information confidential outside of the focus group setting.

Overall, informed consent is an important process in research involving human subjects and must be adhered to carefully. It involves providing relevant information about the study clearly and accurately, answering questions as needed, giving sufficient time for consideration of participation, and obtaining voluntary agreement from participants.

In order to ensure that informed consent is obtained appropriately, researchers must be familiar with the principles of informed consent and their legal obligations.

Question 5: A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject’s legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?

Answer: Participation in the research is voluntary, but if you choose to participate, you waive the right to legal redress for any research-related injuries.

This statement is an example of exculpatory language as it releases those conducting the research from any liability for negligence. Informed consent forms should not contain any exculpatory language and must be reviewed and approved by an Institutional Review Board. In addition, informed consent forms should clearly state that participation in research activities is voluntary, without coercion or undue influence. It is important to ensure that all potential risks and safeguards associated with the study are outlined clearly in the informed consent form before a participant agrees to participate in a research study.

The CITI Informed Consent SBE provides useful guidance on informed consent processes in research. Questions like these can help researchers understand their obligations regarding informed consent and ensure that they carry out their research ethically and humanely. Ultimately, informed consent helps protect the rights of participants while allowing for meaningful science that responds to real-world challenges.

In conclusion, CITI offers a comprehensive FAQ section on informed consent which can help researchers understand their legal obligations when obtaining informed consent from participants in a research study. The FAQs provide detailed answers to common questions about informed consent that researchers should consider when designing their research.

Familiarity with the principles of informed consent and understanding one’s legal obligations is critical to ensuring that research is conducted ethically and responsibly. By following best practices, researchers can ensure a responsible research process while protecting the rights of participants.