47 - Enhancing Informed Consent Administration: A Quality Improvement Survey for Research Personnel

Background: : This quality improvement project aimed to evaluate the knowledge and practices of individuals administering informed consent in research studies. A survey was distributed to those involved in the process, receiving 260 responses to assess current strengths and identify areas for improvement.

Program

Description: : A quality improvement project was conducted to evaluate the knowledge and practices of research personnel administering informed consent within Institutional Review Board (IRB)-approved studies. The goal was to assess staff understanding of the key elements of informed consent and identify areas for improvement in their approach to obtaining consent from participants. An anonymous, electronic survey was distributed to individuals involved in administering informed consent, including research coordinators, study nurses, and study investigators. The survey consisted of 18 questions, combining multiple-choice, Likert-scale, and open-ended formats, designed to assess the respondents' knowledge of informed consent. Data analysis included descriptive statistics for the multiple-choice responses, while qualitative responses were reviewed to identify common themes related to knowledge gaps or ineffective practices in the informed consent process.

Program

Assessment: : Of the 260 responses, 92% of respondents demonstrated strong knowledge of the basic elements of informed consent, including voluntariness of participation. However, only 68% correctly identified the ethical considerations around consenting with a limited English proficiency prospective participant. Notably, 45% of respondents indicated that they felt unsure about the correct process for ensuring participants fully understood the consent form, with many citing the challenges of communicating complex medical or research-related terminology. When asked about their practices, 24% of respondents reported sometimes feeling rushed during the consent process, often due to time constraints or high patient volume, while 17% noted that they felt establishing participant understanding was a challenge. In terms of further education opportunities needed, 29% of respondents revealed that better communication tools or technology would make their consent process more effective.

Limitations:: This survey conducted at a single site may not reflect practices or knowledge at other institutions. Institutional policies, training programs, and local regulations may vary, which can influence the results and limit the ability to generalize findings across diverse research environments.

Discussion: : The qualitative analysis revealed recurring themes around the need for better training in effective communication techniques and in assessing participant understanding. Suggestions included the development of more interactive training modules for consent administrators, as well as clearer guidelines on ensuring participants’ comprehension before obtaining consent. Based on these findings, recommendations were made to improve both the training for consent administrators and the procedures used in the informed consent process. These modifications are expected to enhance the overall quality of the informed consent process and promote ethical practices in clinical and research settings.