Risk Statement Examples
Exempt Level Review
Psychological or Emotional Risk: Although this study involves minimal risk, participants may experience slight discomfort when reflecting on personal opinions or experiences during surveys or interviews. However, the questions are not intended to probe sensitive topics, and participants can skip any question they do not wish to answer.
Confidentiality Risk: While efforts will be made to protect participant confidentiality (e.g., though anonymization of data and secure data storage), there is minimal risk that some identifying information could be unintentionally disclosed. However, no sensitive or identifying data will be linked to the participants in any published results.
Time Inconvenience: The research requires participants to spend approximately 30 minutes completing a survey. The minor inconvenience is expected to be the primary burden on participants, thought it will not significantly disrupt their daily activities.
Technology-Related Risk: For studies conducted online, there is minimal risk associated with data transmissions over the internet. While secure platforms will be used, there is a minor risk of unauthorized access to the data.
Expedited Level Review
Psychological Distress: This study may involve some psychological stress or discomfort as participants are asked to discuss personal or potentially sensitive experiences (e.g., health, family, or mental health concerns). While these topics are relevant to the research, participants may feel uncomfortable discussing them. Participants will be informed that they can pause or stop at any time and will have access to mental health resources if needed.
Physical Discomfort (for biomedical or physiological studies): Participants may experience mild physical discomfort or minor side effects (e.g., temporary bruising, lightheadedness) from blood draws or other non-invasive medical procedures. These effects are short-term and will be managed by trained professionals, with protocols in place to ensure participant safety.
Loss of Confidentiality: Given the sensitive nature of the data collected (e.g., health records, financial information), there is a moderate risk of confidentiality loss. While every effort will be made to de-identify data and store it securely, the potential for data breaches exists, which could result in harm to participants if personal information were exposed.
Invasion of Privacy: Some participants may perceive the collection of personal or medial information as an invasion of privacy. However, the study has been designed to minimize this risk through voluntary participation, informed consent, and the option to omit answering any question that causes discomfort.
Full Committee Review
Serious Emotional or Psychological Distress: This study involves sensitive topics, such as trauma, abuse, or substance use. Participants may experience substantial emotional distress when recalling or discussing these experiences. To mitigate this risk, licensed counselors will be available on-site during the study to provide immediate support, and participants will be reminded of their right to withdraw without penalty.
Physical Risk (for invasive procedures): In this study, participants may undergo more invasive medical procedures (e.g., biopsies, advanced imaging, or experimental treatments), which could result in adverse effects such as infection, prolonged pain, or, in rare cases, serious medical complications. Participants will be closely monitored throughout, and the research team is equipped to respond to any adverse events immediately.
Social or Legal Harm: Given the sensitive nature of the information being collected (e.g., illegal activities, substance abuse), there is a higher-than-minimal risk of social or legal repercussions if confidentiality is breached. Although all measures to protect confidentiality will be taken (e.g., encryption, secure databases), there remains a potential risk that participants could face stigmatization, discrimination, or legal consequences if their participation or data were disclosed.