Safety Monitoring and the IRB
The Code of Federal Regulations addresses data safety monitoring in 45 CFR 46.111(a)(6) which states: "When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects."
What is a Data Safety Monitoring Plan?
A Data Safety Monitoring Plan (DSMP) describes how the Principal Investigator will to oversee the participants' safety and welfare. The level of detail in the plan should be based upon the degree of risk to the participants'. The intensity and frequency of monitoring should be adjusted to fit the expected risk level, complexity, and size of the particular study. Review of safety reports and data by a Data Safety Monitoring Board (DSMB) or medical monitor may be part of a DSMP.
What is a Data Safety Monitoring Board?
A Data and Safety Monitoring Board (DSMB)—also known as a Data Monitoring Committee (DMC) or a Data Safety Monitoring Committee (DSMC)—is an independent group that monitors the data and advises the study investigators and sponsors. The DSMB/DSMC evaluates research data on an ongoing basis to assure participant safety and study integrity. The DSMB/DSMC periodically reviews study data and unanticipated problems and makes recommendations based on their reviews as necessary. If your study will have a DSMB/DSMC, provide the IRB with the charter and any other applicable details about plans for stopping rules, DSMB/DSMC meeting frequency, and DSMB/DSMC composition.
In Guidance for Clinical Trial Sponsors, the FDA has defined a DMC as “a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials. The DMC advises the sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial."
Monitoring Data
Some studies may not have a data and safety monitoring plan (DSMP) that is separate from the research plan or a Data and Safety Monitoring Board/Committee. For example, some minimal risk studies may not collect data on sensitive topics and will not result in information that could impact participant safety/welfare so they may not need additional monitoring of the data to ensure safety of subjects. If that is the case for your study, please provide rationale within your research plan.
However, some studies may result in information that could impact participant safety/welfare and those submissions need to include a plan for monitoring the data collected to ensure the safety of subjects. For example, studies involving questions about self harm/suicidal intent, child abuse, or elder abuse may need to be monitored so researchers can provide participants with resources or other help when needed. Some researchers may also be mandatory reporters and participants should be informed of limitations pertaining to confidentiality during the consent process. Researchers need to have a plan in place for how they will monitor and address participant data that pertain to participant safety/welfare. If there are no plans to monitor responses in a timely manner, rationale is needed. These details can generally be included within the research plan unless a separate DSMP is requested.
Studies involving experimental drugs, devices or procedures that pose greater than minimal risk and/or may have long term or latent side effects will also need a plan for monitoring participant side effects and reactions to determine if actions are needed (e.g., reduce drug dose, withdraw participant from study, stopping rules for ending a study early or modifying the study). Most of these drug/device studies will have a separate DSMPs and sometimes also a Data and Safety Monitoring Board/Committee. However, these requirements will vary based on the research risks, study sponsor specifications, and federal requirements. Please reach out to research compliance services (researchcompliance@uoregon.edu) if you are unsure what is needed.
Safety Monitoring Resources
- Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees; Availability
- NIH Policies and IC Guidance for Data and Safety Monitoring of Clinical Trials
- NIH National Institute of Arthritis and Musculoskeletal and Skin Disease Policies, Guidelines and Sample Templates for Clinical Trials
- NIH National Institute of Allergy and Infections Diseases Decision Tree for Data and Safety Monitoring Plan
- FDA Guidance for Clinical Trial Sponsors - Establishment and Operation of Clinical Trial Data Monitoring Committees
Participant Privacy, Confidentiality of Data, and the IRB
The Code of Federal Regulations addresses participant privacy and confidentiality of data in 45 CFR 46.111(a)(7) which states: "When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data."
Participant Privacy
Participant Privacy refers to a person’s desire to control the access of others to themselves. Participant privacy in the context of research may take on different meaning depending on the topic being studied. When evaluating privacy, it is important to consider the time and setting where private information is obtained, the nature of the information collected, and who receives and uses the information. Protecting participant privacy means giving them control over the information that they share with you and options for how they can share that information in a confidential setting.
Privacy is particularly important to consider when designing recruitment, consent and data collection procedures. Individuals may have medical conditions, experiences or characteristics that they may not want others to know about. For example, recruiting participants in a group setting and announcing that you are targeting potential participants because they are HIV positive, would generally not be appropriate. Consider ways to provide potential participants with information about inclusion/exclusion criteria in a way that does not reveal their personal details to others. When potential participants have enough information to consider their eligibility and interest in a study (e.g., by reviewing these details in a flyer or advertisement), they can reach out to researchers directly. When researchers make contact with potential participants, consider ways to approach them individually when possible.
- Describe the steps that will be taken to promote the protection of participants’ privacy. Consider the following:
- The methods used to identify and contact potential participants.
- The settings in which an individual will be interacting with an investigator
- The appropriateness of all personnel present for research activities.
- The methods used to obtain information about participants.
- The sensitivity of the requested information:
- In relation to the potential privacy risks of the information.
- In relation to options for participants to disclose identity.
- Privacy guidelines developed by relevant professional associations and scholarly disciplines (e.g., oral history, anthropology, psychology).
- Steps to ensure access to the minimum amount of information necessary to complete the study.
- Information that is obtained about individuals other than the “target participants,” and whether such individuals meet the regulatory definition of “human participant” (e.g., a participant provides information about a family member for a survey).
- Describe what personal or identifiable information will be obtained to facilitate the research and as part of data collection. If participant data will be collected without identifiers, please state this.
Confidentiality of Data
Confidentiality pertains to the treatment of information obtained about participants and the researcher’s agreement with the participant about how the participant’s identifiable private information will be handled, managed, and disseminated. All information obtained during research should be protected to ensure that only those who need to access it can do so. However, information that could reasonably place participants at risk of criminal or civil liability or be damaging to their financial standing, employability, educational advancement, or reputation are held to a higher standard for data security. The easiest way to protect confidentiality is to avoid collecting any identifiable information (e.g., names, email addresses, home addresses, social security numbers, facial images, details when used in isolation or in combination could make identities readily ascertainable). If there is no connection between participant identities and their data, the risk associated with a breach of confidentiality is minimal. However, it is not always possible or advantageous to collect data without any identifiers.
Key Terminology:
- Anonymous - data/specimens collected without any identifiable information and in no way can be linked to an individual
- Confidential - Information and/or specimens that may be identifiable but will remain protected from unauthorized access and disclosure. The research team is obligated to keep confidential information/specimens private. For example, responses may be combined and reported in aggregate form. To ensure confidentiality, there should also be other mechanisms limiting access to identifiers (e.g., securely storing the data, removing identifiers from the data and replacing it with a code and maintaining a separate key to the code that is securely stored separately from the data, using passwords and encryption to make data available only to authorized users).
Please include the following within your research plan:
- Describe what data will be collected, including identifiable information and audio/video/digital recordings or photos. In addition, consider the following:
- Any other information collected to facilitate the research (i.e., contact information for recruitment).
- Any exiting data and its disposition (i.e. obtaining data from another source coded, or identifiable etc.).
- Describe the steps that will be taken to secure data and/or specimens for the research:
- Describe if participants’ private information will be coded (i.e., identifying information has been replaced with a number, pseudonym, etc.), include:
- How the key to decipher the code (i.e., list linking participants’ names with pseudonyms or participant number) will be stored
- Who will have access to the code key
- If, how, and why the code key will be retained.
- If participant identities will be disclosed as a result of this research (e.g., attributing a direct quote, etc.), provide:
- Justification for appropriateness of direct identification.
- Parameters for disclosure (e.g., will participants be allowed to review prior to dissemination).
- How permissions from participant will be solicited including any restrictions.
- Describe storage and transfer including:
- How the data will be collected and stored, including format (e.g., audio/video recordings or photographs, hard or electronic copy, identifiable or de-identified).
- Security during transmission and sharing between researchers and participants.
- Who will have access to data (e.g., training of staff, authorization of access).
- How long the records will be kept after the study is completed.
- The security of the area where data will be stored (e.g., locked office, password protected computer, encryption, firewalls, virus detection, etc.).
- Describe any intent for future use of data beyond this research including:
- If other researchers will be permitted access/use the data.
- How data will be maintained and stored.
- How participant permissions for the future use will be obtained and tracked.
- If seeking a Certificate of Confidentiality through NIH, this needs to be stated.
During the informed consent process, participants should be informed of the precautions that will be taken to protect the confidentiality of the data and be informed of who will or may have access (e.g., research team, IRB, FDA, OHRP, sponsor). This will allow potential participants to decide about the adequacy of the protections and whether or not they would like to participate in the research given the possible release of private information to the interested parties. See our informed consent website, template and guidance for more helpful details.