Essential Concepts, Terminology, and Resources
Privacy and Confidentiality
Privacy and confidentiality are supported by two principles of the Belmont Report:
Respect for persons—Individuals should be treated as autonomous agents able to exercise their autonomy to the fullest extent possible, including the right to privacy and the right to have private information remain confidential.
Beneficence—Maintaining privacy and confidentiality helps to protect participants from potential harms including psychological harm such as embarrassment or distress; social harms such as loss of employment or damage to one‘s financial standing; and criminal or civil liability.
Maintaining privacy and confidentiality helps to protect participants from potential harms including psychological harm such as embarrassment or distress; social harms such as loss of employment or damage to one‘s financial standing; and criminal or civil liability. Especially in social/behavioral research the primary risk to subjects is often an invasion of privacy or a breach of confidentiality.
What is Privacy?
Privacy is the control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. The evaluation of privacy also involves consideration of how the researcher accesses information from or about potential participants (e.g., the recruitment process). IRB members consider strategies to protect privacy interests relating to contact with potential participants, and access to private information.
Privacy is ...
- About people
- A sense of being in control of access that others have to ourselves
- A right to be protected
- In the eye of the participant, not the researcher or the IRB
What is Confidentiality?
Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission. Confidentiality refers to the researcher's agreement to handle, store, and share research data to ensure that information obtained from and about research participants is not improperly divulged. During the informed consent process, if applicable, subjects must be informed of the precautions that will be taken to protect the confidentiality of the data and be informed of the parties who will or may have access (e.g., research team, FDA, OHRP). This will allow subjects to decide about the adequacy of the protections and the acceptability of the possible release of private information to the interested parties.
- Is an extension of privacy
- Is about identifiable data
- Is an agreement about maintenance and who has access to identifiable data
- In regards to HIPAA, protects patients from inappropriate disclosures of "Protected Health Information" (PHI)
Privacy is about people. Confidentiality is about data.
Issues Related to Privacy
In regards to privacy, the following issues should be considered and addressed in the protocol narrative as needed:
- The proposed subject population?
- What are the cultural norms of the proposed subject population? Some cultures are more private than others.
- What are the ages of the proposed subject population? There may be age differences in privacy preferences (e.g., teenagers less forthcoming than older adults)
- Sensitivity of the information being collected – the greater the sensitivity, the greater the need for privacy
- Method of data collection (focus group, individual interview, covert observation)
- Will subjects feel comfortable providing the information in this manner?
- If passively observing the subject; could the individual have an expectation of privacy (e.g., chat room for breast cancer patients)?
- Will the researcher collect information about a third party individual that is consider private (e.g., substance abuse in family)? If yes, consider whether informed consent should be obtained from third party?
- Privacy is in the eye of the participant, not the researcher or the IRB
Protocols should be designed to minimize the need to collect and maintain identifiable information about research subjects. If possible, data should be collected anonymously or the identifiers should be removed and destroyed as soon as possible and access to research data should be based on a “need to know” and "minimum necessary" standard.
When it is necessary to collect and maintain identifiable data, the IRB will ensure that the protocol includes the necessary safeguards to maintain confidentiality of identifiable data and data security appropriate to the degree of risk from disclosure.
Adverse Event - an event of any form that leads to a negative experience for the participant or subject of research or other people or elements in their environment (e.g., family members or ecological system)
Anonymous - participants that are anonymous to the research study have no identifying information provided to any member of the research project at any point in time
Confidential - confidential research includes projects that will at some point collect identifying information about participants (e.g., name on consent, IP address, etc.), even if the information will not be shared or linked to responses
Conflict of Interest - a researcher’s financial or commercial interest that may mislead their interpretation of research findings
Debriefing - a process where the researcher discusses with the participant(s) of the study the events that took place during the study and any adverse events that may have occurred during the study, often at the conclusion of the study
- In cases where deception was used, debriefing should include sharing the true nature of the study.
Deception - withholding from the participant(s) information about the true nature of a procedure or treatment involved in a study.
Demographic - a defining characteristic of an individual or group of individuals
- Common demographics include, but are not limited to, gender or sex, race or ethnicity, age, and socioeconomic status.
Exclusion/Inclusion criteria - any characteristic or other qualifier that allows an individual to participate in a study (inclusion) or does not allow them to participate (exclusion)
Experiment - a study in which participants or subjects of research are randomly assigned to the groups/conditions that are being compared and the independent variable is manipulated
Focus Group – a group of participants involved in research that more in-depth questions
- Typically, the questions, or a series of prompts to generate discussion, are created prior to conducting the focus group.
Interview - a research process in which the researcher asks a series of questions to the participant(s), verbally (for instance, in person, over the phone, virtually)
Observational Study (or naturalistic observation) - a study that includes the observation of participants or subjects in their natural environment
- Typically, observational studies do not involve the researcher interacting with the participants or subjects.
- The researcher documents behaviors or events that occur during the observation without the organism knowing they are being observed.
- An outline of such behaviors or events that are anticipated to be observed should be documented prior to performing the study.
Psychological and/or Physical Harm - Research studies can put participants in situations that may make them feel uncomfortable. The result can be psychological harm that can manifest itself through worry, anxiety (warranted or unwarranted), or feeling upset, depressed, embarrassed, shameful, or guilty. This could also result in the loss of self-confidence.
- If you are collecting information from participants about upsetting and/or disturbing events, there is a potential for you to upset or disturb your participants.
- Asking information about painful experiences, sexual trauma, etc., could at minimum upset the participant and may bring other psychological issues to the surface.
- In some studies, considering a physical risk is relevant.
- If you ask your participants to exert themselves beyond their resting state and/or there is a possibility for injury as a result of participating in the study, this risk should be described in the consent form and information should be provided as to what care the participant has access to if they become injured.
- For some studies, it might be necessary to exclude participants whose health conditions increase the likelihood of injury.
- Other types of harm could include legal, social, and/or economic harm.
Protected Populations and Sensitive Participants - active participants that fall within the following categories are considered protected and at‑risk:
- Minors (age <18 years)
- Educationally or economically disadvantaged persons
- Incarcerated persons
- Pregnant women and the fetus
- Persons committing illegal behavior
- Mentally disabled persons
Quasi-experiment - a study in which participants or subjects of research are grouped and comparisons are made between the groups
- Participants/subjects are not randomly assigned to the groups/conditions that are being compared.
Random Selection of Sample - the selection of participants or subjects of research that is done in such a way that all participants or subjects have an equal chance at being selected for the study
Risk - the potential for adverse events to occur during the research process This might include physical or emotional discomfort or damage.
Sample - a subset of the population used in research meant to represent a particular group of people or demographic at large
- Samples are randomly selected when participants in the sample all have equal chance of being chosen for the study.
- When not all members of the general population of interest were equally likely of being chosen, the selection process is not random.
Surveys and Questionnaires - documents that contain items (e.g., questions, activities, readings) that elicit a response for participants
- The responses are typically documented on the paper or electronic version of the survey or questionnaire.
Voluntary - participation in a research study that is by the participant’s choice and not influenced by incentives or compensation, or coercion for their participation
Ethical Principles and Codes
Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
Guidelines for Good Clinical Practice https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) https://www.ich.org/
World Medical Association Declaration of Helsinki https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
Federal Regulatory & Advisory Guidelines
National Institute of Health (NIH)
NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects https://grants.nih.gov/grants/guide/notice-files/not-od-16-010.html
National Institute of Justice
United States Department of Education
United States Department of Energy
United States Department of Health and Human Services
United States Food and Drug Administration
Agency for Healthcare Research and Quality
American Association of University Professors
American Psychological Association
Agency for Healthcare Research and Quality
National Science Foundation
Oral History Association