Items for Consideration

Surveys, Questionnaires, Interviews, Software Usability, Evaluation and Observation of Public Behavior (Video/Audio Taping)

Surveys, questionnaires, interviews, oral histories, and computer software and hardware usability evaluation and testing procedures and observation of public behavior conducted for research purposes must be reviewed by the IRB. In general, the research activities of this type conducted by PNNL staff generally qualify for exemption or expedited review. However, where a risk of harm may exist from the disclosure of sensitive information, full board review may be required. Investigators may apply to the IRB by submitting form HS-2B, Request for Administrative Review.

Note: Battelle Corporate policy 1.1.1.6 forbids the use of Battelle staff or their families as subjects of research without review and approval by the IRB and the Laboratory Director and then only studies that present no more than minimal risk, as determined by the IRB, to the subjects. Contact the IRB for guidance.

Activities that Do Not Require Review

Examples of activities that do not require IRB review include:

Internal or external surveys, interviews, or focus groups (when they do not involve research and the results will not lead to generalizable scientific knowledge). For instance, the PNNL Quality of Life survey or surveys, questionnaires, or focus groups to assess the Laboratory's reputation within the community or to discuss mutual concerns or planned activities with members of a local Tribal community or land-use owners, when the focus of the activity is about the topic itself, not the individual persons involved.
Taking photographs, video or audio taping conducted by PNNL public relations or other staff when the activities are not conducted for research purposes.
Software or hardware evaluation and usability testing when conducted for standard quality assurance purposes before delivery of a product or distribution to staff members if staff performance is not recorded (video, for example) or measured as part of those activities and their privacy is not jeopardized in any way. The use of Best Practices most always applies with some form of simple consent considered, where appropriate. Please refer to SSEP (restricted access) in the IS web site, or contact Anne Schur for information related to Best Practices in this area.

Activities that Qualify for Exemption

Activities that qualify for exemption include: (special conditions apply when vulnerable subjects are involved)

Research involving survey or interview procedures, observation of public behavior, and educational testing (cognitive, diagnostic, aptitude, achievement), unless:
- Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects (video tape/notes, etc.); and,
- Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
Research involving survey or interview procedures, observation of public behavior, and educational testing (cognitive, diagnostic, aptitude, achievement), that is not exempt under 1, if:
- The human subjects are elected or appointed public officials or candidates for public office; or
- Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Activities that Require Expedited or Full Committee Review at PNNL

Examples of activities that require expedited review or review by the convened IRB include:

Any research involving vulnerable subjects.
Audio or video taped data or recorded data that, if revealed, could prove embarrassing or harmful to subjects.
Use of demographic or other private data that, if revealed, could cause harm or embarrassment to a subject.
Surveys or interviews collecting sensitive data such as illegal activities, undesirable work behavior or other data that may be painful or embarrassing to reveal, such as sexual orientation or behavior, death of a family member or memories of abuse.
Surveys or interviews where sensitive information such as personal aspects of a subject's behavior, life experiences or attitudes has the potential to preclude a negative emotional reaction and/or seriously disturb or embarrass the subject.
Surveys, interviews or observation involving vulnerable subjects such as children or surveys or interviews involving the exploration of sensitive information with mentally disabled persons.
Educational research where subjects can be identified directly or through identifying links and disclosure may place them at risk or prove embarrassing.
Observation of children when the investigator participates in or influences the observed activities.
Observation involving sensitive aspects of a subjects' behavior or in settings where subjects have a reasonable expectation of privacy.
Observation of public behavior when an investigator participates in or influences the observed activities.
Observation of employees or workers in the conduct of their normal work performance if the results of their involvement in the research were revealed and could prove embarrassing or harmful (employability).
Deception where an investigator does not disclose the true purpose of the research and/or the results of a subject's participation.
Whenever the potential for coercion or undue influence exists.

The greatest threat to subjects in these types of research is the potential for loss of privacy, in particular when the information gathered from and about them could prove harmful to them or to their extended family or social group. For instance, a subject's employability might be impacted if their (poor) performance in a software usability or evaluation test was measured and recorded as part of a research study and their manager had access to the results.

Sensitive Surveys or Interviews

Sensitive surveys or questionnaires are seldom exempt from IRB review. A sensitive survey includes questions about illegal activities or highly personal aspects of the subjects' behavior, life experiences, or attitudes. Examples include chemical substance abuse, sexual activity or attitudes, sexual abuse, criminal behavior, sensitive demographic data, detailed health history, etc. The potential for provoking a negative emotional reaction from subjects, their families, or the community is a principal determining factor of sensitive survey research.

Breaches of Confidentiality

Additional considerations include risks associated with a possible breach of confidentiality such as an accidental disclosure of drug use to law enforcement personnel.

When sensitive issues and confidentiality are an issue, the presence or absence of subject identifiers may be a decisive factor.

For additional information, contact the IRB.