Any untoward or unfavorable physical and psychological harms that a human participant experiences, including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, or disease, occurring simultaneously with (whether or not related to) research participation. Although they occur primarily within biomedical research, they may occur in social and behavioral research.
When an organization/institution's employees or affiliates conduct (non-exempt) research projects obtaining (1) data about research participants through intervention or interaction; (2) identifiable private information about research participants; and (3) informed consent research participants; or (4) when the institution receives a direct federal award to conduct human participant research, even when subcontractors (employees or agents of another institution) carry out all research activities.
Family Educational Rights and Privacy Act of 1974. This provides protection for children and families with respect to educational data. The important distinction is between Educational Information and Directory Information -- any personally identifiable information (PII) not listed in a directory is protected.
The primary researcher who assumes responsibility to protect research participants. Seattle University recognizes the importance of active research experience for its students, and thus permits students to serve as primary investigators. However, in these cases, the faculty adviser remains ethically and legally responsible for all research activities, and must provide appropriate oversight to ensure the ethical conduct of all aspects of the project, even if determined to be "Exempt."
When the proposed study does not involve risks/harm greater (in magnitude or likelihood) than those normally encountered in daily life or during routine physical or psychological examinations or tests. Studies with minimal risk are usually categorized as Exempt from IRB oversight.
Examples include, but are not limited to: information about sexual attitudes, preferences, practices; the use of alcohol, drugs, or other addictive products; information that could damage an individual’s financial standing, employability, or reputation within the community; information in a participant’s medical record that could lead to social stigmatization or discrimination; information about a participant’s psychological well-being or mental health; and/or other records, such as medical, academic, photographic, audio tapes, and videotapes.
NOTE: According to Federal regulations, "sensitive" means that -- if disclosed and linked to the participant -- data could potentially cause economic, social, psychological, or other harm, or put the participant at risk for criminal or civil liability.
Direct Identifiers are pieces of information about a participant that identify them specifically and individually, without any additional information being necessary. The list of such identifiers includes:
1. Names;
2. All geographical subdivisions smaller than a State;
3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;
4. Phone numbers;
5. Fax numbers;
6. Electronic mail addresses;
7. Social Security numbers;
8. Medical record numbers;
9. Health plan beneficiary numbers;
10. Account numbers;
11. Certificate/license numbers;
12. Vehicle identifiers and serial numbers, including license plate numbers;
13. Device identifiers and serial numbers;
14. Web Universal Resource Locators (URLs);
15. Internet Protocol (IP) address numbers;
16. Biometric identifiers, including finger and voice prints;
17. Full face photographic images and any comparable images; and
18. Any other unique identifying number, characteristic, or code.
Even when you do not collect direct identifiers, a combination of other data could reveal an individual's identify, especially with small sample sizes. These can include gender, age, race/ethnicity; size of town, community character (e.g., industrial, agricultural center, suburban, education community, etc.), and general location; characteristics of family structure (size, sex distribution of children, ages, marital evolution); details of personal characteristics or expressions of individuality.