Adverse Event means an event that occurs during a research study that has unfavorable and/or unintended effects on research subjects and that was not anticipated as a risk in the IRB-approved protocol and consent form, or occurs at a greater frequency or intensity than anticipated.
Aggregate Data means data collected from individual-level records that have been combined for statistical or analytical purposes and that are maintained in a form that does not permit the identification of individuals.
Cell Size Suppression means a statistical method used to report aggregate data in tables that restricts or suppresses disclosure of subsets of aggregate data to protect the identity and privacy of data subjects and to avoid the risk of identification of individuals in small population groups.
Confidential Information means, unless otherwise defined by law, any individually identifiable information, including, but not limited to, medical and demographic information, that:
- Reveals the identity of the data subject or is readily identified with the data subject, such as name, address, telephone number, social security number, health identification number, or date of birth; or
- Provides a reasonable basis to believe that the information could be used, either alone or in combination with other information, to identify a data subject.
Consent means voluntary agreement with what is being done or proposed (express or implied).
Contact means to communicate or attempt to communicate with a data subject or the data subject's parent, guardian, or health care provider by any means, including, but not limited to, in-person, telephone, facsimile, letter, or electronic mail.
Custodian means the MDPH registry, division, or program that collects and maintains the data and is responsible for its protection and appropriate use.
Data Linkage means a method of assembling data contained in two or more different files to relate significant health and other events for the same individual, organization, community, or other unit of analysis.
Data Subject means the individual about whom the data or information relate.
De-identified records means individual level records that do not contain any direct or indirect identifiers or any uncommon characteristics that could lead to the identification of an individual. Fully de-identified records are not considered confidential information.
Direct Identifiers means information that can directly identify an individual, including names; postal addresses; telephone numbers; fax numbers; electronic mail addresses; social security numbers; medical record numbers; health plan beneficiary numbers; and any other data or records that can be directly connected to an individual.
Disclosure means the transfer, dissemination, release, or communication by other means of any confidential information to any unauthorized person or entity.
Electronic Transmission means the use of email or file transfer protocols to exchange information over a computer network.
Indirect Identifiers means information that can be associated with an individual when characteristics are considered in combination or when combined with other data sources. Indirect identifiers include, but are not limited to, geographic identifiers smaller than a State, including city, Zip Code, or census tract; dates directly related to an individual, including birth date, admission date, discharge date, certain procedure dates, date of death, and ages over 89.
Institutional Review Board (IRB) means any board, committee, or other group formally designated by an institution, and approved by the U.S. Department of Health and Human Services pursuant to 45 C.F.R. Part 46 to review, approve, and periodically evaluate research projects to protect the rights of human research subjects.
Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Pledge of Confidentiality means a written statement that certifies the individual's agreement to abide by the confidentiality restrictions specified in the written statement.
Public Health Purpose means a population-based activity primarily aimed at the reduction of morbidity or mortality; the prevention of injury, illness, disease, disability or premature mortality; the improvement of health outcomes; or the promotion of health in the community, including assessing the health needs and status of the community through public health reporting and surveillance, developing public health policy, and responding to public health needs and emergencies.
Research means a systematic investigation designed primarily to develop or contribute to general knowledge, including public health, medical, social, demographic and historical research.
Security means the manner of assessing the threats and risks posed to data and taking the appropriate steps to protect that data against unintended or unauthorized access, use, intrusion, or such other dangers as accidental loss or destruction.