Common use of Deception Clause in Contracts

Deception. The protocol is designed to withhold complete information when consent is obtained. Identities of individual subjects are kept by the investigator. If subjects' identities are inseparable from data, then data is directly identifiable. If subjects' identities are kept separate from data, with information connecting them maintained by codes and a master list, then data is indirectly identifiable. In either case, the investigator must assure that confidentiality will be maintained, and must explain how subjects' identities will be protected. • Direct identifiers: Direct identifiers in research data or records include names; postal address information ( other than town or city, state and zip code); telephone numbers, fax numbers, e-mail addresses; social security numbers; medical record numbers; health plan beneficiary numbers; account numbers; certificate /license numbers; vehicle identifiers and serial numbers, including license plant numbers; device identifiers and serial numbers; web universal resource locators ( URLs); internet protocol (IP) address numbers; biometric identifiers, including finger and voice prints; and full face photographic images and any comparable images. • Identifiable data or records: contains information that reveals or can likely associate with the identity of the person or persons to whom the data or records pertain. Research data or records with direct identifiers removed, but which retain indirect identifiers, are still considered identifiable. • In-direct identifiers: Indirect identifiers in research data or records include all geographic identifiers smaller than a state , including street address, city, county, precinct, Zip code, and their equivalent postal codes, except for the initial three digits of a ZIP code; 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 age and elements may be aggregated into a single category of age 90 or older. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management method. The Common Rule codified in 45 CFR 46.101(b) specifies that research activities may be classified as exempt in the policy if human subjects involvement is limited to one of the listed scenarios, including studies involving the collection or study of existing data when those data either are publicly available or are not personally identifiable. To qualify, research must fall into one of six federally-defined exempt categories. Review of proposed research by the IRB Administrator rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research (see page 9).

Deception. The protocol is designed to withhold complete information when consent is obtained. Identities of individual subjects are kept by the investigator. If subjects' identities are inseparable from data, then data is directly identifiable. If subjects' identities are kept separate from data, with information connecting them maintained by codes and a master list, then data is indirectly identifiable. In either case, the investigator must assure that confidentiality will be maintained, and must explain how subjects' identities will be protected. • Direct identifiers: Direct identifiers in research data or records include names; postal address information ( other than town or city, state and zip code); telephone numbers, fax numbers, e-mail addresses; social security numbers; medical record numbers; health plan beneficiary numbers; account numbers; certificate /license numbers; vehicle identifiers and serial numbers, including license plant numbers; device identifiers and serial numbers; web universal resource locators ( URLs); internet protocol (IP) address numbers; biometric identifiers, including finger and voice prints; and full face photographic images and any comparable images. • Identifiable data or records: contains information that reveals or can likely associate with the identity of the person or persons to whom the data or records pertain. Research data or records with direct identifiers removed, but which retain indirect identifiers, are still considered identifiable. • In-direct identifiers: Indirect identifiers in research data or records include all geographic identifiers smaller than a state , including street address, city, county, precinct, Zip code, and their equivalent postal codes, except for the initial three digits of a ZIP code; 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 age and elements may be aggregated into a single category of age 90 or older. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management method. The Common Rule codified in 45 CFR 46.101(b) specifies that research activities may be classified as exempt in the policy if human subjects involvement is limited to one of the listed scenarios, including studies involving the collection or study of existing data when those data either are publicly available or are not personally identifiable. To qualify, research must fall into one of six federally-defined exempt categories. EXPEDITED REVIEW: Review of proposed research by the IRB Administrator rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research (see page 9).