Look into way of using televisual depression treatment for older people unable to leave the house

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DETERMINATION CHECKLIST

Please provide a detailed description of the proposed activity for the study.

Who or what do you propose to study (specimens, data, and/or individuals)?

How do you plan to obtain the information?

What do you plan to do with the information gathered?

Review the DHHS definition below and answer the following two questions to determine if your activity is research under DHHS regulations:  45 CFR 46.102(d): Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities meeting this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes.

Is the proposed activity a systematic investigation? Consider whether the data/specimens will be obtained in a systematic manner.

Is the proposed activity designed to develop or contribute to the body of knowledge in your discipline?

Review the DHHS definitions below and answer the following questions to determine if your research activity involves human participants under DHHS regulations. 45 CFR 46.102(f): Human participant means a living individual about whom an investigator obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information. Intervention includes both physical procedures by which data are gathered (for example: venipuncture) and manipulations of the participant or participant’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and participant. Private information includes information about behavior occurring in a context in which an individual can reasonably expect that no observation or recording is taken place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

Does or did the research involve obtaining information about living individuals?

Does or did the research involve intervention or interaction with the individuals?

Is the information individually identifiable (see below)?

Individually identifiable, private information:

• Names

• Account numbers

• Certificate/license numbers

• Social security numbers

• Device identifiers and serial numbers

• Health plan beneficiary numbers

• Full-face photographic or comparable images

• Vehicle identifiers and serial numbers, including license plate numbers

• All elements of dates directly related to an individual, except year (of birth, admission)

• Fax numbers

• Telephone numbers

• Electronic email addresses

• Medical record numbers

• Web Universal Resource Locators (URLs)

• Biometric identifiers, including finger and voiceprints

• Internet Protocol (IP) address numbers

• Any geographic subdivisions smaller than a state, except for the initial three digits of a zip code

• Any other unique identifying number, characteristic, or code

Is the information private (see below)?

Individually identifiable, private information:

• Names

• Account numbers

• Certificate/license numbers

• Social security numbers

• Device identifiers and serial numbers

• Health plan beneficiary numbers

• Full-face photographic or comparable images

• Vehicle identifiers and serial numbers, including license plate numbers

• All elements of dates directly related to an individual, except year (of birth, admission)

• Fax numbers

• Telephone numbers

• Electronic email addresses

• Medical record numbers

• Web Universal Resource Locators (URLs)

• Biometric identifiers, including finger and voiceprints

• Internet Protocol (IP) address numbers

• Any geographic subdivisions smaller than a state, except for the initial three digits of a zip code

• Any other unique identifying number, characteristic, or code

Is the goal of the project to learn something to benefit people other than the participants?

Is the project a program evaluation only for stakeholders (see examples below)?

An example of a project only for stakeholders: XYZ Corporation contracts with Professor Wallace to survey their employees’ level of job satisfaction and attitudes towards safety. Professor Wallace conducts the survey, analyzes the data, and presents his report to management. An example of a project for stakeholders that is also research: XYZ Corporation contracts with Professor Wallace to survey their employees’ level of job satisfaction and attitudes towards safety. They reach an agreement whereby Professor Wallace waives his consulting fee in exchange for future use of the data. After obtaining IRB approval, Professor Wallace conducts the survey, analyzes the data, and presents his report to management. Having submitted his report, Professor Wallace is now free to mine the data and pursue academic publications.

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