CU(LEGAL) - RESEARCH

Disclosure of Sponsors

Definitions

"Public Communication"

  1. Testimony in a public administrative, legislative, regulatory, or judicial proceeding;
  2. Printed matter including a magazine, journal, newsletter, newspaper, pamphlet, or report; or
  3. Posting of information on a website or similar internet host for information.

Education Code 51.954(b)(2)

"Sponsor"

"Sponsored Research"

  1. That is conducted under a contract with, or that is conducted under a grant awarded by and pursuant to a written agreement with, an individual or entity other than the institution conducting the research; and
  2. In which payments received or the value of materials received under that contract or grant, or under a combination of more than one such contract or grant, constitutes at least 50 percent of the cost of conducting the research.

Education Code 51.954(b)(4)

Restriction on State Agency Contracts

Research Involving Human Subjects – Institutional Review Board Common Rule

Exceptions

Research That Does Not Adversely Impact Education

Research Involving Tests, Surveys, Interviews, or Observation of Public Behavior

  1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
  2. 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, educational advancement, or reputation; or
  3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination that, when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Benign Behavioral Interventions

  1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
  2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
  3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination that, when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Secondary Research for Which Consent is not Required

  1. The identifiable private information or identifiable biospecimens are publicly available;
  2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
  3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 C.F.R. Parts 160 and 164, Subparts A and E, for the purposes of "health-care operations" or "research" as those terms are defined at 45 C.F.R. 164.501 or for "public health activities and purposes" as described under 45 C.F.R. 164.512(b); or
  4. The research is conducted by, or on behalf of, a federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with Section 208(b) of the E–Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Public Benefit or Service Programs

Taste and Food Quality Studies

Storage or Maintenance for Secondary Research for Which Consent is Required

  1. Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of the Common Rule;
  2. Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with the Common Rule; and
  3. If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Secondary Research for Which Broad Consent is Required

  1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with the Common Rule;
  2. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with the Common Rule;
  3. An IRB conducts a limited IRB review and makes the determination that, when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data and makes the determination that the research to be conducted is within the scope of the broad consent referenced at Storage or Maintenance for Secondary Research for Which Consent is Required, above; and
  4. The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

6 C.F.R. 46.104(a), (d); 7 C.F.R. 1c.104(a), (d); 10 C.F.R. 745.104(a), (d); 14 C.F.R. 1230.104(a), (d); 15 C.F.R. 27.104(a), (d); 20 C.F.R. 431.104(a), (d); 22 C.F.R. 225.104(a), (d); 24 C.F.R. 60.104(a), (d); 29 C.F.R. 21.104(a), (d); 32 C.F.R. 219.104(a), (d); 34 C.F.R. 97.104(a), (d); 38 C.F.R. 16.104(a), (d); 40 C.F.R. 26.104(a), (d); 45 C.F.R. 46.104(a), (d), 690.104(a), (d); 49 C.F.R. 11.104(a), (d)

Weatherford College

CU(LEGAL)-LJC

UPDATE 36

DATE ISSUED: 4/30/2019