1. Regulations 201: Thorny Issues What is Research? Exempt and Expedited Reviews

2. Is it “Research”?

3. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.(.102d)

4. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

5. Thorny Case #1: From Paper to PDA A hospital is instituting a new policy of requiring staff to enter all information related to patient care on personal digital assistants (PDAs) or computers at patients’ bedsides in order to reduce errors, improve record-keeping, and reduce paperwork. Concerns have arisen about increased use of verbal communications to transmit instructions or delegate responsibility for data entry, because staff may be reluctant to use the new procedure. Two focus groups each of nurses, doctors, and other hospital staff will be convened to discuss problems with the process and how to address them.

6. Are there “Human Subjects”?

7. Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1)data through intervention or interaction with the individual, or (2) identifiable private information. (.102f)

8. Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1)data through intervention or interaction with the individual, or (2) identifiable private information.

9. Thorny Case #2: Gender and Race in Medical Education A medical student wants to study the influence of race and gender on interactions among doctors, interns, and patients during clinical rounds for her dissertation. She will observe those interactions during her regular participation in rounds, recording qualitative data along with the race and gender of the three sets of participants. She will not include any information associated with patients’ medical records, or information in any session in which she contributes to the discussion of an individual patient’s case.

10. Is it “Research with Human Subjects”?

11. Thorny Case #3: QA/QI Study of a Research Subject Protection System A federal agency has offered to carry out a quality assurance and improvement activity designed to assess compliance with federal regulations and improve the human research subject protections system of a hospital. Data will be collected through surveys, IRB record reviews, and interviews with administration officials, IRB members, and investigators.

12. Is it “Exempt”?

13. Exempt/Covered Unless otherwise required by Department or Agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy: –[Exemptions b(1-6)] 101(b)

14. Sometimes Covered, Sometimes Exempt All surveys or interviews involving children are covered under the Departments of Health and Human Services, Education, Defense, and Veterans’ Affairs. Surveys or interviews involving children under other federal agencies are exempt if the data are anonymous or benign.

15. Is It a “Covered Activity”?

16. Exempt if it is “ONLY”… Research in one or more exempt categories, for example, an anonymous survey of adults. AND NOT research in any covered research category, for example, collecting private identifiable data from future records.

17. What are the Covered Research Categories? Identifiable private information? Vulnerable populations? Subjects vulnerable to coercion or undue influence? Treatments or procedures? Incomplete Information?

18. Thorny Case #4: Evaluating the Nurse Work-shift Policy Hospital administrators want to evaluate the effects of changing the hospital’s policy regarding the length and pattern of nurses’ work-shift assignments. Nurses will be asked to keep a log for a two-week period before the policy is changed, and then for another two-week period three months after the policy has been changed. The nurses will use their logs to fill out anonymous surveys providing information about level of fatigue, shift transition problems, and error detection.

19. What research activities are eligible for expedited review? The research activity must fit one or more of the categories on the FDA/DHHS Expedited Review Categories List. The research activity must involve no more than Minimal Risk.

20. 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 tests. (102(i))

21. Thorny Case #5: Longitudinal In- Person Health and Retirement Survey To study retirement behavior and health of older adults a sample of 12,000 adults aged 51-62 in the base year is drawn and interviewed at 2-year intervals (spouses are also interviewed; a new sample is drawn periodically. The interviews are in person; advance letters inform respondents about the survey; the interviews are 1 hour in length each; topics include detailed work history, income, benefits, health status and history, retirement plans and expectations, and other characteristics; incentives are used to promote participation. Data are linked with administrative records, including social security earnings records and descriptions of employer pension and health benefit plans. Some of the data are provided for public use; access to the full microdata requires special arrangements.