Exempt Expedited

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Exempt Expedited

  1. 1. Dr. Julie Lowery Associate Director, VA Health Services Research Ann Arbor, MI and Dr. Joan P. Porter Deputy Chief Officer Office of Research Oversight Department of Veterans Affairs November 15, 2006 Washington, DC IRB Chairs' Conference Conducting Exempt and Expedited Reviews ORO Human Subject Protection Research Misconduct Laboratory Animal Welfare Research Laboratory Safety/Security
  2. 2. <ul><li>A brief review of regulator requirements in the Common Rule (38CFR16 for VA) for exempt and expedited review </li></ul><ul><li>Case “snippets” for discussion </li></ul><ul><li>Questions and your advice on where more help is needed </li></ul>Agenda
  3. 3. <ul><li>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 exempt from this policy. </li></ul>Exemptions: 38 CFR 16.101(b)
  4. 4. <ul><li>Research conducted in established or commonly accepted educational settings, involving normal educational practices such as: </li></ul><ul><li>Research on regular and special education strategies, or </li></ul><ul><li>Research in the effectiveness of or comparison among instructional techniques, curricula, or classroom management methods </li></ul>
  5. 5. <ul><li>Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior , unless : </li></ul><ul><li>Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects and </li></ul><ul><li>Any disclosure of the human subjects’ responses outside the research could reasonable place the subjects at risk or criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation </li></ul>
  6. 6. <ul><li>(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) or this section, if: </li></ul><ul><li>The human subjects are elected or appointed public officials or candidates for public office; or </li></ul><ul><li>Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. </li></ul>
  7. 7. <ul><li>Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens , if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. </li></ul>
  8. 8. <ul><li>Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: </li></ul><ul><li>Public benefit or service programs ; </li></ul><ul><li>Procedures for obtaining benefits or services under those programs; </li></ul><ul><li>Possible changes in or alternatives to those programs or procedures; or </li></ul><ul><li>Possible changes in methods or levels of payment for benefits or services under those programs. </li></ul>
  9. 9. <ul><li>Taste and food quality evaluation and consumer acceptance studies </li></ul><ul><li>If wholesome foods without additives are consumers or </li></ul><ul><li>If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. </li></ul>
  10. 10. <ul><li>In VA: Investigators submit the proposed research and the request for exemption. The IRB Chair, or an IRB member designated by the Chair, must review all requests in a timely manner and make a determination based on Section 6.101, and record the decision. The decision must be communicated in writing to the investigator and the IRB Documentation must include the specific categories justifying exemption. The Research and Development Committee review regulations even though exempt. </li></ul>Remember: &quot;Not human subject* is not the same as &quot;exempt&quot; <ul><li>*.102(f) Human subject means a living individual about when an investigator </li></ul><ul><li>(whether professional or student conducting research obtains: </li></ul><ul><ul><li>Data through intervention or interaction with the individual, or </li></ul></ul><ul><ul><li>Identifiable private information . . . </li></ul></ul>
  11. 11. <ul><li>Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research </li></ul>Expedited Review 38 CFR 16.110
  12. 12. <ul><li>(a) The Secretary, HHS, has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedures. The list will be amended, as appropriate, after consultation with other departments and agencies, through periodic republication by the Secretary, in the FEDERAL REGISTER. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office. </li></ul>
  13. 13. <ul><li>An IRB may use the expedited review procedure to review either or both of the following: </li></ul><ul><ul><li>Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk, </li></ul></ul><ul><ul><li>Minor changes in previously approved research during the period (of one year or less) for which approval is authorized. (Note that if approved, the continuing review date does not change and if the change involves biosafety or ionizing radiation, the appropriate committee must be consulted prior to approving the change; the consultation must be documented in the IRB file. </li></ul></ul>
  14. 14. Also Note: An IRB (or Privacy Board) may use the expedited review process to review (3) waiver or alteration of authorization for the use and/or disclosure of Protected Health Information.
  15. 15. The IRB Chair may carry out the review or delegate the review to one or more experienced reviewers from among IRB members. VA Procedures for Expedited Review (1) In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewer may not disapprove the research. A research activity may be disapproved only after review in accordance with the full-review procedures.
  16. 16. (2) If a proposal has been initially approved through the full review procedure, the continuing review may not be done by the expedited review procedure Except Continuing review of research previously approved by the convened IRB as follows: (a) Research in which the enrollment of a new subject is permanently closed; all subjects have completed all research-related interventions, and the research remains active only for long-term follow-up of subjects; or (b) Research in which no subject have been enrolled and no additional risks have been identified, or (c) Research in which the remaining research activities are limited to data analysis.
  17. 17. In VA — <ul><li>Each IRB that uses an expedited review process must adopt a method for keeping all members advised of research proposals that have been approved under this process. </li></ul><ul><li>The minutes and/or the protocol files must reflect the expedited review eligibility category that the research meets. </li></ul>
  18. 18. Categories of Expeditable Research Remember: (1) Research activities that present no more than minimal risk and (2) involve only procedures listed in one or more categories on the expedited review lists. Remember: Expedited review procedures may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects (e.g. employability, insurability, reputation), unless protectiions are in place to minimize invasion of privacy and breach of confidentiality so risks are no greater than minimal.
  19. 19. Categories of Expeditable Research (Paraphrased) <ul><li>Clinical studies of drugs and medical devices only when condition (a) or (b) is met. </li></ul><ul><ul><li>Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risk associated with the use of the product is not eligible for expedited review.) </li></ul></ul><ul><ul><li>Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. </li></ul></ul>
  20. 20. <ul><li>Collection of blood samples by finger stick heel stick, ear stick, or venipuncture as follows: </li></ul><ul><ul><li>From healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than two times per week; or </li></ul></ul><ul><ul><li>From other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood collected, and the frequency with which it will be collected. For these subjects the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than two times per week. </li></ul></ul>
  21. 21. (3) Prospective collection of biological specimens for each research purposes by noninvasive means. Examples: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
  22. 22. <ul><li>Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) </li></ul>
  23. 23. <ul><li>Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). </li></ul>
  24. 24. <ul><li>Collection of data from voice, video, digital, or image recordings made for research purposes. </li></ul>
  25. 25. <ul><li>Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies . (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects, 45 CFR 46.101 (b)(2) and (b)(3). This listing refers only to research that is not exempt.) </li></ul>
  26. 26. <ul><li>Continuing review of research previously approved by the convened IRB as follows: </li></ul><ul><ul><li>Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains actively only for long-term follow-up of subjects; or </li></ul></ul><ul><ul><li>Where no subjects have been enrolled and no additional risks have been identified; or </li></ul></ul><ul><ul><li>Where the remaining research activities are limited to data analysis. </li></ul></ul>
  27. 27. <ul><li>Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories (2) through (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. </li></ul>
  28. 28. Useful Websites OPRR Guidance on .101 (6)(5) Exemption for Research and Demonstration on Public Benefit and Service Program http://www.hhs.gov/ohrp/humansubjects/guidance/exmpt-pb.htm Office of Human Research Protections (OHRP) Guidance on the Use of Expedited Review Procedures http://www.hhs.gov/ohrp/humansubjects/guidance/exprev.htm Categories of Research that May be Reviewed by the Institutional Review Board (IRB) through Expedited Review Procedures http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm
  29. 29. Case Studies
  30. 30. Case Study 1 <ul><li>Investigator Chew is a dentist working as a WOC. He would like to collect photographs, dental plaque, and saliva from all his patients to see if there are characteristics of dental decay and ulcerations that can help predict HIV infection. He will: </li></ul><ul><li>Test the saliva and plaque for the presence of HIV. </li></ul><ul><li>Obtain informed consent from his subjects. </li></ul><ul><li>Keep the results of his findings in a locked cabinet in his office at the university. </li></ul><ul><li>He must have his proposal reviewed by the IRB and the R&D committee within 2 weeks to meet the deadline for funding. He requests that the IRB Chair expedite the project since he will be merely collecting dental plaque by routine methods that he would be doing anyway and he will collect sputum after saline mist nebulization. </li></ul>
  31. 31. Case Study 1 Continued <ul><li>Is Dr. Chew’s study Expeditable? Why or why not? </li></ul><ul><li>If not, can the IRB and R&D committee approve it tentatively by expedited means so that he can get the funding that would otherwise be “swept”? </li></ul>
  32. 32. Case Study 2 <ul><li>Dr. Curio is going to look at medical records in the VA to determine if veterans with psoriasis have a high rate of diabetes and he wants to check records from May 2004 to May 2007. He will: </li></ul><ul><li>Be using the medical records at three sites in his VISN to see if there is any correlation </li></ul><ul><li>Contact each of the medical centers, rather than using a VISN or central data base </li></ul><ul><li>Not be recording nay names when he looks at the records from each site. </li></ul>
  33. 33. Case Study 2 Continued <ul><li>At his VA facility, the IRB chair says that the project is exempts, and because he is not recording any information by name or other identifiers, the IRB need not review the project </li></ul><ul><li>The IRB in the second facility indicates that the project is not exempt, but that it could be expedited, but informed consent must be obtained to do an expedited project that has prospective data. </li></ul><ul><li>The third IRB indicated that the project could be expedited and that informed consent can be waived by the RIB consultant who is doing the expedited review. </li></ul><ul><li>Who is right? </li></ul>
  34. 34. Case Study 2 Continued <ul><li>Answer. All three responses have regulatory issues. </li></ul><ul><li>For IRB 1: The project is not exempt. Some of the data will be collected prospectively. </li></ul><ul><li>For IRB 2: Waiver of consent can be given if appropriately justified in accordance with Section .116 of the regulations. </li></ul><ul><li>For IRB 3: The reviewer must be the Chair or a member or members of the IRB appointed by the Chair. A non-IRB member cannot do the expedited review. </li></ul>
  35. 35. Case Study 3- Analysis of Patient Data from Secondary Sources <ul><li>This study includes analysis of patient data from existing VA databases (originally established for patient care and administrative purposes- not research) to compare statistical models of risk adjustment and mortality prediction. There is no direct patient contact, and scrambled patient identifiers are used to link data from various sources. </li></ul><ul><li>Data are collected on 5,000 VA patients with ICU admissions. Subjects are to be identified from VA databases using diagnostic criteria. </li></ul>
  36. 36. Case Study 3 Continued <ul><li>Data collection: </li></ul><ul><li>Patient data to be collected include demographic information, date of birth, zip code, gender, ethnicity, ICU admissions, diagnoses, lab results, inpatient treatment information, mortality data, and other outcomes. </li></ul><ul><li>These data are collected via database search (e.g., Austin data, Pharmacy Benefits Management data, DSS data) and will be used to test and compare risk adjustment methods. </li></ul>
  37. 37. Case Study 3 Continued <ul><li>Data Confidentiality: </li></ul><ul><li>The patient cohort will be obtained from existing VA databases using diagnostic criteria. </li></ul><ul><li>Some of the databases contain real SSNs, others contain scrambled SSNs. </li></ul><ul><li>After the study data, including SSNs and scrambled SSNs are pulled, all real SSNs will be converted to scrambled SSNs, using a file linking scrambled SSNs with the real SSNs obtained from a separate Austin database. Thus, as study files with patient data will include only scrambled SSNs. </li></ul><ul><li>The file linking scrambled SSNs with real SSNs will be maintained by the research team as a separate file, in a password protected drive that is separate from the drive containing the study data. </li></ul>
  38. 38. Case Study 3 Continued <ul><li>What type of review should this application receive and why? </li></ul>
  39. 39. Case Study 3 Continued <ul><li>Chart 2: Is the research involving human subjects eligible for exemption under 45 CFR 46.101(b)? </li></ul><ul><li>Will the only involvement of human subjects be in one or more of the following research categories? </li></ul><ul><li>Research conducted in established or commonly accepted educational settings, involving education practices? </li></ul><ul><li>Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior? </li></ul><ul><li>Research involving the collection of existing data, documents, records, or pathological or diagnostic specimens? </li></ul><ul><li>Research studying, evaluating, or examining public benefits or service programs? </li></ul><ul><li>Research involving taste and food quality evaluation or consumer acceptance studies? </li></ul>
  40. 40. Case Study 3 Continued <ul><li>YES: Research involving collection or study of existing data, documents, records, or pathological or diagnostic specimens. </li></ul><ul><li>Exemption 45 CFR 46.101(b) may apply. Go to Chart 5. </li></ul>
  41. 41. Case Study 3 Continued <ul><li>Are these sources publicly available? (No.) </li></ul><ul><li>Will information be recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects? </li></ul><ul><li>If no, research is not exempt. Go to Chart 8. </li></ul>
  42. 42. Case Study 3 Continued <ul><li>Has the research been previously reviewed and approved by the IRB? (No.) </li></ul><ul><li>Does the research present no more than minimal risk to the human subjects? AND </li></ul><ul><li>Does the research involve only procedure indicated in categories 1-7 on the list of categories that may be reviewed though an expedited review procedure? [45 CFR 46 110 (b)(1)] </li></ul>
  43. 43. Case Study 3 Continued <ul><li>YES (category 5): Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis). </li></ul><ul><li>Is this research classified? (No.) </li></ul><ul><li>Research is eligible for IRB review through expedited procedures. [45 CFR 46.110(d)] </li></ul>
  44. 44. Case Study 3- Modification A <ul><li>Data Confidentiality: </li></ul><ul><li>Data obtained from these databases will include scrambles SSNs, which are needed to link patients across time and across multiple databases. The scrambled SSN for a given VA patient is the same across all Austin databases; so, the scrambled identifier can be used to link data for a given patient across databases. </li></ul><ul><li>All study files with patient data will include only scrambled SSNs. The file linking scrambled SSNs with real SSNs is in a database maintained in Austin. </li></ul>
  45. 45. Case Study 3- Modification B <ul><li>Data Confidentiality: </li></ul><ul><li>The SSNS of eligible patients are obtained are used to identify the patients’ electronic medical records, from which relevant clinical data for the study are obtained. </li></ul><ul><li>These clinical data are entered into the study database, which doesn't contain any SSNs or linkages to patient identifiers. </li></ul><ul><li>A file containing the list of SSNs of eligible patients- but no linkages and no other data- is temporarily maintained until all of the medical record data are obtained. </li></ul>
  46. 46. Case Study 4 Observational Study Using Patient Interviews and Questionnaires <ul><li>This study examines health related quality of life (QOL) for individuals in the VA health care system with a specific, non-sensitive chronic illness. Investigator propose to administer two QOL measures to patients at baseline and a follow-up structured interview every month for a 1-year study period. They will use written informed consent, which will include a HIPAA authorization form. </li></ul><ul><li>The subjects are 500 patients at 8 VAMCs. They are identified via VA databases and initially contracted and invited by letter to participate in the project. Interested patients are scheduled to meet with project staff at an upcoming clinic appointment to go over requirements for participation and sign the consent form. </li></ul>
  47. 47. Case Study 4 Continued <ul><li>Data Collection and Confidentiality: </li></ul><ul><li>Baseline interviews are conducted in person at a regularly scheduled clinic appointment, and follow-up interviews are conducted over the telephone. </li></ul><ul><li>Data collected from patients include demographics/SES, general health information, and QOL data. </li></ul><ul><li>Data are confidential but not anonymous- linkages are maintained in a crosswalk file to facilitate the monthly follow-up. </li></ul><ul><li>The crosswalk file linking patient identifying data to study identification numbers will be maintained as a separate file, in a password-protected drive that is separate from the drive containing study data. </li></ul><ul><li>No study data will be maintained with the patient identifying data. </li></ul>
  48. 48. Case Study 4 Continued <ul><li>What type of review should this application receive and why? </li></ul>
  49. 49. Case Study 4 Continued <ul><li>Chart 2: Is the research involving human subjects eligible for exemption under 45 CFR 46.101(b)? </li></ul><ul><li>Will the only involvement of human subjects be in one or more of the following research categories? </li></ul><ul><li>Research conducted in established or commonly accepted educational settings, involving education practices? </li></ul><ul><li>Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior? </li></ul><ul><li>Research involving the collection of existing data, documents, records, or pathological or diagnostic specimens? </li></ul><ul><li>Research studying, evaluating, or examining public benefits or service programs? </li></ul><ul><li>Research involving taste and food quality evaluation or consumer acceptance studies? </li></ul>
  50. 50. Case Study 4 Continued <ul><li>YES: Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior. </li></ul><ul><li>Exemption 45 CFR 46.101(b)(2) or (b)(3) may apply. Go to chart 4. </li></ul>
  51. 51. Case Study 4 Continued <ul><li>Is the information recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND </li></ul><ul><li>Could any disclosures of the human subject’s responses outside the research reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability or reputation? </li></ul><ul><li>If yes, research is not exempt. Go to Chart 8. </li></ul>
  52. 52. Case Study 4 Continued <ul><li>Has the research been previously reviewed and approved by the IRB? (No.) </li></ul><ul><li>Does the research present no more than minimal risk to human subjects? AND </li></ul><ul><li>Does the research involve only procedure included in categories 1-7 on the list of categories that may be reviewed through an expedited review procedures? [45 CFR 46 110(b)(1)] </li></ul>
  53. 53. Case Study 4 Continued <ul><li>YES (Category 7): Research on individual or group characteristics (including but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. </li></ul><ul><li>Is this research classified? (No.) </li></ul><ul><li>Research is eligible for IRB review through expedited procedures. [45 CFR 46 110(d)] </li></ul>
  54. 54. Case Study 5 Observational Study Using Provider Interviews and Questionnaires <ul><li>This study will use provider interviews and written surveys to assess how a new clinical reminder system is working at 8 VAMCs. (This study is an investigator initiated research project, not a quality improvement project initiated by medical center management.) </li></ul><ul><li>The subjects are 70 VA primary care physicians at 8 VAMCs. </li></ul>
  55. 55. Case Study 5 Continued <ul><li>Data Collection and Confidentiality: </li></ul><ul><li>Data collected will include perceptions of barriers and facilitators to implementation of the system, provider self-efficacy, satisfaction with the system, and data about organizational structure. </li></ul><ul><li>Data are confidential, but are not anonymous, since providers are interviewed in person and data from interviews and surveys must be linked. </li></ul><ul><li>The crosswalk file linking provider identifying data to study identification numbers will be maintained as a separate file, in a password-protected drive that is separate from the drive containing the study data. </li></ul><ul><li>No study data will be maintained with the provider identifying data. </li></ul>
  56. 56. Case Study 5 Continued <ul><li>What type of review should this application receive and why? </li></ul>
  57. 57. Case Study 5 Continued <ul><li>Chart 2: Is the research involving human subjects eligible for exemption under 45 CFR 46.101(b)? </li></ul><ul><li>Will the only involvement of human subjects be in one or more of the following research categories? </li></ul><ul><li>Research conducted in established or commonly accepted educational settings, involving education practices? </li></ul><ul><li>Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior? </li></ul><ul><li>Research involving the collection of existing data, documents, records, or pathological or diagnostic specimens? </li></ul><ul><li>Research studying, evaluating, or examining public benefits or service programs? </li></ul><ul><li>Research involving taste and food quality evaluation or consumer acceptance studies? </li></ul>
  58. 58. Case Study 5 Continued <ul><li>YES: Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior. </li></ul><ul><li>Exemption 45 CFR 46.101(b)(2) or (b)(3) may apply. Go to chart 4. </li></ul>
  59. 59. Case Study 5 Continued <ul><li>Is the information recorded in such a manner that human subjects can be identified, directly or though identifiers linked to the subjects; AND </li></ul><ul><li>Could any disclosure of the human subjects’ responses outside the research reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation? </li></ul><ul><li>If yes, research is not exempt. Go to Chart 8. </li></ul>
  60. 60. Case Study 5 Continued <ul><li>Has the research been previously reviewed and approved by the IRB? (No.) </li></ul><ul><li>Does the research present no more than minimal risk to human subjects? AND </li></ul><ul><li>Does the research involve only procedure included in categories 1-7 on the list of categories that may be reviewed though an expedited review procedure? [45 CFR 46 110(b)(1)] </li></ul>
  61. 61. Case Study 5 Continued <ul><li>YES (Category 7): Research on individual or group characteristics (including but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. </li></ul><ul><li>Is this research classified? (No.) </li></ul><ul><li>Research is eligible for IRB review through expedite procedures. [45 CFR 46 110(d)] </li></ul>
  62. 62. Case Study 5 Modification <ul><li>Data Collection: </li></ul><ul><li>Data collected will include information on how providers were education in the use of the system, and data about organizational structure. </li></ul><ul><li>The providers will not be asked about their satisfaction with the system or their opinions on how the system could be improved. </li></ul>
  63. 63. Case Study 5 Continued <ul><li>What type of review should this application receive and why? </li></ul>
  64. 64. Case Study 5 Continued <ul><li>Chart 1: Is an activity research involving human subjects covered by 45 CFR Part 46? </li></ul><ul><li>Is the study a systematic investigation designed to develop or contribute to generalizable knowledge? (Yes.) </li></ul><ul><li>Activity is research. Does the research involve obtaining information about living individuals? </li></ul><ul><li>If no, the research is not research involving human subjects. </li></ul>
  65. 65. www.va.gov/annarbor-hsrd/irb/subjectsreview.htm Guidelines for Human Subjects Review of Health Service Research Studies Veterans Health Administration Ann Arbor HSR&D
  66. 66. Contact Information Dr. Julie Lowery Associate Director VA Health Services Research Phone: (734) 769-7100 (ext. 6222) [email_address] Dr. Joan P. Porter Deputy Chief Officer Office of Research Oversight (10R) Phone: (202) 565-7197 [email_address] And, of course, COACH

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