exempt research mary banks bs, bsn irb director crc irb and bumc irb

Download Exempt Research Mary Banks BS, BSN IRB Director CRC IRB and BUMC IRB

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  • Slide 1
  • Exempt Research Mary Banks BS, BSN IRB Director CRC IRB and BUMC IRB
  • Slide 2
  • Exempt from Further IRB Review Studies are Exempt from further IRB review when: The IRB determines that the project does not meet the definition of human subjects research The IRB determines that the project does not meet the definition of human subjects research there are by definition NO HUMAN SUBJECTS the study does not meet the regulatory definition of RESEARCH Categorical Exemption: the IRB determines that the study fits into one or more exempt categories defined in the regulations Categorical Exemption: the IRB determines that the study fits into one or more exempt categories defined in the regulations BU investigators are not engaged in the research BU investigators are not engaged in the research BU investigators are engaged in the research but there is an authorization agreement for IRB review by another IRB BU investigators are engaged in the research but there is an authorization agreement for IRB review by another IRB
  • Slide 3
  • Human Subjects Human subject means a living individual about whom an investigator conducting research obtains 1. Data through intervention or interaction with the individual, OR 2. Identifiable private information 45CFR 46.102(f)
  • Slide 4
  • Research A systematic investigation (including research development, testing and evaluation), designed to develop or contribute to generalizable knowledge. 45CFR 46.102(d)
  • Slide 5
  • Examples of NHSR (not human subjects research) Analysis of anonymous biological samples previously collected (for examples blood obtained from the Red Cross) Analysis of anonymous biological samples previously collected (for examples blood obtained from the Red Cross) Program evaluation determined by the IRB to not meet the definition of research Program evaluation determined by the IRB to not meet the definition of research Analysis of publically available, anonymous data sets Analysis of publically available, anonymous data sets
  • Slide 6
  • Categorical Exemptions Under the Regulations Categorical Exemptions Under the Regulations Exempt Studies Exempt Studies 45CFR 46.101(b) 45CFR 46.101(b)
  • Slide 7
  • Studies are Exempt Unless Human subjects can be identified AND Disclosure could place the subject at risk
  • Slide 8
  • Risks Physical Risks Physical Risks Other Risks Other Risks Criminal / civil liability Damaging to financial standing, employability, or reputation
  • Slide 9
  • Very Important Point Unless otherwise required Exemption applies to research activities in which the ONLY involvement of human subjects will be in one or more of the following categories Unless otherwise required Exemption applies to research activities in which the ONLY involvement of human subjects will be in one or more of the following categories
  • Slide 10
  • 45 CFR 46.101 (b) (1) Research conducted in established educational settings Research conducted in established educational settings Involving normal educational practices Involving normal educational practices Regular/special ed strategies Effectiveness of / comparison among instructional techniques, curricula, classroom management methods
  • Slide 11
  • 45 CFR 46.101 (b) (2) Research involving use of educational tests Research involving use of educational tests Research using survey procedures, interview procedures, observation of public behavior Research using survey procedures, interview procedures, observation of public behavior Except: Except: If subjects can be identified directly or through identifiers linked to subjects AND Disclosure of responses could place subjects at risk (i.e. civil or criminal liability, financial standing, etc.) If subjects are children there are limitations on the research
  • Slide 12
  • 45 CFR 46.101 (b) (3) Educational tests, survey / interview procedures, observation of public behavior not covered in #2 if : Educational tests, survey / interview procedures, observation of public behavior not covered in #2 if : Subjects are elected or appointed public officials Subjects are elected or appointed public officials Federal statues require without exception that the confidentiality of information will be maintained throughout the research and thereafter Federal statues require without exception that the confidentiality of information will be maintained throughout the research and thereafter
  • Slide 13
  • 45 CFR 46.101 (b) (4) Collection or study of EXISTING data, documents, records, specimens (diagnostic/pathological) Collection or study of EXISTING data, documents, records, specimens (diagnostic/pathological) If sources are publicly available If sources are publicly available If data will be recorded so that subjects cannot be identified either directly or through identifiers linked to subjects If data will be recorded so that subjects cannot be identified either directly or through identifiers linked to subjects
  • Slide 14
  • Clarification :Existing Data Data must exist prior to the IRB submission Does not apply to studies where data or specimens will be collected in the future
  • Slide 15
  • Subjects Can Not Be Identified Data collection sheets must use unique identifiers and there can be NO MASTER CODE list that links those identifiers back to the subjects Data collection sheets must use unique identifiers and there can be NO MASTER CODE list that links those identifiers back to the subjects Application must include information regarding Application must include information regarding how the data will be collected If there are any links to subjects Copies of the data collection tools
  • Slide 16
  • 45 CFR 46.101 (b) (5) Research and demonstration projects Research and demonstration projects Conducted by/Approval of governmental department heads which are designed to evaluate/ examine Conducted by/Approval of governmental department heads which are designed to evaluate/ examine Public benefit or service programs Procedures for obtaining benefits/services Changes/ alternatives Methods of payment
  • Slide 17
  • 45 CFR 46.101 (b) (6) Taste and food quality evaluation Taste and food quality evaluation Consumer acceptance Consumer acceptance Wholesome foods Without additives Safe by FDA Approved by EPA
  • Slide 18
  • Which Categories Most Frequently Apply to BU Researchers? Anonymous surveys (Category 2) Anonymous surveys (Category 2) Interviews (Category 2) Interviews (Category 2) Research Use of Existing Data (Category 4) Research Use of Existing Data (Category 4) Databases Chart reviews Specimens
  • Slide 19
  • Exemptions do NOT apply to: Research involving Research involving Pregnant women Fetuses Human in-vitro fertilization Prisoners Survey/interview exemption Survey/interview exemption Does not apply to children Observation of public behavior Observation of public behavior Does not apply to research with children (except when investigator does not participate)
  • Slide 20
  • Review Process for Exempt Exempt proposal reviewed by IRB Administrative Staff Exempt proposal reviewed by IRB Administrative Staff Determination of Exemption Determination of Exemption Exempt letter generated Exempt letter generated No further review by IRB needed unless a change is made to the protocol No further review by IRB needed unless a change is made to the protocol Administrative oversight-ensure research remains within the bounds of the Exempt category- if anything changes must be resubmitted for new Exempt determination Administrative oversight-ensure research remains within the bounds of the Exempt category- if anything changes must be resubmitted for new Exempt determination
  • Slide 21
  • Process Investigator presents the research to the IRB via Exempt application Investigator presents the research to the IRB via Exempt application Presentation includes clear documentation of how the study meets the Exempt criteria or does NOT meet the definition of human subjects research Presentation includes clear documentation of how the study meets the Exempt criteria or does NOT meet the definition of human subjects research IRB office makes the determination of Exempt IRB office makes the determination of Exempt IRB generates Exempt letter IRB generates Exempt letter Annual Review not required- no expiration date Annual Review not required- no expiration date Changes must be submitted to IRB Changes must be submitted to IRB
  • Slide 22
  • Application for Exempt Studies Simplified application Submissions still must be signed by the department Chair or Faculty Advisor Student research must be signed off by faculty advisor- faculty advisor must be listed as a co- investigator Human subjects protection training for all investigators is required
  • Slide 23
  • HIPAA Be aware that HIPAA regulations could apply (i.e. if study involves medical record review) for exempt research Be aware that HIPAA regulations could apply (i.e. if study involves medical record review) for exempt research www.bumc.bu.edu/hipaa www.bumc.bu.edu/hipaa Many will require a HIPAA Waiver of Authorization Many will require a HIPAA Waiver of Authorization No HIPAA Authorizations (because research is anonymous) No HIPAA Authorizations (because research is anonymous) Contact CRC IRB office with HIPAA questions Contact CRC IRB office with HIPAA questions
  • Slide 24

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