• Share
  • Email
  • Embed
  • Like
  • Save
  • Private Content
OHRP Regulatory Interpretations That You Need To Know But Have Never Been Told
 

OHRP Regulatory Interpretations That You Need To Know But Have Never Been Told

on

  • 281 views

The Health and Human Services (HHS) human subjects regulations aren't always clear-cut and often times Institutional Review Boards (IRBs) and researchers struggle with how to interpret them. During ...

The Health and Human Services (HHS) human subjects regulations aren't always clear-cut and often times Institutional Review Boards (IRBs) and researchers struggle with how to interpret them. During this webinar, the presenters will share the knowledge Huron has gained through communications with the Office for Human Research Protections (OHRP) about topics such as: How to handle "protocol exceptions for a single subject", When an unanticipated problem involving risks to subjects or others does not have to be reported to OHRP, Whether the IRB has to require the submission of the names of all study staff on a research study, and When Subpart C does not apply to a subject who becomes incarcerated.

Statistics

Views

Total Views
281
Views on SlideShare
281
Embed Views
0

Actions

Likes
0
Downloads
0
Comments
0

0 Embeds 0

No embeds

Accessibility

Categories

Upload Details

Uploaded via as Adobe PDF

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…

Comments are closed.

Edit your comment

    OHRP Regulatory Interpretations That You Need To Know But Have Never Been Told OHRP Regulatory Interpretations That You Need To Know But Have Never Been Told Presentation Transcript

    • Clinical Research Management Webinar Series:OHRP RegulatoryInterpretations That You Need To KnowBut Have Never Been ToldWednesday, November 14, 201212:00 p.m. - 1:00 p.m. CT
    • About Our Speakers Madeleine Williams, MA, CIP Director, Huron Life Sciences P 312. 479. 3374 mwilliams@huronconsultinggroup.com Maddie has over 10 years of research experience and assists clients with research biorepository design and development, institutional review board (IRB) assessments and operational support, regulatory compliance evaluations, and human research protection program evaluation and accreditation. Frank Conte, MS Manager, Huron Life Sciences P 312. 404. 6413 fconte@huronconsultinggroup.com Frank has more than 10 years of project management experience in higher education and research compliance. He focuses on assisting higher education and healthcare organizations with operational analysis, regulatory compliance evaluations, process improvement and software design and implementation.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 2
    • Agenda Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners In today’s session, we plan to discuss topics including: • Exempt Determinations • Category 1 • Category 4 • Expedited Review • Category 8b • Institutional Engagement • Modifications to Previously Approved Research • Changes in Study Personnel • Single Subject Exceptions • Research Involving Prisoners as Subjects • HIPAA • Unanticipated Problems Involving Risks to Subjects or Others • IRB Record Retention© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 3
    • Disclaimer The information in this webinar is representative of Huron’s experience and correspondence with OHRP and should not be interpreted as official guidance. We encourage the audience to contact OHRP for feedback on specific questions.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 4
    • Current Environment OfHuman Research Protections
    • Human Subjects Protections Current Environment • Lots of Regulations • 45 CFR 46 (Department of Health & Human Services) • 21 CFR 50 and 56 (Food and Drug Administration) • 45 CFR 164.512 (HIPAA) • Interpretation of regulations can be confusing; guidance documents are helpful . • Best Practices • Association for the Accreditation of Human Research Protection Programs (AAHRPP) • Huron HRPP Toolkit© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 6
    • Scenarios for Discussion and Interpretations
    • Exempt Determinations - Category 1 Modifications Research Expedited Unanticipate Record Exemptions Engagement to Approved Involving HIPAA Review d Problems Retention Research Prisoners  45 CFR 46.101 (b)(1) states: • (b) 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: (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 8
    • Exempt Determinations - Category 1 Modifications Research Expedited Unanticipate Record Exemptions Engagement to Approved Involving HIPAA Review d Problems Retention Research Prisoners Scenarios: A. Does “involving normal educational practices” to refer to: (1) The procedures involved in the research are normal educational practices; (2) The purpose of the research involves normal educational practices; or (3) Both B. Suppose a standard practice in a high school current events class is to have a teacher-led group discussion about how current events affect US society by having a discussion of how the news of the day has personally affected them and their families. An investigator/teacher wants to conduct research by facilitating the class discussion. 1. If the purpose of the research was to improve methods of classroom discussion, would this be exempt under #1? 2. If the purpose of the research was to understand high school student responses to current events, would this be exempt under #1?© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 9
    • Exempt Determinations - Category 1 Modifications Research Expedited Unanticipate Record Exemptions Engagement to Approved Involving HIPAA Review d Problems Retention Research PrisonersInterpretations: Scenario A - In order to qualify for exemption under §46.101 (b) (1), the study would need to fit BOTH: - The procedures involved in the research are normal educational practices AND - The purpose of the research involves normal educational practices Scenario B • #1 qualifies for exemption under §46.101 (b) (1), because the research is conducted in an established or commonly accepted setting and the research involves a normal educational practice • #2 may be exempt but it would depend on why the investigator wants to understand high school students’ responses to current events; if it is because the investigator is trying to better understand the education of high school students, it could be considered exempt under §46.101 (b) (1)Email correspondence dated April 2010© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 10
    • Exempt Determinations - Category 4 Modifications Research Expedited Unanticipate Record Exemptions Engagement to Approved Involving HIPAA Review d Problems Retention Research Prisoners  45 CFR 46.101 (b)(4) states: • 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.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 11
    • Exempt Determinations - Category 4 Modifications Research Expedited Unanticipate Record Exemptions Engagement to Approved Involving HIPAA Review d Problems Retention Research PrisonersScenario:An investigator does the following: 1. Creates a data collection form-this is constructed such that the identity of the subject cannot readily be ascertained by the investigator or associated with the recoded information. (e.g., the investigator wants to see if there is a relationship between length of stay for laparoscopic surgery and age, so the data collection form records age and length of stay. The data collection form contains no other information.) 2. Creates a list of medical record numbers-runs a search to get a list of MRNs of subjects/potential subjects. This list is separate from the data collection form. 3. Picks a medical record number and get the corresponding medical chart. 4. Checks the chart to see if the individual meets inclusion criteria. If so, complete the data collection form. 5. Marks the medical record number on the list as complete. 6. Repeats steps #1-#3 until done and then analyzes the data. © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 12
    • Exempt Determinations - Category 4 Polling Question Modifications Research Expedited Unanticipate Record Exemptions Engagement to Approved Involving HIPAA Review d Problems Retention Research Prisoners Polling Question: Is the described process acceptable for exempt #4 under 45 CFR 46? A. Yes B. No C. Not Sure© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 13
    • Exempt Review - Category 4 Modifications Research Expedited Unanticipate Record Exemptions Engagement to Approved Involving HIPAA Review d Problems Retention Research Prisoners Interpretation:  Yes-the described process is consistent with OHRP’s interpretation of exemption 4.  Exemption 4 applies even if an investigator records a list of identifiable information (e.g. medical record numbers) for the purpose of linking this list with other records, provided that: (1) the investigator does not include any private information such as medical information on this list of identifiers; and (2) does not record identifiers once the data for the study have been obtained and the analyses begin.  Note: VA has issued guidance in July 2011 that does not allow exemption 4 to be applied to such activities.Email correspondence dated August 2011© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 14
    • Expedited Review - Category 5 Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners  Expedited category 5 states: 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). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.) Scenario:  Can this category be interpreted to encompass: • Research involving materials (data, documents, records, or specimens) that have been collected (for any reasons either for research or for non-research purposes) OR • Research involving materials (data, documents, records, or specimens) that will be collected solely for non-research purposes?© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 15
    • Expedited Review - Category 5 Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners Interpretation:  In 2007 OHRP proposed to amend expedited review category 5 to clarify that the category includes • Research involving materials that were previously collected for either non-research or research purposes, provided that any materials collected for research were not collected for the currently proposed research, OR • Research involving materials that will be collected solely for non-research purposes.  http://www.hhs.gov/ohrp/archive/requests/com102607.htmlEmail correspondence dated August 2012© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 16
    • Expedited Review - Category 8b Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners  Expedited category 8 states: (8) Continuing review of research previously approved by the convened IRB as follows: (a) 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 active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 17
    • Expedited Review - Category 8b Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners Scenario: • A study is initially reviewed and approved by the convened IRB on 1/6/12. • A new risk is identified by the investigator and reviewed by the convened IRB on 6/25/12 where the IRB approves a modification. • The research then comes up for continuing review on 12/10/12. If no subjects have been enrolled at the site since initial review and no additional risks have been identified (at any site) since the convened IRB review on 6/25/12, can the study undergo continuing review via expedited review under category 8b?© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 18
    • Expedited Review - Category 8b Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners Interpretation:  Yes, the IRB could review the research at the time of continuing review under an expedited review procedure • Since there are no additional risks since the last IRB review (the modification on 6/25/12), it would be considered to have “no additional risks identified” and could be reviewed via expedited procedures.Email correspondence dated August 2010© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 19
    • Guidance on Engagement of Institutions in Human Subjects Research Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners Scenario: Dr. Smith at institution A asks individuals at institutions X, Y, and Z to release private identifiable information to institution A for Dr. Smith’s HHS supported research. The individuals at institutions X, Y, and Z will review medical records, fill out case report forms with information extracted from the medical records, and submit them to Dr. Smith. • None of the data being abstracted from the medical records was obtained for research purposes and the individuals would normally have access to these records. • Individuals at institutions X, Y, and Z will not interact or intervene with subjects and will not be involved in the analysis of private identifiable data. • Institutions X, Y, and Z are not awardees through a grant, contract, or cooperative agreement directly from HHS. • Institutions X, Y, and Z have ensured that institutional requirements have been satisfied as well as compliance with other applicable regulations and laws (e.g., HIPAA.)© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 20
    • Guidance on Engagement of Institutions in Human Subjects Research Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners Questions: 1. Are institutions X, Y, and Z engaged in the research? 2. The protocol says that institutions X, Y, and Z are “sites” and that the individuals providing data to Dr. Smith are “co-investigators.” Does this change the engagement determination? 3. Dr. Smith says that the individuals at institutions X, Y, and Z will be co-authors on the paper. Does this change the engagement determination? 4. Dr. Smith will pay institutions X, Y, and Z to reimburse for the work of extracting the medical records. Does this change the engagement determination?© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 21
    • Guidance on Engagement of Institutions in Human Subjects Research Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners Interpretation:  Institutions X, Y, and Z are NOT engaged in the research, regardless of whether the collaborating employees at institutions X, Y, and Z are listed as co-investigators, will be co-authors on publications related to the research, or will be reimbursed for extracting medical record data.  The OHRP guidance on engagement states that if an institution releases private identifiable data to an investigator conducting research outside the institution, the institution is not engaged in research.  The person gathering the data for release needs to have legitimate access to the data. • If the individuals at institutions X, Y, and Z did not normally have access to the subjects’ medical records and were accessing them for the purposes of the research, then those individuals would be doing more than just releasing identifiable private information to institution A – they would also be obtaining identifiable private information for research purposes and, thus, institutions X, Y, and Z would be engaged in the research.Email correspondence dated August 2010© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 22
    • Single Subject Exceptions Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Research Problems Retention Prisoners A common activity in a clinical trial are “protocol exceptions” or “single subject exceptions.” An exception is when an individual is otherwise eligible for participation in a protocol but does not meet an inclusion or exclusion criterion or is eligible but one or more procedures cannot be conducted as specified in the protocol. The investigator contacts the sponsor and asks to follow a variation on the protocol for one subject. The sponsor provides permission provided the IRB approves the plan. Examples of exceptions include: • The protocol specifies that a patient must have a creatinine (kidney function measure) level of <=1.0. As individual is otherwise eligible for the trial except for a creatinine level of 1.1. The investigator contacts the sponsor and asks for permission to enroll the subject because the difference between a creatinine of 1.0 and 1.1 is not clinically significant. • The protocol specifies that subjects will not be paid for participation nor provided any reimbursement. The investigator finds an individual who qualifies for the research except that the subject has insufficient funds for taxi fare to and from the hospital for clinic visits. The investigator contacts the sponsor and asks for permission to enroll the subject and reimburse for transportation costs.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 23
    • Single Subject Exceptions Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Research Problems Retention Prisoners  45 CFR 46.103 (b)(4) states: • (b) Departments and agencies will conduct or support research covered by this policy only if the institution has an assurance approved as provided in this section, and only if the institution has certified to the Department or Agency head that the research has been reviewed and approved by an IRB provided for in the assurance, and will be subject to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall at a minimum include: – (4) Written procedures which the IRB will follow… (iii) for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 24
    • Single Subject Exceptions Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Research Problems Retention Prisoners Questions: 1. Are these exceptions “proposed changes in a research activity”? 2. If these exceptions are not “proposed changes in a research activity”, what procedures, if any, does the IRB need in place to grant permission for these exceptions before they are initiated by the investigator? 3. If these exceptions are “proposed changes in a research activity”, can the IRB approve these proposed changes in a research activity by any mechanism other than review by the convened IRB or, if eligible for review using the expedited procedure, review by the IRB chair or one or more experienced IRB members designated by the IRB chair?© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 25
    • Single Subject Exceptions Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Research Problems Retention Prisoners Interpretation:  OHRP would consider such circumstances to be changes to the protocol which would require prior IRB review and approval unless necessary to eliminate apparent immediate hazards to subjects  It would be reasonable to review these in an expedited manner by the IRB chair or one or more experienced IRB members designated by the IRB chairEmail correspondence dated July 2011© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 26
    • Changing Study Personnel Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Research Problems Retention Prisoners  In many IRB offices, a huge effort goes into tracking the specific study personnel assigned to a research protocol. For example: • In cancer centers where there is a large pool of coordinators who cross cover many protocols. When a new coordinator is hired, the PI is submitting dozens (or more) modifications to add that coordinator to all possible protocols in which the coordinator might be involved.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 27
    • Changing Study Personnel Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Research Problems Retention Prisoners Scenario:  Can an IRB approve a protocol that describes the qualifications of personnel and the minimal complement of personnel, without knowing the specific names of the study personnel, and then allow the principal investigator to change study personnel provided the qualifications are met? • A protocol submitted to the IRB indicates that the investigator will have the following study personnel: – One or more coordinators who are RNs and CITI trained who will perform specific study procedures and be involved in the consent process. – A licensed pharmacist who will dispense study drug. – One or more physician sub-investigators who will be licensed by the state, credentialed by the hospital, trained on the study protocol and CITI trained. These individuals will work under the supervision of the principal investigator.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 28
    • Changing Study Personnel Polling Question Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Research Problems Retention Prisoners Polling Question: Can the IRB approve a protocol without knowing the specific names of the study personnel, provided that the protocol indicates specific criteria for selecting study team members? A) Yes B) No C) Not sure© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 29
    • Changing IRB Personnel Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Research Problems Retention Prisoners Interpretation:  It is reasonable for the IRB to approve a protocol without knowing specific names of research personnel, provided that the proposal includes detailed criteria for selecting research personnel • Any changes to the proposed criteria would involve a modification to the approved research, and would need to be reviewed and approved by the IRB.Email correspondence dated January 2012© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 30
    • Research Involving Prisoners as Subjects Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners  OHRP Guidance states: • Upon receipt of the investigators report that a previously enrolled research subject has become a prisoner, if the investigator wishes to have the prisoner subject continue to participate in the research, the IRB must promptly re-review the proposal in accordance with the requirements of subpart C, and the institution(s) engaged in the research involving the prisoner subject must send a certification to OHRP and wait for a letter of authorization in reply. Otherwise, the prisoner subject must stop participating in the research, except as noted below…© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 31
    • Research Involving Prisoners as Subjects Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners Scenarios: A. An investigator discovers on a follow-up visit that a participant was incarcerated for two weeks, but at the time of the follow-up visit is no longer incarcerated. The investigator had no knowledge that the participant was incarcerated at the time of incarceration, and performed no interventions, interactions, or gathering of private identifiable information during the time of incarceration. Does Subpart C apply at the time of the follow-up visit? B. An investigator attempts to reach out to a subject via phone at the time of his scheduled follow-up visit and finds out that the subject is now incarcerated. The investigator wants to keep the subject enrolled in the study. No private identifiable information is collected while the subject is incarcerated and the investigator makes a note in the file to follow up with the subject again when he is released. Does Subpart C apply?© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 32
    • Research Involving Prisoners as Subjects Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners Interpretation:  In both scenarios Subpart C would not apply • If there is no interaction or intervention with, or collection of private identifiable information about the incarcerated subject, the research would not involve prisoners as subjects  Subpart C would not apply if all non-exempt human subjects research activities associated with this subject were suspended until the subject is no longer a prisoner.Email correspondence dated November 2011© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 33
    • IRB Review of HIPAA Authorizations Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners  NIH Guidance indicates: • The HHS Protection of Human Subjects Regulations do not expressly require that Privacy Rule Authorizations be reviewed or approved by the IRB. However, under HHS regulations at 45 CFR 46.117(a) and FDA regulations at 21 CFR 50.27(a), IRB review and approval is required for any document that contains the IRB-approved informed consent document for human subjects research. Therefore, if the Authorization language is part of the IRB- approved informed consent document, such as when the Authorization form is combined with an informed consent, the IRB is required to review such language.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 34
    • IRB Review of HIPAA Authorizations Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners Scenario:  Institutional policy indicates to have the IRB review a consent document, the privacy officer review and approve a HIPAA authorization (but no IRB review of the authorization language), and after the investigator goes over both and obtains consent for the research and authorization for use and disclosure of PHI, ask the subject to sign a single signature block (indicating that their signature provides consent to both documents) Question:  Does the IRB have to review and approve the authorization language if the consent document and HIPAA authorization are independent documents except for having a single common signature block?© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 35
    • IRB Review of HIPAA Authorizations Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners Interpretation:  FDA has informally indicated that it would not consider the HIPAA Authorization document to be a stand-alone document if a joint signature page/block is used for both a research consent document and a HIPAA Authorization document.  The IRB should review and approve the HIPAA authorization language if the consent document and HIPAA authorization have a single common signature block.  Alternatively, separate signature blocks could be used for both documents, in which case the IRB would not have to review and approve the HIPAA authorization language.Email correspondence dated February 2010© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 36
    • Reporting of Unanticipated Problems Involving Risks to Subjects or Others Modifications to Research Expedited Unanticipated Record Exemptions Engagement Approved Involving HIPAA Review Research Problems Retention Prisoners  45 CFR 46.103 (b)(5) states: • (b) Departments and agencies will conduct or support research covered by this policy only if the institution has an assurance approved as provided in this section, and only if the institution has certified to the Department or Agency head that the research has been reviewed and approved by an IRB provided for in the assurance, and will be subject to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall at a minimum include: – (5) Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and (ii) any suspension or termination of IRB approval.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 37
    • Reporting of Unanticipated Problems Involving Risks to Subjects or Others Modifications to Research Expedited Unanticipated Record Exemptions Engagement Approved Involving HIPAA Review Research Problems Retention Prisoners Scenario:  A new risk is identified for a federally funded multi-site study. The sponsor modifies the protocol and informed consent form to add this new risk. A participating site receives the protocol and informed consent modification and submits it to their IRB for review. In the process of reviewing the modification, the IRB also determines that this is an unanticipated problem involving risk to subjects or others because a new risk that was unexpected and related to the research was identified.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 38
    • Reporting of Unanticipated Problems Involving Risk to Subjects or Others – Polling Question Modifications to Research Expedited Unanticipated Record Exemptions Engagement Approved Involving HIPAA Review Research Problems Retention Prisoners Polling Question: Who does the IRB need to report this unanticipated problem involving risk to subjects or others to? A. OHRP B. Institutional Official (IO) C. Both OHRP and the IO D. None of the above© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 39
    • Reporting of Unanticipated Problems Involving Risk to Subjects or Others Modifications to Research Expedited Unanticipated Record Exemptions Engagement Approved Involving HIPAA Review Research Problems Retention Prisoners Interpretation:  For multicenter research projects, only the institution at which the subject(s) experienced an event determined to be an unanticipated problem must report the event to the supporting agency head (or designee) and OHRP (45 CFR 46.103(b)(5)). • Alternatively, the central monitoring entity may be designated to submit reports of unanticipated problems to the supporting agency head (or designee) and OHRP.  In the scenario, the participating site would be responsible for reporting the unanticipated problem involving risks to subjects or others to the institutional official. Reporting to OHRP would not be required as there was no local event that was determined to be an unanticipated problem.Email correspondence dated July 2010© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 40
    • Retention of IRB Records Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners  45 CFR 46.115 states: • (b) The records required by this policy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. Scenario:  An IRB reviews a study that is being conducted by the sponsor at 25 sites. The local investigator enrolls one subject and the investigator closes the study after the one subject completes all protocol required interactions, interventions, and collection and analysis of private identifiable data. Three years later, can the IRB dispose of its protocol records or does the three years start when all 25 sites no longer have activities that involve human subjects?© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 41
    • Retention of IRB Records Modifications Research Expedited Unanticipated Record Exemptions Engagement to Approved Involving HIPAA Review Problems Retention Research Prisoners Interpretation:  The requirement for retention of IRB records for at least three years after research is completed is institution-specific; that is, each institution must retain its records for three years following the completion of the research study at that institution. • In the case when an institution is part of a multi-site clinical trial, the institution must retain records for three years after the subjects’ participation at that institution has ended, even if the clinical trial continued after that time at some other institutions. • In the case when a research study is transferred from the original institution to a second institution, the original institution must only retain records for three years following the date of the transfer.Email correspondence dated April 2010© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 42
    • Questions?
    • Thank You! Madeleine Williams, MA, CIP Director, Huron Life Sciences P 312. 479. 3374 mwilliams@huronconsultinggroup.com Frank Conte, MS Manager, Huron Life Sciences P 312. 404. 6413 fconte@huronconsultinggroup.com Visit us online, and download the Huron HRPP Toolkit: besthrppsops.com Also stop by the Huron/Click booth at PRIM&R in December!© 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 44