Changes in the Common Rule The Final Rule

Changes in the Common Rule: The Final Rule Presented by Office of Research Compliance (ORC) Jeffrey Lenz January 28, 2019

Protecting the fundamental rights of human subjects • All subjects are entitled to fundamental rights and protections at all times during a research process • This protection is the responsibility of researchers, the institution, and the Institutional Review Board • All human subjects research is subject to Federal Law, University Policy, and ethical principles 2

The Common Rule: 45 CFR Part 46 • The Common Rule uses the Belmont Principles to protect human research subjects • Subpart A: the common rule adopted by over 15 separate Federal Departments/ Agencies • Defines Human Subjects Research, Exempt, and Expedited Categories and the concept of minimal risk • Defines an Institutional Review Board and how it serves to protect human subjects • Sets requirements for Informed Consent • Subpart B: Additional Protections for Pregnant Woman, Fetuses, and Neonates • Subpart C: Additional Protections of Prisoners • Subpart D: Additional Protections of Children • The full Common Rule can be found in the Department of Health and Human Service's Office of Human Research Protections website: https: //www. hhs. gov/ohrp/regulations-and-policy/regulations/45 -cfr-46/index. html 3

Updates to the New Common Rule • Initial New Common Rule (the Final Rule) has gone into effect on Jan. 21 st 2019 • The latest official release from the Office for Human Research Projections (OHRP) established this new Jan. 2019 effective date and currently releasing continuing guidance and resources for upcoming changes. 4

Rowan IRB specific changes New IRB Policies and Procedures changing include: 1. Updated Exempt Review Categories 2. Progress Reports 3. Close out of studies in data analysis only 5

New Exempt Categories • Studies qualifying for exempt review category are now changed to eight categories as opposed to six categories in the old Common Rule. Some of these new categories may require limited IRB review and/or the use of new boilerplate consent. • The Rowan IRB has deemed that some of these exempt categories will require being elevated to expedited review. These include Exempt categories 2 -iii, 3 -(C)-iii, 4 -iii, 7 and 8.

New Exempt Category 2: Research that includes interactions involving educations tests, surveys, interviews, or public behavior observations and meets one of the following: • 2(i): information obtained is recorded such that identity of human subjects cannot readily be ascertained directly or through identifiers • 2(ii): Any disclosure of subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or damage financial standing, employability, education advancement, or reputation • 2(iii): information obtained is recorded such that identity CAN be ascertained directly or through identifiers. This will require a limited IRB review. The Rowan IRB will elevate this subcategory to an Expedited Review.

New Exempt Category 3 • 3(i) Research involving benign behavioral interventions in conjunction with collection of information from an adult subject through verbal, written responses, or audiovisual recording if the subject prospectively agrees and one of the following criteria is met: • 3 (i-A) Information is recorded such that identity of subjects cannot be ascertained directly or through identifiers • 3 (i-B) Any disclosure of subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or damage financial standing, employability, education advancement, or reputation • 3 (i-C) information obtained is recorded such that identity CAN be ascertained directly or through identifiers. This will require a limited IRB review. The Rowan IRB will elevate this subcategory to an Expedited Review.

New Exempt Category 3 • 3 (ii): Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have significant adverse lasting impact on subjects, and investigators have no reason to think subjects will not find interventions offensive or embarrassing. (examples including online game, solve puzzles, allocate nominal values of cash between themselves and others). • 3 (iii): If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorized the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that they will be unware of or misled regarding the nature/ purposes of the research. The Rowan IRB will elevate this subcategory to an Expedited Review.

New Exempt Category 4 • Category 4: Secondary research in which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: • 4(i): The identifiable private information or identifiable biospecimens are publicly available • 4(ii): Information, including about biospecimens, is recorded such that identity of human subjects cannot readily be ascertained directly or through linked identifiers, investigator does not contact subjects, and will not re-identify subjects • 4(iii): Research involves only information collection and analysis of investigator’s use of identifiable health information when that use is regulated under HIPAA regulations for healthcare operations or research as defined by HIPAA regulations. The Rowan IRB will elevate this subcategory to an Expedited Review under the jurisdiction of Medical IRB at Stratford. • 4(v): Research conduced by or on behalf of Federal department/agency using governmentgenerated or collected information for nonresearch activities, if the research generates identifiable private information, it is subject to E-Government Act of 2002, Privacy Act of 1974, and Paperwork Reduction Act of 1995 if applicable.

New Exempt Category 7 • Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review. The Rowan IRB will elevate this Category to an Expedited Review (May require Stratford IRB review)

New Exempt Category 8 • Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use if the following criteria are met: • 8(i): 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 Informed Consent requirements • 8(ii): Documentation of informed consent or waiver of documentation of consent was obtained • 8(iii): An IRB conducts a limited review and makes a determination that research is conducted within the scope of the broad consent • 8(iv): The investigator does not include returning individual results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirement to return individual results. The Rowan IRB will elevate this Category to an Expedited Review (may be reviewed by Stratford IRB)

Progress Reports • The IRB will make a determination, based largely on the expedited category, if the study can use the simplified Progress Report as the annual report to IRB • Progress reports will consist of an abbreviated list of basic questions about the study and will quickly be reviewed administratively by the IRB office • This will reduce the burden and review time, benefiting both researchers and the IRB 13

Progress Report Requirements • Progress reports will consist of a simple form that will allow you to provide summary information and allow for re-approval of the study for another year. • A determination will be made by the IRB reviewer as to whether or not your study will require a Progress Report or the currently used Continuing Review during the annual re-review process • Continuing Reviews will remained unchanged • The main requirements to qualify for Progress Reports are: • Minimal Risk Studies • No collection of Private Health Information (PHI) • Exempt Level studies still will not require any annual reports • All studies will need to be closed out via the Final Report when the study has been completed 14

Does your study require a Progress Report or Continuing Review 15

Progress Report Process 16

Progress Report e. IRB Page 17

Progress Report Form 18

Close out for studies in Data Analysis • New Regulations now allow for studies to be closed out if no new subjects will be recruited and all data collection of current subjects has been completed • This allows Expedited studies to be closed out if only Data Analysis is ongoing • Use the same Final Report option to officially close out study • *Note *if you wish to collect more subjects/ data after closing out study you must receive NEW IRB approval 19

Frequent e. IRB submission errors/omissions • Section 4. 0 Select “Yes. ” Study is funded. • In section 4. 1 indicate Department Funded if research is not funded by grant • Section 7. 0 Protocol subsection 3. 1 Duration of study. This section requires both anticipated length of entire study and individual time anticipated single subject to complete study (survey/ interview lengths etc. ) • Section 7. 0 All uploaded Protocol, Instruments, Consent forms require a version number and version date in the footer of each page. • Rowan letterhead/logo are also preferred on the top of the first page of each document. • Section 13. 2 Expedited 6 Reviews missing the required Audio/Video Addendum to the consent form • Section 12. 2: Is Principal Investigator the data steward (data must be stored at Rowan even if PI is not data steward) • If you plan on using an online survey note that Rowan policy requires you use Qualtrics to administer if your subjects are Rowan/CMSRU students or staff • Be sure to upload a link of any/all completed surveys for IRB approval (Protocol section 3. ) 25

Quick e. IRB submission tips 26

Q&A 27

Contact us! Office of Research Compliance Pat Gessner 856 -566 -2712 gessnepm@rowan. edu 28