The IRB X Review Process: Exempt Reviews Elaine Stashinko, Ph.D., RN IRB 6 Board Member IRB X Exempt Reviewer IRB Open House– May 11, 2018

Three Human Subjects Research (HSR) review type categories Exempt: Includes some research done in educational settings, observations of public behavior, surveys, most retrospective chart reviews, use of publically available data, or taste and food quality evaluation. This category does not apply to FDA regulated research. Expedited: The project must be judged by the IRB to be minimal risk and on the list published in the federal regulations. Research falling in the expedited category may be reviewed by one member of the IRB and does not require review at a convened meeting. Convened: Research involving more than minimal risk and/or research that includes vulnerable populations. Research can be categorized as HSR or NHSR.

Not Human Subjects Research NHSR and QA/QI NHSR if research does not involve identifiable human subjects. • No contact with human subjects is involved for the proposed activity. • Data and/or specimens have been collected for another purpose (routine collection of individual patient data for clinical purposes). • No extra data or specimens are being collected for project purposes. • Identifying information is removed prior to receipt, so that data cannot be linked or re-linked with identifiable humans subjects. When publish, need to identify as QI project because not consent for prospective research; Department director letter required

Not Human Subjects Research NHSR and QA/QI Quality Improvement / Quality Assurance (QI/QA): Data collection and analysis activities in the health services area that are not intended to generate scientific knowledge, but rather are used as a management tool to improve the provision of services to a specific health care population.  Aim is improvement in patient safety or quality of care to this target population. When publish, need to identify as QI project because not consent for prospective research; Department director letter required

Not Human Subjects Research NHSR and QA/QI NHSR/QI applications do not require IRB review. NHSR/QI applications may be submitted for IRB review and acknowledgement Per ICMJE journal submission requirement Per Grant/Sponsor requirement (e.g. MSCRF) When publish, need to identify as QI project because not consent for prospective research; Department director letter required

Exempt and Expedited Review for Human Subject Research Most Exempt, Expedited and NHSR applications are reviewed by IRB X

2018 Common Rule The Final Common rule has been delayed [in its effective date and compliance date] to July 19, 2018. There is also indication that there will be an effort to set forth a new rule for public comment to request a longer delay [until January 2019].

Exempt Research The project is minimal risk and falls into 1 of the 6 specified exempt categories. The exempt category does not apply to most FDA regulated research 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.

Exempt Research The project is minimal risk and falls into 1 of the 6 specified exempt categories. The exempt category does not apply to most FDA regulated research Research involving use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) The information recorded may allow the subjects to be identified, directly or through identifiers linked to the subjects; and  (ii) Disclosures of the subjects’ responses could place the subject at risk of criminal or civil liability; or be damaging to the subjects reputation, employability, or financial standing.

Exempt Research The project is minimal risk and falls into 1 of the 6 specified exempt categories. The exempt category does not apply to most FDA regulated research 3. Research involving use of educational tests, survey procedures, interview procedures or observation of public behavior not exempt under #2 above if: The human subject is a public official or candidate for office Federal statute mandates confidentiality of the PHI

Exempt Research cont’d 4. Research involving 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 PI without identifiers. * Existing at the time of JHMeIRB submission.

Exempt Research cont’d 5. Research and demonstration projects conducted by or subject to the approval of government department or agency heads, and which are designed to study: Public behavior or service programs Procedures for obtaining benefits or services under these programs Possible changes in or alternatives to the programs Possible changes in methods or levels of payment for benefits or services under the programs 6. Taste and food quality evaluation and consumer acceptance studies

Expedited Research The project may not pose any more than minimal risk to subjects AND must be on the list of DHHS and FDA categories Drug studies not requiring an IND or device studies not requiring an IDE (approved products for approved uses) Collection of blood (small amounts – for healthy adults, 550ml per 8-wk period) Non-invasive prospective collection of biological samples (hair, saliva, nail clippings, etc.) Collection of data through non-invasive procedures (weighing, MRI, etc.) Using materials (records, specimens) collected for non-research purposes (e.g., diagnosis or treatment) Collection of data from voice, video, digital or image recordings made for research purposes Research on individual or group characteristics or behavior, or research using surveys, interviews, etc. that does not qualify as exempt Continuing review when research remains open for long-term follow-up or data analysis Continuing Review of research where (1)-(8) don’t apply and IRB determines it is minimal risk with no additional risks identified

Exempt and Expedited Review Please keep in mind that “exempt” does not mean “exempt” from IRB review. Please keep in mind “expedited” does not mean “fast.”

Exempt or Expedited Review? NHSR or exempt with investigational devices (e.g. assays) that require FDA oversight require Board review to determine if NSR (expedited or convened). Surveys or personal interviews (exempt) Focus groups or interviews with children, patients or sensitive data (expedited)

Exempt or Expedited Review? Retrospective record review If not recording any HIPAA identifiers and not maintaning a link to re-identify the participants (exempt category 4) If recording any HIPAA identifiers (i.e. date of surgery) or recording a link to re-identify the participants (expedited). Request a data variable list be uploaded within 20Q2 and, if not all patients of the PI or study team, a HIPAA Form 4 privacy waiver be uploaded within 13Q11.

Application work flow: We’ve submitted our application, Now what? RSS Pre-review Scheduled for committee review Ancillary Pre or Concurrent Reviews Pre: KKI, FM Kirby Center, JHHS Nursing Concurrent: Student Affairs, Graduate Education, Pathology, COI, Clinical Engineering Imaging and Recording Oversight Committee (IROC)

Primary Reviewer Oversight of research activities Critical review of application and documents for consistency and clarity Initial analysis of risk/benefit ratio Ensure compliance with institutional (JHM), state and federal regulations governing the protection of human subjects Purpose: Provide multiple layers of risk and safety review and safeguards Provide Quality Assurance for all aspects of the research project Alert PI about concerns that might come up during the JHMIRB review Review scientific justification and logical flow between hypotheses and procedures Confirm that risks are balanced by potential benefits Confirm that consent forms clearly explain purpose, procedures, risk, and benefits for informed consent to be obtained All research projects enrolling KKI patients or caregivers undergo extensive and thorough review for safety, scientific integrity, and adherence to the highest ethical standards. Risks associated with research participation are always balanced against prospects for benefit, either directly to participants or to society as a whole. Those risks and potential benefits are clearly explained prior to participation, as are options for ending participation without penalty. KKI has in place a system to assist investigators with the IRB approval process that both serves as a quality assurance function and contributes to research productivity.

Consider Potential Risks, Burden and Benefits Meet DHHS and FDA regulations to minimize risks to participants sound research design acceptable risk/benefit ratio equitable subject selection protection of vulnerable populations appropriate consent (or consent waiver) and safety monitoring; Confidentiality and privacy protections

Research Data Security Data security and management plan: -The research plan makes adequate provision for monitoring the data collected to ensure the safety of participants. -There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data. - Studies abstracting more than 500 patient records require Data Trust review and approval The Data Trust will generally review your plans for data acquisition, management and storage, as well as data transfer if plan to share externally.

IRB Review Outcome Outcome Acknowledge (exempt, NHSR or QI) or Approve (expedited) Acknowledge/Approve with Administrative Changes Table with Reviewer Issues Disapprove

Common Exempt Reviewer Issues Educational research (exempt 1) Upload pre-post knowledge test Describe recruitment process and upload recruitment text Survey recruitment (exempt 2) Upload recruitment material (email script, flyer) Upload survey with consent statement.

Common Exempt Reviewer Issues Retrospective Record Review - Records must be existing at the time of eIRB submission - Cannot record any PHI or maintain links to re-identify the data - If not all your own patients, upload a HIPAA Form 4 privacy waiver - Upload data variable list within supplemental study documents Remember there are18 HIPAA identifiers, not just name, MRN, DOB

JHU SOM IRBX Portfolio (2017) IRBX: NHSR, Exempt and Expedited IRBX Initial Submission = 1397 IRBX Protocols Approved = 1092 NHSR protocol = 42 Exempt protocols = 223 Expedited protocols = 827

Contact and resources Elaine Stashinko, IRB 6 Board and Exempt reviewer - stashinko@kennedykrieger.org 443-923-9146 Kristin MacNeal, Expedited Study Specialist kmacneal@jhmi.edu 443-287-4232 eIRB Help Desk jhmeirb@jhmi.edu 410-502-2092