Current IRB at DMACC September 2018

General Types of Human Research RESEARCH that involves direct interaction with individuals (e.g., in person, or via mail, email, web survey, or telephone), or data from human subjects for which the researchers will have access to identifiers. RESEARCH that is limited to secondary analysis of data, records or specimens that are either publicly available, de-identified or otherwise impossible to be linked to personal identities.

DMACC is NOT a Research Institution Does not support providing IRB services for commercial or private use unless there is a benefit to DMACC students ALL External & Internal Researchers need a DMACC Mentor (relative internal support is a requirement) IRB Proposals must be submitted for structured research that will be used outside of specific course assignments (internal/Honors/external) Requests are initially screened for External IRB Approval, Human Subject Risk, and potential DMACC Liability concerns Non-Exempt IRB requests (even with Home Institution IRB approval) are approved by Cabinet Expedited IRB requests are approved in conjunction with Relevant Departments (HR, Academic Affairs, President, etc. as appropriate and screening for human subject risk). Exempt IRB requests are approved in conjunction with Relevant Departments (HR, Academic Affairs, President, etc. as appropriate and provided screening for human subject risk). Honors IRB requests are approved by Honors Program & if necessary IRB

Considerations: Outside Investigators: DMACC requires a DMACC Mentor/Sponsor DMACC requires “home institution” documentation of IRB approval (as primary) DMACC requires completed IRB application & subsequent approval IRB technically focuses only on ensuring protection of human subjects IRB does not: judge the merits of research proposals base decisions on political, religious or moral perspectives of the reviewers

Screening Concerns Protected Classes Risks Children (<18 yrs) People with intellectual disabilities (impaired decision-making ability) People with physical disabilities Economically disadvantaged Prisoners Elderly Pregnant women Risks Students FERPA Staff Confidentiality and Anonymity of both Subjects and Institution DMACC Liability Potential Informed Consent / Coercion

IRB Review for Approval Office for Human Research Protections (OHRP) http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

Full Non-Exempt IRB Review Involves human subjects (living people – identifiable or personal information – involves potentially greater than minimal risk to those human subjects) Always required for protected classes Requires Majority IRB Board Review – IRB @ DMACC is Cabinet

Expedited IRB Review Involves human subjects (living people – identifiable or personal information – databases, bio specimens) Involves no more than minimal risk to individuals Involves minor changes to update previously approved protocols Research for which limited IRB review is a condition of exemption under §46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8). Can be carried out by one IRB reviewer Minimal risk defined: the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation

Exempt IRB Review Research in one of eight approved categories Information obtained is not identifiable Disclosure outside of the research would not put subjects at risk of harm, civil or criminal liability or be damaging to the subjects financial standing, employability, educational advancement, or reputation. Adequate privacy safeguards for protecting private information, identifiable bio specimens, and maintaining confidentiality (46.111(a)(7) Minimal risk Equitable subject selection Informed consent Provisions for privacy Generally does not include protected classes Can be carried out by one IRB Reviewer

Eight Exempt IRB Categories effective January 2019 Research, conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. Research using educational tests, surveys interviews, observation of public behavior (data collection is recorded by the investigator that identity cannot be readily ascertained, does not place subjects at risk of criminal/civil liability, or cause risk to financial standing, employability or reputation OR Limited review conducted determines that adequate provisions for protection and confidentiality exist)

Eight Exempt IRB Categories effective January 2019 Research involving benign behavioral interventions in conjunction with the collection of information from adult subjects (does not include children) through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Eight Exempt IRB Categories effective January 2019 Secondary research for which consent is not required - Secondary research uses of identifiable private information or identifiable bio specimens, if at least one of the following criteria is met: The identifiable private information or identifiable bio specimens are publicly available; Information, which may include information about bio specimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501

Eight Exempt IRB Categories effective January 2019 Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants Taste and food quality evaluation and consumer acceptance studies: If wholesome foods without additives are consumed, or 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.

Eight Exempt IRB Categories effective January 2019 Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable bio specimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8). Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable bio specimens for secondary research use Broad Consent in Exempt Research: Broad consent may be obtained in lieu of informed consent with respect to the storage, maintenance, and secondary research uses of identifiable private information and identifiable bio specimens. Broad consent defines specific parameters as to: specific timeframes of storage, how secondary data will be used and specific types of institutions or researchers will be able to access it.

Informed Consent Sufficient information must be provided: The research purpose, The procedure, Risks Anticipated benefits or no benefits, (no coercion) Protection and destruction of personal information Address broad consent for potential use in unspecified future research (minimal risk) Alternative procedures/resources (where therapy is involved), and A statement offering the subject the opportunity to ask questions and to withdraw at any time from the research

Considerations Internal Requests Honors IRB – projects need to be completed in a semester Graduate Class data requests – projects need to be completed in a semester External Requests (includes graduate dissertations) Exempt - currently less than two weeks Expedited – currently about two weeks can take up to 30 days for a decision depending approval levels Full Non-Exempt Review – take a month or more

New Final Rule Implications January 2019 implementation Modifies and adds to Exempt approval categories Extends Exempt approval as long as one of three criteria is met: Information obtained is not identifiable Disclosure outside of research would not put subjects at risk of harm Information obtained can be identifiable but Limited Review in keeping with 46.111(a)(7), which relates to adequate provisions for protecting privacy and maintaining confidentiality Limited IRB review within Exempt Approvals – Sometimes an option for Categories 2 & 3 – Always required for Categories 7 & 8 Limited IRB Review is required if research involves identifiable information recorded by the researcher in such a manner that the identity of the human subjects can readily be ascertained, , directly or through identifiers linked to the subjects (HHS 2017). A limited IRB review is conducted to determine if there are adequate provisions in place to protect privacy and confidentiality as defined under 46.111(a)(8). Provides for Broad Consent vs Informed Consent on certain Secondary Studies – Category 7 & 8 Allows Exempt review using Prisoners as incidental to human subject focus the study and low risk Eliminates continuing review of certain categories of research

Final Rules Exempt Categories (January 2019) Category 1: Research in Established or Commonly Accepted Educational Settings Category 2: (Limited Review option) Educational Tests, Surveys, Interviews, Observations of Public Behavior Category 3: (Limited Review option) Benign Behavioral Interventions in Conjunction with the Collection of Information from Adult Subjects Category 4: Secondary Research which Consent is not Required Category 5: Research and Demonstration projects that are Conducted or Supported by a Federal Department or Agency Category 6: Taste and Food Quality Evaluation and Consumer Acceptance Studies Category 7: (Limited Review required) Storage or Maintenance for Secondary Use for which Broad Consent is Required Category 8: (Limited Review required) Secondary Research for which Broad Consent is Required.