Current IRB at DMACC September 2018 General Types

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 • Non-Exempt IRB requests (even with Home Institution IRB approval) are approved by Cabinet • ALL External & Internal Researchers need a DMACC Mentor (relative internal support is a • Expedited IRB requests are approved in conjunction with Relevant Departments (HR, Academic Affairs, President, etc. as appropriate and screening for human subject risk). • IRB Proposals must be submitted for all research (internal/Honors/external) • Exempt IRB requests are approved in conjunction with Relevant Departments requirement) • Requests are initially screened for External IRB Approval, Human Subject Risk, and potential DMACC Liability concerns (HR, Academic Affairs, President, etc. as appropriate and provided screening for human subject risk). • Honors IRB requests are approved by Honors Program & IRB Representative

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 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 greater than minimal risk to those human subjects) • Always required for protected classes • Requires Majority IRB Board Review

Expedited IRB Review • Involves human subjects (living people – identifiable or personal information - databases) • Involves no more than minimal risk to individuals • Involves minor changes to update previously approved protocols • 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.

Exempt IRB Review • • Research in one of six approved categories Information obtained is not identifiable Disclosure outside of the research would not put subjects at risk of harm Adequate provisions for protecting privacy and maintaining confidentiality (46. 111(a)(7) • • Minimal risk Equitable subject selection Informed consent Provisions for privacy • Does not include protected classes • Can be carried out by one IRB Reviewer

Exempt IRB Categories • Research falls into one of six approved categories of Exempt Research based on risk profile (2018) • Research in a commonly accepted educational setting – effectiveness of instructional techniques, curricula, classroom management, etc. • Research using educational tests, surveys interviews, observation of public behavior (data collection is anonymous and unidentifiable, does not place subjects at risk of criminal/civil liability, or cause risk to financial standing, employability or reputation) • Research using educational tests, surveys interviews, observation of public behavior (subjects are public officials, candidates for public office) • Research of existing data, documents, records (subjects cannot be identified directly or through identifiers) • Research designed to study, evaluate or examine public benefit or service programs, (procedures for obtaining benefits under those programs, possible changes or benefits in those programs) • Research on taste or food quality evaluation and consumer acceptance studies (wholesome food, food grade ingredients at safe by FDA or approved by the EPA or US Dept. of Agriculture)

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 • Postponed to 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 • Discolsure 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 • Allows for Broad Consent on secondary studies • Limited IRB review Concept within Exempt Approvals • Allows Exempt review using Prisoners as incidental to human subject focus the study and low risk • Eliminates continuing review of certain categories of research

Proposed 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.