Human Subjects Protection Program Office of Research Compliance Navigating through the current HSPP and IRB Presented by: Danielle Griffin, M.S. Research Compliance Coordinator

Is it Research The federal regulations define research as –a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (45CFR46.102(d)). As described in the Belmont Report –"...the term 'research' designates an activity designed to test a hypothesis [and] permit conclusions to be drawn... Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that objective.“ –Data must be generated and some sort of analysis of the data should occur –If there is no statistical analysis can we say it is research or is it simply a case study Office of Research Compliance

Is it Research "Research" generally does not include operational activities such as practice activities in medicine, psychology, social work, and public health (e.g., routine outbreak investigations and disease monitoring) and studies for internal management purposes such as program evaluation, quality assurance, quality improvement, fiscal or program audits, marketing studies, or contracted-for services. It generally does not include journalism or political polls. Some of these activities may include or constitute research in circumstances where there is a clear intent to contribute to generalizable knowledge. –Conducting a statistical analysis and publishing the results Office of Research Compliance

Is it Human Subjects Research A human subject is defined by Federal Regulations as "a living individual ABOUT whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." (45 CFR (f)(1),(2)) –Intervention includes physical/psychological procedures, manipulations of the subject, or manipulations of the subject's environment for research purposes. –Studies that are not human subjects research: Information-gathering interviews where questions focus on things, products, or policies rather than about people or their thoughts regarding themselves are not human subjects research. Office of Research Compliance

Is it Human Subjects Research Research on Deceased individuals is not human subjects research –If you are doing research on cadavers – Not Human Subjects –If you are interviewing one person to ask them about someone else’s past life – Not Human Subjects –Crosses over when you ask someone about their present life and/or opinions Office of Research Compliance

Is it Human Subjects Research Research on 1 person is not Research –According to the federal definition this information cannot be generalized Cannot come to a conclusion about a population based upon one person’s data How many people do you need for it to be considered research and have statistically significant data? –Power analysis –It can become research if it will be used as pilot data for future research. Office of Research Compliance

Is it Human Subjects Research Not everything is black and white –Sometimes we need to take things on a case by case basis. –Some things are left up to a reviewers interpretation or opinion Program Evaluations Risk levels Office of Research Compliance

Changes Office of Research Compliance

Changes Initial Application –One form for all types of research Amendments –All changes must be highlighted and/or track changed –All forms and documents associated with the change must be revised and updated (this includes the initial application) The complete document needs to be submitted not just relevant pages –When do need to submit an Amendment? If it effects the context of any document or procedure in the protocol or is a new document or procedure Office of Research Compliance

Changes cont. Grants and Contracts –Submit the complete copy (cover-to-cover) of the approved grant or contract including the Office of Sponsored Research Services (OSRS) award letter. –OSRS will not distribute funds until there has been a grant/contract comparison done with the IRB application. –If funding is not approved at the time of initial application submit complete information along with an Amendment application Office of Research Compliance

Changes Cont. Completion Reports –All approved research must submit a Study Completed/Not Initiated form upon completion of the study –Study can be closed when Participant enrollment and data collection is complete and all identifiers have been removed and cannot be linked back to participant data Or data analysis is complete Office of Research Compliance

Continuing Reviews Need copies of the consent forms used during that review period Need clean copies of the consent forms for stamping Literature Review Reporting of enrollment numbers, screen failures, participant dropouts and withdrawals –These all count toward the total approved Office of Research Compliance

Other Changes Devices –Device manuals –Inspections Office of Research Compliance

Other Changes Staff Forms Templates –Consent Forms Website Standard Operating Procedures Principal Investigator Handbook Office of Research Compliance

Why Were these Changes Necessary To help create a culture of compliance To comply with the regulations and guidance Sometimes the old ways just don’t work anymore Office of Research Compliance

Changes to Come Faculty Sponsors as PI and Students as Protocol Director Proposed changes to the Common Rule (45 CFR 46) Proposed changes to FERPA Proposed changes to the Privacy Laws Office of Research Compliance

Questions? Where to go for questions: The Human Subjects website: Or call: Follow Office of Research Compliance