Understanding the Role of the IRB in Scholarship of Teaching and Learning (SoTL)Research Mary Travis Director of Research Compliance Office of Research & Sponsored Programs

Objectives Provide a brief introduction to the ethical considerations involved in human subjects research. Evaluate research activities to determine whether IRB review is required. Describe steps for obtaining DU Institutional Review Board (IRB) approval.

Events that were pivotal in focusing public attention on issues related to research ethics Nuremberg Trials Tuskegee Syphilis Experiment Willowbrook Hepatitis Studies Jewish Chronic Disease Hospital Studies Milgram Studies of Obedience to Authority San Antonio Contraception Study Tearoom Trade Study

1948: The Nuremberg Code voluntary and informed consent a favorable risk/benefit analysis the right to withdraw without penalty 1964: The World Medical Association Declaration of Helsinki a document that builds on the Nuremberg Code of 1948 to describe the standards of ethical research involving human subjects. 1974: The National Research Act Congress passed this Act to create federal regulations that govern human subjects research and established the Institutional Review Board. 1978: The Belmont Report outlines the basic ethical principles and guidance used for the Protection of Human Subjects in Research

Code of Federal Regulations (CFR) Health and Human Services (HHS) Food and Drug Administration 45 CFR 46 – Federal Policy for the Protection of Human Subjects Subpart A – basic set of protections for all human subjects of research conducted or supported by HHS (late 1970s) Subpart B - additional protections for pregnant women, human fetuses, and neonates involved in research (1975) Subpart C – additional protections for biomedical and behavioral research involving prisoners as subjects (1978) Subpart D – provides additional protections for children involved as subjects in research (1983) Subpart E – requires registration of institutional review boards (IRBs) which conduct review of human research studies conducted or supported by HHS (2009) 21 CFR 11 – Electronic Records; Electronic Signatures 21 CFR 50 – Protection of Human Subjects 21 CFR 54 – Financial Disclosure by Clinical Investigators 21 CFR 56 – Institutional Review Boards 21 CFR 312 – Drugs (Investigational New Drug – INDs) 21 CFR 812 - Medical Devices (Investigational Device Exemption – IDEs)

Institutional Review Board (IRB) Serves as an independent committee comprised of members with scientific and non- scientific backgrounds and from the community. The committee functions as a kind of ethics committee focusing on what is right or wrong. In other countries, terms such as Research Ethics Committee and Ethical Review Board are used to describe a committee that evaluates the ethical aspects of research involving human subjects.

Institutional Review Board (IRB) The mission of the institutional review board (IRB) is to protect the rights and welfare of human research participants. Every decision made by the IRB is driven by this specific goal and the Belmont ethical principles.

The Belmont Report “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” Respect for Persons – individuals should be treated as autonomous agents and that persons with diminished autonomy are entitled to protection. Beneficence – persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Related to research (1) do not harm and (2) maximize possible benefits and minimize possible harms. Justice – “fairness in distribution” – all individuals have the opportunity and right to received the benefits of research and be treated equally.

STEP 1: Determine whether your research requires IRB review

Is your project Human Subjects Research as defined by Federal Regulations? Research is defined as “a systematic investigation designed to develop or contribute to generalizable knowledge”. Human Subject is defined as “a living individual about whom an investigator obtains data through intervention or interaction or identifiable private information”. In order for a project to require IRB review it must be BOTH research and involve human subjects.

CASE STUDY #1 A faculty member helps a colleague at another institution develop a survey given to the colleague’s students. Students are asked for feedback on the course content, assignments, and tests. (Providing names on the survey is optional.) The faculty member will also help to analyze the survey results; names (if any) will not be removed before surveys are sent to the faculty member. Results will be used only to improve the course.

IS IT RESEARCH?

The activity is not research. IS IT RESEARCH? NO The activity is not research. Results will only be used for program improvement.

CASE STUDY #2 A faculty member will conduct a federally-funded study to describe, compare, categorize and analyze the tobacco use policies/restrictions of the most heavily used public transportation systems in several countries and correlate results to local tobacco use rates. The goal is to develop or contribute to generalizable knowledge and results will be published/presented. Data will be collected from existing datasets, websites, policies and from transit authority personnel (phone/email questionnaires). Publically available data will be collected from transit authority websites to document current policies/restrictions regarding tobacco usage. Online publically-available, aggregate data on tobacco use from the respective areas will also be obtained. Transit authority personnel will be contacted to obtain a written copy of any tobacco-related policies and to obtain factual information about how the policies are communicated. An email questionnaire will be sent first, followed by a phone call if no response. Only factual information about policies/organizations will be obtained.

IS IT RESEARCH?

The activity is research. IS IT RESEARCH? YES The activity is research. It is a systematic investigation designed to develop or contribute to generalizable knowledge.

ARE THERE HUMAN SUBJECTS?

There are no human subjects. ARE THERE HUMAN SUBJECTS? NO There are no human subjects. The information gathered via questionnaires is not about living individuals. All information is factual information about the organizations policies and procedures. Note: If the researcher wanted to include questions about personal opinions on the policies/procedures or if additional personal data about the respondents and policy makers was collected, then it would be determined that data about living individuals was being collected and the research would include human subjects.

CASE STUDY #3 A researcher is writing a grant and collects preliminary data about a subset of children to test a new measurement mechanism. The measures are noninvasive and occur in a context of typical educational practice. The intent of the data collection is to gather information for a grant proposal to support a rigorous evaluation of the measure. There is no intention to publish this data apart from including it in a grant proposal.

IS IT RESEARCH?

This activity is research. IS IT RESEARCH? YES This activity is research. Pilot testing, even if results are only used for grant proposals, is considered research because it is a systematic investigation that is used to develop generalizable knowledge.

ARE THERE HUMAN SUBJECTS?

There are human subjects. ARE THERE HUMAN SUBJECTS? YES There are human subjects. The data about the children are collected through intervention or interaction. IRB Review is Required.

STEP 2: Register in IRBNet and familiarize yourself with the electronic submission system

RESOURCE: IRBNet User’s Manual Step by step instructions on how to navigate through the electronic submission system

STEP 3: Complete Human Subjects Protection Training and any other mandatory training

www.citiprogram.org University of Denver Courses/Learner Groups Human Subjects Research Responsible Conduct of Research Conflict of Interest Laboratory Animal Welfare Biosafety Export Compliance Health Information Privacy and Security& Education Research) Investigators

STEP 4: Prepare IRB application and complete appropriate forms

RESOURCE: IRBNet Forms & Templates Library

RESOURCE: Submission Checklists Use them as guides to make sure you submit a complete application. Incomplete submissions will delay IRB review and approval.

Protocol Narrative Supplemental Forms DU IRB Application

RESOURCE: IRB Guidance & Appendix Forms Example: Conducting Research in Schools

“If we knew what we were doing, it wouldn’t be called Research” Albert Einstein

DU Office of Research Integrity & Education Mary Reed Building, Room 222 Mary Travis – 303-871-4049 Mary.Travis@du.edu Katie Myhand – 303-871-4037 Katie.Myhand@du.edu Department e-mail: IRBAdmin@du.edu Main Office: 303-871-2121