Protecting the rights, safety and welfare of human subjects March 2015

Learning Objectives 1. Definitions of “research” vs “not research” 2. Regulation of research and not research activities 3. UW IRB Application of research ethics principles to non- research activities in the global health setting

U.S. federal definition of research A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Questions about research vs not research activities?

The Foundation of Research Ethics: The Belmont Principle Respect for persons Beneficence Justice

Who regulates your research & not research data collection activities? U.S.-based Institutional Review Boards (IRBs) Operate under federal regulations Usually see consistency in adjudication among U.S.- based IRBs Non-U.S.-based IRBs or Ethics Committees (ECs) Generally adhere to Belmont Principals May interpret guidelines AND DEFINITIONS differently May prioritize specific human subjects protection elements in a different way May have own in-country laws and guidelines Gets complicated when multiple IRBs oversee a research study, evaluation or program activities

Identifying your regulatory bodies Is the activity “research?” A systematic investigation, designed, generalizable Does it involve “human subjects?” A living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information. Who is “engaged” in the project? Anyone who interacts with subjects for research purposes Anyone who obtains individually identifiable private information for research purposes Anyone having significant responsibility for design and conduct of the study Who is funding/responsible for study funds?

One I-TECH project, many regulators… Determine whether other institutions are involved in implementation or as funders Affiliation: Collaborator with I-TECH, engaged in program activities Affiliation: I-TECH Tanzania Country Office and engage in Program Implementation Affiliation: Funding and I- TECH Headquarters base University of Washington IRB National Institute for Medical Research (NIMR) Other regulatory players (UCSF, HRSA, others) CDC IRB

Questions about regulatory bodies?

UW IRB 101 Types of IRB applications: Full Board Application Minimal Risk (Expedited) Application Exempt Application Not Research Determination (NRD) Starting point & tools UW HSD self-determination worksheet UW helpline Federal Regulations

Full IRB Review Poses greater risk to subjects than would be encountered in daily life. Clinical trials Manipulation of clinical setting in ways that affect care Disclosure of potentially harmful information (HIV status, sexual orientation, domestic abuse)

Minimal Risk (Expedited) Review Poses no greater risk to subjects than would be encountered in daily life. Evaluation of medical care via survey or focus groups TB program intervention evaluation including medical records review, home visits to conduct surveys

Exempt Review Minimal risk review that fits into one of 5 categories: 1. Involves normal educational practices 2. Surveys, focus groups, interviews or observations of public behavior 3. Ditto #2 for public & federal officials requiring special confidentiality considerations 4. Use of publicly-available data recorded in a non- identifiable manner 5. Conducted by or subject to approval of an agency, and examines public programs

Not Research Determination (NRD) Documentation of Non-Research Determination may be driven by external factors such as: funder or local EC/MOH requirements Student thesis/dissertation program requirements

UW IRB Starting Points Research or not research? HSD Self-Determination Worksheet: UW Helpline: HHS Federal Regulations: 5cfr46.html 5cfr46.html

Any questions about the UW IRB?

Why apply Research Ethics Principles to Non-Research Activities? Ethical standards to treatment of subjects remains regardless of regulatory requirements of engaged institutions We have an obligation to obtain all requisite approvals/determinations from all IRBs/ECs We need to remember that conducting research is a privilege, not a right.

Activities typically NOT considered to be human subjects research by the UW IRB: Quality improvement projects are generally not considered research as long as purpose of activity is limited to: a) Implementing practice to improve quality of patient care, and b) Collecting patient or provider data regarding implementation of the practice for clinical, practical or administrative purposes Procedures carried out under an independent contract for an external agency (examples: personnel studies, cost- benefit analyses, customer/provider satisfaction studies).

Quiz! Research or not research? The purpose of this evaluation is to document best practices to support ART adherence in Haiti. The project will asses QI interventions for improving ART adherence at 2 regional hospitals. Data will be shared with the regional Ministry of Health to advise structural improvements in clinic infrastructure. Publications from this project will be presented as specific to the sites studied and not as generalizable to ART providers.

Applying Research Ethics Principles in Non-Research Settings Informed Consent Confidentiality De-identification of project data Publications

Elements of Informed Consent Description of research (purpose, duration, procedures, duration) 2. Description of potential risks or discomfort 3. A description of any benefits to the subject or to others 4. A disclosure of appropriate alternative procedures or courses of treatment 5. Level of confidentiality 6. Compensation or medical treatments are availability, 7. whom to contact for answers to pertinent questions or if injury occurs 8. A statement that participation is voluntary,

Confidentiality Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.

De-identification of data To de-identify your data, you must de-link subject names or other identifiers and destroy the codes that link identifiers to the data. If you have access to the codes, your data is not de-identified.

Publications Publishing NON-RESEARCH data: De-identified data Confirmation of not-research status: Activity for this project does not meet the federal definition of “research” under 45 CFR (d), therefore the HHS regulations for the protection of human subjects do not apply and we were not required under these regulations to submit our data collection activities for review by the IRB. Publishing RESEARCH data: De-identified Confirmation of IRB review: This study was conducted in accordance to the U.S. federal regulations for human subjects research, and approved by the University of Washington IRB prior to data collection.

Questions??

Regulatory/IRB Resources Elements of Informed Consent (U.S. Health & Human Services – OHRP) Office of Human Protections (OHRP) FAQs on Quality Improvement Activities: University of Washington Human Subjects Division (HSD) website:

Additional Resources & Recommended Reading Declaration of Helsinki Belmont Report elmont.html elmont.html CITI Human Subjects and Ethics Online Training Immortal Life of Henrietta Lacks (Rebecca Skloot)

Thank you!