1 Responsible Conduct in Human Research (Fall 2009) Header image designed by Michelle Jordan, UMBC Creative Services, 2009

2 In brief Ethics/Regulations What is research Involvement of the IRB Types of review and the consent process The Bottom line

3 Doing the right thing Real integrity is doing the right thing, knowing that nobodys going to know whether you did it or not - Oprah Winfrey 1 Various codes for the proper and responsible conduct of human research have been incorporated into researchers interact with people and how universities conduct business. 1

4 To do the right thing, know about the ethics 45CFR46 - Protection of Human Subjects - ensures minimal standards for the ethical treatment of research subjects based on past history Medical research Social and Behavioral Research Foundations of ethics in human research Freedom from harm Privacy Voluntary participation Protection from risks and safeguard from harm

5 Understand what research is: Research: Systematic investigation that contributes to generalizable knowledge In other words, an investigator will be "engaged in research", has proposed an intention to explore a particular topic, while interacting with a living person and either publish (e.g., in a journal) or present at a conference. Human Subjects: Living individuals about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information

6 Purpose of human research compliance Required by the federal government as well as the University of Maryland Ethical review of research Ensure participants rights are protected and that they are safeguarded from risk and harm Compliance with federal guidelines and principles Department of Health and Human Services University of Maryland System U.S. Department of Education

7 The IRB Members include: Scientists and non scientists from various disciplines on campus as well as graduate and undergraduate student members Individuals not affiliated with the Campus who represent the concerns of the Community Provides assurance to the federal government that UMBC will comply with the rules and regulations and provides oversight for the university's human research use program

8 Safeguards from harms Emotional or psychological harm Social harm Physical harm Financial harm Legal harm Moral harm

9 Protection from risks The greatest risk is often a breach of confidentiality This risk could lead to: social stigma, loss of employment legal prosecution embarrassment damaged family relationships emotional risks (relive or reveal violence ), which may lead to physical danger

10 Enhancing voluntary participation Involves the consent process It is a Process or a Conversation that most of the time uses a Document Research statement Purpose Procedures Confidentiality Risks Benefits Freedom to withdraw statement Contact info for the investigator and the IRB Signature and date line

11 Types of Approval Exempt Federal regulations specify that certain types of research pose no or very low risks to participants, a minimal review from the IRB is required. Expedited Activity must not involve no more than minimal risk to subjects. The regulatory definition of "minimal risk" is 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 and falls within list of expedited procedures Full Board Full board review is performed by the whole committee and reviews studies that are more than minimal risk, involve vulnerable populations, or involve special circumstances. Sensitive topics include: sex, drugs, alcohol use, suicide.

12 Types of research: Low or less than minimal risk Educational research - improving educational practice in educational settings (no clinical and counseling research) Educational tests - use of educational tests (cognitive, diagnostic, aptitude, achievement) where subjects cannot be identified, directly or through identifiers linked to the subjects. Surveys, questionnaires, interviews, or observation not involving "sensitive" topics, such as criminal or sexual behavior, alcohol or drug use on the part of the participants unless anonymity is guaranteed and informed consent cannot be reasonably obtained (i.e. anonymous observations). Preexisting data/samples that are publicly available and the data is deidentified and uncoded and stripped of identifiers. If on the IRBs list of pre- approved data holders, no need for IRB reviewlist of pre- approved data holders Minimal Risk Survey or interview procedures where responses are recorded in such a manner that subjects can be identified, and if known outside the research, could reasonably place the subject at risk of criminal or civil liability Research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol, unless data is recorded in such a fashion that identities are kept secure and protection mechanisms put in place Deception Research which include minors (under the age of 18) as participants May not require IRB review Activities that are not hypothesis driven Data collected for educational or teaching purposes and is not disseminated outside the institution. Literature review to support research purpose or research question Surveys issued or completed by University personnel for the intent and purposes of improving services and programs of the University

13 What does an IRB expect of an application? Consideration of how the substantive issues & methods fit with ethical guidelines & IRB requirements Clarity in statement of problem, Research Questions & Methods of data collection Consistency in content of all documents Completeness of all materials C+C+C+C= Successful Protocol Courtesy of University of Louisville Human Subjects Protection Program Office

14 What happens after review? Annual Continuation and Approval Expedited board approved human subject protocols at UMBC are approved for a total of five years. A protocol is initially approved for a period of up to 12 months. Four (4) continuations or renewals may be requested, each for a period of up to 12 additional months. Protocol Modifications Any proposed change to an already approved human subject research protocol, measures, or informed consent document during the period of IRB approval must be submitted in writing to the IRB immediately for review and approval Closing a Protocol Protocol closure may occur when data collection is completed, when basic data analyses are completed and when all contact with participants has ended. Reporting Adverse Events Unanticipated problems involving risks to subjects or others Protocol Deviations and Violations Protocol deviations and/or instances of noncompliance with IRB regulations Protocol Monitoring (PAPM) Post approval protocol monitoring (PAPM) to protect research participants, to educate researchers about human subject protection issues and to improve the quality of research by detecting errors and/or omissions that might occur when performing research activities.

15 What is the bottom line for an investigator? Be trained and fully aware Following IRB conditions and requirements Reporting progress of research Be aware of your own ethics

16 Expectations from the IRB? When in doubt, ask questions; seek help Remember: consideration, clarity, consistency, completeness Dont initiate research before obtaining IRB approval. Renew ongoing proposals each year in a timely fashion. Stay within the approved scope of the project. Submit modifications to the IRB and wait for approval before initiating the change to the research. Report Adverse Events. IRBs are more than enforcers/regulators

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