1 Responsible Conduct in Human Research (Fall undergraduate) 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 What does this all mean?

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 Foundations of ethics in human research Freedom from harm Privacy Voluntary participation Protection from risks and safeguard from harm

5 Protection from risks and safeguards from harms The greatest risk is often a breach of confidentiality Safeguards from: Emotional or psychological harm Social harm Physical harm Financial harm Legal harm Moral harm

6 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

7 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

8 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

9 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

Students as Researchers The previous information is important to remember when planning to conduct research Faculty advisors play an important role 10

Class Projects enrolled in courses learn skills through a combination of readings, lectures and research activities or projects expectation for the student to apply what is taught (i.e. use skills outside of the classroom) 11

Class Projects Class instructors play active role Will help choose an acceptable topic Will develop and submit application forms Will advise students on research methods and consent information procedures Only non-sensitive information may be collected No personal identifiers may be collected These types of projects CANNOT be approved by instructors participants under the age of 18 deception collection of information about participants sexual history, religious orientation and views, mental health history, substance use and abuse, etc. 12

Class Projects May not collect personal information of a sensitive nature from participants, they may ask participants to make judgments about behaviors of anonymous others. For example, participants may be asked to read about a crime and be asked to judge the appropriateness of the sentence as a factor of characteristics of the perpetrator. 13

Independent Research projects Student researchers conducting independent research are, as faculty investigators, required to follow the appropriate application review and approval process 14

15 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

16 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. Educational tests where subjects cannot be identified, directly or through identifiers linked to the subjects. Surveys, questionnaires, interviews, or observation not involving "sensitive" topics Expedited Activity must not involve no more than minimal risk to subjects. Survey or interview procedures where responses are recorded in such a manner that subjects can be identified deals with sensitive aspects of the subject's own behavior Research which include minors (under the age of 18) 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.

17 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.

18 What does this all mean? Be trained and fully aware Following IRB conditions and requirements Reporting progress of research Be aware of your own ethics

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