1. L12:Big Idea 1-Question and Explore- Engaging in Ethical and Safe Research Practices

2. Lesson 12: Learning Goals
Identify what types of inquiries will require institutional review board (IRB) approval and how to seek such approval.
Revise your research methods to meet ethical guidelines.
Learning Objective 1.5D: Employing ethical research practices.

3. Lesson 12: Focus
Read the Maschke (2008) excerpt and consider your understanding of ethical research as it pertains to human subjects.
What does ethical research imply?

4. Misconception Alert
You may think that any inquiry involving a survey or just talking to human subjects or observing human subjects is permissible. However, there are strict guidelines about conducting human subject inquiries.
If you are engaged in human subject research, you must align your methods with these guidelines (whether they require IRB approval or not).

5. L12: Teach

6. What is Ethical Research?
What constitutes ethical research practices as it pertains to the use of human subjects?
Respect for persons
Causing no harm (minimizing harm and maximizing benefits)
Ensuring benefits are equal to all

7. Three Guiding Principles
Respect for Persons (volunteer or protect)
Individuals should be treated as autonomous agents
Persons with diminished autonomy are entitled to protection
Persons should be made free to volunteer to enter and/or leave the research study without restraint or punishment
Persons in need of protection should be given such even if it means preventing them from entering the research study
Beneficence
Do not harm
Maximize possible benefits and minimize possible harms.
Justice (justly distribute burdens and benefits)
To each person an equal share
To each person according to individual need
To each person according to individual effort
To each person according to societal contribution
To each person according to merit

8. Potential Problem Areas with Human Subject Research
Academic scandal:
misconduct (e.g. fabrication of data and plagiarism)
Scientific and medical research:
human experimentation
animal experimentation
Social sciences:
misuse/abuse of confidential information

9. Additional Guidelines for Ethical Research Practices
There is a duty to protect the rights of people in the study as well as their privacy and sensitivity.
Researchers should secure the permission and maintain the interests of all those involved in the study.
The confidentiality of those involved in the research must be met, keeping their anonymity and privacy secure.
Researchers should not misuse any of the information discovered.
Receiving Institutional Review Board (IRB) approval provides protection against individuals engaging in unethical research practices.

10. U.S. Department for Health and Human Services: Guidelines for Ethical Research Practices

11. Institutional Review Board (IRB)
What is an IRB?
A committee of specific composition at an affiliated fair, high school or institution that reviews research plans involving human subjects to determine potential physical and/or psychological risk.
The IRB reviews and approves ALL research involving human subjects BEFORE experimentation begins. (This includes surveys, professional tests, questionnaires, and studies in which the researcher is the subject of his/her own research.)
The IRB determines the level of RISK involved in the project.
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information.
Minimal risk means that 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.
IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

12. Risk Assessment and Safe Research Practices
What is risk?
Exercise other than ordinarily encountered in daily life
Emotional stress to questioning or activity or stress resulting from an invasion of privacy
Ingestion of and/or physical contact with any substance
Who is at risk?
Any student 21 or under doing experimentation with toxic chemicals, radiation, or known pathogens and carcinogens
Any member of a risk group (e.g., anyone with a disease, cardiac disorder, pregnant women, etc.)
Any member of special groups covered by federal regulations (e.g., Native Americans, prisoners, special needs persons, including the disabled and gifted, children, economically or educationally disadvantaged persons)
Federal definition of risk: No more than minimal risk exists when 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 performance of routine physical or psychological examinations or tests.

13. Questions the IRB Will Ask
Correct Response
1. Does this project or study involve collection of data that identifies individuals (e.g., SSN# data on individuals, surveys, or interviews identifiable by name or student number etc.)?
This question should be answered with a “NO” and should be made clear how you are avoiding this via your method.
2. Will data identifiable by individual be shared with anyone (such as in conference presentations, published articles and reports, etc.)?
3. Are the participants being offered one or more of the incentives to participate (such as money, extra credit for the class, etc.)? List the incentive(s) here:
This question could be answered YES or NO but it should be clear that participants all receive the benefit even if they leave the study before its finished.
4. Is participation in this project or study voluntary for the individuals participating in the program or study?
This question should be answered with a “YES” and should be made clear how you are addressing this via your method.
5. Will participants be fully informed about the benefits and any risks?
# 1 and 2 are a NO NO.
#3 is frowned on.
#4 better always be answered with a YES
#5 better always be answered with a YES

14. IRB Questions (cont.)
6. Will participants be videotaped during the project or study?
This question could be answered YES or NO but it should be clear that the identifiable evidence is deleted and not published.
7. Will participants’ privacy and personal information be protected? Briefly explain how privacy and information will be protected:
This question should be answered with a “YES” and should be made clear how you are addressing this via your method.
8. Will participants be debriefed following completion of the project or study?
9. Will participants, prior to the project, indicate informed consent to participate by completing and signing a written form?
10. Are data sources clearly identified (such as interviews, survey, existing project data such as services received, reports, grades, existing school records, focus group, etc.)?
6. Videos must be destroyed after data is analyzed
#7-9 better be answered with a YES

15. IRB Approval Process: Decision Tree
Does your research (data collection) involve human subjects No
Obtain teacher approval prior to performing research
Identify whether or not research study is EXEMPT from IRB approval
Yes
Exempt (YES)
Exempt (NO)
Send approval documents to teacher who sends docs to IRB
IRB determines risk of human subjects and will determine approval status
See next slide

16. IRB Exempt Decision Tree
If you are performing your research as a class assignment (such is the case for the AP Research course) and are engaged in interviewing, surveying, etc. types of research, this is not classified as human research so long as it is NOT PUBLISHED.
This type of research is exempt from IRB approval
YOU MUST STILL include safety measures in your method (see previous slides on IRB questions).

17. IRB Exempt Decision Tree
If you plan on publishing your research in which you interact with humans, you must submit your proposal to an IRB for approval.
You will need:
Informed Consent Forms
Confidentiality agreements
IRB application

18. Institutional Animal Care and Use Committee (IACUC)
Public Health Service (PHS) and U.S. Department of Agriculture (USDA) require research involving animals receive review by IAUCC.
IACUC Protocol must be submitted at least 60 days before submission deadline

19. Common Documents Needs for IRB Approval
Common documents for IRB Approval
Application for IRB Approval
Informed Consent Form(s)
Letters of approval from cooperating entities (organizations or institutions-where applicable)
Research methods (research design, data source, sampling strategy, etc.)
Questionnaires, surveys, or other data-gathering forms
Sample s, letters, flyers etc., that will be distributed to the study subjects

20. When are Informed Consent Forms for Under 18 Research Subjects not required?
Research conducted in established settings:
Involving normal educational practices;
Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subject.
Research involving observation of legal public behavior.
Research involving collection or study of existing publicly available data.

21. Rule of Thumb for Students
Do not come in contact with or use harmful/hazardous substances or organisms
If you are working at an institution or organization performing scientific experiments where you will come in contact with harmful/hazardous substances or organisms, your supervising scientist will not allow you to perform research without engaging in IRB approval with their institution/organization and should work with you to develop these documents.
You will need copies of these documents for your PREP
Do not experiment on yourself

22. Rule of Thumb for Students
Do not experiment on other human beings with anything other engaging in surveys, focus groups, interviews, or questionnaires
When doing so:
Include ethical/safety measures in your method (see table on IRB questions)
Do not collect identifiable information
If you have to do interviews/surveys face to face then:
Code all information so that it is “de-identified”
Do not publish identifiable information
Destroy all identifiable information collected

23. Safe Research Practices and Risk Assessment
It goes without saying that students should not be engaging in research dealing with hazardous substances on their own and in locations where they are not supervised or safety precautions are not explicit nor carried out.
Additional forms to protect students and to ensure safe research settings and the implementation of safe research practices:
Industrial Setting Form
Risk Assessment Form

24. L12: Practice

25. Checking for Safe and Ethical Research Practices
Proposal Title
Explicit
Implied
Missing
Should Safe/Ethical Practices be Made Explicit (Y/N) and why
How could this proposal be IRB Exempt?
Example: Image of Islam in the U.S. Y
Student should include information about maintaining the anonymity of interviewed students.
Agree to not publish the study regardless of maintaining adherence to ethical research standards.
All of these are exempt as long as the rules are obeyed and as long as work isn’t published.

26. Your Turn Proposal Title Explicit Implied Missing
Should Safe/Ethical Practices be Made Explicit (Y/N) and why
How could this proposal be IRB Exempt?
Sustainable Operations Y
The student does not need to include safe/ethical practices because he/she will be using public databases to gather information.
Mathematical Incompetence
Student should include information about maintaining the anonymity of interviewed students.
The Politically Correct Movement

27. L12: Reflect

28. Reflection-Include your response in your workbook.
What additional information do you need to make sure you are acknowledging and applying safe and ethical research practices throughout your research?
In order to receive approval for your research proposal, what must you include in your proposal form to make sure you are appropriately addressing ethical and safe research practices?