CITICourseGuidedNotes.docx

PSYC 510 CITI Training Overview and Guided Notes 5

Social and Behavioral Researchers Basic CITI Course

When conducting research, the researcher is responsible for ensuring the welfare of the subjects. Through the years, institutional, federal, and even international measures have been put into place to protect subjects from harm, and these regulations are constantly evolving. It is essential for researchers to keep up-to-date on the major concepts, laws, and regulations governing research.

To expand the concepts covered in your e-book in regards to ethical human research, you must also successfully complete the CITI Ethics Program titled “Social & Behavioral Researchers Basic Course”. To do so, you will need to complete all required modules and several elective modules, earning a minimum of 80% to pass the course and receive your certificate.

To enroll and complete the CITI training follow these directions:

1. Go to .

2. If you have not previously created an account, select Register. This will take you to the registration page.

a. Do not select Log in; this option is for individuals who already have a CITI account.

b. If you have previously created an account, even if it was while you were associated with another institution, use your existing username and password.

3. Affiliate with “ Liberty University.” Note: Do not enter “Liberty IRB.” Check the box to agree to Terms of Service, and then check the box to affirm you are an affiliate of Liberty University.

4. Enter your name and email address.

5. Create a username, password, and establish a security question.

6. Select your country of residence.

7. Select whether or not you would like to receive continuing education credits. Note: This costs money that you would be responsible for paying – receiving CECs is NOT required for this course.

8. Select whether or not CITI may contact you later regarding research surveys and/or marketing information.

9. Respond to the University-specific information as required (LU Email Address, Highest Degree, Department, and Role in Research).

10. Answer the following questions, making sure you select the appropriate course under QUESTION 1:

a. QUESTION 1: HUMAN SUBJECTS RESEARCH (HSR)

i. Select – Social & Behavioral Researchers

b. QUESTION 2: ANIMAL CARE AND USE (ACU)

i. Skip this question!

c. QUESTION 3: BIOSAFETY/BIOSECURITY

i. Select “Not at this time”!

d. QUESTION 4: RESPONSIBLE CONDUCT OF RESEARCH

i. Select “Not at this time.”

e. QUESTION 5: CONFLICT OF INTEREST

i. Select “No”.

f. QUESTION 6: RESEARCH ADMINISTRATION

i. Select “No”.

g. QUESTION 7: STATISTICAL ANALYSIS

i. Select “Not at this time”!

11. Click “Complete Registration”.

12. Check your email, and click the confirmation link to verify your CITI registration.

13. Return to the login page and enter your username and password.

14. Begin your coursework.

Once you begin, make sure to take the following elective modules by clicking on the title of each within the CITI webpage (Choose any of the others that are most relevant to your personal career trajectory – you can take them all, but the following are required, and you must complete enough to earn your CITI certificate). Required “elective” modules:

· Research with Children

· Research in Public Elementary and Secondary Schools

· Internet-based Research

· Students in Research

Once you successfully complete the course, make sure you View/Print your “Completion Certificate”. You can then SAVE your certificate. You will include it in your homework for Week 1 and may need it in the future (e.g., thesis / dissertation / other research methods courses). This certificate is valid for three years and you will be able to access it as long as you remember your log-in and password. (Note: If you already have a valid (unexpired) certificate, you can use it in this class.)

The certificate will be inserted into your homework post as a portion of your grade. Here is mine as an example (note mine has “refresher” course yours won’t have listed). To insert it into your homework, you can take a screenshot of it, use the snipping tool, or save it and then insert it within word.

As the training is rather lengthy and there is a lot of information provided, here is an outline of major objectives you should focus on for each of the required modules (including the required “elective” modules). The material from this outline may be used in course assessments (e.g., homework, discussion boards, and exams) beginning with Week 1. Please complete this form as you take the CITI course so that you have the necessary information that will be emphasized in this course. The title of each module is presented, along with guided notes to take for each module. Note all of the information is important as a researcher, but the information covered in the guided notes will be used in graded activities (e.g., homework, quizzes) for PSYC 510/515. You must complete enough modules, however, to earn the certificate. The certificate is a large portion of the grade for your first assignment.

Module: Belmont Report and Its Principles

· Identify the three principles and apply them to research.

Module: Populations in Research Requiring Additional Considerations and/or Protections

· Four common types of abuses in human research:

· NBAC identified six broad areas that may contribute to being able to provide voluntary informed consent. What are they?

· List the four examples of vulnerable subjects identified in HHS at 45 CFR 46.111.

· When a subject cannot consent for themselves, researchers may obtain consent from

· a LAR, which stands for:

Module: History and Ethical Principles

· 1979 Belmont Report.

· Three principles and definitions (add this information to your notes from the Belmont Report module):

Module: Defining Research with Human Subjects

· Define research:

· Define human subject:

Module: Federal Regulations

· Most recent general compliance date (day, month, year) for the revised Common Rule:

Module: Assessing Risk

· Which basic principle from the Belmont Report embodies the need for informed consent?

· What types of review are available through an IRB?

Module: Informed Consent

· Define Broad consent:

· Vulnerable: subjects vulnerable to possibility of coercion or undue influence

· Understand process of consent verses documentation of consent

· NINE items typically included in informed consent:

Module: Privacy and Confidentiality

· Distinguish privacy from confidentiality

· Define Privacy and know examples:

· Define Confidentiality:

· Described during informed consent process

· Define snowball sampling:

· Invasion of privacy can occur by being asked _________ questions.

· Examples: sexual behavior, childhood abuse, use of psychotropic medications, other personal topics

· State reporting laws – may limit promise of _____________ (e.g., suspected child abuse and neglect)

· Can obtain a certificate of confidentiality for sensitive research through ___________ (even if research is not funded through them)

Module: Unanticipated Problems and Reporting Requirements in Social and Behavioral Research

· Unanticipated problems should be reported to the ____________ and when appropriate, __________________

Elective Module: Research with Children

· Federal definition of “children”:  

· Three layers of regulations / policies to protect child research subjects:

· Parental ______________ is obtained first, then researcher contacts the child for the child to provide ____________.

· Type of assent (as determined by the IRB) should be tailored to the child’s age, __________, and degree of __________________

Elective Module: Research in Public Elementary and Secondary Schools

List the TWO additional regulations that govern research in private and public schools IF they receive federal funds:

Even if an IRB waived the requirement to secure parental permission in accordance with the Common Rule, __________________ requires that, in accordance with school system procedures, parents be notified about the proposed research and be given the opportunity to ask that their children not take part.

Elective Module: Internet-based Research

· Avatars, non-player characters (NPCs) as examples of the difficulties in internet research in defining what is “living individuals”

· One method to determine whether content on a webpage is public or private is to:

· As stated in this module, If individually identifiable information available online is public, it may be compared to collecting information about people from _________________ (which the IRB is not required to review).

· However, individuals may have privacy expectations that are _____________ with the technology they are using.

· Online surveys that offer researchers the option to be given data without an _______________ is an added measure to protect confidentiality and privacy of respondents

· The Common Rule allows IRBs to waive the requirement to document consent, but waiving the requirement to document consent does not waive the requirement for ________________________ .

Elective Module: Students in Research

· List the FOUR requirements that are implied by the term “Voluntary consent”:

· Who makes up an IRB?

· What does an IRB have the authority to do?

· The IRB is charged with reviewing all projects involving human subjects for compliance with __________________________________________________________________

· List / define the three levels of review:

· Federal definition of research

· State categories of studies that are NOT human subjects research, and know examples of each:

· Define Informed consent

· Differentiate “Consent” from “Assent”

· Faculty advisors may be chosen by the student investigator or assigned to the student. Their role as the advisor is to do what?

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