CITI Training Basic Research Course

Introduction

The Council for International Organizations of Medical Sciences (CITI) is a nonprofit organization that promotes the highest ethical standards in research. CITI provides training and mentoring to scientists conducting human studies, including basic research. The goal of this course is to help researchers understand the importance of protecting human subjects and ensure that they meet all requirements outlined by their institution’s IRB or institutional review board (IRB).

Course Overview

The course is designed to provide you with an introductory understanding of the various types of research that can be conducted in a clinical setting. You will learn about the types of patients who are most likely to benefit from treatment using evidence-based practices, as well as other factors that may influence their response. You will also learn about how these factors might affect your ability to interpret test results and make recommendations for treatment decisions.

The course contains videos, as well as interactive exercises that allow students to interact with each other while learning new information. The goal is for students to become comfortable asking questions about each topic presented so they can use this knowledge when making decisions on how best serve their patients’ needs in future sessions!

Introduction to Human Subjects Research

The first step to designing your research study is to define the problem. In other words, what do you want to find out? This can be as simple as “I want to lose weight” or more complicated like “I want to learn about how my fitness goals affect my health overall.”

The second step is setting goals for yourself and your study. You should always have one overarching goal that drives all your individual research questions and another broad category of subgoals (or multiple categories) that will help guide you through this process.

For example: if I were helping someone who wanted to lose weight but didn’t know where they could start or what kind of information would be helpful, then I might ask them questions like: “How much do you weigh now?”; “When was the last time you weighed yourself?”; “What type(s) of exercise do/did work best for losing weight?” These types of questions give us insight into their current habits and knowledge levels so we can better tailor our approach toward achieving their desired outcome(s).

Assessing Risks and Potential Benefits of Research Involving Human Subjects

• Assess risks and benefits.

• Assess the risks and benefits of the study.

• Assess whether the risks are reasonable in relation to the potential benefits for the subject population, taking into account any relevant ethical considerations (e.g., risk-benefit ratio). It is also important that you consider how your research will be used by others after its completion; this may be an issue if it could lead to harm or distress for individuals or groups who participated in your study (see Section 4).

Evaluating the Risks and Potential Benefits of Study Interventions

The IRB should consider the risks and potential benefits of available alternative research methods, if any.

• The IRB should weigh the risks and potential benefits of each intervention in relation to other available treatments, if any.

• The IRB should balance these two factors as carefully as possible so that they can be considered together when making decisions about whether or not to approve a study design or protocol.

Informed Consent and Informed Consent Process

Informed consent is a process of communication between a researcher and a research participant. The researcher must explain the purpose of the research study, what procedures will be used, what risks are involved and what benefits may be expected.

During this course you will learn how to obtain informed consent from participants/subjects before starting any experiment or study on them.

IRB Review of a Protocol

IRB review is a committee of volunteers, who are experts in their field and are not paid. They must be unbiased and independent of the researcher to ensure the protection of human subjects. The IRB can get involved at different stages of research: before the study begins, during its execution and after it has been completed.

IRBs must approve all proposed studies involving human subjects (studies that do not involve animals) prior to their implementation or implementation plans must be submitted for approval before starting a project

Minimal Risk and Greater-Than Minimal Risk Research

Minimal risk research is the process of studying a topic and finding that there are no significant differences between groups being studied. In other words, it’s not likely to lead to any significant changes in practice or policy. The results are presented in a way that implies a lack of harm or benefit over what already exists. For example, if you’re conducting a study on whether people who drink coffee have lower rates of heart disease than those who do not drink coffee, your study might conclude that there is no difference between these two groups; however, this would be considered minimal risk because it doesn’t tell us anything new about how much better one group does than another (or worse). This type of study does not require approval from an ethics board because its purpose isn’t to change current practice but rather simply show whether something works—but only under certain circumstances!

Greater-than-minimal risk research involves looking at potential benefits and harms associated with certain behaviors or practices before deciding which ones should be adopted into public policy decisions like putting warning labels on cigarette packs or requiring seat belts for teenage drivers.”

Vulnerable Populations in Research (Children, Pregnant Women, Fetuses, Prisoners, Cognitively Impairment)

• Children

• Pregnant women

• Fetuses

• Prisoners, cognitively impaired

IRB Consideration for Vulnerable Participants in Research

When conducting research with vulnerable populations, you must comply with the IRB requirements. This means that your institution must have a physical or virtual location designated as an “IRB site” where your study will be conducted. You can also recruit participants from other sites, but they will need to be registered at the same location and follow all other rules of engagement from there (e.g., informed consent). As part of this registration process, you’ll need to file an application for certification as a research facility (this is called “IRB Certification”).

Finally, if you’re enrolling participants who are at risk for physical harm based on their demographics—such as old age or low income—you may also want to consider submitting an application for exemption under Section 508 of the Rehabilitation Act of 1973 if it applies in your situation; this would allow them access without having gone through any kind of pre-screening process first!

Scientific Misconduct and Data Safety Monitoring Boards

Scientific misconduct and data safety monitoring boards are two forms of oversight to ensure that research is conducted in an ethical manner.

• Scientific misconduct refers to the intentional or unintentional distortion, falsification, or fabrication of data that results in a study being reported incorrectly. Examples include:

• Forgery, which involves making up research results;

• Plagiarism (copying someone else’s work as your own), which can be committed either knowingly or unknowingly;

• Falsification/fabrication (making up data), which is considered more serious than fabrication alone because it involves deliberate deception. This type of fraud may also be referred to as “research misconduct.”

Learn what CITI training is all about.

CITI Training is a certification program that helps you to become a Certified IT Trainer (CIT). You will learn about the purpose and benefits of CIT training, as well as how to get started on your own journey to becoming a certified instructor.

The following topics will be covered during this class:

• What is CITI Training?

• What is the purpose of CITI Training?

• How do I get started on my own adventure in becoming a certified instructor?

We’ll also be covering what questions you should ask yourself when deciding whether or not this course would be right for me.

Conclusion

CITI training is the perfect way to prepare your team for effective research. Research projects can have unforeseen consequences if done wrong. This is why it’s important for you and your CITI team members to be well-versed in how to handle ethical responsibilities when conducting research in order remain compliant with both federal and state laws.