Human Subjects Research Ethics

<p>1953 (B)</p> Signup and view all the answers

<p>Clear communication of risks involved (B)</p> Signup and view all the answers

<p>A Cayuse account (C)</p> Signup and view all the answers

<p>They do not necessitate a COI Disclosure. (C)</p> Signup and view all the answers

<p>The Principal Investigator (PI) (B)</p> Signup and view all the answers

<p>CITI training and COI disclosure (A)</p> Signup and view all the answers

<p>Answers to relevant questions based on the project (D)</p> Signup and view all the answers

<p>Email communication with further instructions (B)</p> Signup and view all the answers

<p>A CITI account and a Cayuse account (B)</p> Signup and view all the answers

<p>Conflict of Interest disclosure (B)</p> Signup and view all the answers

<p>To address past abuses in human rights research (C)</p> Signup and view all the answers

<p>Informed consent (A)</p> Signup and view all the answers

<p>The goal of maximizing possible benefits while minimizing harm (C)</p> Signup and view all the answers

<p>They often lack the ability to provide voluntary consent (B)</p> Signup and view all the answers

<p>The historical exploitation of certain groups in research (B)</p> Signup and view all the answers

<p>Participants should have thorough understanding before agreeing to participate (A)</p> Signup and view all the answers

<p>Participation can be terminated by a participant at any time (C)</p> Signup and view all the answers

<p>Providing extra layers of protection against exploitation (D)</p> Signup and view all the answers

<p>Meeting specific criteria (C)</p> Signup and view all the answers

<p>Electronic products (B)</p> Signup and view all the answers

<p>Insurance requirements (D)</p> Signup and view all the answers

<p>Limited data set (A)</p> Signup and view all the answers

<p>Psychological risks (D)</p> Signup and view all the answers

<p>Social risk (B)</p> Signup and view all the answers

<p>Ensuring participant understanding (B)</p> Signup and view all the answers

<p>Data set with all 18 identifier categories removed (C)</p> Signup and view all the answers

<p>Participant withdrawal from the study (A)</p> Signup and view all the answers

<p>To ensure participants are making an informed decision about their involvement (C)</p> Signup and view all the answers

<p>Possibility of job loss (B)</p> Signup and view all the answers

<p>Program evaluation (A)</p> Signup and view all the answers

<p>Findings are designed to be generalizable (B)</p> Signup and view all the answers

<p>Research involving living individuals (A)</p> Signup and view all the answers

<p>Randomized controlled trials (B)</p> Signup and view all the answers

<p>Identification of best practice recommendations (C)</p> Signup and view all the answers

<p>Compliance with quality improvement standards (D)</p> Signup and view all the answers

<p>Use of comparison or control groups (B)</p> Signup and view all the answers

<p>Control subjects often experience the same conditions as participants (D)</p> Signup and view all the answers

<p>Enhancing internal processes (A)</p> Signup and view all the answers

<p>Incorporating focus group feedback (C)</p> Signup and view all the answers

<p>Confidentiality and protection of identity must be maintained (D)</p> Signup and view all the answers

<p>Evidence-based decision-making (B)</p> Signup and view all the answers

<p>Emphasis on site-specific findings (C)</p> Signup and view all the answers

<p>To protect the rights and welfare of human research subjects (D)</p> Signup and view all the answers

<p>Risks to subjects should be minimized and reasonable in relation to anticipated benefits (D)</p> Signup and view all the answers

<p>Harm is equivalent to that encountered in daily life or routine exams (B)</p> Signup and view all the answers

<p>The privacy of individually identifiable health information (D)</p> Signup and view all the answers

<p>In a way that ensures participants understand it is a research study (C)</p> Signup and view all the answers

<p>If researchers have financial stakes in the study’s outcome (C)</p> Signup and view all the answers

<p>Equitable distribution of research burdens and benefits (D)</p> Signup and view all the answers

<p>To oversee compliance with the HIPAA Privacy Rule (D)</p> Signup and view all the answers

<p>Vulnerable subjects who may be at increased risk (D)</p> Signup and view all the answers

<p>It ensures the safety of subjects and compliance with protocols (C)</p> Signup and view all the answers

<p>Obtain signed authorization from participants (D)</p> Signup and view all the answers

<p>Release of identifiable health information without consent (D)</p> Signup and view all the answers

<p>To ensure participants are voluntarily making informed decisions (A)</p> Signup and view all the answers

<p>To prevent research misconduct and maintain ethical standards (B)</p> Signup and view all the answers

Ethical framework for research involving human subjects, establishing key principles like respect for persons, beneficence, and justice.

Principle in research ethics emphasizing autonomy and protection of vulnerable populations.

A participant's voluntary agreement to take part in research after understanding the procedures, risks, and benefits.

First US policy for protecting human research subjects, initiating mechanisms for review of research proposals.

Principle in research ethics, maximizing benefits and minimizing harms to participants.

A committee that reviews research involving human subjects to ensure ethical practices.

Research that focuses on understanding, protecting, and promoting human rights.

Groups of people who are more susceptible to harm in research due to factors like age, illness, or social status.

IRBs exist because past research practices exploited people, especially vulnerable groups. They ensure ethical research standards to prevent harm and promote fairness.

A participant's voluntary agreement to participate in research after fully understanding its risks and benefits.

A principle that requires researchers to maximize benefits and minimize risks to participants.

Research that respects the rights of individuals, ensures voluntary participation, and strives for fairness and justice.

Research information should be detailed enough for participants to understand, not just long and complicated. Participants need to easily comprehend what they're getting into.

The IRB's process of evaluating research proposals before the research begins.

The IRB's ongoing monitoring of approved research projects to ensure ethical and safety protocols are maintained.

A law that protects the privacy and security of people's health information, ensuring it is handled carefully and confidentially.

Research participants who are especially susceptible to coercion or undue influence, requiring extra protections.

Research where the risks to participants are no greater than those encountered in everyday life.

Evaluating potential harms and benefits of research to ensure risks are minimized and benefits outweigh potential harms.

Choosing research participants fairly, without bias or favoring any specific group.

Ensuring the benefits and burdens of research are shared fairly among individuals or groups.

Protecting the privacy of participants' data, ensuring it is only accessible to authorized individuals.

The process of regularly checking on the well-being of research participants throughout the study.

The process of gathering information from research participants, using methods like surveys, interviews, or observations.

The plan for how a research study will be conducted, including the methods, procedures, and data analysis.

Any research that involves living individuals, collecting information or biospecimens, or interacting with them.

A special permission granted by a research ethics board to collect personal health information without individual consent, but only under specific circumstances where it is essential and poses minimal risk to privacy.

A type of data that has been stripped of direct identifiers (like name, address, etc.) but still allows for some analysis of health information.

A data set where ALL 18 categories of personal identifiers have been removed, making it completely anonymous.

Anything used in research that is being studied, such as a drug, device, or even a new app.

Any action taken by researchers to influence the participants, such as giving them a treatment or observing them in a particular way.

A type of 'intervention' where researchers might use needles to draw blood or administer medication, raising safety concerns.

Any potential harm or negative consequence that participants might experience as a result of their involvement in the research.

Ensuring that the research is designed and conducted in a way that minimizes the possibility of harm to participants.

Protecting the confidentiality and anonymity of participant information to prevent it from being disclosed to unauthorized individuals.

Informed consent is a process where participants understand the research, its risks and benefits, and willingly agree to participate. It's a cornerstone of ethical research.

Potential harms or negative consequences that participants might face while taking part in research.

Identify the project type (Research/Non-Research), obtain a Cayuse account, complete CITI training, create a Cayuse project master file and submit a Cayuse SMART form.

A platform used by Kettering Health for electronic submission of research projects, ensuring compliance and ethical review.

Protected health information like names, addresses, and Social Security numbers, regulated by the Health Insurance Portability and Accountability Act.

Mandatory online modules for researchers, covering ethical principles and regulations related to human subject research.

A structured effort to enhance internal processes and outcomes within an organization or institution.

A systematic process of using research findings to guide healthcare practices and improve patient care.

A situation where a researcher's personal interests could influence their work or the research's outcome.

A standardized form in Cayuse used to submit research projects to the IRB for review and approval.

A systematic investigation using scientific methods to explore a phenomenon and generate new knowledge.

The extent to which research findings can be applied to other populations or settings.

An ethical review process conducted by the Institutional Review Board, evaluating research proposals to ensure protection of human subjects.

The lead researcher responsible for overseeing all aspects of a research project, including ethics and compliance.

A group in research that does not receive the intervention or treatment being studied, used for comparison.

The IRB notifies the researchers of their decision (approved, rejected, or needs revision). If approved, the project can proceed with data collection and analysis.

Assigning participants to different groups (e.g., treatment vs. control) randomly to minimize bias.

The process of presenting research proposals to an Institutional Review Board for ethical review and approval.

Steps taken before formally submitting a research proposal to an IRB, such as reviewing guidelines and preparing documents.