Human Subjects Research Ethics

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.