Determine Feasibility of Conducting the Study

Ethical Board Approvsl or Institutional Review Board, (IRB)

Aim is to protect human subjects for that institution.

Informed consent is rendered.

A statement of the study’s purpose in lay terms and simply stated.

A statement about the type of data to be collected.

A description of why the subject was chosen to participate in the study.

An explanation of the potential risk or costs and benefits, or both, to the subjects.

A description of the study procedures, including the length of time the study will take.

Assurance of confidentiality or anonymity about the way the data will be handled.

Names and numbers of the researchers so the subjects may contact them if there are any questions.

A statement about the subjects’ rights to withdraw from the study that clearly states that the subject is a volunteer and has not been coerced in any way to participate in the study.

igenerally required for research involving human participants, human data, or biological specimens to ensure the study is conducted ethically and in compliance with regulations. Below are the primary types of studies requiring ethical board approval:

1. Human Participants

Clinical trials: Testing drugs, devices, or medical procedures.
Behavioral studies: Observing or intervening in human behaviors.
Psychological experiments: Studies on cognition, emotions, or mental health.
Surveys and questionnaires: If they involve sensitive topics or identifiable information.
Social science research: Studies on groups, cultures, or human interactions.

2. Human Biological Material

Use of tissues, blood, or other bodily samples.
Studies on genetic material, including DNA or RNA.

3. Secondary Use of Human Data

Retrospective studies using existing medical records or datasets containing identifiable information.
Data from biobanks or registries.

4. Vulnerable Populations

Studies involving children, prisoners, pregnant women, or other groups requiring special protections.

5. Risk-Intensive Research

Studies that could cause physical, psychological, social, or financial harm.
Research with deception or incomplete disclosure.

6. Innovative Procedures

Research using experimental interventions or off-label uses of medications.

When IRB/Ethical Approval May Not Be Needed

Quality improvement/assurance activities: If intended solely for internal improvement and not generalizable.
Publicly available data: Research involving completely anonymized datasets.
Non-human studies: Research on animals or computer models (requires separate ethical oversight like IACUC for animals).

If you're unsure, consult your institution's ethical review board or guidelines, as requirements can vary based on jurisdiction and research type.