Research Principles: IRB

What is the Institutional Review Board (IRB)?

Administrative body established to protect the rights and welfare of participants conducted under an affiliated institution. Mostly Universities. Private practices do not have an IRB.

What is a human subject?

A living individual about whom an investigation conducting research obtained 1) data, intervention, interaction with the individual or 2) identifiable private information.

An IRB must have 5 members or more of

varying backgrounds including those knowledgeable of relevant vulnerable populations. At least 1 member whose primary concern is relevant to the research and 1 member who is not. 1 Member who is not a affiliated with the institution.

An IRB member…

Cannot review their own proposal. Can invite individuals with special competence to assist in review.

What do IRBs do?

approves or denies protocol based on whether or not human subjects are adequately protected. Can approve with modifications (minor or major) or disapprove under it’s jurisdiction.

Officials of an Institution (administrators) can

disapprove a study approved by an IRB but not approve one the IRB rejected.

What does the IRB look at?

Protection of human subjects, research design, noncompliance, Protection of animals.

Protection of Human subjects involves

Risk-benefit analysis, informed consent, reasonable selection of subjects, privacy, confidentiality, monitoring and observation of risk, incentive for participation explanation, and continuing review.

What is de-identification?

when data has had the personally identifying information removed.

Continuing Review

The rate at which the IRB reevaluates the project. Is sometimes dependent on risk-benefit ratio.

Research Design

There are no federal regulations for IRB to review the scientific validity of the research design. But some studies can be so methodologically flawed so that there will be no benefits to outweigh the risks.

Noncompliance

when a researcher/institution does not obey the IRB. FDA and OPRR can conduct inquiries or investigations into alleged noncompliance. Sanctions can be imposed or the IRB can stop the study, suspend your ability to do research, suspend the entire institution’s ability to do research. There are also appeals that can be filed.

Research Integrity involves?

Disclosure of conflicts of interest, proper crediting for intellectual effort, proper attribution of ideas, accurate reporting of results, proper data management, and confidentiality.

What is conflict of interest?

When you have personal stakes in research that may effect your role as an investigator. Conflicts may be personal, financial, or institutional. If there is a conflict, you must state/plan to minimize them.

Attributation of Ideas

Appropriately referencing where you got your additional information (other research, books, etc.) Know the difference between plagiarism vs. paraphrasing. Did you use AI or is it fully your work? Acknowledge the use and how you used it.

What is the most common pitfall when it comes to research writing and the attribution of ideas?

Using too many direct quotes.

What is scentific misconduct?

Inaccuracies in collecting, interpreting, or reporting results can affect the overall impact of the study. Fabricating results Representing another’s work as your own.

What are some relevant bodies to research data and ethics?

HIPAA, AAA code of ethics, ASHA code of ethics.