What is an IRB and what is its purpose?

What is an IRB and what is its purpose?

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

How long does IRB approval last?

How long does my IRB approval last? IRB approval is for a 12-month period from time of original approval. A renewal notice will be sent 60 days and 30 days prior to your expiration date of your study by an automated notification through iMedRIS.

How do you protect participants in a research study?

To protect participants’ confidentiality, you should encrypt computer-based files, store documents (i.e., signed consent forms) in a locked file cabinet and remove personal identifiers from study documents as soon as possible.

In what way is the IRB involved in using participants in a research study?

In sum, IRB members, IRB administrators, and investigators each play a role in protecting research participants within an institutional framework that removes impediments to quality research while ensuring compliance with applicable regulations.

How do you ensure anonymity in research?

Researchers employ a number of methods to keep their subjects’ identity confidential. Foremost, they keep their records secure through the use of password protected files, encryption when sending information over the internet, and even old-fashioned locked doors and drawers.

What rights do research participants have?

Obtain informed consent from all study participants. Maintain the confidentiality of study participants. Quickly respond to all participant concerns and questions. Tell participants about changes to the risks or benefits of the study.

How can you protect participants from harm in research?

In order to minimising the risk of harm you should think about:

1. Obtaining informed consent from participants.
2. Protecting the anonymity and confidentiality of participants.
3. Avoiding deceptive practices when designing your research.
4. Providing participants with the right to withdraw from your research at any time.

What is the common rule for research?

The Common Rule is the baseline standard of ethics by which any government-funded research in the US is held; nearly all U.S. academic institutions hold their researchers to these statements of rights regardless of funding.