Sage-Tips

What is an IRB and what is its purpose?

Under FDA regulations, an Institutional Review Board is 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.

What do you need IRB approval for?

FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).

What is the purpose of a 1572?

The 1572 has two purposes: 1) to provide the sponsor with information about the investigator’s qualifications and the clinical site that will enable the sponsor to establish and document that the investigator is qualified and the site is an appropriate location at which to conduct the clinical investigation, and 2) to …

What is the term for the process that is used to prove that a drug is safe and effective in treating specific conditions in certain patient populations?

Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people.

What are the 4 important ethical issues IRB guidelines address?

IRB’S must be guided by principles outlined in Belmont Report:

• Respect for persons: respect for patient autonomy.
• Beneficence: maximize benefits and minimize harm.
• Justice: Equitable distribution of research burdens and benefits.

What is IRB charged with?

In general, an institutional review board is a committee charged by the U.S. government with protecting the rights and welfare of human subjects involved in research.

Which type of IRB does not require approval?

“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.

Do 1572 expire?

Despite the fact the form carries an expiration date, there is no need to provide a new form after the new version with the latest expiration date has been released.

Who needs to be on a 1572?

A new 1572 is required when an investigator is participating in a new protocol that is added to an active IND and when the Principal Investigator of an ongoing study changes, when a Sub-Investigator is added, and when there is a change of location in which the study is being conducted.

How many phases are in a drug trial?

There are 3 main phases of clinical trials – phases 1 to 3. Phase 1 trials are the earliest phase trials and phase 3 are later phase trials. Some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed. Some trials are randomised.

What is an Investigational New Drug Application?

Investigational New Drug Application. In many ways, the investigational new drug (IND) application is the result of a successful preclinical development program. The IND is also the vehicle through which a sponsor advances to the next stage of drug development known as clinical trials (human trials).

How long does it take to get FDA approval for clinical trials?

Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.

What are the requirements for a sponsor to initiate a clinical trial?

Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations. Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials.

Can an investigational drug be shipped to clinical investigators?

Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement.