COMMON QUESTIONS

21 CFR 50.27(a) requires that a copy of the consent document be given to the person signing the form. Does this copy have to be a photocopy of the form with the subject's signature affixed?

21 CFR 56.115(a)(1) requires that the IRB maintain copies of "research proposals reviewed." Is the "research proposal" the same as the formal study protocol that the investigator receives from the sponsor of the research?

Approved, Granted or Cleared – which term for what pathway?

Are FDA inspections of clinical investigator sites announced or unannounced?

Are IRBs Inspected by FDA?

Are annual IRB reviews required when all studies are reviewed by the IRB each quarter?

Are placebo-controlled studies effective?

Are research sponsors obligated to determine IRB compliance with regulations?

Are research sponsors permitted to contact the Institutional Review Board (IRB) directly?

Are there activities that are prohibited by sponsors of an investigational device?

Are there alternatives to obtaining informed consent from a subject?

Are there any regulations that require clinical investigators to report to the IRB when a study has been completed?

Are there any screening procedures that could be performed without first obtaining consent?

Are there different goals for IVD studies compared to other device studies?

Can a physician use an unapproved device in an emergency?

Can a sponsor conduct a foreign clinical study under an IND, and if so, must investigators who conduct studies outside of the United States sign a 1572?

Can subjects be screened prior to initiation of a clinical study to determine eligibility? Is informed consent required for screening?

Can you add additional testing on the same subject to the dataset, particularly when it is hard to find study subjects?

Could the software change significantly affect clinical functionality or performance specifications that are directly associated with the intended use of the device?

Do Radioactive Drug Research Committees (RDRCs) have authority to approve initial clinical studies in lieu of an IND?

Do clinical screening procedures require IRB oversight?

Do the FDA regulations permit non-local IRB review?

Does FDA prohibit direct communication between sponsors and IRBs?

Does FDA require IRB review of off-label use of a legally marketed device?

Does FDA require the informed consent document to contain a space for assent by children?

Does a non-affiliated member need to attend every IRB meeting?

Does a physician, in private practice, conducting research with an FDA regulated product, need to obtain IRB approval?

Does a sponsor need FDA authorization to charge for the costs of drug delivery, formulation, packaging, instrumentation, monitoring, disposables, setup, and nursing care?

Does a treatment IND/IDE require prior IRB approval?

Does an IRB or institution have to compensate subjects if injury occurs as a result of participation in a research study?

Does clinical investigation of a marketed drug or biologic always require an IND submission?

Does your software device qualify for a special 510(k) submission?

Does your software device qualify for the abbreviated 510(k) program?

Explain the difference between Significant Risk (SR) vs. Non-Significant Risk (NSR) devices

For foreign clinical studies conducted under an IND, how can an investigator sign the 1572 when the investigator knows he/she cannot commit to all of the requirements on the form, specifically IRB membership?

How are Biopharma Clinical Trials categorized?

How are IRB inspections conducted?

How are Medical Device Clinical Trials categorized?

How are clinical investigator inspections conducted?

How are study subjects made aware of possible costs associated with participation?

How can FDA protect human subjects following the discovery of clinical investigator misconduct?

How can a sponsor charge for its investigational drug in a blinded, controlled clinical trial without compromising the blind and the integrity of the clinical data generated from the trial?

How can a sponsor know whether an IRB has been inspected by FDA, and the results of the inspection?

How can informed consent be obtain from non-English speaking subjects?

How can informed consent be obtained from illiterate English-speaking subjects?

How can manufacturers identify and protect device assets and functionality?

How can you determine if an in vitro diagnostic (IVD) device is of significant risk?

How can you determine the extent of risks and harms associated with a device change?

How can you determine the level of concern of your software device?

How can you obtain an emergency IND?

How do 510(k) submissions review measures taken towards patient safety?

How do you design a comparison study?

How do you design a reproducibility study?

How do you determine if an in vitro diagnostic (IVD) study is applicable for an IDE regulation?

How do you determine substantial equivalence for a 510(k) submission?

How do you prepare a 510(k) using the safety and performance based pathway?

How do you submit a 510(k) using the safety and performance based pathway?

How does FDA classify medical devices?

How does a sponsor submit information to FDA about a foreign clinical study that was not conducted under an IND?

How does the non-local IRB obtain knowledge of local community attitudes, conditions surrounding the conduct of the research, and the continuing status of the research?

How have the FDA policies on enrollment of special populations changed?

How is payment to research subjects for participation in studies viewed and assessed by IRBs?

How long may a sponsor charge for an investigational drug for expanded access use after FDA authorizes the charging?

How should animal allocation to experimental grouping be done in animal studies?

How should animal quarantine and conditioning be performed?

How should gender differences be factored into the clinical investigation process?

How should informed consent be documented?

How should risks be evaluated for animal studies?

How should the 1572 be completed?

How should the risk/benefit analysis be performed in the practice of oncology?

How should unresolved anomalies, like bugs or defects, be documented?

How should you link your Q-Submission to future regulatory submissions?

How should you use animal studies in preparation for a regulatory submission?

How will your Q-Submission be tracked by the FDA?

If a site uses a receptionist to screen subjects for studies, must the script he/she uses be reviewed by the IRB?

If a sponsor chooses to conduct a foreign clinical study under an IND and the investigators comply with ICH E6 GCP Consolidated Guidance, would non-US investigators also be in compliance with FDA’s IND requirements?

If a sponsor’s own approved drug is used as concomitant therapy during a clinical trial intended to evaluate another drug, should the sponsor obtain authorization to charge for the drug used?

If an IRB disapproves a study submitted to it, and it is subsequently sent to another IRB for review, should the second IRB be told of the disapproval?

If an IRB uses a standard "fill-in-the-blank" consent format, does the IRB need to review the filled-out form for each study?

If your device is an In Vitro Diagnostic Device, what should you do if your device undergoes a technology, engineering, performance, or material change?

In selecting animal models, what should your rationale include?

In what circumstances does FDA intend to exercise enforcement discretion as to the requirements for informed consent for use of specimens in FDA regulated IVD studies?

Is getting the subject to sign a consent document all that is required by the regulations?

Is informed consent required when treating/diagnosing a patient with an HUD?

Is it acceptable for the consent document to say specimens are "donated"?

Is it permitted to incentivize participants to complete the study by offering more money for completion?

Is the name and address of the research facility a sufficient description for supporting information intended for FDA acceptance of foreign clinical studies not conducted under an IND?

Is the purpose of the IRB review of informed consent to protect the institution or the subject?

May a clinical investigator be an IRB member?

May a hospital IRB review a study that will be conducted outside of the hospital?

May informed consent be obtained by telephone from a legally authorized representative?

May the IRB use alternate members?

Must an IRB review a study conducted after submission of 510(k) to FDA but prior to FDA’s decision on the submission?

Must an institution establish its own IRB?

Must an investigator's brochure be included in the documentation when an IRB reviews an investigational drug study?

Must foreign clinical study sites in a multinational study that includes domestic sites be conducted under an IND?

Should sponsors consider anything else in deciding whether or not to conduct a study that may fall within the exercise of enforcement discretion?

Should the sponsor prepare a model informed consent document?

The FDA regulations exempt an emergency use of a test article from prospective IRB review, however, "... any subsequent use of the test article at the institution is subject to IRB review." What does the phrase "subsequent use" mean?

The informed consent regulations require the consent document to include a statement that notes the possibility that FDA may inspect the records. Is this statement a waiver of the subject's legal right to privacy?