ELEMENT I.7.A.

ELEMENT I.7.A.: When research involves investigational or unlicensed test articles, the organization confirms that the test articles have appropriate regulatory approval or meet exemptions for such approval.

This Element applies only to an organization that conducts research or an independent IRB or EC that oversees research involving investigational articles regulated by a national regulatory authority.

When research involves an investigational drug, the organization must ensure researchers have approval from regulatory agencies to use the investigational drug in research, or ensure the drug meets an exemption from this requirement. For example, under the U.S. FDA regulations, research that involves the use of a drug other than a marketed drug in the course of medical practice must have an investigational new drug (IND), unless the research meets one of the five exemptions from this requirement. In other countries, researchers must obtain approval from the regulatory authorities in those countries.

When research involves a device, the organization must ensure researchers have approval from regulatory agencies to use the device in research, or ensure the device meets an exemption from this requirement. For example, under U.S. FDA regulations, research that is conducted to determine the safety or effectiveness of a device must have an IDE issued by the U.S. FDA, unless the device meets the requirements for an abbreviated investigational device exemption (IDE) (21 CFR 812.2(b)(1)) or the research meets one of the five exemptions from the requirement for an IDE (21 CFR 812.2(c)). When device research is conducted in other countries, researchers or the sponsor must obtain approval from the regulatory authorities in those countries.

When research involves the use of an investigational drug or device, the organization must confirm approval from regulatory authorities exists before research may commence. For example, in the U.S., organizations must confirm the drug has an IND or meets an exemption from this requirement, and must confirm a device has an IDE, the device fulfills the requirements for an abbreviated IDE, or the research meets one of the FDA exemptions from the requirement to have an IDE. When research involves a drug or device with an IND or IDE, respectively, the organization should evaluate whether the IND or IDE number is valid. This prevents situations where researchers begin studies that require regulatory authority approval, such as an IND or IDE, before the FDA or other regulatory authority has issued a number. Validation can be done by determining that an approval number granted by the regulatory authority, such as an IND or IDE number, matches the sponsor protocol, or communication from the sponsor, or communication from the relevant government regulatory authority. In the case of a researcher who holds the approval from the government regulatory agency, such as an IND or IDE number, the number should match information provided by the government regulatory agency. An investigator’s brochure may not be used because one investigator brochure often covers multiple government-issued approval numbers, for example, multiple INDs or IDEs.

Regulatory and guidance references

FDA: 21 CFR 11, 21 CFR 54, 21 CFR 210, 21 CFR 211, 21 CFR 312, 21 CFR 314, 21 CFR 320, 21 CFR 330, 21 CFR 601, 21 CFR 807, 21 CFR 812, 21 CFR 814, 21 CFR 820, 21 CFR 860
ICH-GCP: 4.65
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)

Required written materials

Essential requirements:
1. Policies and procedures describe the legal and regulatory requirements that apply to the use of investigational test articles.
  1. Policies and procedures describe the process the organization uses to confirm that test articles have appropriate regulatory approval, such as a clinical trial certificate or an IND or IDE, or meet exemption requirements for such approvals.
When following FDA regulations:
1. When research involves the use of a drug other than a marketed drug in the course of medical practice, policies and procedures describe the process to confirm that:
  1. The drug has an IND or the research meets one of the FDA exemptions from the requirement to have an IND.
  2. When research is conducted to determine the safety or effectiveness of a device, policies and procedures describe the process to confirm that the device has an IDE issued by the FDA, the device fulfills the requirements for an abbreviated IDE, or the research meets one of the FDA exemptions from the requirement to have an IDE.
  3. The IRB or EC makes a determination whether the device is a significant or non-significant risk device.
2. When research involves a drug with an IND or a device with an IDE, policies and procedures describe the process to confirm that the IND or IDE number is valid.
  1. For FDA-regulated research involving an investigational drug conducted outside of the U.S., an IND is not required provided the research is conducted under the Declaration of Helsinki (1989) and Good Clinical Practice guidelines.
  2. For FDA-regulated research involving an investigational drug, the research does not commence until a valid IND is in place.
When following requirements in countries other than the US:
1. Organizations should follow requirements in country law. Guidance for some countries are provided in the country-specific AAHRPP Addenda to the Evaluation Instrument.

Common types of materials that may be used to meet the element

Application form
Reviewer checklist

Outcomes

Research involving the use of investigational articles complies with regulations governing investigational articles.

Proceed To: ELEMENT I.7.B.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.7.A.