ELEMENT III.1.C.

ELEMENT III.1.C.: Researchers employ sound study design in accordance with the standards of the discipline. Researchers design studies in a manner that minimizes risks to participants.

Researchers should design research studies so that the research will most likely develop or contribute to generalizable knowledge. Studies should be designed according to standards and ethical practices of the discipline. When researchers do not design a research study, they should judge the research design to be sound enough to meet the study’s objectives before agreeing to enroll participants.

As part of their obligation to protect participants, researchers should understand the concept of minimizing risks. When researchers design research, they should consider designs that minimize risks. In protocols, researchers should describe the rationale for the chosen procedures and provide a risk- potential benefit analysis of the research.

When appropriate, researchers who design research should incorporate plans to monitor the data for the safety of participants. For example, research studies involving more than minimal risk are expected to have a plan for monitoring the data for the safety of participants. Researchers should understand that monitoring might occur at specific points in time, after a specific number of participants have been recruited, or upon recognition of harms. Monitoring might be conducted by a third party (e.g., the sponsor, medical monitor, data monitoring committee, or another researcher).

Regulatory and guidance references

DHHS: 45 CFR 46.111(a)(1), 45 CFR 46.111(a)(2), 45 CFR 46.111(a)(6)
DOJ: 28 CFR 512.11(a)(6), 28 CFR 512.12
FDA: 21 CFR 56.111(a)(1), 21 CFR 56.111(a)(2), 21 CFR 56.111(a)(6)
ICH-GCP: 4.7,4.5.1
VA: 38 CFR 16.111(a)(1), 38 CFR 16.111(a)(2), 38 CFR 16.111(a)(6), VHA Directive 1200.05(3) section 5
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 pertaining to Elements II.3.A., II.3.B., and II.4.A. that address essential requirements are consistent with educational materials or Web site information for researchers, or the Investigator Handbook.
2. In the case above, the policies and procedures pertaining to Elements II.3.A., II.3.B., and II.4.A. also address the written material requirements for this Element. If the same policies and procedures are provided to researchers and research staff, simply reference those documents in the application for this Element. If there are additional materials, such as an Investigator Handbook or Web pages for researchers, that are not included in the materials used to support Elements II.3.A., II.3.B., and II.4.A., but are in support of Element III.1.C., include them here.
When following DOJ requirements:
1. Policies and procedures indicate that for research conducted within the Bureau of Prisons, the researcher must have academic preparation or experience in the area of study of the proposed research.
2. Policies and procedures indicate that for research conducted within the Bureau of Prisons, when submitting a research protocol, the applicant must provide a summary statement, which includes:
  1. Names and current affiliations of the researchers.
  2. Title of the study.
  3. Purpose of the study.
  4. Location of the study.
  5. Methods to be employed.
  6. Anticipated results.
  7. Duration of the study.
  8. Number of participants (staff or inmates) required and amount of time required from each.
  9. Indication of risk or discomfort involved as a result of participation.
3. Policies and procedures indicate that for research conducted within the Bureau of Prisons, when submitting a research protocol, the applicant must also provide a comprehensive statement, which includes:
  1. Review of related literature.
  2. Detailed description of the research method.
  3. Significance of anticipated results and their contribution to the advancement of knowledge.
  4. Specific resources required from the Bureau of Prisons.
  5. Description of all possible risks, discomforts, and benefits to individual participants or a class of participants, and a discussion of the likelihood that the risks and discomforts will actually occur.
  6. Description of steps taken to minimize any risks.
  7. Description of physical or administrative procedures to be followed to:
    1. Ensure the security of any individually identifiable data that are being collected for the study.
    2. Destroy research records or remove individual identifiers from those records when the research has been completed.
  8. Description of any anticipated effects of the research study on organizational programs and operations.
  9. Relevant research materials such as vitae, endorsements, sample consent statements, questionnaires, and interview schedules.
  10. A statement regarding assurances and certification required by federal regulations, if applicable.
When following the ICH-GCP (E6) guideline:
1. Policies and procedures describe that researcher and research staff are knowledgeable about the following responsibilities:
  1. During and following a participant’s participation in a clinical trial, the researcher ensures that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the clinical trial. Researchers inform participants when medical care is needed for other illnesses of which the researchers become aware (not applicable to independent IRBs or ECs).
  2. The researcher follows the clinical trial's randomization procedures, if any, and ensures that the code is broken only in accordance with the protocol. If the clinical trial is blinded, the researcher promptly documents and explains to the sponsor any premature unblinding.
When following VA requirements:
1. The VA researcher is responsible for developing and submitting a research protocol that is scientifically valid and ethical, describes the research objectives, background and methodology, and is relevant to the health or welfare of the Veteran population.

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

Researcher manual

Outcomes

Researchers use sound scientific designs in the conduct of research.
Researchers design studies using methodologies and ethical standards consistent with the standards of the discipline.
Researchers understand the concept of minimizing risk.
Researchers consider whether other procedures involving less risk are appropriate when designing a research study.
Researchers design studies that use procedures already being conducted on the participants for non-research reasons.
Researchers modify research designs to mitigate potential injuries in on-going research.
Researchers design studies to monitor data to ensure the safety and well-being of participants.

Proceed To: ELEMENT III.1.D.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT III.1.C.