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Information Requirements for Ethical Review

The Required Information on an Ethical Clearance Application for Ethical Assessment

Risk/Anticipated Benefit Analysis
  • Identification and assessment of risks and anticipated benefits
  • Determination that risks are minimized
  • Determination that risks are reasonable in relation to potential benefits
Informed Consent
  • Informed Consent process and procedures
  • Documentation of Informed Consent (form)
Assent
  • The affirmative agreement of a minor or individual with impaired decision-making capacity to participate in research
  • Assent process
  • Documentation of assent
Selection of Subject
  • Equitable selection in terms of gender, race, and ethnicity
  • Benefits are distributed fairly among the community’s populations
  • Additional safeguards are provided for susceptible  vulnerable populations to be pressured to participate (for example, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons)
Privacy/Confidentiality
  • Ensure that subject recruitment does not invade individual privacy and that procedures are in place to assure that the confidentiality of the information collected during the research is maintained
Research Plan for Collection, Storage, and Analysis of Data
  • Clinical research studies often include data safety monitoring plans and/or Data Safety Monitoring Boards/Committees (DSMBs/DSMCs). KEP LPEM FEB UI will review the plans to ensure the adequacy for subject’s safety.
  • Researchers are qualified to collect, handle, and analyze the data responsibly and have a plan for analyzing the data in a meaningful fashion
Research Design/Methods
  • Are appropriate and scientifically valid, and therefore do not unnecessarily expose subjects to risk
Additional Information
  • About identification, recruitment, and safeguards if the research involves special populations (vulnerable populations such as, pregnant woman, child, prisoner, disability group, etc.)
Additional Items IRBs Must Review
  • Qualifications of the principal investigator (PI) and scientific collaborators (for U.S. Food and Drug Administration [FDA]-regulated research)
  • Complete description of the proposed research
  • Provisions for the adequate protection of rights and welfare of subjects
  • Compliance with pertinent federal and state laws/regulations, and organizational policies
  • Investigator’s Brochure/Investigator Protocols (for FDA-regulated research)

 

Ethical Review Guide Questions

Furthermore, the following questions can be used by the reviewer in considering the decision of ethical approval application and may also help the researcher in writing the protocol:

 

Research Design

  • Why should this study be conducted? What data are presented to support the reasons? Does that reason make sense?
  • Can the research objectives be achieved with this research design?

 

Experimental Procedure

  • How are treatment and control groups divided? Is that fair?
  • What are the possible risks of dividing the treatment and control groups? What is the researcher’s plan to minimize and mitigate risks?

 

Recruitment

  • Who are included in research and who are excluded? Is that fair? Ethical? Safe?
  • Does the research target an appropriate population based on fairness, safety, and ethical considerations? Population of convenience should be avoided. For example, researchers should not target populations simply because they are ‘accessible’ or populations that do not benefit from research either individually or in social groups.
  • Is the election not coercive? Is there an authoritative relationship between recruiters and potential participants, such as teachers/students, doctors/patients, bosses/subordinates? Are there procedures designed to minimize the potential coercion?
  • Are there people who you think belong to vulnerable groups (children, elder, people with cognitive impairment)? Do the researchers describe any additional safeguards to protect them?

 

Subject Compensation

  • Is the subject compensation reasonable in terms of the effort the subject puts into participating in research?
  • Is there a potential undue influence of subject compensation?

 

Risks and Benefits

  • What procedures will be applied to the subject for the reason of research? Are these procedures necessary?
  • What are the anticipated risks associated with the procedures? Can these risks be minimized and mitigated?
  • If so, what benefits will the subject get by participating in research? Are the benefits worth the risks? In addition, what are the risks that will be faced by society?
  • Is there a potential undue influence of the benefits of subjects?

 

Privacy and Confidentiality

  • Does the research mention ways to keep participation and data confidential? For example, if the researcher is conducting research on a sensitive topic, such as domestic violence or drug use, are there precautions to protect the identity and confidentiality of participants?
  • How is subject privacy considered? For example, do consent discussions take place in the waiting room or in a more private room?
  • If the identity and confidentiality of subjects has been protected, is there still a communal/group risk that may exist for a particular group as a result of participation? How well does the researcher plan to minimize and mitigate risk?

 

Subject Safety

  • For research with more than minimal risk, does the research specify how the data will be monitored to ensure subject safety? For example, does the researcher propose to conduct self-directed, ‘real-time’ analysis to assess whether subject’s responses in the treatment group are better or worse than the other group? Or, if the risk/benefit of the research has been agreed, but KEP wants to review its own data after a certain period of time, or after several subjects have been conducted.

 

Consent Sheet

  • If you are a potential subject, are you able to understand the consent form and what is expected if you agree to participate? Can you explain the research to others after reading the consent form?
  • Are there descriptions (type, frequency) of the research procedure on the consent form and the identical research protocol?
  • Have all important components of the consent form been written down?
  • If there are additional procedures (recording, admin data access, future data reuse) or sensitive questions, has the researcher explained these? Are these also a required condition of participation?

 

Conflict of Interest

  • Is there a potential conflict of interest? (between researchers and donors, researchers and subjects, researchers and implementers of interventions/experiment or survey partners, survey partners and implementers of intervention/experiment, or survey partner or implementers of intervention/experiment with subjects or donors)

 

The guiding questions above are adapted from “The IRB Member Module – ‘What Every New IRB Member Needs to Know” module in IRB Member course of CITI Program.

Download this guide: Requirements of Information for Ethical Review Guidelines.

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