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Informed Consent Guidelines

Informed Consent Guide

Introduction

The Informed Consent Guide was formed on the basic principle of respect for persons contained in the Belmont Principles. Informed consent is required to ensure potential respondents receive the necessary information about a research before participating in one. Without obtaining the informed consent requirement waiver issued by KEP, no researcher may involve humans as research subjects unless they have obtained an informed consent from the subject. 

 

Informed Consent Process

  1. Providing research information on the subject in an understandable manner.
  2. Answering the subject’s questions to ensure their understanding of the research and their roles.
  3. Ensuring participation is voluntary and free from coercion and misuse of the circumstances.
  4. Ensuring the informed consent process does not allow misuse of the circumstances.
  5. Providing subjects with adequate time to consider their decision.
  6. Obtaining the subject’s consent to voluntarily participate.

 

In obtaining the informed consent, researchers must ensure:

  • Understanding

Researchers must present information in an understandable manner. Especially when the study is complex and the education level of the subject is relatively low, the role of dialogue and explanation becomes crucial.

  • Voluntariness
    Subjects should be given sufficient time to consider whether they wish to participate in the study. Researchers must also consider the possibility that the circumstances surrounding the informed consent process may influence the subject. For example, children whose parents are present in the same room may not feel entirely free to decide on their participation. Furthermore, compensation or incentives for participation should not be overly generous, as this may lead the subject to prioritize these incentives over other considerations.

 

General Requirements

Researchers must minimize the possibility of coercion or misuse of circumstances (undue influence). Subjects must be provided information in a language that can easily be understood, and it must not contain sentences that waive the subject’s rights and the researcher’s obligations (exculpatory language).

The basic elements of informed consent consist of nine things that must be included. Further guidance can be found in: Basic Elements of Informed Consent section (p.8) in the Informed Consent Guideline (currently, the guideline is only available in Bahasa Indonesia).

Depending on the nature of the research and the risks that may arise, KEP may require additional elements. Further guidance can be found in the Additional Elements section (p.10) in the Informed Consent Guideline (in Bahasa Indonesia).

 

informed consent Exemption

KEP may allow researchers to modify the informed consent process by eliminating some or all elements required in the informed consent. Exemption may be possible in cases of deception or lack of planned notification to research subjects (complete non-disclosure). An exemption may be granted only if the five criteria listed in the Informed consent Exemptions section (p. 11) in the Informed Consent Guideline (in Bahasa Indonesia) are applied to the proposed research protocol.

KEP may also approve a study in which the researchers will collect information or biological specimens of subjects for the purpose of selecting, recruiting, or determining eligibility for subject participation without the subject’s informed consent, under the conditions that can be found in the Exceptions to Screening, Recruitment, or Determination of Eligibility section (p. 13) in the Informed Consent Guideline (in Bahasa Indonesia).

 

Informed consent Documentation

In general, there are two methods to obtain an informed consent:

 

  1. The subject or the subject’s legal representative signs a form containing all elements of the informed consent requirements. The party who signs the form is also given a copy.
  2. The informed consent process is carried out verbally in a language the subject understands and is documented by a witness. This process also involves document requirements, details of which can be found in the Informed Consent Documentation section of the Informed Consent Guideline (p.13) (in Bahasa Indonesia)

 

Documentation Exemption

Documentation requirements may also be waived under specific circumstances. Nevertheless, it’s important to note that exemption from documentation does not equate to exemption from the informed consent process. Conditions for documentation exemptions can be found in the Documentation Exemption (Page 14) of the Informed Consent Guideline (in Bahasa Indonesia).

 

Additional Requirements for Research Involving Vulnerable Populations

If your research involves:

  • Children;
  • Pregnant women, fetuses, or babies;
  • Prisoners;
  • People who are economically or educationally disadvantaged;
  • Subjects with disabilities in reading, hearing, or seeing;
  • Subjects with a limited level of understanding;
  • Subjects who cannot speak Indonesian

Additional requirements for informed consent may apply. You can see detailed requirements in the Informed Consent Guideline section Additional Requirements for Research Involving Vulnerable Populations (p.14) (in Bahasa Indonesia).

 

Informed Consent Exemption Application Form and Example of Informed Consent Form

You can find examples of Informed Consent forms and Informed Consent Exemption Application forms from the links in the following table.

 

No. Document Objective Link
Consent to Participate in Research Required for all research involving human subjects unless exempted by KEP.

Researchers can use this document as a reference (not a template) in writing the Informed Consent Form that suits the needs and context of the research.

Indonesian
Consent to Participate in Research (for minor groups/children) Required to be read for all human subjects under 18 years of age, unless exempted by KEP.

Researchers need to understand that this document is only a reference (not a template) and it must be adjusted to the child’s level of understanding.

Indonesian
Request for Exemption or Change of Informed Consent Elements Required if researchers request exceptions or changes to the informed consent elements for research. Indonesian

 

References:

  • National Health Research and Development Ethical Guidelines and Standards (2017)
  • 45 CFR 46
  • CITI Training on Informed Consent – SBE (2019).
  • Guidelines for Vulnerable Populations. Committee on the Use of Humans as Experimental Subjects MIT (2019).

 

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