KEP LPEM FEB UI is a review committee established to help protect the rights and welfare of human research subjects. To clarify when an ethical clearance is required, the table that follows reviews some definitions from federal regulations and guidance. A research activity must meet the definitions of “research” and “human subjects” in order to be considered human subjects research by the regulations. The following are the definition related to the research involving human subjects:

• IRB or Institutional Review Board is an administrative board to protect rights and well-being of human subjects which are recruited to participate in activities or research projects that involve staff or funding coming from institutions with which IRB is affiliated.

• KEP LPEM FEB UI or Komite Etik Penelitian Lembaga Penyelidikan Ekonomi dan Masyarakat, Fakultas Ekonomi dan Bisnis Universitas Indonesia is a board acting as IRB for FEB UI and responsible for review of research projects involving human subjects. FEB UI’s staff, academic, researcher as well as student as a principal investigator, and also researches that involve FEB UI’s support, such as funding, human resources, facilities, academic credit, or access to experiment subjects should be reviewed and receive an approval from KEP LPEM FEB UI. Researches mentioned above are included in the definition, regardless of the location where researches are conducted.

• Research means “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” Activities that meet this definition constitute formal interviews, answering questionnaires, and all activities related to study of a data set.

• Secondary research is the use of information or biospecimens that were collected for another (primary) purpose (for example, tissue collected for clinical purposes, samples left over from previous research studies, or medical records).

• Human subject, according to 45 CFR 46 (US Federal Guidelines) means “a living individual about whom an investigator (whether professional or student) conducting research:
  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

• Intervention includes both physical procedures by which information or biospecimens are gathered, such as interviews or collecting data through questionnaires (without manipulation) and manipulations of the subject or the subject’s environment that are performed for research purposes, such as showing a video, giving guidance, or poster to manipulate subject’s visual for research’s purposes. Interaction includes communication or interpersonal contact between investigator and subject.

• Interaction includes any form of communication between researcher and subject.

• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). Private information should be able to be identified by each person and should be unique (subject’s identity can be easily identified by researchers) to conduct research involving human subjects. Private information includes all identification, both individuals and relatives, employers or household member of the individual, such as:

• Names
• Addresses
• Dates of birth
• Social security number
• Medical record number
• Bank account number
• ID numbers
• Family card numbers
• Telephone or fax numbers
• Electronic mail addresses
• Vehicle identifiers or serial numbers
• Certificate or licence numbers
• Internet Protocol (IP) address numbers
• Biometric recognition, including finger and voice prints
• Full face photographic images
• Any other unique identifying number, characteristic, or code
• Protected health information does not include education or employment record

• Unidentified Information is information that cannot be used to identify an individual. To satisfy de-identification standard, the information must not include:
  • Names
  • All geographic subdivisions smaller than a State
  • All elements of dates, except year
  • Social security numbers
  • Medical record numbers
  • Bank account numbers
  • ID numbers
  • Family card numbers
  • Telephone or fax numbers
  • Electronic mail addresses
  • Vehicle identifiers and serial numbers
  • Certificate/license numbers
  • Internet Protocol (IP) address numbers
  • Biometric identifiers, including finger and voice prints
  • Full face photographic images
  • Any other unique identifying number, characteristic, or code

• Limited Dataset is a limited set of identifiable patient information, which removes all personal identifiers except dates or geographic information such as city or postal code. Limited dataset may be used or disclosed if the researcher has completed the formal agreement, which allows information disclosure, with KEP LPEM FEB UI.

• Authorization to Disclose Protected Private Information is a written document that must be signed by research’s subjects in order to specifically give authorization to researchers to be able to use or disclose protected private information. This must be written in plain language and must explain the information that is going to be disclosed. This document also contains:
  • A description of the information to be used or disclosed that identifies the information in a specific and meaningful fashion.
  • The name or other specific identification of the person(s), or class of persons, authorized to make the requested use or disclosure.
  • The name or other specific identification of the person(s), or class of persons, to whom the covered entity may make the requested use or disclosure.
  • A description of each purpose of the requested use or disclosure.
  • An expiration date or an expiration event that relates to the individual or the purpose of the use or disclosure. 
  • Signature of the individual and date.
  • The individual’s right to revoke the authorization in writing and that the individual must not participate in the research if they sign the authorization

• Waiver Authorization is an authorization given to researchers by KEP LPEM FEB UI to use or disclose protected information without authorization from the subject. KEP LPEM FEB UI may give waiver if it satisfies the following criteria:
  • An adequate plan to protect the identifiers from improper use and disclosure;
  • An adequate plan to destroy the identifiers from improper use and disclosure;
  • Adequate written assurances that the protected private information will not be reused or disclosed to any other person or entity
  • The research could not practicably be conducted without the waiver or alteration; and
  • The research could not practicably be conducted without access to and use of the protected private information.

• Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Furthermore, KEPPKN 2017 Guidelines define minimal risks as the possibility of a risk that is too small so that it can be waived in assessing research proposal, or with expedited/exempted approval.

• Vulnerable population is part of the society that needs full attention, special considerations, and extra protection is research. Furthermore, KEPPKN 2017 Guidelines define vulnerable population as human being, either individually, household, group, socially, or in society who are relatively or absolutely unable to protect their own or group interests. They may lack freedom, intelligence, education, economy, resources, power, and other qualities necessary to protect their own interests. Subjects are considered as vulnerable if:
  • they are incapable of making autonomous decisions in their own interests;
  • their situation forces or pressures them to make a decision. In this guideline, vulnerable population includes: 
    • Baby;
    • Children;
    • Prisoners;
    • Elders;
    • Pregnant women and human fetuses;
    • IVF (in vitro fertilization);
    • Subjects with visual and/or hearing impairment;
    • Subjects with cognitive impairment;
    • Subjects from minority groups (racial/ethnic/gender/religion)
    • Subjects from economically marginalized group
    • Subjects from socially marginalized group
    • Subjects with critical/terminal illness
    • TNI/Polri
    • Women living in unequal relationship (e.g. victim of domestic violence)
    • Subjects with HIV and AIDS
    • Drug users
    • Groups vulnerable to stigmatization or negative stereotypes

• Informed consent refers to the process to achieve effective and legal agreement from human subjects before involving them in the research. According to KEPPKN 2017 Guidelines, informed consent is given by a competent individual who has received the necessary information, adequately understood and made a decision without any coercion, undue influence or persuasion, or intimidation. In general, informed consent includes three points: 
  • informing potential subjects about all information needed to make informed decisions; 
  • giving understanding about information given to potential subjects; 
  • prioritizing voluntariness of prospective subjects in deciding whether to participate in the research. Researchers should receive effective and legal informed consent before involving humans as research subject, unless if the research project is exempted or there are reasons which may eliminate the obligation to obtain informed consent.

• Legal Representative is an individual or entity who is authorized under applicable law to represent prospective subjects to give consent to participate in research.

References:

Protection of Human Subjects, 45 CFR § 46 (2018)

KEPPKN 2017 Guidelines

KEPPKN 2011 Guidelines

Download this Guideline: Glossary.