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11/21/2025 5:49:13 AM
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Operational Framework of the of the Institutional Review Board for Humanities and Social Science Research, Academia Sinica

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Operational Framework of the of the Institutional Review Board for Humanities and Social Science Research, Academia Sinica

Approved on April 12, 2012
Amended on October 24, 2012
Amended on January 15, 2013
Amended on April 16, 2014
Amended on September 25, 2015
Amended on October 4, 2016
Amended on April 19, 2019
Amended on October 25, 2019
Amended on April 21, 2023
Amended on June 9, 2023
Amended on August 29, 2023
Amended on December 11, 2023
Amended on November 26, 2024

  • General Rules
    • Based on Point 2, Sections 2 and 3 of the Guidelines for the Establishment of the Institutional Review Board for Humanities and Social Science Research, Academia Sinica (the Guidelines for the Establishment), the Operational Framework of the Institutional Review Board for Humanities and Social Science Research, Academia Sinica (the Framework) is hereby prescribed. These guidelines aim to establish an independent review mechanism for enhancing review efficiency and protecting the rights and welfare of research participants.
    • The Internal Review Board for Humanities and Social Science Research, Academia Sinica (IRB-HS) shall consider the following principles when reviewing research projects:
      • The ethical principle of respecting autonomy: Ensuring research participants have received sufficient information so that their participation in the research is voluntary, free from coercion, manipulation and improper inducement. For participants without autonomous capacity, or with compromised decisional capacity, their rights and interests shall be particularly protected.
      • The ethical principle of beneficence: Ensuring the interest of research participants and holding the principle that potential risks shall not outweigh the benefits of protecting participants from unnecessary harm and promoting their welfare.
      • The ethical principle of impartiality and justice: Ensuring research participants are given fair procedures and opportunities to be included in the research and be treated equally. Groups that do not benefit from the results of the research shall not be selected as the study population.
      • The importance of privacy and confidentiality: Ensuring that personal data of research participants are properly documented, managed and retained so that participant rights are not violated.
  • The Operations of the IRB-HS
    • The IRB-HS is established in accordance with Point 3 of the Guidelines for the Establishment.
    • An IRB-HS meeting or a subcommittee meeting cannot take place unless a quorum is present, consisting of a majority of the members. This quorum must include at least one member from a scientific field (defined as an individual with training in the natural or social/behavioral sciences), at least one member from a non-scientific field (defined as an individual without such scientific training, but from disciplines such as religion, philosophy, theology, or ethics), and at least one participating member who is a non-affiliated legal expert or an impartial citizen representing the views of human research subjects. Meetings shall not proceed if only members of a single gender are present.
    • The Chairperson of an IRB-HS Meeting is the Chairperson of the IRB-HS or a member designated by the Chairperson. No votes shall be cast, nor decisions made, if all members with the most relevant expertise, including the experts and scholars in a specialized field, are absent, or if all non-scientific or non-affiliated members are absent.
    • IRB-HS members are required to obey the following conflict of interest principles:
      • IRB-HS members must recuse themselves from reviewing a research project if one of the following conditions exists:
        • The member is the PI, Co-PI, or Sub-PI or Sponsor of the research project.
        • The member is currently or was previously the spouse or within the fourth degree of consanguinity or the third degree of affinity of the PI of the research project under review.
        • The member is an employee of the Sponsor.
        • There is substantial evidence pointing to the member’s possible bias.
        • Other situations for which the IRB-HS has determined the member shall be recused.
      • For the following conditions, members may not need to recuse themselves from the meeting and may participate in the discussion, but they cannot vote:
        • The PI, Co-PI, or Sub-PI of the research project under review is the master/Ph.D. student or post-doctoral fellow of the member in the past five years.
        • The PI, Co-PI, Sub-PI, or Sponsor of the research project under review is the master/Ph.D. or research project advisor of the member in the past five years.
        • Other situations for which the IRB-HS has determined the member must not participate in the voting.
      • The member must disclose the following relationships with Academia Sinica and the research Sponsor:
        • Employment relationship, unless the member is a staff of Academia Sinica.
        • Paid consultancies.
        • Financial transactions.
        • The member himself/herself, the spouse, and individuals with the fourth degree of consanguinity or the third degree of affinity or closer has, or previously had, an investment in Academia Sinica or the Sponsor.
    • If the recusal of the member will result in difficulties in proper decision making due to the lack of their special professional knowledge and experience, the IRB-HS may determine that the member may not be restricted by Point 2, Section 4, Paragraphs 1 and 2 of this Framework. However, such exceptions shall be recorded in the meeting minutes.
    • If the Sponsor mentioned in Point 2, Section 4, Paragraphs 1 and 3 of the Framework is a juristic person or an incorporated body, the relationship between the IRB-HS member and the Sponsor can be decided based on their relationship with the responsible person.
  • Application for Review
    The Principal Investigator shall attach the following documents for the IRB-HS to review:
    • Application form.
    • Self-evaluation form.
    • Project plan.
    • Project proposal.
    • Mechanisms for obtaining informed consent from research participants (including written, oral or other types).
    • Other relevant materials: e.g., questionnaires, any communication documents with research participants, invitation letters to relevant entities or personnel for assisting in research implementation, gifts for participants, etc.
    • Relevant certificates of ethical training of the personnel to be involved in the implementation of the project.
  • Types of Review
    Types of review include: exempt review, minimal risk review and the full board review. Applicants are required to prepare a complete self-evaluation form for relevant types of research.
    • Exempt review: Research that meets Point 4, Item 1, Paragraph 1 or 2 may be qualified for exempt review:
      • Research that meets all the following conditions:
        • The probability and magnitude of physical or psychological harm encountered by research participants is almost zero.
        • The research will not be secret, where all information is withheld from the public.
        • The research is not governed by the regulations or control of the Ministry of Health and Welfare, Executive Yuan.
        • The research does not involve the following populations: minors, prisoners, indigenous peoples, pregnant women, disabled persons, patients with psychological disorders, and other persons who, as determined or judged by the IRB-HS, cannot make decisions based on their free will or can be improperly coerced.
        • The research does not involve using personal identifiable information.
        • The research does not involve using healthcare information.
      • Multi-center human research in which the Academia Sinica researcher is a sub-PI or co-PI, and the research has been approved by an IRB.
    • Minimal risk review: Research that meets all the following criteria may be qualified for minimal risk review:
      • The probability and magnitude of physical or psychological harm to research participants are not greater than those encountered in daily life.
      • The research will not be secret, where all information is withheld from the public.
      • There is no direct interaction with the following populations: detained persons (e.g., prisoners, persons subject to court-ordered rehabilitation, persons in custody, patients subject to mandatory hospitalization orders, etc.) or incapacitated persons.
      • The prospective collection of biological specimens for research purposes does not involve invasive means.
    • Full Board Review: Research determined to be not eligible for exempt review or minimal risk review should be evaluated by full board review. Responses to any application will be made within three Board Meetings.
  • Application Review Procedure
    • The IRB-HS or relevant reviewers shall conduct application review in accordance with the following procedures:
      • For a new application, after administrative inspection has determined it does not meet the scope of exempt review, it will be considered a non-exempt application. In this case, the application will initially be reviewed by at least two members referred by the Chief Executive Officer, or reviewed by experts otherwise appointed based on the type of application indicated in the self-evaluation form. For research determined by the Chief Executive Officer or the primary reviewers to be qualified for exempt review or minimal risk review, the primary reviewers may exercise the authority of the full board on behalf of the IRB-HS.
        • For an application determined by the Chief Executive Officer and all primary reviewers to be qualified for exempt review, the application will be exempted from review, and submitted to the Board Meeting for reference.
        • For an application determined by the Executive Officer, and all primary reviewers, to be qualified for minimal risk review, or to be qualified as exempt by some reviewers and minimal risk by other reviewers, the application will be reviewed by minimal risk review, and submitted to the Board Meeting for reference.
        • For an application determined by the Chief Executive Officer, or any of the primary reviewers, to be subject to full board review or not approved, it should be reviewed at a full board meeting.
      • Board Meetings shall be held regularly to review submitted applications.
      • Members shall be given sufficient time to review relevant materials before the meeting.
      • The Chairperson should ask the primary reviewer to explain relevant documents indicated in Point 3 of this Framework before initiating discussion at a meeting.
      • The IRB-HS may invite the PI, Co-PI, Sub-PI or research implementation personnel to attend the meeting for explanation.
      • The IRB-HS may invite experts in specific fields, or group representatives, to attend the meeting to act as independent consultants, or provide their comments in writing. These individuals shall sign confidentiality agreements.
      • IRB-HS members may directly discuss an application with the attendees at the meeting where it is discussed.
    • If there are any changes to a previously approved application during the execution period, the changes shall be reviewed according to the procedures prescribed in the previous paragraph.
  • Main Considerations in Reviewing Applications
    The following items are among the main considerations in reviewing applications:
    • Project design and implementation:
      • The suitability of the qualifications and experience of the principal investigator and research staff for the research.
      • The correlation between the study design and the objectives, and the appropriateness of the research methods.
      • The appropriateness of anticipated risks compared to anticipated benefits.
      • The appropriateness of control group selection.
      • The voluntary withdrawal procedures by research participants.
      • The criteria for study suspension or termination.
      • The sufficiency of rules made for monitoring and auditing the study; the necessity of forming a Data and Safety Monitoring Board (DSMB).
      • The ways in which research results and data will be reported/presented.
    • Recruitment of Potential Research Participants:
      • The characteristics of the potential participants (including gender, age, race/ethnicity, educational level, culture and economic status).
      • Reasons to include any prisoners, incapacitated persons or persons with limited capacities in the research.
      • The approaches of initial contact and recruitment.
      • The approaches to convey information to the potential participants.
      • Participant inclusion criteria.
      • Participant exclusion criteria.
    • Protection measures for participant privacy:
      • Measures to ensure the participant privacy and the security of personal information.
      • Measures to ensure delinking between research data and participant personal information.
    • Procedures to obtain participant consent:
      • Relevant procedures to obtain consent from research participants.
      • Providing research participants, or their legal representatives, with complete written or oral materials.
      • Ensuring that the participants will receive the most updated information related to their rights, safety, and welfare during the research in real time.
      • The mechanism to receive participant, or their representative, queries or complaints, and how proper responses will be provided.
      • The participant may withdraw their consent at any time.
    • Participant care:
      • The psychological and social support to participants, and the mechanisms for handling urgent problems that arise.
      • The rationale for canceling or suspending any standard treatment for research purposes.
      • Providing care for the participants and the most updated information regarding the rights, safety and welfare after the research has been completed.
      • The procedures for voluntary participant withdrawal from participation during the study.
      • The procedures to inform the primary caregiver of a participant with the consent of the participant.
      • The potential impact on the financial status of the participants, including the compensation and reimbursement.
      • The compensation and treatment for injuries, disabilities or deaths of the participants arising from their participation in the study.
      • The arrangements for compensation and insurance.
  • The Resolution Process of the IRB-HS Meeting
    • Decisions should not be made at a Board meeting without proper discussion. The Chairperson may consult with the attending members, if necessary.
    • For an application to be approved in a full Board meeting, a majority vote is needed. The number of for, against and void votes should also be recorded. IRB-HS members who did not participate in the discussion have no voting rights.
    • The following determinations can be made for an application subject to full Board review. The applicant will be informed about review results within 14 days of a decision.
      • Approved.
      • Approved after amendments.
      • Re-review after amendments.
      • Not approved.
      • Suspension or termination of a previously-approved research project.
    • Approval letters should specify the following items:
      • The complete title, version (including versions of amendments) and dates of the research project.
      • The names, versions (including versions of amendments) and dates of other documents for review.
      • The name of the applicant.
      • The name of the affiliation.
      • The approval dates and the location of meeting.
      • The approval contents, including the duration of the approval period.
      • The procedures and requirements of regular subsequent review
      • The signature of the Chairperson.
    • When a re-review decision is made, the revisions required to obtain IRB approval should be specified in the IRB-HS meeting minutes and the notification letter to the applicant. The applicant shall be informed about the procedures for re-review.
    • When a not approved decision is made, the reasons underlying the negative decision should be specified in the IRB-HS meeting minutes and the notification letter to the applicant.
  • Supervision and Management
    • The IRB-HS shall establish monitoring mechanisms to continue reviewing the implementation progress of approved projects. Determining the period of continuing review is based on the type of research. Review frequency shall not be less than once a year. The IRB-HS may decide the period of continuing review for a project after its completion, if necessary.
    • IRB-HS actions regarding continuing review:
      • The IRB-HS shall perform a mid-term review and a final report review.
      • The applicant shall report to the IRB-HS about the reasons for research suspension or termination, and the research results at the time of research suspension or termination.
      • The IRB-HS is required to promptly conduct review for unanticipated events including on-site review, if necessary, when one of the following occurs:
      • The occurrence of incidents that may adversely affect the rights and safety of research participants, or any changes in implementation of the project.
      • The occurrence of unanticipated events affecting the rights and interest of participants during the project.
      • The occurrence of events or discovering information that may affect research participant assessment of the risk/benefit ratio to their continued participation.
    • The applicants shall be informed about the decision of the continuing review along with the amendments, suspension or termination of the original decisions, or the confirmation of the original decisions.
    • The procedures for continuing review shall be established by the IRB-HS.
  • Administrative Personnel
    • The required administrative personnel for the IRB-HS will be filled by the persons affiliated with the Department of Academic Affairs and Instrument Service.
    • The administrative personnel are required to sign confidentiality agreements.
    • The assignments and obligations of the administrative personnel shall be established by the IRB-HS.
  • Records
    • The IRB-HS shall establish documentation and archiving management procedures for all documents and communication records and specify the eligibility and procedures for accessing documents, files and databases.
    • The IRB-HS shall retain review procedure records, lists of members, the records of member occupations and contact information, documents submitted for review, meeting minutes, letters, and other research-related data for at least five years after the completion of a project.
  • Attachments
    [Attachment 1] Confidentiality Agreement, IRB-HS (irbhs50 Privacy Agreement)


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