TEMPLETE OLD 2022
TEMPLETE NEW 2023
p-ISSN: 2302-9706
INDEXING:
It is the policy of the Organization that no one may involve a human being as a participant in research or in a clinical investigation unless the investigator has obtained INFOKUM approval and, when required by the, that person’s legally effective informed consent. The INFOKUM s may alter or waive the requirement of informed consent under the INFOKUM regulations governing human subject research, but may not waive consent for studies regulated by the INFOKUM unless the subject is in a life-threatening condition and criteria under 21 CFR 50.23 or 50.24 are met. If the participant is an adult who is unable to consent for him/herself, the investigator must describe the process of evaluating the individual’s capacity to provide consent, and if that capacity is lacking in a subject, must obtain informed consent from a legally authorized representative in accordance with State law. If the participant is a minor, the investigator must describe the consent/assent process in accordance with federal and state law.
Informed Consent Process
The INFOKUM s must review the proposed consent process. Investigators must seek consent under such circumstances that provide the prospective participant with sufficient time and opportunity to consider whether or not to participate. The INFOKUM ’s evaluation of the investigator’s proposed participant selection/recruitment process and informed consent process will include:
The JINFOKUM must judge the information to be presented to a potential participant in a written or oral form to be understandable to the participant or the participant’s legally authorized representative. The informed consent may not include any language which waives, or appears to waive, any of the participant’s legal rights, or releases or appears to release the parties to the research from liability for negligence.
Informed Consent Documentation
The content of the written information provided to the potential participant must include the elements outlined in 45 CFR 46.116(a) and, if subject to FDA regulations, 21 CFR 50.25(a), and when appropriate, the additional elements provided in 45 CFR 46.116(b) and 21 CFR 50.25(b). The will review all documents that are part of the informed consent process. If a standard informed consent document is used, the Organization requires use of standard boilerplate language in consent forms. The standard boilerplate language includes:
1) the HIPAA Privacy Authorization, and
2) “What other things should you know about this research study” including:
Changes proposed to the boilerplate language must be approved by the . As of January 1, 2009, the INFOKUM approved consent document(s) will have an approval date, but will not include an expiration date. The approval for the consent document will last the life of the study, or until it is amended – whichever comes first. Only copies of approved documents may be presented to participants.
Short Form Documentation of Informed Consent
The federal regulations under 45 CFR 46.117(b)(2) and 21 CFR50.27(b)(2) permit the use of a short form consent document stating that the required informed consent elements have been presented to the subject or the subject’s legally authorized representative (LAR) orally, with a witness present. The witness must be fluent in both English and the language of the participant. Additionally:
INFOKUM has several -approved short form consents posted on the INFOKUM website. For a short form consent in a language that has not been approved by the INFOKUM :
The witness to the consent process may also be the translator of the short form. If, however, the translator is the PI or a study team member, that individual may not also serve as the witness, who must be unaffiliated with the study.
Waiver or Alteration of Informed Consent or Documentation of Informed Consent
The may for some or all participants, waive the requirement to sign a written consent document if the makes the following determinations under DHHS regulations 45 CFR 46 and documents them with protocol specific findings justify those determinations:
The is authorized to waive documentation for either the participant, or the adult participant's legally authorized representative, or waive parental permission for research involving children. The may not waive the requirement for a consent process under FDA regulations. However, the may require the research to include an oral consent process rather than require written, documented consent.
The may for some or all participants, waive the requirement under FDA regulations 21 CFR 50 if the makes the following determinations and documents them with protocol specific findings to justify those determinations:
The may approve waiver or alteration of the consent procedure, or waive the requirement to obtain informed consent, if the makes the following determinations and documents them with protocol specific findings to justify those determinations:
(i) Public benefit or service programs;
(ii) Procedures for obtaining benefits or services under those programs;
(iii) Possible changes in or alternatives to those programs or procedures; or
(iv) Possible changes in methods or levels of payment for benefits or services under those programs; and
The may approve waiver or alteration of the consent procedure, or waive the requirement to obtain informed consent, if the makes the following determinations and documents them with protocol specific findings to justify those determinations:
The may not waive the consent process for any research to be conducted under DoD regulations where the research participant meets the DoD definition of an ‘experimental subject.” A waiver of the consent process for such DoD regulated research requires permission of the Secretary of Defense.
For research subject to Department of Education regulations, the will follow the requirements of the Family Educational Rights and Privacy Act (FERPA) when considering whether it may grant exceptions to parental/student consent to release of records for research.
Research Data Retention
INFOKUMSean InstituteAlamat: Komplek New Pratama ASri Blok C, No.2, Deliserdang, Sumatera Utara, Indonesia email : infokum@seaninstitute.org ![]() INFOKUM is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0) |
Policies and Regulations Link
|
View My Stats |