Objective to ensure that the principal investigator pi and all research team members assisting in the. Core standard operating procedure for informed consent. A copy of the summary and the short form must be given to the subject or hisher representative. Informed consent process for research number date author approved by page hrp090 06252019 c. This standard operating procedure sop document describes the policies and procedures for documenting informed consent from human research subjects. Every investigator and clinical research coordinator crc should recognize the importance of obtaining valid and appropriate informed consent as an important protection of the rights and welfare of human subjects. Example standard operating procedure for informed consent in. Informed consent is an ongoing process that starts with the initial presentation of a research study to a prospective subject by the investigator and continues through the research activity until the subject. The process of obtaining informed consent should be documented in.
Standard operating procedures manual for human subjects research. For consent to be valid, it must be given voluntarily. Informed consent is defined in ich good clinical practice as a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subjects decision to participate. Sop informed consent requirements page 3 of 23 informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subjects or legally authorized. Related documentation and references tmpqa5 informed consent form tmpqa site delegation log tmpqa38 pis guide sopqa9 appendix 1. If a waiver of documentation or waiver of informed consent is requested and approved by the cu irb, this sop does not apply. Documents that informed consent has been taken, when, and by whom. General requirements researchers must obtain consent from human subjects in accordance with. Additional considerations when obtaining informed consent research involves adult subjects with decreased decisional ability. This standard operating procedure sop document describes the policies and procedures for obtaining informed consent from human research subjects. To explain the process for obtaining consent from potential research subjects or their legally authorized representative. Sop title date page irb200 informed consent and assent july 2018 2 of 5 3. Free text entry, which allows automated emailing of a pdf of the signed completed eic to lar.
The informed consent process is the critical communication link between the prospective human subject and an investigator, beginning with the initial approach of an investigator to the potential subject e. Every investigator and clinical research coordinator crc should recognize the importance of obtaining valid and appropriate informed consent as an. Mmc irb sop, informed consent general requirements and documentation. Sop qa9 v4 receiving informed consent page 4 of 4 5. Process, documentation and waivers page 5 of 6 subject or her or his representative sign only the short form. Informed consent process for research number date author approved by page hrp090 32514 f. The following is an example, edit as needed to reflect sitespecific procedures. A short form written consent document stating that the elements of informed consent as required have been presented.
Informed consent process for research number date author approved by page hrp090 12618 t. The following is an example, edit as needed to reflect sitespecific. Documentation requirements of the informed consent process, as well as providing the participant the completed informed consent form. This procedure establishes the process to obtain informed consent from subjects, the legally authorized representatives of adults unable to consent, or the parents or guardians of children. A statement that the particular treatment or procedure may involve risks to the subject or. It is the responsibility of the head of research governance horg of the jrco to ensure that this sop is. Objective to ensure that the principal investigator pi and all. A short form written consent document stating that the elements of informed consent have been presented orally to the subject or the subjects legally authorized representative. Legally authorized representatives, children, and guardians hrp0. It is an ongoing conversation between the human research subject and the researchers that. The person obtaining informed consent or another research team member must ensure that. Related documentation and references tmpqa5 informed consent form tmpqa site delegation log tmpqa38 pis guide sop qa9 appendix 1 recording the receipt of informed consent in medical notes from a participant taking part in a ctimp. Informed consent process for research number date author approved by page 090 12012018 hspp institutional official io 4of 5.
Process, documentation and waivers page 5 of 6 short forms a short form is a written consent document. Informed consent process for research number date author approved by page hrp090 11072017 l. Electronic signatures for documentation of consent. The purpose of this sop is to describe requirements for researchers to obtain. Kiel 1 of 4 1 purpose this procedure establishes the process to obtain informed consent from subjects, the legally authorized representatives of adults unable to consent, or the parents or guardians of children. The person who conducts the informed consent process must sign and date the consent form. Informed consent is defined in ich good clinical practice as a process by which a subject voluntarily confirms his or her willingness to participate in a. It is an ongoing conversation between the human research subject and the researchers that begins before consent is given and continues until the end of the subjects involvement in the research see consent process diagram, below.
Informed consent process for research number date author approved by page hrp090 1192019 rio office vice chancellorvice president for research and technology transfer 3 of 5. Standard operating procedure informed consent procedures and. Informed consent process for research number date author approved by page hrp090 3312019 m. Process, documentation and waivers page 5 of 6 short forms a short form is a written consent document stating that the elements of informed consent required by 45 cfr46. It is the principal investigators responsibility to ensure that the consent is obtained according to this.
This procedure establishes the process to obtain informed consent from subjects, the legally authorized representatives of adults unable to consent, or the parents. Informed consent procedures and writing participant informed consent forms prepared by the research ethics and governance unit may 2010 1 of 6. Informed consent process for research number date author approved by page hrp090 1192019 rio office vice chancellorvice president for research and technology transfer 3 of 5 4. All procedures and processes followed for obtaining initial consent apply to obtaining consent from subjects with a revised consent form. Sop 6 informed consent procedures and writing participant. Irb sop 701 informed consent university of south alabama. Informed consent process for human subjects research. Once a child indicates that he or she does not want to. The potential subject must be given sufficient time. Sop 6 01 informed consent process, documentation, and. Standard operating procedure obtaining informed consent. The hhs regulations at 45 cfr part 46 for the protection of human subjects in research require that an investigator obtain the legally effective informed consent of the subject or the subjects legally authorized representative, unless 1 the research is exempt under 45 cfr 46.
Standard operating procedure electronic informed consent. Sop 6 01 informed consent process, documentation, and waivers. Consent script same as the consent form used for long form of consent documentation, except that the signature block is optional references. Informed consent document for human subject research. It is the principal investigators responsibility to ensure that the consent is obtained according to this sop, even if the task of obtaining informed consent has been delegated to another individual. This sop describes the procedures for obtaining and documenting informed consent from a study subject or the subjects legal representative. Page 1 of 8 standard operating procedure informed consent. The process of obtaining informed consent should be documented in the subjects medical records. This sop details the appropriate procedures for obtaining and documenting the informed consent process for.
Informed consent procedures and writing patient informed consent forms version. A statement that the particular treatment or procedure may involve risks to the subject or to the embryo or fetus, if the subject is or may become pregnant that are currently unforeseeable. Subject identification medical record number and name or initials is on all pages of the signed informed consent document. Legally authorized representative lar informed consent process adult. Fda internal compliance program guidance manual, 1994. Informed consent process for research number date author approved by page hrp090 8202012 c. Objective to ensure that the principal investigator pi and all research team members. Objective to ensure that the principal investigator pi and all research team members assisting in the conduct of clinical. Sop obtaining informed consent research ut health san antonio. Informed consent process for human subjects research number approved by effective date hsr410 miranda van tilburg, phd irb chair, irb office campbell university 10082019 version. Sop informed consent requirements page 3 of 23 informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way.
This section should outline how the site will document the informed consent process, including any too. Waiver or alteration of the documentation of consent and irb sop. Even in the absence of new information or changes to research. The purpose of this sop is to describe requirements for researchers to obtain informed consent from human research subjects. Written documentation of consent hrp091 references. Waiver or alteration of the informed consent process. A short form written consent document stating that the elements of informed consent as required have been presented orally to the subject or the subjects legally authorized representative. Taking informed consent page 2 of 10 the consent form. Informed consent process for research number date author approved by page hrp090 10220 l. Standard operating procedure sop sop no xxxxxxpage 10 of 10. Sop informed consent maine medical center research institute. Informed consent process for research uc davis office of. Core standard operating procedure for informed consent process 2 page subject and research team to witness the consent process, if required. Sopqa9 v4 receiving informed consent page 4 of 4 5.
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