Informed Consent Policy
The IRB will ensure that informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.166 and 21 CFR 50.20.
In addition, the committee will ensure that informed consent will be appropriately document in accordance with, and to the extent required by 45 CFR 46.117 and 21 CFR 50.27.
Medical Record’s Copy of Informed Consent Document
The informed consent document is to be filed in the LSUHSC-S Medical record. This includes the current LSUHSC-S medical records, clinic records, physician office records, and any other applicable record. This is to alert all health care providers, as well as the investigators, to studies which the research subject may be enrolled in presently or previously.
The following documents should be place in the medical record:
- Informed consent
- Assent form if applicable
- HIPAA Authorization Form for Use and Disclosure of Protected health Information for Research Purposes
- Drug/Device Record
- Enrollment/Termination note
- Other pertinent information related to the study
Requirement of Obtaining Informed Consent
No investigator conducting research under the auspices of the Institution may involve a human being as a subject in research without obtaining the legally effective informed consent of the subject or the subject’s legally authorized representative unless a waiver of consent has been approved by the IRB in accordance with the Waiver of Informed Consent policy and procedures, except as provided in the Waiver of Documentation of Informed Consent policy and procedure, informed consent must be documented by the use of a written consent form approve by the IRB.
The IRB will evaluate both the consent process and the procedures for documenting informed consent to ensure that adequate informed consent is obtained from participants.
Legally Authorized Representative
A legally authorized representative is an individual or body authorized under Louisiana law to provide permission on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. For the purposes of this policy, a legally authorized representative includes not only a person appointed as a health care agent under a Durable Power of Attorney (DPAHC), a court appointed guardian, tutor or curator of the person, but also next-of-kin in the following order of priority: spouse, not judicially separated, adult child (18 years of age or older), parent, adult sibling (18 years of age or older), grandparent, or adult grandchild (18 years of age or older).
LA. C.E. 510(5) "Representative of a patient" is any person who makes or receives a confidential communication for the purpose of effectuating diagnosis or treatment of a patient.
LA. R.S. 44:17(A) (4) “Representative of a patient” means a person who is a parent, tutor, curator, spouse, trustee, attorney, or other legal agent of the patient and who is authorized, by and on behalf of the patient, to exercise any of the patient’s rights or privileges.
A person appointed by a court of appropriate jurisdiction.
LA ChC 116(12.1)(a)(i)(b) “Legal Guardianship” means the duty and authority to make important
decisions in matters having a permanent effect on the life and development of the child and the responsibility for the child’s general welfare until he reaches the age of majority, subject to any residual rights possessed by the child’s parents. It shall include but not necessarily be limited to: The authority to consent to marriage, to enlist in the armed forces of the United States, or to major medical, psychiatric, and surgical treatment, to represent the minor in legal actions, to make other decisions of substantial legal significance concerning the minor. The term “legal guardian” means the caretaker in such a relationship.
Delegation of Responsibility
If someone other than the investigator conducts the interview and obtains consent from a patient, the investigator needs to formally delegate this responsibility, and the person so delegated must have received appropriate training to perform this activity. The person so delegated must be knowledgeable about the research to be conducted and the consenting process, and must be able to answer questions about the study.
Basic Requirements of Informed Consent
The following procedures describe the requirements for obtaining consent from participants in research conducted under the auspices of LSUHSC-S.
Investigators must obtain consent prior to entering a subject into a study and/or conducting any study related procedures required by the protocol, unless consent is waived by the IRB.
These informed consent requirements are not intended to preempt any applicable federal, state or local laws that require additional information to be disclosed for informed consent to be legally effective.
Informed Consent Process
Informed consent must be obtained under the following circumstances:
- Informed consent may only be obtained from subjects who have the legal and mental capacity to give consent. For subjects without that capacity, consent must be obtained from a legal guardian or a legally authorized representative.
- The informed consent process shall be sought under circumstances that provide the subject (or legally authorized representative) with sufficient opportunity to consider whether or not to participate.
- The informed consent process shall be sought under circumstances that minimize the possibility of coercion or undue influence. Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast often occurs through an offer of an excessive or inappropriate reward or overture in order to obtain compliance.
- The informed consent information must be presented in language that is understandable to the subject (or legally authorized representative). To the extent possible, the language should be understandable by a person who is educated to 8th grade level and layman’s terms shall be used in the description of the research.
- For subjects whose native language is not English, informed consent must be obtained in a language that is understandable to the subject (or the subject’s legally authorized representative). In accordance with this policy, the IRB requires that informed consent conferences include a qualified translator when the prospective subject does not understand the language of the person who is obtaining consent. The Translator must sign and personally date the approved translated consent form as the witness.
- The informed consent process may not include any exculpatory language through which the subject is made to waive, or appear to waive any of the subject’s legal rights or through which the investigator, the sponsor, the Institution or LSUHSC-S employees or agents are released from liability for negligence, or appear to be so released.
- The Principal Investigator is ultimately responsible for insuring that each prospective subject is adequately informed about all aspects of the research and understands the information provided. However, the HRPP, the research investigators and the research staff all share in the responsibility of ensuring that the informed consent process is adequate.
- The informed consent process must also be conducted and consent obtained in person in addition to the reading and signing the informed consent document. LSUHSC-S HRPP does not allow for obtaining informed consent over the phone or by mail to ensure subject understanding and to allow for question/answer sessions.
- In addition to signing the consent, the subject /representative should enter the date of signature on the consent document to permit verification that consent was actually obtained before the subject began participation in the study. If the consent is obtained on the same day as the subject’s involvement in the study begins, the subject’s medical records/source documentation should document that consent was obtained prior to participation in the study.
- A copy of the consent document should be provided to the subject, a copy placed on all of the appropriate LSUHSC-S medical records, and the original signed consent document should be retained in the study records. It is not required that the subject's copy be a signed copy, although a photocopy with a signature is preferred.
- HHS regulations at 45 CFR part 46 do not specify how far in advance of study entry a subject can provide consent. The amount of time required by a subject to make a decision would presumably depend upon the nature of the study, taking into consideration the degree of risk, potential benefits, alternatives, and desire to consult with family. For the sake of clarification, LSUHSC-S HRPP policy is that consents are current for 30 days but it may be prudent to review information contained in the consent document with the research subject prior to initiating any research procedures.
Note: Translation/interpreting Services
Services are provided by the Institution through the use of contracted professional resources that have been identified as able to provide multi-lingual translation/interpreting services. Nursing units shall have a princess phone stored on the unit with a splitter that will be used to access interpreting services. When interpretative services are needed, the extra phone with the splitter will be taken into the room and the phone in the room will be taken out of the wall jack, the splitter inserted into the wall jack and both lines connected to the splitter. This will allow the patient and another person to speak and hear responses without delay. A princess phone line with splitter can be obtained from Telecommunication. These services shall be made available upon request by contacting the Social Services Department. A list of employees that can provide interpretive services is also maintained by Social Services.
Elements of Informed Consent
Legally effective informed consent includes the basic required elements and the additional elements , if applicable to the study, as specified in 45 CFR 46.116 and 21 CFR 50.25.
Basic Elements: (must be provided to each subject)
- Statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
- A description of any reasonably foreseeable material risks or discomforts to the subject. A material risk is a risk that if disclosed to a prospective participant, would have affected the decision of a reasonable person whether or not to participate.
- A description of any benefits to the subject or to others which may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. For FDA regulated studies, the possibility that the Food and Drug Administration may inspect the records.
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
- An explanation of whom to contact for answers to pertinent questions about the research subjects’ rights, and whom to contact in the event of a research-related injury.
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
For VA Research: The following is required:
- A statement that in the event of a research-related injury the VA has to provide necessary medical treatment to a subject injured by participation. This includes any research approved by a VA RDC and conducted under the supervision of one or more VA employees. VA research is defined as research that is conducted by VA investigators (serving on compensated, without compensation, or Intergovernmental Personnel Agreement appointments) while on VA time, utilizing VA resources, and/or on VA property including space leased to, and used by, VA whether funded by VA, by other sponsors or unfunded.
- A statement that a veteran-subject does not have to pay for care received as a subject in a VA research study except in accordance with federal law.
- An indication that all regulations pertaining to the participation of veterans as subjects, including requirements for indemnification in case of research-related injury, pertain to non-veterans subjects enrolled in VA-approved research.
Additional Elements: (when appropriate, one or more of the following elements of
information must also be provided to each subject)
- A statement that particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
- Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent
- Any additional costs to the subject that may result from participation in the research.
- The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
- A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.
- The approximate number of subjects involved in the study.
- For applicable clinical trials, the following statement shall be provided in informed consent documents and processes: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”