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New Mexico Informed Consent Forms

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					                      HSC CLINICAL RESEARCH WORKING GUIDELINES
                     OBTAINING AND DOCUMENTING INFORMED CONSENT

         Informed consent is an ongoing process during which information is presented to an individual to
         enable them to voluntarily decide whether or not to participate in or continue participation in a
         research study. Informed consent for research involves presenting the research information (the
         categories of which are required by the federal regulations) orally and obtaining written consent
         on an HRRC approved consent form prior to entering a subject into a study and documenting the
         consent process in the subjects’ medical record or research file.
         THE INFORMED CONSENT PROCESS

         Reading and signing the consent form document does not replace the verbal presentation and
         communication between the investigator and individual deciding to participate. When initiating
         the consent process, investigators and research staff should consider:
                   The potential subject’s physical and mental state when choosing an appropriate time to present
                    the research information.
                   The consenting process should occur over a period of time (which may include days or weeks) to
                    allow time for the individual to consider whether to participate and to discuss the research with
                    his/her family.
                   It is best to present the research information and consent document separately from standard
                    clinical or hospital information, and emphasize the difference between the conduct of the
                    research and regular patient care.
                   A copy of the consent form should be provided to the participant to take home.
                   The Investigator and/or a member of the study team should be available to answer any questions
                    or concerns the participant may have during the decision process.
                   If a treatment study, a family member or person involved in the care of the participant should be
                    encouraged to participate in the consenting process.
                   Where particularly complex issues are discussed, an investigator might consider testing the
                    subject’s understanding of the information by asking questions about the presentation.
                   The Investigator and/or research staff conducting the consent process should ask the subject if
                    they have been given adequate time to make a decision and if the consent document is written in
                    a language they can understand.
                   The investigator and/or research staff must minimize the possibility of coercion or undue
                    influence, while providing information about the research and during the consenting process.

THE INFORMED CONSENT DOCUMENT

Informed consent language and documentation (especially explanation of the study's purpose, duration,
experimental procedures, alternatives, risks, and benefits) must be written in “lay language” (generally
recommended to be at a fifth grade reading level). The written presentation of information is used to document
the basis for consent and for the participants' future reference. The consent document should be revised when
new information about the study becomes available. The HRRC must approve all changes made to the consent
document.

The process of obtaining signed informed consent must comply with the requirements of 45 Code of Federal
Regulations (CFR) 46.116 and the consent form must contain the “Required Elements of Informed Consent”. A
written consent form should follow the Sample Consent Form located on the HRRC web page. Consent must
be obtained in person (no telephone consents) from the participant. A Legally Authorized Representative


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(LAR) as designated in the Uniform Health Care Decisions Act for the State of New Mexico may sign but only
after HRRC approval of that process.
If the LAR has been approved to provide consent, the relationship of the consenter to the subject should be
documented in the subject’s medical record or research file. A copy of the signed consent form must be given
to the person signing the form.

Each consent form (most current HRRC approved version) should be completed in its entirety including:
    Initials on each page by the person signing the form
    Printed name and signature of person obtaining consent
    Printed name and signature of research participant (or legal representative)
    Each individual must date his/her own signature at the time of signing.
    For VA research, printed name, signature and date of witness whose role is to witness the subject’s (or
       legal representative’s) signature.
    Note: If the HRRC or sponsor requires a witness to the consenting process in addition to the witness to
       the participants signature, a note to that effect must be placed under the witness’s signature line.
A copy of the signed and dated consent form should be given to the person signing consent.

DOCUMENTING THE CONSENT PROCESS
A signed and dated consent form is not sufficient in documenting the informed consent process. A written note
(ie progress report, clinic note, etc.) should be created at each encounter documenting the communication
between investigator and subject about the research. This note should include what was discussed; the fact that
the subject’s questions were answered, if the subject received a copy of the consent form to take home, or if the
subject signed the consent form. The accumulation of these notes over a period of time will document the
consenting process. Note that for VA research, consent must be documented through use of VA Form 10- 1086.

Enrollment Progress Note

At the time of study consent a written study enrollment note should be placed in the patient's medical record or
shadow file. For studies (inpatient and outpatient) involving greater than minimal risk, the original, signed
consent form must be placed in the medical record.

For ease of completion and to ensure capturing of pertinent study information, a pre-printed enrollment progress
note with fill- in blanks or circling of choices is recommended. This note should be reviewed with and signed
by the PI or physician subinvestigator to indicate that he/she has reviewed the information and agrees that the
participant meets protocol requirements.

It is suggested that the enrollment note be dated and timed and contain the following information:
      HRRC number and name of study
      Patient identifiers (initials and study number assigned to a particular patient). If the research treatment
         is based on a patient’s weight, then the weight to be used for study should be documented.
      If a pregnancy test is required, results should be reported in the note. (i.e. Urine (or serum) pregnancy
         test done on 1/2/01 - results are negative).
      A brief explanation of the study treatment: If patients are randomized to a treatment, if the study is
         blinded, the drugs (including placebo) or devices used in the study and the route and length of treatment
         (Note: This information could already be included on a pre-printed enrollment note). If possible,
         provide the time of first treatment and if it the patient tolerated the treatment or had any side effects.
      It is advisable to note who dispensed the study drug (Per New Mexico state law, only a licensed
         practitioner may dispense medications)
      If the patient is self- medicating any study medication, a statement should be made stating that patient
         received appropriate teaching (i.e. drug administration, dosing and recording, return demonstration of


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         successful administration to patient/family, return of study medication and if patient/family has a contact
         number to call for questions or problems).
        A statement should be made that "no protocol procedures were done prior to consent” or if a
         test/procedure was done for standard care it should be so noted.
        A note stating that study has been discussed with patient and that all questions were answered.
        Who to call with questions/problems related to the study.
        If there is a deviation from study inclusion/exclusion criteria, there must be WRITTEN documentation
         that the subject has been prospectively approved for study enrollment by both the HRRC and the study
         sponsor.

Registration of All Research Subjects into Patient Management System and Consent
Forms in the Medical Record

All patients receiving care at the Health Sciences Center must be registered or admitted into the Patient
Management System by clinic or admitting staff. [UNM HSC Administrative Policies and Procedures – Patient
Billing]

For inpatient studies and for outpatient studies that have above- minimal risk, the investigator should place the
Informed Consent Document in the medical chart. For minimal- risk outpatient studies, the investigator is not
required by the JCAHO or OHRP to put a copy of the informed consent document in the hospital chart. If the
informed consent document will be placed in the medical record, this should be indicated in the informed
consent document. In addition, the research subject should also be informed if a medical record will be created
because of participation in a research study.

In certain instances, for confidentiality reasons or clinical research involving sensitive topics, an investigator
may wish to refrain from placing a copy of the consent form in the medical record. In such instances, at a
minimum the following information should be placed in the participant’s medical record:

        Date and Time of Consent
        Statement that JCAHO requirements for consent have been met
        A note stating that this patient has been enrolled in a research study involving an investigational drug (or
         other treatment). For any questions or additional information please call (provide study contact
         information provided to the participant in the consent form).

If the research protocol may impact the research subject's health, the statement in the chart must include an
adequate description of the intervention required by other health care professionals to deal with any potential
medical problems.

No Deviation from Written Informed Consent in Research without HRRC Approval

The general rule is that to involve a subject in research, the investigator must document and obtain informed
consent, as provided in HRRC Manual - See Section 7.3. In some cases, however, the HRRCs are permitted to
waive the requirement that a consent form be signed. In these instances, informed consent should be obtained;
however, documentation is not needed. In other situations, the HRRCs may waive particular elements of
informed consent or waive the requirement for info rmed consent entirely. With the exception of emergency
situations, unless waivers/alterations of informed consent are justified by the investigator and approved by the
HRRC in writing, they may not be used.

Informed Consent for Non-English Speakers




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With a population such as exists in New Mexico, consent forms written in Spanish or short forms with an oral
presentation as per 45 CFR 46.116 and 46.117 should be considered for most studies being conducted. Below
is a section from OHRP Compliance Activities: Common Findings and Guidance – 9/1/2000, for your guidance.

Documentation of Informed Consent for Non-English Speakers. The regulations require that informed consent
information be presented "in language understandable to the participant" and, in most situations, that informed
consent be documented in writing (see 45 CFR 46.116 and 46.117). Where informed consent is documented in
accordance with HHS regulations at 45 CFR 46.117(b)(1), the written informed consent document should
embody, in language understandable to the participant, all the elements necessary for legally effective informed
consent. Participants who do not speak English should be presented with an informed consent document written
in a language understandable to them. OHRP strongly encourages the use of this procedure whenever possible.

Alternatively, HHS regulations at 45 CFR 46.117(b)(2) permit oral presentation of informed consent
information in conjunction with a short form written informed consent document (stating that the elements of
consent have been presented orally) and a written summary of what is presented orally. A witness to the oral
presentation is required, and the participant must be given copies of the short form document and the summary.
A sample short form consent document for subjects who do not speak English may be found at:
http://www.hhs.gov/ohrp/humansubjects/guidance/ic-non-e.htm.

   When this procedure is used with participants who do not speak English, (i) the oral presentation and the
    short form written informed consent document should be in a language understandable to the participant; (ii)
    the IRB-approved English language informed consent document may serve as the summary; and (iii) the
    witness should be fluent in both English and the language of the participant.

   At the time of consent, (i) the short form document should be signed and dated by the subject (or the
    subject's legally authorized representative); (ii) the summary (i.e., the English language informed consent
    document) should be signed and dated by the person obtaining consent as authorized under the protocol; and
    (iii) the short form document and the summary should be signed by the witness. When the person obtaining
    consent is assisted by a translator, the translator may serve as the witness. For VA and FDA regulated
    research, the participant or the participant’s Legally Authorized Representative (LAR) must sign and date
    the main consent document as well.

   A copy of the signed and dated short form must be given to the participant or the participant’s LAR along
    with copies of the written summary of the information.

   The IRB must receive all foreign language versions of the short form document as a condition of approval
    under the provisions of §46.117(b)(2).

Informed Consent for Research Participants that do not Speak English and do not have
a Written Language

New Mexico has a significant Native American population that does not speak English and does not have a
written language. For research involving such participants, HHS regulations at 45 CFR 46.117(b)(2) (as
described above) should be followed. The only difference would be that instead of using the short form,
another sentence should be added to the full consent form, which states, "Signing this document means that the
research study, including the above information, has been described to you orally, and that you agree to
participate." A similar informed consent process can be used for consenting illiterate persons.

Obtaining Informed Consent in Research Involving Children

HRRC Investigator’s Manual (7.4.3 Children)

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"Children" are defined as "persons who have not attained the legal age for consent to treatments or procedures
involved in the research, under the applicable law of the jurisdiction in which the research will be conducted."
45 C.F.R. 46.202(a). The age of adulthood in New Mexico is 18, unless a person is at least 16 and has been
emancipated by court order, marriage, or active military duty, or is 14 and may consent to treatment with
psychotropic medication, with parental notification. Thus, in most cases, persons under 18 are "children" for
research purposes, and their entry into research requires their parent(s)’ consent. This is true for medical, as well
as psycho-social, research (although in some such cases the HRRC may agree that waiving parental consent is
appropriate, see Section 7.5.6 of the HRRC Investigator’s Manual).

Children may not be enrolled in research without the "permission" (agreement under standard consent
provisions, Section 7.3) of a parent or guardian (and of both parents for research of greater than minimal risk,
with no prospect of direct benefit to individual subjects, see Section 6.2.1). The HRRCs are often asked who
qualifies to provide consent for a child. As noted, the federal regulations require that the person be either the
parent or the guardian. A "guardian" is a person "who is authorized under applicable State or local law to
consent on behalf of a child to general medical care." 45 C.F.R. 46. 402(e). Under New Mexico law, a person
appointed through the court system as a child’s legal guardian may consent to inclusion of the child in research.
To enroll the child, guardianship papers should be presented. There may be other lega l mechanisms of granting
permission to a person other than the parent to consent to health care that may suffice as well (such as a health
care power of attorney). Where there is any question whether a particular person is permitted under the law to
consent to the inclusion of the child, the investigator should contact the Office of the University Counsel for the
HSC.

In addition to parental/guardian permission, investigators are required to obtain the "assent" of the child. Assent
is "a child’s affirmative agreement to participate in research. Mere failure to object should not, absent
affirmative agreement, be construed as assent." 45 C.F.R. Section 46.402(b). The HRRCs generally require
assent to be obtained from all children age 7 and older, unless the nature of the research dictates otherwise (for
example, research on brain injured children). An assent paragraph and signature line can be added to the
parental consent for children ages 12-17 years; For children 7 – 11years of age, the investigator must use a
separate simple one page assent form (in language appropriate for a child).

Waiver of Informed Consent for Research on Emergency Therapies

In certain emergency situations legally effective informed consent cannot be obtained and the requirements for
informed consent may be waived by the HRRC because of the subjects' medical condition and the unavailability
of legally authorized representatives of the subjects. For an "Emergency Research Consent Waiver" to be
granted, the research activities must meet very strict conditions. For more information, please contact the
HRRC office or review the HRRC Investigators Manual.

Additional information on informed consent requirements may be found in the HRRC Manual - See section 7.




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