1.0 KEY WORDS:

Informed Consent; Institutional Review Board (IRB); Research; Clinical Trials; Study; Investigator; Authority; FDA;

2.0 PURPOSE:

To delineate responsibility for obtaining research informed consent (ICF), and to define the roles of the investigator, study staff and hospital employees in the informed consent policy and process.

3.0 REVISION HISTORY:

4.0 PERSONS AFFECTED:

4.1 IRB Committee members, hospital staff, participating physicians, Driscoll Children’s Hospital Healthcare System Employees, other internal and external customers such as physicians, nurses, patients, families, insurance companies, managed care, etc.

5.0 STANDARD/POLICY STATEMENT:

5.1 It is the responsibility of the Principle Investigator (PI) or his/her designee to obtain a signed, Driscoll Children’s Hospital (DCH),IRB approved, ICF from the potential research subject (or the subject’s legally authorized representative) prior to the initiation of any research procedures per title 45 Code of Federal Regulations part 46(45 CFR 46) and 21 CFR part 50. It is the right of the subject or subject’s legal guardian to give permission for volunteering for participation in the research study per 45 CFR 46 and 21 CFR 50. It is the right of the subject to withdraw from the research study at any time.

5.2 A DCH IRB ICF template may be obtained from the DCH IRB website at www.driscollchildrens.org, which provides standard language that must be utilized. The DCH IRB Website also contains instructions for investigators that should be followed to assure the safety of human research subjects and adherence to the Federal, State, and local regulations governing human subjects’ research. The research consent is to be written at a reading level that is understandable by the potential research subject. This level minimally is no greater than an eighth grade reading level and should be in a language understandable by the subject.

6.0 DEFINITIONS/RELATED INFORMATION:

6.1 DCH IRB is the Driscoll Children’s Hospital Institutional Review Board: that reviews, approves and oversees human subject research at DCH. the hospital mentioned above.
6.2 The Research Informed Consent Process is a continuing education about the research study, its methods and procedures, the risks and benefits, rights and liabilities of the research participant.
6.3 Research Informed Consent (ICF) Document is a marker of the informed consent process. The document contains the elements of the informed consent as describe in 45 CFR 46.116 and 21 CFR 50.25.
6.4 HIPAA is the Health Insurance Portability and Accountability Act regarding protected health information
6.5 Assent is an agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

7.0 PROCEDURE/GUIDELINE:

7.1 It is the responsibility of the Primary Investigator(PI) to obtain DCH IRB approval of the research informed consent, research protocol and related materials.

• The research consent is approved for one year. The PI must use the currently approved consent.
  • If the research informed consent is modified in terms of the risk, procedures or science, then it is the responsibility of the PI to submit the modified consent to DCH IRB for approval. The research participant already enrolled in the research must be re-consented with the approval-modified consent.
    • If the child should reach the age of maturity while participating in a research study, the child if they previously had signed an assent, should sign the full consent as they are no longer considered minors.
    • The PI or his/her designee shall obtain informed consent at a time and place that is convenient and appropriate for the potential subject and their family to consider , asks, and obtain information about the research study.

7.2 The PI shall assure the subject and family understands the study by assessing their comprehension of the experimental procedures, risks and benefits.

• If the PI believes that the family and or the subject are unable to comprehend the study, the PI shall not enroll the subject into the study. This decision shall be documented in the study files.

7.3 If agreeing to participate in the research and between the ages of 7 to 18 years, the subject shall sign an assent while the parent(s) or legal guardian shall sign the informed consent. A subject less than 7 years of age only requires the parent(s) signature on the informed consent.
Subjects greater than 18 years of age shall sign the consent. The family shall also sign a research HIPAA authorization detailing whom shall receive the research related protected health information.

• A subject who is considered mentally incompetent and the parent or legal guardian have legal decisional powers for the subject, then the parent or guardian may sign the consent for the subject if research participation is in the best interest of the subject. Under these circumstances, it is necessary for the parent/guardian to definitively comprehend the research study. The parent must be available to monitor the child’s recruitment, participation, and withdrawal from the study.
  • A subject who is mentally incapacitated, such as traumatic head injury, and unable to assent for themselves may be consented to a study by a parent or legal guardian if the research is in the best interest of the subject. It is imperative the subject be assented when/if they regain mental capacity.
    • If the research is minimal risk (45 CFR 46.404) or contributes to the generalizable knowledge about the disease (45 CFR 46.406, the parent or legal guardian may not override the child’s dissent. Research that is greater than minimal risk and has then potential for direct benefit (45 CFR 46.05), the parent or legal may override the child’s dissent if the treatment has a greater than 60% chance of benefiting the child and the child’s disease is life- threatening.

7.4 Certain research regarding behavioral/treatment issues such as sexually transmitted
disease or substance abuse is permitted under Texas and Federal law and requires
only the child’s permission to participate. These research programs require DCH IRB
review and waiver of parental permission. The child signs the full consent under
these circumstances.

7.5 Under certain circumstances, the DCH IRB may waive the requirement of informed
consent or documentation of the informed consent process, provided the study is
minimal risk and provides generalizable knowledge about a disease or social
question.

• The DCH IRB may impose additional requirements under these circumstances such as, but not limited to, a letter about the study provided to the participants, or verification of verbal consent.

7.6 Foreign Language/Limited English Proficient (LEP)/Hearing Impaired Patients and Families

• If the family and the subject are unable to comprehend the study due to a language barrier or hearing impairment, the PI may request a hospital medical interpreter in a language understandable by the family and the subject, or may coordinate language assistance for deaf and hearing impaired families by utilizing Telecommunication Devices For The Deaf (TDD) phones and contract services for on site American Sign Language (ASL) interpreters. On site ASL interpreters can be coordinated directly through the Council for the Deaf or by contacting the DCH Interpretation and Translation Services Department. This process should be documented in the study files. A telephone-based medical interpretation service is available 24 hours a day and should be used in the absence of a staff medical interpreter and for spoken languages other than Spanish.
  • Patient care and admitting areas have “Quick Reference Cards” explaining both emergency and routine use of the phone interpretation service.
  • The study subject gets a copy of the full-length informed consent.

  7.7 Emergency (Compassionate) use of a drug or device must meet certain Federal
  requirements (21 CFR 50.23) before the use of the test article occurs.

  • The obtaining of informed consent shall occur unless, before the use of the test article both the investigator and a physician who is not participating in the clinical investigation, certify in writing all of the following: confronted by a life-threatening situation necessitating the use of the test article.
    • The human subject is confronted by a life-threatening situation, necessitating the use of the test article.
    • Informed consent cannot be obtained form the subject.
    • Time is not sufficient to obtain consent from the subject’s legal representative.
    • No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the life of the subject.
  • All of the above information needs to be provided to a Chair or Co-Chair of the DCH IRB for acceptance prior to obtaining the test article from a sponsor.
    • If the immediate use of the test article is, in the investigator’s opinion, required to preserve the life of the subject, and time is not sufficient to obtain the independent determination required, the determinations of the clinical investigator shall be made and be reviewed and evaluated in writing by a non-study related physician. These evaluations shall be turned into DCH IRB within five (5) days of test article use.
    • All of the information from the sponsor, the signed DCH IRB Chair or Co-Chair letter, and signed consent from the legally authorized representative of the subject shall be sent to the DCH IRB within five (5) days of article use.
    • The emergency use approval is for a single patient, if the investigator believes that they will see multiple subjects then they must submit a protocol to DCH IRB for approval of additional subjects.

  7.8 Humanitarian Device Exemption (HDE) is a Food and Drug (FDA) approved device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals per year in the United States.

  • While the FDA does not consider the HDE to be research, it does require that investigators who are planning to utilize a HDE obtain DCH IRB approval of the labeling and protocol before the use of the device (21 CFR 814). In many cases the labeling may take the appearance of an informed consent. The DCH IRB approval is for only the FDA approved medical indication.
  • Copies of the signed informed consent and HIPAA authorization shall be sent to the DCH IRB Office and Medical Records. Copies of the signed informed consent and HIPAA authorization shall be given to the subject and their family. The PI shall retain the original signed informed consent and the HIPAA authorization for their research files. Copies of the signed informed consent and HIPAA authorization should be retained in the subject’s clinical chart and placed under an “aqua research tab” which may be obtained in the IRB Office.
  • Failure to document the informed consent process and consent form is a violation of 45 CFR 46 and 21 CFR 50.

8.0 REFERENCES:

8.1 Office for Human Research Protections. Compliance Oversight, 12 Dec. 2000. Access date 20 Mar 2001. http://ohrp.osophs.dhhs.gov/compovr.htm
8.2 Code of Federal Regulations. Title 45A- Dept of Health and Human Services; Part 46-Protection for Human Subjects. http://www.law.cornell.edu/cfr/45p46.htm

9.0 INTERNAL CROSS-REFERENCES:

9.01 IRB Authority #1
9.02 IRB Relationships #2
9.03 IRB Membership # 3
9.04 IRB Management # 4
9.05 Conflict of Interest # 5
9.06 Functions of the IRB # 6
9.07 Vulnerable Subjects # 6.1
9.08 Medical Devices in Research # 6.2
9.09 Operations of the DCH IRB # 7