CROs Must Know Patient Consent Requirements

Clinical Research Organizations (CROs) in Florida have to be careful about ensuring compliance with state and federal patient consent requirements.

To begin with, let’s agree on the following language.

  • Institutional Review Board (“IRB”): Empowered by FDA to oversee trials on human subjects.  IRB oversees informed consent process.
  • “Investigator” is person conducting the study.  Often a physician but not always.
  • “Article” is the drug, device or other item being tested.
  • “Subject” is the human upon which the test is conducted.


Federal law contains the following for effective informed consent:

  • •A 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.
  • •Description of any reasonably foreseeable risks or discomforts to the Subject.
  • •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 and that notes the possibility that the FDA 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 and research Subjects’ rights, and whom to contact in the event of a research-related injury to the Subject.
  • •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.
  • •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) 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.  Non-specific statement that Subject’s participation will be terminated for a failure to follow protocols is insufficient if Subject has not been apprised of all protocols.
  • •Any additional costs to the Subject that may result from participation in the research.
  • •The consequences, to the Subject’s health, of the 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.

Under federal law, informed consent is not required if, before the test is conducted, the Investigator and a physician who is not participating in the trial certify in writing:

i.    Subject is confronted by life-threatening condition necessitating use of the test article; AND

ii.    Informed consent is not possible due to inability to communicate with, or obtain legally effective consent from, the Subject; AND

iii.    There is not enough time to obtain consent from the Subject’s legal representative; AND

iv.    There is available no alternative method of approved or generally recognized therapy that provides at least as good of a chance of saving the Subject’s life.

If the Investigator feels that all items above are true, but the Investigator does not have time to obtain determination by an independent physician prior to administering the Article, the Investigator can obtain determination by an independent physician within five working days after administering the Article to the Subject.  Certifications must be submitted to the IRB within five working days after administering the Article to the Subject.

When informed consent is required, it must be documented.

  • •Via written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent. A copy shall be given to the person signing the form.  A “long form” or a “short form” of documentation may be used
  • •A written “long form” embodies the elements of informed consent set forth above in section II.  This form may be read to the Subject or the Subject’s legally authorized representative.  The Investigator shall give either the Subject or the representative adequate opportunity to read the form before it is signed.
  • •A written “short form” states that the elements of informed consent set forth in section II have been presented orally to the Subject or the Subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the Subject or the representative. Only the short form itself is to be signed by the Subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the Subject or the representative in addition to a copy of the short form.

IRB will sometimes waive the requirement that informed consent be documented for some or all Subjects.  This waiver only concerns documentation.  Informed consent must still be obtained.  IRB itself can issue such a waiver if the trial presents a minimal risk of harm, and does not involve any procedures for which written consent customarily would be required in ordinary, non-trial, healthcare delivery, or if emergent circumstances justify such a waiver.  If documentation is waived, informed consent must still be obtained verbally.


Current Florida law does not regulate the clinical trials research process.  The investigational drug program and the Florida Drug Technical Review Panel were repealed by the Florida Legislature in 2000.  Instead, clinical trials research is regulated entirely by federal law.

That said, clinical trials in Florida are subject to applicable state law, including the Florida Medical Consent Law (Section 766.103) and the health care surrogate provisions (Section 765).

The seminal law in Florida regarding patient consent is Section 766.103, F.S., the Florida Medical Consent Law.  It precludes recovery in any court action based on a claim of failure to obtain informed consent, in essence, if:

  1. The physician, ARNP or PA obtains the consent “in accordance with an accepted standard of medical practice among members of the medical profession with similar training and experience in the same or similar medical community as that of the person treating, examining, or operating on the patient for whom the consent is obtained;” and
  2. A reasonable person, based on the information provided above, would have a general understanding of the procedure, medically acceptable alternatives and the substantial risks in the proposed treatment; or
  3. The patient would have reasonably undertaken the treatment had the patient been so advised; and
  4. The consent is signed by a mentally and physically competent patient or other authorized person.

The failure to meet the above does not violate any law.  Rather, meeting the above essentially precludes any successful lawsuit based on the claim that there was a failure to obtain informed consent.

Relatedly, Section 381.026, the Florida Patient’s Bill of Rights and Responsibilities state—“Every individual has the basic human right to be informed about the medical treatment or procedure that is being proposed to them.”  under this state law, the key principles that comprise Informed Consent are:

  • The proposed Treatment  
  • The purpose of the treatment to be provided
  • The common risks
  • Benefits
  • Side effects
  • The specific dosage range for the medication, when applicable
  • Alternative treatment modalities
  • The approximate length of care
  • The potential effects of stopping treatment
  • How treatment will be monitored
  • That any consent given for treatment may be revoked orally or in writing before or during the treatment period by the patient or by a person who is legally authorized to make health care decisions on behalf of the patient.  (Section 394.459)

CROs have a lot of ground to cover to ensure patients understand the risks and benefits associated with participating in clinical research.  They have to be particularly astute regarding not only federal law, but also the law of the state where the research is performed.

2 thoughts on “CROs Must Know Patient Consent Requirements

  1. Pingback: Adding Nutritional Supplements Can Contribute to a Healthy Bottom Line | Florida Healthcare Law Firm Blog

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