Guidelines for Developing Informed Consent Documents

Please read through these guidelines carefully and insert those portions that are applicable to your research and your targeted population(s)

Reading Levels

The informed consent document is just one aspect of the consent process but is very important.

  • The informed consent form must:
  • Be written in lay language (6th - 8th grade reading level).If using MS Word to develop the consent document, check the readability via Flesch-Kincaid Grade Level during spell check.
  • Avoid scientific / technical terms.
  • Avoid abbreviations and acronyms.
  • Be written in the second person:i.e., “you.”
  • Be free of exculpatory language.

Required Elements of Informed Consent

  • Include the required eight (8) elements of informed consent. When research is greater than minimal risk,include the six (6) additional elements of informed consent. Elements are available here:
  • For FDA-regulated research, the participant or the participant’s legally authorized representative must date the consent form.
  • Participants must receive a signed copy of the approved consent document for their records. Therefore, it must be a stand alone document, not attached to or be part of any instrument or survey.

Research Authorization to Use Protected Health Information

  • If using or collecting Protected Health Information (PHI), you must use a consent template that includes the Research Authorization language. Please check the HIPAA Decision Tree to determine whether or not your study involves PHI:

Audio and Video Taping as Part of the Research

  • If audio- or videotaping will be used, the participant must be informed of taping and, if applicable, given the option to agree to the recording. Additionally, please state:
  • How long the tapes will be stored
  • How long they will be used
  • How will they be kept confidential and kept secure
  • Whether they will be shown to any other professionals

Multiple Procedures

  • If there are multiple visits with different procedures occurring at each visit it is suggested to break these out into separate paragraphs and/or bulleted items.
  • USF IRB does not require the signature of a witness, unless specifically stated as a requirement for IRB approval. However, if you are conducting this research in a facility other than USF, check with the research office on the policy of that facility regarding witness signatures. Delete this section if not required by the IRB or facility at which research is conducted.

Affiliate Language

Veterans’ Administration

  • If the study involves recruitment of VA human participants (patients, staff, volunteers) or uses VA resources(funds, equipment, space, VA personnel) it must:
  • be approved by the VA Research and Development Committee (regardless of source of funding) prior to coming to the IRB;
  • be conducted under the supervision of one or more VA employees;
  • You are required to use the VA Form 10-1086, VA Research Consent Form (VA Research Forms are posted here:)
  • The VA consent must disclose:
  • that participants are eligible for treatment unless injuries are the result of the participant’s noncompliance with study procedures.
  • VA will provide medical care in those circumstances where VA has some responsibility for the need for medical care. If this study meets these criteria, include the following statement:
  • “If you are eligible for Veterans Affairs medical benefits, the VA may provide medical care if you get hurt or get sick as a result of taking part in this study.”
  • Documentation of the Informed Consent VA Form 10-1086(From VA handbook 1200.5 )
  • a. Except as provided in subparagraph 3d of this appendix, informed consent must be documented by the use of a written consent form approved by the IRB and
  • dated and signed by the participant (or legally authorized representative);
  • dated and signed by a witness to the signature
  • dated and signed by the person obtaining informed consent; (If the sponsor or IRB requires a witness to the consenting process in addition to the witness to the subject’s signature; if the same person needs to serve both capacities then a note to that effect must be placed under the witness’s signature)
  • a signed and dated copy of the consent document must be provided to the research participant.
  • Include the following elements in the informed consent where appropriate:
  • Payment for Treatment. Informed consent information must include a statement that veteran-participants shall not be required to pay for treatment received as a participant in a VA research program. Investigators should note, however, that veterans in the “discretionary work load” category are participant to co-payments, if so indicated by a means test.
  • Authorization for Use of Bodily Fluids, Substances, or Tissues. VA policy requires that if the investigator believes that bodily fluids, substances, or tissues could be part of or lead to the development of a commercially viable product, the informed consent information should include the following verbatim statement:

“I authorize the use of my bodily fluids, substances or tissues in this research. It is possible that commercially profitable products may someday be developed from these bodily fluids, substances, or tissues. There are no plans to share any profits from such products with the participants who were the source of these bodily fluids, substances, or tissues.”

  • Payment for Participation. The informed consentinformation should include a clear statement describing any payment the participant is to receive for participation, the required conditions for payment, and the payment schedule. Since VA regulations at 38 CFR 16.116(a)(8), the Common Rule, and FDA regulations all state that participants may withdraw from research at any time without penalty of loss of benefits to which they are otherwise entitled, completing the research may not be made a condition of payment. For this reason there should be a description of how payment will be prorated and calculated for participants who withdraw early.

Proxy or Health Surrogate Consent

a) Under appropriate conditions, investigators may obtain consent from the legally authorized representative of a subject (proxy or health surrogate consent).

  • Such consent may be obtained from: a health care agent appointed by the person in a DPAHC or similar document; court-appointed guardians of the person, or from next-of-kin in the following order of priority, unless otherwise specified by applicable state law: spouse, adult child (18 years or older), parent, adult sibling (18 years of age or older), grandparent, or adult grandchild (18 years of age or older). NOTE: The preceding list contains the only surrogate entities who are allowed to provide consent for research purposes.
  • Such consent may be requested and accepted only when the prospective research participant is incompetent or has an impaired decision-making capacity, as determined and documented in the person’s medical record in a signed and dated progress note. The determination must be made in accordance with the following requirements in subparagraphs 11a(3)(a-d), or as established by a legal determination. NOTE: The consent requirements described in this Handbook are not intended to preempt any applicable Federal, State or local laws that require additional information to be disclosed for the informed consent to be legally effective in accordance with 38 CFR 16.116(e).
  • (a) The practitioner, in consultation with the chief of service, or COS, may determine after appropriate medical evaluation that the prospective research subject lacks decision-making capacity and is unlikely to regain it within a reasonable period of time.
  • (b) Consultation with a psychiatrist or licensed psychologist must be obtained when the determination that the prospective research subject lacks decision-making capacity is based on a diagnosis of mental illness.
  • (c) Disclosures required by this Handbook to be made to the subject by the investigator must be made to the subject’s surrogate.
  • (d) If feasible, the practitioner must explain the proposed research to the prospective research subject even when the surrogate gives consent. Under no circumstances may a subject be forced or coerced to participate in a research study.
  • For additional information for VA research, refer to VHA HANDBOOK 1200.5

Tampa General Hospital

The following injury statement is required:

“In the event you suffer an injury or illness as a result of participating in this research study, please be aware that immediate, short-term medical treatment for the injuries or illness will be available to you from Tampa General Hospital. The cost of the medical treatment will be billed to you to the extent not covered by your insurance company or government program or study sponsor. No other compensation will be offered. You are not giving up any legal rights by signing this form. If you believe you have experienced a reaction to the study medication or have been injured as a result of research procedures performed at Tampa General Hospital, please contact the Department of Risk Management at (813) 844-7666.”

Shriners Hospital for Children – Tampa

The following injury statement is required:

“Participation in this study does not include patient treatment or bodily risk of illness or injury. Shriners Hospital investigators and their colleagues who provide services at Shriners Hospitals for Children, Tampa Hospital, recognize the importance of your child’s contribution to research studies that are trying to improve medical care. Shriners Hospital investigators and their staffs will make every effort to minimize, control and treat any complications that may arise as a result of this research; however, Shriners Hospitals for Children's policy is not to pay financial compensation for research-related injury or undesirable reaction. Your child is not waiving any legal rights as a research participant by signing this form. If you believe that your child has been injured solely as a result of the research study, please contact Nancy R. Pisciotto RN, ONC at 813-972-2250 extension 7712.”

HIV testing (Florida Statute §381.004)

Informed consent for HIV testing is mandatory and it must include:

  • that a prior explanation of the right to have the information treated confidentiallyhas been given (i.e., identity of the test participant and the results will be kept confidential)
  • a disclosure that a positive HIV test result will be reported to the county health department with sufficient information to identify the test participant
  • the availability and location of sites where anonymous testing is performed (this is available from the county health department)

Genetic testing; informed consent; confidentiality; penalties; notice of use of results (§760.40)

Informed consent must always be obtained prior to DNA testing. If, during your research, you ask the participant to volunteer a biological sample for the purpose of genetic testing (now or in the future); you are required to use the Genetic Informed Consent Addendum.

Diagnosis and/or treatment of STDs (including HIV and AIDS). State law (§384.25)

Requires that practitioners report evidence of sexually transmissible diseases, including HIV and AIDs, to the county health department. The informed consent form must disclose to the participant that a positive test result indicating the presence of an STD will be reported to the county health department with sufficient information to identify the test participant.

Childrenin Research

Regardless of risks, signatures from both parents must be obtained unless:

  • The other parent is not reasonably available (an explanation is required)
  • The other parent is unknown
  • The other parent is legally incompetent
  • The parent who signed has sole legal responsibility for the care and custody of the child.

Children are given the opportunity to give assent to participate in research.

  • Written assent is required for children 12 – 17 years of age.
  • Children 7 to 11 should be given the opportunity for assent & their agreement should be noted in the research record
  • For children below school age (e.g., infants, toddlers, and preschoolers), the investigator should give explanations that match the level of understanding. In many instances, the children’s nonresistant behavior may be interpreted as assent, but the investigator must use special care to discontinue the participation of children who appear to experience undue stress from the research procedures. A verbal script must be submitted as part of the protocol
  • Wards of the State/Foster Children: Children who are foster children or otherwise wards of the state may participate in research only if the research is:
  • related to their status as wards; or
  • conducted in schools, camps, hospitals, institutions, or similar setting in which the majority of children involved as participants are not wards.
  • If the research is approved, the IRB will require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis.
  • Guardians: Individuals authorized under applicable State or local law to consent on behalf of a child to general medical care [45 CFR 46.402(e)] when general medical care includes participation in research [21 CFR 50.3(s)]. However, unless specifically authorized by the court, a guardian cannot give legal consent to participation in research. (Florida Statute §744.3215(4)(b); §744.3725) A guardian can give consent to medical and mental health treatment. (Florida Statute §744.102(8)(b); §744.301; §743.0645(1)(c)).

Prisoner Research

The informed consent form must clearly state that participation would have no direct effect upon their parole or treatment.

Pregnant Women / New Mothers

The informed consent form must fully disclose any reasonably foreseeable impact of the research on the fetus or neonate.

  • The consent form must disclose that the consent of the pregnant woman is required if the research holds:
  • The prospect of direct benefit to the pregnant woman
  • The prospect of direct benefit to the pregnant woman and the fetus;
  • No prospect of benefit for the women or the fetus when the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means.

Neonates

The investigator must obtain the informed consent of both parents of the fetusor, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of both parent’s legally authorized representative must be obtained.

Fetuses. The consent of the mother is obtained in accordance with the federal regulations and state laws. If the research holds out the prospect of direct benefit solely to the fetus, then the consent of the father is also obtained in accordance with the regulations, except that the father’s consent does not need to be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.

Neonates of uncertain viability. If neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent’s legally authorized representative is obtained in accordance with the regulations of this part.

The consent of the father or his legally authorized representative does not have to be obtained if the pregnancy resulted from rape or incest.

Non-viable neonates. The legally effective informed consent of bothparents of the neonate is obtained in accordance with the regulations. If either parent was unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a nonviable neonate is sufficient, except that the consent of the father does not have to be obtained if the pregnancy resulted from rape or incest.

The consent of a legally authorized representative of either or both of the parents of a nonviable neonate after delivery is not allowed under federal regulations 45 CFR 46.205(d).

The waiver and alteration provisions cannot be applied.

Individuals with Mental Disabilities

In obtaining informed consent from individuals who are mentally disabled, additional protection is necessary. The Principal Investigator is required to obtain consent from a legally authorized representative (LAR). LAR consent does not negate the responsibility to obtain assent from the person being enrolled in the study. Assent should be considered a requirement, even when permission from a LAR is obtained.

Decisionally Impaired Participants

ThePrincipal Investigator is required to obtain consent from a legally authorized representative (LAR). LAR consent does not negate the responsibility to obtain assent from the person being enrolled in the study.

Report of Abuse

For research involving the possibility of finding reasonable evidence of abuse (child or adult) or report of harm to themselves or others; the consent form should include a warning that suspected harm or abuse to another individual or to themselves will be reported to the appropriate authorities.

Students as Research Participants

Include a statement indicating that neither the students’ status nor grades would be affected based on their decision to participate or not to participate. For students who do not wish to participate and extra credit is given, you must provide an alternative method to obtain extra credit.

Traumatized or Sedated Individuals

For individuals whose capacity might be temporarily diminished by trauma or sedation, USF has adopted the Modified Ramsey Sedation Scale.

  • The investigator must consult with two professionally qualified persons who are not part of the research team in presence of one witness
  • The consult must include either two physicians or one physician and one professional qualified person
  • Professional qualified persons include:
  • Physician not associated with the research
  • Clinician not associated with the research
  • Therapist not associated with the research
  • Counselor not associated with the research

Research involving a Placebo

The following statements should be included in the informed consent form when applicable:

You may be given the research drug or a placebo.

A placebo is a pill or something that looks like the medicine we are studying but has no active medicine in it. We use a placebo to make sure that it really is the study medicine that is making a difference in your condition. It does not have anything in it that would normally help or harm most people. [If the placebo is made with an agent that might cause an allergic reaction, explain what ingredients are in the placebo.]

Sometimes people seem to feel better just because they are given something that looks like medicine. We want to make sure that the[experimental drug, device, procedure, or biologic]we are testing really works. We need to have some people take/use the placebo and some people take/use [the experimental drug, device, procedure, or biologic]. That way we can compare how well [the experimental drug, device, procedure, or biologic] works to how well the placebo works.