Obtaining Consent: Special Situations
When a subject cannot read/speak English
If your study does not specifically target subjects who cannot speak or read English, regulations permit the use of a “Short Form” to be used along with (a) an approved Informed Consent form and (b) a translator (or third party outside the research team who reads the English version to the potential subject).
Please read our position paper on the use of this form. This form has been reviewed and approved by the IRB and may be used by any investigator without prior approval for your specific study IF your study does not specifically target subjects who cannot speak or read English (in which case your full consent must be translated by a qualfied person and submitted to the IRB for approval). If your study targets English speaking subjects and you happen to have a subject who cannot read or speak English present for enrollment, download the appropriate form below, have a translator read the form to the subject and obtain appropriate signatures. The translator must also translate your “full sized” normal consent(s), and if the subject agrees to participate obtain signatures as usual. Per our position paper, the translator should sign the full Informed Consent form
Sometimes patients have a life-threatening or possibly severely debilitating condition where there are no acceptable treatment alternatives. In such a case a clinician may use an unapproved treatment/article (drug, device or other) prior to obtaining IRB approval. The clinician however must submit the IRB’s Emergency Use paperwork within 5 days of the using the unapproved article.
Usually the manufacturer of the unapproved article requires the clinician to obtain an acknowledgement from the IRB chair that this meets Emergency Use conditions. You may contact our chairs directly to obtain such an acknowledgement. Our Chairman, Dr. Iafrate, can be reached at 352-273-9600.
It is important to note: Emergency Use is not identical to Compassionate Use or Treatment INDs. The usual difference between Emergency Use and these categories is (a) the patient doesn’t have a life-threatening/severely debilitating condition, and/or (b) there are alternative treatments available.
- View the Emergency Use Checklist
- Within five days of using the unapproved treatment submit the Report of Emergency Use of a Test Article without IRB Review.
- Patients/legally authorized representatives should be consented prior to using the device. The manufacturer of the test article usually has a sample Informed Consent form. If not, you may use our sample Emergency Use Informed Consent form.
- Lastly, if the subject cannot consent for themselves or if a legally authorized representative is not available, you may use the unapproved article without consent provided you obtain certification from an independent physician (use and submit this form).
NOTE: the regulations indicate that each institution may only use an article Emergently once. Regulations indicate that researchers at the institution must obtain IRB approval prior to any subsequent uses of the article. What happens if another patient arrives and needs the test article emergently? If you or another investigator chooses to use the unapproved article on a second or greater occasion, follow the steps described above. Be advised however that the IRB will have to report this additional use to the FDA. It is possible that the FDA may choose to take action against you if you had the opportunity to obtain IRB approval prior to using the article.
Enrollment of Adults with diminished decision-making capacity
If an adult lacks the capacity to consent, for example, as a result of trauma, developmental disability, or dementia (either temporary, progressive, or permanent) only a legally authorized representative (LAR) for that adult can give consent for participation in research (once IRB approved), unless the requirement to obtain informed consent has been waived by the IRB.
Should the subject regain or develop the capacity to consent, and they are still an “active participant” then his/her consent must be obtained for any further research, as the consent of the LAR is no longer valid (i.e. still have study procedures performed, specimens collected, on-going data collected).
In some research, such as longitudinal studies involving progressive disorders or aging populations, enrolled subjects may be competent to consent on their own behalf at the outset, but over the course of the study they may become decisionally impaired. IRB-01 will require that the investigator discuss with the prospective subjects the importance of designating someone to serve as a legally authorized representative at the outset of the study, so at the time the subject loses decision-making capacity, the designated LAR is on file with the investigator and is aware of the subject’s desire to continue with study participation.
In the absence of a designated healthcare surrogate, IRB-01 lists the order of LAR status for adults according to Florida Law on our forms. Below is the LAR precedence order as follows:
- Attorney in Fact – court documentation required
- Judicially appointed guardian – documentation required
- Subject’s spouse
- An adult child of the subject
- A parent of the adult subject
- An adult sibling of the subject
- An adult relative of the subject
- A close friend of the subject
NOTE: This list is not in order of convenience. If the subject has a spouse with decisional capacity, the adult child cannot consent in the spouse’s place. If a proxy provides consent for an adult subject, you must document in the medical or research records how validity of the proxy was determined.
Enrollment of Adults with full capacity who have physical limitations to sign for themselves
If an adult has full decision making capacity but has physical limitations due to injury, physical disability, or other restraints due to their treatment, that prevent signing a consent form for research the following process should be followed:
- The subject should be encouraged to make whatever mark he/she can on the signature line of the consent form
- A witness should be present as the subject makes this mark. The witness should not be a family member, part of the medical team caring for the subject, or part of the research team.
- A consent note should be part of the subject’s medical record and as a Note to File in the research file (with the consent form) about the consent process, the physical limitations the subject has, and the name /title of the witness present at the time the subject provided consent. The consent note should contain a statement for the witness to sign/date stating that the subject is voluntarily agreeing to participate in the proposed study and that they were present for the signature.
- If the subject cannot make any mark at all on the signature line of the consent form,
i. A witness must be present for the consent discussion. The witness should not be a family member, a member of the medical team caring for the subject, or a member of the research team
ii. A detailed note should be placed in the subject’s medical record and as a Note to File in the research file (with the consent form) detailing the consent process, why the subject could not make a mark on the consent form, and contain a statement that the witness will sign and date stating he/she was present for the discussion of the study, and the subject agreed to voluntarily participate in the study
HIV Testing for Research Purposes
Florida law establishes the parameters for consents and disclosures of results relating to HIV testing in Florida and will apply to all human research where an HIV test will be performed during either the eligibility screening or the research study itself.
Informed consent for HIV testing is mandatory and it must include:
1. Prior explanation of the right to have the information (i.e., identity of the test subject and the results) treated confidentially;
2. Disclosure that a positive HIV test result will be reported to the county health department with sufficient information to identify the test subject; and
3. Availability and location of sites where anonymous testing is performed (this is available from the county health department).
In addition, reasonable efforts must be made to notify the test subject of the results. If the test is positive, notification must include:
1. Information on the availability of appropriate medical and support services;
2. Information on the importance of notifying partners who may have been exposed; and
3. Information on preventing the transmission of HIV.
In the event of a positive test result, confirmatory testing must be conducted before any positive test result is released to the person. The identity of the test subject and the test results are confidential and may not be disclosed except:
1. to the person or the person’s legal representative;
2. someone with a legally effective release for HIV test results executed by the person (a general release won’t do);
3. agents and employees of the healthcare provider/facility who have a need to know as defined by the department of health;
4. health care providers for consulting on treatment;
5. the department of health/county health department;
6. authorized medical researchers who may not disclose the results further or any identifying information;
7. others as specified by statute.
Disclosure of test results to anyone on the exception list must be accompanied by the following statement: “This information has been disclosed to you from records whose confidentiality is protected by state law. State law prohibits you from making any further disclosure of such information without the specific written consent of the person to whom such information pertains, or as otherwise permitted by state law. A general authorization for the release of medical or other information is not sufficient for this purpose.”
HIV ICF Template Draft
To determine if you are eligible for this study a blood sample will be tested for the antibody to HIV. An antibody is a substance that blood cells make to fight infection. A positive HIV test means that your blood sample tested positive for HIV and that repeat testing will be performed to confirm (prove) this finding. If your sample is proved to be positive for HIV, it means that you are a carrier of HIV and that you can pass the virus to others by intimate sexual contact, by sharing needles, and through donating blood and organs. A negative HIV test means that no antibody to HIV was found in your blood sample based on the result of the initial screening test, repeat screening tests, or a confirmatory test.
There can be individuals who have HIV test results that are called “false positive,” i.e., for some reason, the test indicates that HIV antibodies are present in the blood when they are not. There can also be false negative results which can have two possible meanings; the person has been infected with HIV, but that person’s body has not yet made antibodies to the virus, or HIV antibody is present in the person’s blood, but for some reason the test failed to detect it.
A study doctor taking part in this study will meet with you before and after the HIV test. You may be asked to sign a separate consent form to have your blood tested for HIV. Because we will test your blood for HIV (the virus that causes AIDS), Florida Law requires that we tell you that:
- Your identity and HIV test result will be kept confidential to the extent provided by law.
- Any physician who performs an HIV test that has a positive result or lab that processes a blood sample for HIV that has a positive result must report this information to County Health Department with information that will identify you.
- If you want to get tested for HIV outside of this study, test sites that keep your results anonymous are available. You can contact the County Health Department for information on those sites.
When your test results are complete, you will be scheduled for an appointment to discuss your HIV results. If you test positive for HIV, we will do the following:
- Confirm the result by sending a sample of your blood for another HIV test.
- If the second test result is positive, the positive test result and your identity will be reported to the County Health Department. Florida law requires that we report this information.
- Provide information on medical and support services available to you; and
- Discuss information on the importance of notifying previous and current sexual partners that they may have been exposed to HIV and how to prevent HIV transmission.
Testing positive for human viruses (HIV) can be upsetting. You will be provided with information on medical and support services that may be available to you. If you test positive for HIV and that information were to become public, you could have problems getting insurance or a job.
Your identity and test results will be kept confidential to the extent permitted by Florida Law. If test results are released in accordance with Florida Law, this disclosure will be accompanied by the following statement: “This information has been disclosed to you from records whose confidentiality is protected by state law. State law prohibits you from making any further disclosure of such information without the specific written consent of the person to whom such information pertains, or as otherwise permitted by state law. A general authorization for the release of medical or other information is not sufficient for this purpose.”
Minors who reach the age of maturity
Florida law provides that “performing any procedure or prescribing any therapy which, by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject, without first obtaining full, informed, and written consent” constitutes grounds for disciplinary action 458.331 (1)(u). In Florida, disciplinary action can be taken against the investigator if the subject is not consented as an adult, even on data analysis (if not de-identified).
If a minor is enrolled in a research study and during the course of their participation becomes an adult (or becomes capable of consenting for another reason, such as emancipation by the courts, or by marriage, etc) you will need to seek consent directly from the subject in order to continue their participation.
When the subject is a minor
In the state of Florida, anyone under the age of 18 years of age is considered a minor, unless the minor has been legally declared emancipated.
In Florida, the following people may consent to research involving minors:
- Natural or Adoptive parents
- Legal custodians or legal guardians
- Minors, when the research involves treatments for which the minor can consent under Florida Law (eg. STDs, HIV, substance abuse treatment)
- Minors emancipated by marriage (the investigator should obtain a copy of the marriage certificate). Emancipation by marriage applies to both genders, and does not require that the minor marry an adult. If both minors are 16 years old and they get married, they are emancipated, and they remain emancipated even if they get divorced at age 17.
- Minors emancipated by court order (NOTE: the court order can outline which decision(s) the minor can make, for example, the minor can make decisions regarding healthcare but not for research. The investigator should obtain a copy of the court order)
- Unwed pregnant mothers, only when the research involves treatment relating to their pregnancy. NOTE: once the baby is delivered, the minor-mother can only make decisions (medical and research) for the baby but not for herself.
Minors and Assent
The IRB Executive Reviewer or Board will make the final determination as to when assent from the minor subject is required. Assent can be obtained from children who are seven years or older and not considered to have a cognitive impairment, be mentally immature, or seriously ill. If the subject is seven years or older and cannot provide assent, the reason should be documented on the consent document in the assent section or by attaching a Note to File to the consent document. Following are some considerations as to when assent may be required versus sought from a minor participant:
- Minimal risk study, regardless of benefit, consent of one parent and the assent of the child (45 CFR 46.404/408 and 21 CFR 50.51/55).
- Greater than minimal risk study which may be of direct benefit to the child, requires the consent of one parent, assent of the child should be sought but not required (45 CFR 46.405/408 and 21 CFR 50.52/55)
- Greater than minimal risk that is a minor increase over minimal risk study which may not be a direct benefit to the child but yields generalizable knowledge about the condition or disorder, requires content of both parents (if possible) and assent of the child (45 CFR 46.608/408 and 21 CFR 50.53/55).
- Greater than minimal risk study that is not a direct benefit to the child but provides an opportunity to understand, prevent, or alleviate serious problems to the health or welfare of children will require review and approval of the Secretary of the Department of Health & Human Services as well as consent of both parents and assent of the child (45 CFR 46.407/408 and 21 CFR 50.54/55).
Minors and Pregnancy Testing for Research Purposes Only
Minors and Pregnancy Testing for Research Purposes Only
If you are conducting a study which involves minors, in which a negative pregnancy test is required as part of exclusion criteria, and is not also part of the standard of care for that patient, the minor has the right to consent to that pregnancy test, without the knowledge of her parents. The lower age range to require such a test is not a fixed number, and may be specified in the sponsor’s protocol.
There is no statute regarding this specific consent issue, but rather court cases upholding a minor’s right to privacy, including a right to exercise her constitutional right to make her own reproductive decisions.
Article I, Section 23 of the Florida Constitution provides a right to privacy:
Every natural person has the right to be let alone and free from governmental intrusion into the person’s private life except as otherwise provided herein. This section shall not be construed to limit the public’s right of access to public records and meetings as provided by law.
In BB v. State, the court stated that “the constitutional right to privacy extends to minors.” (659 So.2d 256 (1995)). The same view was held in S.C. v. Guardian Ad Litem where the court stated [the] “State Constitution affords right to privacy to every natural person, irrespective of age.” (845 So.2d 953 (2003)).
In J.B. v. Florida Dep’t of Children and Family Servs., the court stated “Substantive due process under the Florida Constitution protects the full panoply of individual rights from unwarranted encroachment by the government.” (768 So.2d 1060, (Fla.2000)). Citing a New Jersey case, a Florida court agreed that “’a woman’s right to control her body and her future,” [is] a right she has even as an un-emancipated minor.’” The same court agreed that due process requires that laws not “operate as a functional bar to a minor’s exercise of her constitutional right to make her own reproductive decisions.”
Based on those court decisions, a minor has a right to privacy as it relates to whether she is pregnant or not, and thus we can only tell the parent if the minor consents to that disclosure.
An approved process to protect the rights of the pregnant minor regarding her consent to a pregnancy test is as follows:
- The investigator or approved study staff meet with the female child in private
- The child is told that she may be qualified for a research study, but in order to determine this, she would have to have a pregnancy test that was negative.
- The child is told that she has the right to have a pregnancy test and receive the results without her parents’ knowledge.
- If the child wants to hear more, then she must agree to and sign the “Consent for Pregnancy Test” form in which she agrees to have a pregnancy test, and also agrees to waive the right to receive the results without her parents’ knowledge.
- If agreed to and signed, the proposed study is then presented to the parent(s) and the child, if not, the conversation ends, the parent(s) are never notified of the potential study.
Minors who are wards of the state participating in research
NOTE: if you think that you want to involve this population in your research study, it would be advisable to call the IRB-01 office for guidance and confirmation that they can be included per the regulations.
Section 39.01(75), Florida Statutes, defines “temporary legal custody” as
the relationship that a court creates between a child and an adult relative of the child, legal custodian, agency, or other person approved by the court until a more permanent arrangement is ordered. Temporary legal custody confers upon the custodian the right to have temporary physical custody of the child and the right and duty to protect, nurture, guide, and discipline the child and to provide the child with food, shelter, and education, and ordinary medical, dental, psychiatric and psychological care, unless these rights and duties are otherwise enlarged or limited by the court order establishing the temporary legal custody relationship.
Ward of the State: Florida allows a state agency or institution to serve as guardian of a child, and in this circumstance the child is considered a “ward of the state,” as that phrase is used under applicable FDA regulations and The Common Rule. A ward of the state as defined by FDA regulation 21 CFR 50.3(q), is a child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable federal, state, or local laws (21 CFR 50.3 (q)). 45 CFR 46 and 21 CFR 50 Subparts D limit the types of research activities and sets additional conditions for research involving children who are wards of the State or any other agency, institution, or entity. Children who are wards of the state or any other agency, institution, or entity can be included in research approved under 45 CFR 46.406 or 45 CFR 46.407 only if such research is:
- Related to their status as wards; or
- Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.
These limitations also apply to FDA-regulated clinical investigations approved under 21 CFR 50.53 and 21 CFR 50.54. (21 CFR 50.56).
PI Responsibilities for the inclusion of children who are wards of the state in research: When a child is a ward of the state, a guardian must have court-appointed authority to give permission for the child to participate in a specific research project. When a child has been appointed a temporary guardian there must be procedures to obtain parental permission of the child to participate in the research.
If the research involves Florida Department of Children and Families (DCF) and contracted provider staff that engage in, plan to engage in, or are asked to authorize or support research using human subjects within the Department’s areas of responsibility, additional requirements apply, including approval by DCF’s Human Protections Review Committee (HPRC). Please call the IRB Office for more guidance utilizing this subject population, (352) 273-9600.
IRB Provisions for the Participation of Wards of the State in Research: If the research is approved under the conditions set above, the IRB shall require the appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guarantor in loco parentis (in the place of the parent). One individual may serve as the advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child’s participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.