(1) Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject’s legally authorized representative.

(2) An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.

(3) The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative.

(4) The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.

(5) (i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
(ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.
(6) No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

The following information shall be provided to each subject or the subject's legally authorized representative:

(1) 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 that are experimental;

(2) A description of any reasonably foreseeable risks or discomforts to the subject;

(3) A description of any benefits to the subject or to others that may reasonably be expected from the research;

(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(6) 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;

(7) 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;

(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and

(9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: (i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
(ii) A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

One or more of the following elements of information, when appropriate, shall also be provided to each subject or the legally authorized representative:

(1) 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) that are currently unforeseeable;

(2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s or the legally authorized representative’s consent;

(3) Any additional costs to the subject that may result from participation in the research;

(4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;

(5) A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject;

(6) The approximate number of subjects involved in the study;

(7) A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;

(8) A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and

(9) For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Certificates of Confidentiality (CoC) can serve to promote recruitment in studies requiring disclosures of sensitive personal information, and the IRB may require or recommend that investigators apply for a CoC when the IRB deems a CoC appropriate.

NIH-funded Research: CoCs are automatically deemed to be issued for any NIH-funded research that collects or uses identifiable, sensitive information that was on-going on or after December 13, 2016. For these projects, the CoC is issued as a term and condition of the award, and NIH does not issue a physical certificate (see this NIH CoC link).

Other Research: For studies that may not be NIH-funded, NIH may upon application to NIH consider issuing a CoC for research for which research the data may be subject to legal proceedings or risk and for research that may involve the use or disclosure of sensitive personal information. For some non-NIH funded studies, another DHHS agency or another federal agency may issue CoCs or their equivalent. This NIH CoC website provides information about contacting non-NIH and other federal agencies to obtain Certificates of Confidentiality or their equivalent. As long as a certificate is in place when a subject enrolls in a study, the protection provided by the certificate is permanent. Information identifying the subject will never be disclosed unless it is volunteered by the subject or investigator.

How to Apply for a NIH CoC:

You may apply for a CoC here or go to https://grants.nih.gov/policy/humansubjects/coc/request-certificate.htm

In the CoC application, be sure to list your RAMP IRB study title verbatim and your RAMP IRB study ID (e.g., STUDY0000xxxx) and list T. Howard Stone as the Institutional Official. Please let us know when you have submitted the CoC for our tracking purposes. Upon receipt of the CoC, we will provide you with additional instructions about revising (if you have not already done so; see below) your consent to include the requisite CoC language, as may be applicable.

Required Informed Consent Language:  

CoC Consent Language: when an NIH CoC is issued for any study, a statement to the following effect MUST be included in the consent form (similar language may be included when the CoC is issued by an agency other than NIH; replace "National Institutes of Health" with the name of the other agency):

"This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot release or use information, documents, or samples that may identify you in any action or suit unless you say it is okay. They also cannot provide them as evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena. There are some important things that you need to know. The Certificate DOES NOT stop reporting that federal, state, or local laws require. Some examples are laws that require reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate CANNOT BE USED to stop a sponsoring United States federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA). The Certificate also DOES NOT prevent your information from being used for other research if allowed by federal regulations.

Researchers may release information about you when you say it is okay. For example, you may give them permission to release information to insurers, medical providers, or any other persons not connected with the research. The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from having access to your own information."

Federal regulations provide four basic criteria for waiver of consent or alteration of any element of informed consent. [external link] The same criteria also apply to waivers of parental permission (and also to child assent). In order to approve of a researcher's request for a waiver of informed consent or to alter any element of informed consent, the IRB must find and document that all of the following criteria have been met:

1. the research involves no more than minimal risk to the subjects;
2. the waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. the research could not practically be carried out without the waiver or alteration (inconvenience and expense are not acceptable factors - scientific validity would be acceptable); and,
4. whenever appropriate, the subjects will be provided with additional pertinent information after participation.

In addition to the above general waiver criteria, if the IRB finds, accepts and determines, again based upon sufficient justification and information provided by a researcher, that research is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), the IRB may (but is not required to) waive the usual consent and parental permission requirements, but only if the IRB finds and document that researchers have proposed and will implement an appropriate, substitute mechanism for protecting the child subjects, and only if the waiver is not inconsistent with other federal, state, or local law. [external link] The choice and acceptance by the IRB of an appropriate mechanism will depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and the children's age, maturity, status, and condition. Refer to this Waiver of Parental Permission algorithm to see the IRB review pathways, decision points and outcomes that apply when researchers request waivers of parental permission.

Important Note: neither the researcher nor institutional officials are authorize under applicable federal regulations to grant any such waiver or alteration in the absence of specific IRB approval. [external link]

"Passive Consent" has been used in school based research in response to the challenges of securing prior written permission from parents. The passive consent process involves notifying parents that research will take place and giving them an opportunity to state that they do not want their children to participate. Thus, if parents do not affirmatively indicate that they do not extend such permission, they might be considered to have provided such permission. However, the passive consent process is not equivalent to informed consent, and the IRB will consider such process to constitute a waiver of parental permission to which waiver only the IRB can grant.

The federal regulations require that parental or guardian permission for children to participate in research must be secured or waived in accordance with the four criteria provided in the regulations. On a very practical level, sending notice does not mean that notice is received for a variety of reasons, including parents' inability to read. The parental notification process can be used to provide parents with the option to remove their children from research, but only if the requirement for parental permission has been waived by an IRB.

Some research has the potential to reveal child abuse and neglect. A study about behaviors for at-risk children might do so, and study about art and reading abilities would probably not touch on this possibility. If the potential does exist, then researchers should inform parents and older children during the informed consent process that the confidentiality they can provide is limited by Florida's child abuse reporting requirements.