INFORMED CONSENT / HIPAA GUIDELINES AND TEMPLATES
| Informed Consent |
| Writing the Consent document |
| Structure of an Informed Consent |
| Samples/Templates of Informed Consent |
| Waiver of Informed Consent |
| Waiver of Documentation of Informed Consent |
Some research involves health information (medical records, patient prescription, health status, disease progression, etc.). Whenever research involves health information, HIPAA regulations come into play...
Contemporary ethics regarding human subject research as stated in the Belmont Report underline the moral principle of "respect for persons". This ethical principle requires individuals in research to have the opportunity to make a conscious decision regarding what shall or shall not happen to them (autonomous agents). The application of this principle is the informed consent document by serving as an "autonomous consent" to participate in research. Information, comprehension and willingness to participate (voluntariness) are fundamental elements of the informed consent document. The consent should adequately convey all the information needed for the subject to understand the study, in addition, to being in a language understandable to the subject. A subject's consent to participate must be free from coercion. Above all, the subject should be able to understand the information presented in order to make an informed decision.
However, true informed consent goes beyond a document. Informed consent is really a process that begins with the recruitment phase and ends in the completion of the study. An investigator and research staff should have an informative interaction with the subject throughout each phase of the research.
UNDER CONSTRUCTION: You may access BMSC 5400 power point lecture created and given by Dr. Brian Gladue, OPHS Director and IRB Chairman, for more guidance on informed consent and the consent process by following this link.
Often research studies involve the collection and use of health information in order to successfully carry out the protocol. Whenever research involves health information, a new batter is brought to the informed consent plate...HIPAA. For more guidance regarding HIPAA authorization for research purposes click here or call OPHS at 817-735-0409.
What are the elements of the Informed Consent document?
According to federal regulations (45 CFR 46.116), there are specific elements or items that need to be included in the informed consent.
The following are basic elements of informed consent [45 CFR 46.116 (a)]:
(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 which 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 which 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; and
(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.
The following are additional elements of informed consent. When appropriate, one or more of these elements of information shall also be provided to each subject [45 CFR 46.116 (b)]:
(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) which are currently unforeseeable;
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject'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 which may relate to the subject's willingness to continue participation will be provided to the subject; and
(6) The approximate number of subjects involved in the study.
How should an Informed Consent document be written?
The regulations state that the consent shall be in language understandable to the subject. This goes beyond having the consent document just in the language understandable to subject (English, Spanish, etc.). To enhance understandability and readability, the consent should be written in active voice, and avoid grammatical and typographical errors. It is primarily recommended, in order to maintain consent language simple (layman terms), the consent should not be written beyond a 9th grade reading level (Flesch-Kincaid Grade level). However, the investigator should consider the subject population (target audience) when writing the consent. For example, an investigator interviewing doctors might include in the consent technical (medical) terminology instead of using the equivalent simplified version.
Nonetheless, it is important for the consent document to be clear and have a concise explanation of the various elements of the research study. In addition, the language should not contain any element of coercion nor appear to waive subject's legal rights, or release the investigator, sponsor or institution from liability for negligence (no exculpatory language).
The structure of the consent document entails the following:
(1) Heading and Title of the Study: Office for the Protection of Human Subjects (OPHS) recommends the heading of the document to be "INFORMED CONSENT TO PARTICIPATE IN A RESEARCH PROJECT"
(2) Identification of Investigators: Starting with the PI, the names and titles of all the investigators should be included. In addition, name the institution affiliated with each investigator(s).
(3) Introduction: Give a brief description why the subject is being asked to participate in this research study.
(4) Study Purpose: State in layman terms the overall purpose, objective or goal of the study. The subject must understand how this procedure, intervention or observation differs from medical/health care, and research.
(5) Study Procedures: Give a step-by-step description of the procedures to occur in the study place. The subject should be able to understand what is expected of them, when and how often the visits will take place, and the duration of each visit and study. Be thorough- describe what will occur when and for how long with each visit, etc.
(6) Risks and Discomforts of the Study: There are two types of risks associated with research studies i) informational and ii) physical risk. Informational risk involves the possibility of a breach of confidentiality. This is not limited to only personal identifiers but also responses to sensitive questions. Physical risk also called "procedural risk" is more common in biomedical research studies or clinical trials.
(7) Contacts: Indicate the contact information of the principal investigator (research coordinator, if applicable) and the Chairman of the Institutional Review Board (for UNTHSC, 817-735-0409).
(8) Benefits: Explain whether the study will have a direct or indirect benefit to the subject. If no direct benefit to a subject say so but also mention the value of doing this research. NOTE: Receiving compensation is NOT considered a benefit for the subject.
(9) Alternative Treatment (if any): If applicable, explain if there is any alternative to a subject's research procedure or intervention.
(10) Confidentiality: Provide a description of the measures that will be taken to secure the privacy of subject data and identifiers. Since there is always a potential risk of loss of confidentiality, refrain from any language guaranteeing/assuring complete privacy.
(11) Compensation for Injury (if applicable): Explain the availability of compensation and/or medical treatment in case of a research-related injury.
(12) Costs and Compensation of the Study: If applicable, detail any costs subject may accrue during this study or any payment the subject may receive for time and effort.
(13) Withdrawing from the Study: This statement must clearly indicate that participation is voluntary and the subject may withdraw/leave at any moment without penalty or loss of benefits that the subject was otherwise entitled. If investigators will be recruiting from UNTHSC, the following statement must be included.
"If you are a student of the University of North Texas Health Science Center, your participation (or non-participation) will in no way affect your academic standing or employment status."
(14) Consent Statement: This statement should indicate that the subject will receive a copy of the signed informed consent and the subject voluntarily agrees to participate in the study. This is the only statement that should be written in first person (e.g. "I" instead of "you").
(15) Signatures: Have signature lines for the subject or legal representative and the investigator/research staff who administered consent. Label signature lines as well as indicate the date of signing.
For more guidance on writing an informed consent document, please follow the link shown below for various informed consent templates or examples.
Social/Behavioral Informed Consent Samples/Templates:
Cover Letter (in lieu of informed consent)
Biomedical Informed Consent Samples/Templates:
Integrative Physiology Consent
Clinical Trial (non-sponsor driven) Informed Consent
Parental Consent (permission) and Child Assent
Cover Letter (in lieu of informed consent)
OPHS would like to extend our grateful appreciation to , Dr. Cardarelli, Dr. Larrañaga , Dr. Anthony, Dr. Dawson and Dr. Mathew, all principal investigators at UNTHSC, for permission to use their informed consent for educational purposes.
Do all Research Studies require a written Informed Consent?
In some instances, under certain requirements, federal regulations permit the IRB to grant a waiver of informed consent or allow an adaptation to the required elements of an informed consent. The following criteria must be met to qualify for this waiver or alteration of consent [45 CFR 46.116 (d)]:
(1) The research presents no more than minimal risk to subjects
(2) The waiver will not adversely affect the rights and welfare of the subjects
(3) The research could not practicably be carried out without the waiver; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after they have participated in the study
It is important to note that numbers (1), (2), (3) and (4) must all apply and must be cited as justification for waiver of informed consent. Number (4) is particularly important in Social Behavioral research for example in the following types of situations:
There may be new information as a result of a survey or focus group that would be relevant to the subjects.
- The purpose of the research requires elements of deception, in order to obtain a natural response that the subject would not display if the elements of deception were disclosed prior to the exercise. However, after the completion of the study, pertinent information must be disclosed to the subject.
- Subjects may be undergoing manipulation to elicit emotional responses.
An investigator who qualifies for an alteration of federal required elements of consent must still disclose to subject pertinent study information. This consent can be in form of a recruitment/cover letter, which includes a brief study explanation and procedures. The letter should also include a brief statement about:
- Risks associated with the study
- Option to withdraw
- Voluntary participation
- Confidentiality and
- Appropriate contact information (principal investigator and IRB Chairman)
If a research study qualifies for a waiver informed consent, UNTHSC-IRB requires an investigator to have an oral or written script containing core information about the research study. Follow this link for a sample template of a cover/recruitment letter (used in lieu of informed consent).
Investigators must formally request a waiver of informed consent in the Exempt application or protocol synopsis. This request must also include a justification apart from citing the federal requirements.
Do all Research Studies require Documentation of Informed Consent?
The Institutional Review Board under federal regulations can waive the requirement to obtain documented informed consent (i.e. initials, signature). Research studies that fall under the following criteria may qualify for a waiver of documentation of consent:
(1) The only record linking the subject and the research would be the consent document; and the principal risk would be potential harm resulting from a breach of confidentiality.
45 CFR 46.117 (c) (1)
For example, a study recruiting individuals involved in criminal activities may qualify for this waiver as their signature alone (personal identifier), if exposed, could lead to criminal liability.
OR
(2) The research presents no more than minimal risk of harm to subjects; and involves no procedures for which written consent is normally required outside the research context.
45 CFR 46. 117 (c) (2)
For example, a study evaluating the effectiveness of a smoking cessation program among its participants. The anonymous questionnaire containing no personal identifiers will be administered after the completion of the program. The research is deemed by IRB chair to be no more than minimal risk and study procedures (evaluation survey) would normally be carried out regardless of research intention. This study may qualify for a waiver of documentation of consent.
It is important to note that either regulation needs to apply in order to qualify for this waiver. Both do not need to apply to justify for this waiver. An explanation for waiver of documentation of consent must be included in the application or protocol synopsis.
Do HIPAA regulations apply to Human Subject Research?
Health Insurance Portability Accountability Act (HIPAA) regulations were designed to protect confidentiality of individual's medical records and protected health information. HIPAA regulations apply to human subject research under the Privacy Rule, which require investigators to request subject authorization for the use and disclosure of protected health information (PHI). HIPAA regulations define PHI as individually identifiable health information. Identifiable refers to data including demographic information as well as health information that can either link (directly or indirectly), or enable individual identification or recognition.
Therefore, investigators must include a valid HIPAA authorization request during subject consenting if they will be collecting, using or disclosing personal identifiers that are considered PHI.
Note: In Non-Clinical Trial Human Subject Research, informed consent language needs to be customized to each circumstance. Required verbiage is offered for this purpose: Consent Language (pdf)
For more information about UNTHSC policy on HIPAA, please click here.
UNDER CONSTRUCTION: You may access BMSC 5400 power point lecture created and given by Dr. Brian Gladue, OPHS Director and IRB Chairman, for more guidance on HIPAA and Privacy Rule Regulations by following this link.
Which identifiers are considered Protected Health Information (PHI)?
HIPAA regulations state Protected Health Information may be but is not limited to the following:
- Name, Social Security Number
- Geographic subdivisions smaller than a state (i.e. street address, city, county, zip code and their equivalent geocodes, precinct)
- All elements of dates (except year) directly related to an individual (i.e. birth date, discharge date, death date, medical visit, screening date, etc.)
- Voice/fax phone numbers, email addresses
- Health insurance, medical record, health account numbers
- Driver License, Vehicle ID, License plate numbers
- Certificate/license numbers
- Internet Protocol (IP) addresses, Uniform Resource Locators (URLs)
- Biometric identifiers, finger/voice print
- Full face/body photo
- Medical diagnosis, screening, treatment
- Unique identifying number, characteristic, or code*
* This is considered PHI when the assigned code can potentially be linked to individually identifiable health information
What are the elements to a valid HIPAA Authorization Form?
A valid HIPAA authorization must include the following core elements:
- A description of the purpose of the requested use or disclosure of PHI
- A description of the information to be used or disclosed that identifies the information in a specific fashion
- A list of those who are authorized to use and disclose PHI
- A list of those whom may request disclosure of PHI (i.e. Institutional Review Board, Office of Human Research Protection, regulatory offices, etc.)
- Information regarding the expiration of the authorization
- Information regarding individual's right to revoke the authorization in writing
- Signature of the individual and the date
The federal regulations regarding protected health information, allows HIPAA authorization to be combined with the consent form. At UNTHSC, HIPAA authorization can be done in two ways 1) embedded within the consent form or 2) attached separately as an addendum to the consent form. However, each IRB may differ in this requirement. Follow the link to view a sample HIPAA authorization addendum.
When can protected health information not be considered individually identifiable?
HIPAA regulations state when health information DOES NOT include any identifiers AND there is no reasonable basis to believe that the remaining information could be used to identify a person it is NOT considered protected health information (individually identifiable health information). Rather, the health information is de-identified and not subject to the Privacy Rule (HIPAA regulations).
The National Center of Health Statistics or Census Bureau is a good example of a truly de-identified data source. Therefore, public available data are not considered protected health information (PHI) as the information cannot individually identify a specific person.
Alternatively, the Institutional Review Board (IRB) may determine that health information is de-identified if a person with the appropriate knowledge and experience with generally accepted statistical and scientific principles and methods can render the information not individually identifiable. The risk should be minimal that information whether alone or in combination with other information can be used to identify a person. Investigators must indicate to the IRB the methods to which they will render the data de-identifiable.
However, investigators should not assume that by assigning a code to the data it might qualify as de-identified. Investigators must bear in mind that if there is a mere chance or manner to link the data with a personal identifier then it is not de-identified.
When can a waiver or alteration of HIPAA authorization be used?
A waiver of HIPAA authorization may be granted by the Institutional Review Board (IRB) if the research study involves the following:
1) The use of protected health information (PHI) is solely for preparatory research. This refers to activities such as designing the protocol or research questionnaire (i.e. sample size, etc.).
2) Research uses PHI from decedent's information. This means research involves PHI from deceased individuals and it is not practical to request authorization. PHI collected must be minimal and necessary in order to carry out effectively the study.
The Institutional Review Board must be able to review and document the following information in order to grant a waiver of HIPAA authorization:
1) The use or disclosure of protected health information involves no more than minimal risk to the privacy of the individuals.
a) There must be an adequate plan to protect the identifiers from improper use and disclosure
b) An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research unless there is a justification for retaining the identifiers
c) Adequate written assurances that the protected health information will not be reused or disclosed to anyone or entity, except required by the law for authorized oversight of the research study
2) The research study could not practicably be conducted without the waiver
3) The research study could not practicably be conducted without the access to and use of protected health information
It is important to note that a HIPAA waiver is not the same as a waiver of informed consent. An investigator must request either separately.
Which studies may qualify for a HIPAA waiver?
- Gathering billing information (i.e. breast cancer screening visits) from clinic records to identify prospective subjects for recruitment. NOTE: The investigator must request HIPAA waiver and IRB approval of research project before accessing protected health information.
- A minimal risk study involving a retrospective (medical) chart review of breast cancer screening behavior in Hispanic women.
- A minimal risk study involving a short anonymous questionnaire regarding healthcare plans in family clinics may qualify for a HIPAA waiver. Although subject's name will not be included in the survey, the responses will generate protected health information making a HIPAA waiver necessary.
HIPAA regulations under the Limited Dataset Use Agreement allow researchers to use protected health information that excludes direct identifiers of individuals or of relatives, employers or household members of the individuals. Geographic location (i.e. city, state, zip codes) and dates (i.e. birth date) are permissible protected health information (PHI) for investigator's use and disclosure without an authorization or waiver of authorization. However, investigators must list to the Institutional Review Board the permitted uses and disclosures of the PHI. In addition, the investigator is required to do the following:
- Have appropriate safeguards
- Not use/disclose outside of the agreement or as required by law
- Report any non-permitted uses/disclosures
- Ensure all parties with access agree to terms
- Not identify the information or contact the individuals
UNTHSC has two separate forms to request the use (internal and external covered entity) of Human Subject data under a Limited Dataset Use Agreement.
For questions regarding the use of these forms, please contact OPHS at 817-735-0409.