University Hospital of Brooklyn
College of Medicine
College of Health Related Professions
College of Nursing
School of Graduate Studies
Graduate Program in Public Health / IRB Guidance:
Obtaining Legally Effective Informed Consent and HIPAA Research Authorization
For more information please contact the IRB Office at 718-270-8480.
Introduction
Form Requirements for Informed Consent and HIPAA Research Authorization
Informed Consent Form Document Requirements
Readability of Forms
Informed Consent Requirements for research which must comply with the International Conference on Harmonization ICH Good Clinical Practice
Using a Model Informed Consent Form From a Sponsor, CRO, or External IRB
Single vs. Multiple Consent Forms
Consent for Data or Specimen Repositories
Consent for Genetic Testing, Analysis and Tissue Banking
Consent for Return of Genetic Results to Research Participants
Consent for the Use of HIV/AIDS related Information
Consent for Release of Alcohol or Substance Abuse Information
Offer For Counseling
Consent Form Language for Incidental and Secondary Findings
Consent for Withdrawing Drugs
Exculpatory Language Is Not Permitted
Pregnant Partner Authorization
HIPAA Research Authorization
Information Sheet
Assent Form for Children
Considerations for Obtaining Remote Consent and Electronic Signatures
Data Use Agreement (DUA) or Business Associate Agreement (BAA)
Forms and Materials Used When Enrolling Research Participants with Limited English Proficiency (LEP), and for Those with Low Literacy and Numeracy, Physical Challenges, or a Religious Objection to Signing Documents
Translation and Certification of Written Research Materials
Process for Obtaining Informed Consent and HIPAA Research Authorization
Determining Ability to Provide Consent to Research
Verifying an Adult’s Capacity to Provide Consent
Known Cognitive Impairment
Determining Decision Making Capacity Of Others
Legally Effective Process
Individuals Involved In the Consent Process
Investigator
Witness
Interpreter
Adult (With Capacity)
Parent or Legal Guardian
Legally Authorized Representative (LAR)
Child
Cognitively Impaired Adult
Obtaining Informed Consent From Those With LEP
Long Form Process
Short Form Process
Process For Obtaining Informed Consent of Individuals with LEP When The IRB Approves A Waiver Of Documentation Of Informed Consent (Waiver Of Signatures)
Provision of Reasonable Accommodations
Research Participants with Low Literacy or Numeracy
Obtaining Informed Consent in Braille
Obtaining Informed Consent in American Sign Language (ASL)
Making a Mark
Signaling Consent
Audio or Video Consent
Research Participants with Religious Objections for Signing Documents
Re-Obtaining the Consent of Research Participants
References
Authors
Review and Approval History
Introduction
Please refer to IRB Policy-01 and the “informed consent” and “information sheet”templates within the IRB Application and Reporting system to ensure all requirements are met.
Waivers of the requirements of informed consent and HIPAA waivers are discussed in IRB Policy-01. Forms used to requests waivers are available in the IRB Application and Reporting System.
Additional guidance on the informed consent requirements and process for obtaining informed consent are provided below.
This guidance represents the IRB’s current thinking on this topic; however, the use of the word “must” in this document means the concept is a Downstate policy or regulatory requirement.
The use of the word “should” in this document means the concept can be treated as guidance or something is recommended or suggested, but not required. An investigator may use an alternative approach if the approach satisfies regulatory requirements.
Form Requirements for Informed Consent and HIPAA Research Authorization
Informed Consent Form Document Requirements
Please refer to the IRB Policy-01 and templates within the IRB Application and Reporting System to ensure all required elements and additional elements are included in the informed consent, including any required HIPAA authorization language.
Additional guidance on form requirements is provided below.
Readability of Forms
To the extent possible, the language should be understandable by a person who is educated to 6th to 8th grade level and layman’s terms shall be used in the description of the research. The PI is encouraged to use readability resources, such as:
- Readability Formulas
- MS Word -Test your document's readability
Informed Consent Requirements for research which must comply with the International Conference on Harmonization ICH Good Clinical Practice
To fully comply with ICH requirements, please refer to the E6 GCP Guidance ( One may also wish to refer to information in the training modules listed in the SUNY Downstate IRB Guidance for COI and Training requirements to understand important differences and additional requirements that are above and beyond IRB policy and FDA regulations. In specific see ICH 4.8.10, 4.8.12, and 4.8.14.
Using a Model Informed Consent Form From a Sponsor, CRO, or External IRB
The IRB may accept the model informed consent form that is created by a sponsor, CRO, or External IRB. However, in general, will require the HIPAA (PHI/IHII) authorization language from be used from the DMC informed consent template. For an industry-sponsored study, it is best to compare the language from the DMC informed consent template regarding injuries and any additional costs to make sure it is consistent with the sponsor. This language may be altered with the assistance of the IRB and Pre-Award to insure it is consistent with contractual obligations.
When a sponsored project is being conducted at multiple sites, the sponsoring company may require the use of their IRB approved informed consent for uniformity; however, the DMC IRB may recommend or require additional information to the informed consent, to ensure compliance with local laws and policy.
Single vs. Multiple Consent Forms
A single informed consent document with HIPAA authorization may cover uses and disclosures of PHI for multiple activities of a specific research study, including the collection and storage of tissues for that study and for disclosure of information pertaining to genetic studies. A multiple consent form approach may be used when the research involves different research studies (e.g., where a research study collects information for the study itself, and collects and stores PHI or specimens in a central repository for future research). However, the PI may choose to use a tiered consent approach to include options that allow a research participant to opt-in or opt-out of participation of specific research activities.
Consent for Data or Specimen Repositories
If the banking of data or specimens is proposed within the context of a larger research study, the following issues can be addressed within the main research consent form, or be addressed in a separate repository consent form. If included in the main consent, this may be achieved by a tiered consent approach by adding yes/no statements (with a signature or initial lines) within the document.
At the time of the proposed activity, if it is the intent of the investigator or the company collaborator/sponsor to produce a commercially valuable product, disclose in the consent form whether the research participant or his/her heirs will receive a portion of the profits. The consent forms cannot contain language through which the research participant is made to waive, or appear to waive, any of his/her legal rights. An acceptable example of consent language is:
We may, in the future, produce a commercially valuable product from the work done on samples collected from research participants in this study. It is not our intention to pay you or your heirs, for profits derived from such a product.
Do you agree to allow use of extra blood obtained from this study/extra tumor from your surgery for use in future research, the purposes of which are unknown now? (initial) ___ Yes
(initial) ___ No
If you agree, any future studies using your sample will be subject to further regulatory review.
Do you agree to allow someone to contact you in the future to ask you questions about your health or to ask you to participate in more research?
(initial) ___ Yes
(initial) ___ No
Determine what happens to the specimen(s), and the data derived thereof, if the research participant decides to withdraw from the study. If the tissue is removed from the study analysis or from the tissue bank, state so in the consent. If it is not the intention to remove the sample or any data derivedfrom it, state so in the consent. Disclose what will happen to cell lines that may be generated, if a research participant decides to withdraw from the study.
Describe the time period to indicate how long the data or specimens will be kept. It is acceptable to indicate, in the consent form, that the data or specimens will be kept for an indefinite amount of time.
If a new study proposes secondary use of biological specimens, i.e., use of samples collected for a previously conducted study, an assessment will be made by the IRB regarding whether the consent that was obtained for the first study is applicable to the second. If the purpose of the new study differs significantly from the purposes stated in the original study, and the specimens are identifiable, obtaining new consent will be required, unless the consent waiver criteria are met. The IRB therefore recommends obtaining the initial consent for research with as broad a stated purpose as possible such as, e.g., “the causes and treatments of lung cancer” etc.
Consent for Genetic Testing, Analysis and Tissue Banking
All research involving genetic testing, analysis and tissue banking shall be given special consideration regarding the unique risks presented by such research, and per current regulation governing such research.
In genetic research and research using stored tissue samples, there are potential health, societal, emotional and legal issues to consider. Many research participants may be naive to these issues and it is therefore necessary for the IRB to evaluate the protocols and consent forms for such studies with great care.
Such genetic studies include the following:
- Prospective studies in which the collection of the new samples is part of the study design.
- Retrospective: Studies that utilize previously obtained samples collected for a purpose that is different from that of the current study.
In general, research involving the prospective collection of coded or identified samples requires consent and authorization. Additionally, the investigator has the obligation to maintain confidentiality to the extent permitted by law.
In addition to the standard elements of consent the consent/authorization forms for such research should clearly indicate, as appropriate:
- What information could result from the research,
- What the implications and limitations are,
- That unexpected findings that may result from the research,
- What follow-up information research participants will receive (if any, as many studies are preliminary and results may not be meaningful or validated), and if research participants have consented to and authorized storage of samples for future studies, they need to be informed of how long storage will continue and the possibility of storage failure.
- Research participants should be given the option of being re-contacted to consider use of their samples in future studies.
Consent for Return of Genetic Results to Research Participants
Return of genetic research findings to a research participant is encouraged, particularly if the findings have significant implications for the research participant or the public’s health or there is a course of action to ameliorate or treat the research participant or the public’s health concerns is readily available. However, the IRB should approve the return of test results to the research participant when the testing is done in the context of the research and the research findings are scientifically valid and performed in a CLIA approved lab.
In certain cases,research participants will be given the option to determine whether they want to be informed of the results of their testing.
Consent for the Use of HIV/AIDS related Information
If a research protocol will involve the collection and/or study of HIV/AIDS information, research participants will need to sign a special consent form, required under New York law, permitting the release of that information for purposes of the research study.
The information from the HIV Consent may be merged into the informed consent or HIPAA research authorization document when applicable; however, all the required elements of the most current version of the New York State Department of Health HIV Consent should be included in the document. See the informed consent template for more information.
Consent for Release of Alcohol or Substance Abuse Information
Special restrictions apply to the disclosure of certain information maintained in connection with the operation of an alcohol or substance abuse treatment program, and require consent consistent with the Public Health Service Act (PHSA) for the Release of Confidential Alcohol or Drug Treatment Information.
The information from the PHSA consent may be merged into the informed consent document when applicable; however, all of the required elements of the PHSA must be included in the document, and are generally covered by the standard HIPAA authorization language.
All original signed and dated forms must be retained in the investigator’s research files, secure but readily retrievable.
If alcohol or substance abuse information is released outside of DMC, certain information must be included to protect the documents.
For more information, please consult the SUNY DMC HIPAA-2 Policy: Alcohol and Substance Abuse Information.
Offer For Counseling
Availability of consoling should be disclosed in the consent document, when it is appropriate to offer counseling. This may be particularly important for research that could lead to adverse psychological outcomes, social stigmatization and discrimination, such as return of certain test results or with research related to HIV, genetics, paternity, devastating diseases, or research on substance abuse.
Consent Form Language for Incidental and Secondary Findings
Incidental and Secondary Findings
For more information, see the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) report: Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to Consumer Contexts, the primer for IRB Members: Incidental and Secondary Findings, or the primer for Researchers: Incidental and Secondary Findings.
Anticipatable Incidental Finding
An anticipatable incidental finding is one that is known to be associated with a test or procedure. Anticipatable incidental findings need not be common or even likely to occur --their defining characteristic is that the possibility of finding them is known.
Incidental Finding
Incidental findings traditionally are defined as results that are outside the original purpose for which a test or procedure was conducted. These are distinct from primary findings, which are the results that are actively sought as the primary target of a test or procedure. Incidental findings can be either “anticipatable” or “unanticipatable.”
An Incidental Finding (IF) is a finding that:
- Concerns an individual Research Participant that has potential health or reproductive importance;
- Is discovered in the course of screening for, conducting, or analyzing results from Research; and
- Is beyond the aims of the study, i.e., occurring from variables not directly under study.
Secondary Finding
A secondary finding, by contrast, is not the primary target of the test or procedure; rather, it is an additional result actively sought by the practitioner. Secondary findings might be sought deliberately when doing so is recommended by an expert body or by a consensus of practitioners.
Unanticipatable Incidental Finding
Unanticipatable incidental findings include findings that could not have been anticipated given the current state of scientific knowledge. Researchers cannot plan for these types of findings specifically. However, they can consider in advance what they might do if a particular kind of unexpected finding arises, for example, one that could be actionable or lifesaving.
Informed Consent Considerations
Adapt the informed consent to the specific study, based on the assessment/disclosure plan proposed to the IRB. The following should be considered regarding incidental findings (IF) and secondary findings (SF)when developing the language in the consent form:
- Convey to the research participant that the study is for research purposes only and is not designed or intended to detect health problems.
- Convey to the research participant that during the review of research results, information may be uncovered that may have health or reproductive importance or incidental or secondary findings.
- The consent form should provide information as to whether a described IF is anticipated to be common or rare.
- If the IF or SF are uncovered, the PI must determine the clinical significance of the findings and determine whether the research participant should be referred to a physician for a follow-up. This would be addressed in the informed consent. DMC will assist in finding a physician if the research participant is in need.
- Expenses related to care needed to diagnose or treat an IF or SF are not covered by the research study. These expenses are the responsibility of the research participant and must be disclosed.
- Include language in the consent asking for permission to release medical information to the researchparticipant’s healthcare provider or indicate separate permission will be obtained.
Consent for Withdrawing Drugs
When drugs must be withdrawn from a research participant (e.g., run-in/wash out period) for him/her to participate in a study, this must be disclosed in the informed consent. The consent should describe the period which research participants will receive no treatment for the indication under study, the effects of eliminating the treatment, and any rescue procedures.
Exculpatory Language Is Not Permitted
No informed consent, whether oral or written, may include any exculpatory language through which the research participant or the representative is made to waive or appear to waive any of the researchparticipant’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.