Sorry, you need to enable JavaScript to visit this website.

Sign Up For Mailing List Button

Donate to Genetic Alliance

Disease Search Button

Chapter XIII - Requirements for Informed Consent

Facebook icon
Google+ icon
Twitter icon
LinkedIn icon
Del.icio.us icon
Digg icon

GENERAL OVERVIEW OF INFORMED CONSENT
Informed consent is one of the primary ethical requirements underpinning research involving humans; it reflects the basic principle of respect for persons. It should always be remembered that informed consent is an ongoing process, not a single event, designed to provide potential research participants with all the relevant information they need to make a fully informed, autonomous decision as to whether they wish to participate in a research study.

The GA IRB reviews the planned research activities to ensure that the informed consent process adequately describes how informed consent will be sought from each prospective participant or the participant's legally authorized representative, in accordance with and to the extent required by 32 CFR 219.116. The IRB reviews the informed consent document to determine whether it is consistent with the protocol plan, Investigator’s brochure, and Sponsor’s or Investigator’s protocol, and contains the necessary elements of informed consent as required by the federal regulations.

The GA IRB may require that information, in addition to that required in federal regulations, be given to research participants when in its judgment the information would meaningfully add to the protection of the rights and welfare of participants.

The GA IRB may request necessary revisions to the content, language, punctuation, and/or grammar for the intended target population to clearly understand the proposed research activities and make an informed decision on whether to participate in the research.

IRB REVIEW OF INFORMED CONSENT DOCUMENT(S)/PROCESS
During its review of the informed consent process as described in the protocol, the IRB reviewer must determine that:

  • Adequate opportunity is provided to the participant or the participant’s legally authorized representative to read the consent document and ask questions regarding the study before the informed consent document is signed;
  • The consent process minimizes the possibility of coercion or undue influence. The consent discussion is in language understandable to the participant or the participant’s legally authorized representative;
  • The information communicated to the participant or the participant’s legally authorized representative during the consent process does not include any exculpatory language that waives or appears to waive any legal rights that the participant may have, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for harm caused by their negligence.

In addition, the IRB requires that the consent document include all the basic elements of consent set forth in 45 CFR 46.116 and, if applicable, 21 CFR 50.25, except those which can be waived, or altered, according to regulation. The IRB may also require that additional elements or information be given to the prospective participants when, in the IRB’s judgment, the information would meaningfully add to the protection of the rights and welfare of the research participant.

Basic Elements of Informed Consent 45 CFR 46.116 (a) or 21 CFR 50.25(a) include:

  • A statement that the study involves research;
  • A description of any reasonably foreseeable risks or discomforts to the participant;
  • A description of benefits to the participant or others that may be reasonably expected from the research;
  • The disclosure of appropriate alternative procedures or course of treatment, if any, that might be advantageous to the participant;
  • A statement describing the extent to which confidentiality of records identifying the participant will be maintained;
  • For medical research involving more than minimal risk, an explanation as to whether or not any compensation or any medical treatments are available if injury occurs during study participation;
  • The identification of an individual who can be contacted by the participant for answers to questions related to the research, research-related injury, or their rights as a research participant;
  • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which s/he is otherwise entitled.

Additional Elements of Informed Consent 45 CFR 46.116 (b) or 21 CFR 50.25(b) that should be addressed, as appropriate include:

  • A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) which are currently unforeseeable;
  • Anticipated circumstances under which the participant's participation may be terminated by the investigator without regard to the participant's consent;
  • Any additional costs to the participant that may result from participation in the research;
  • The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant;
  • A statement that significant new findings developed during the course of the research which may relate to the participant's willingness to continue participation will be provided to the participant;
  • The approximate number of participants involved in the study;
  • Consent Form Addendum. When participants need to be informed of specific changes in the risk or benefit of study participation, an addendum consent, which focuses on the new information, may be more appropriate than a modified consent document. A consent form addendum may also be used to inform enrolled participants about significant new findings that may have a bearing on their willingness to continue participation in the study.

OUTLINE FOR CREATING AN INFORMED CONSENT DOCUMENT
Study Title: Title of the study must match the title provided on the IRB application.
Principal Investigator: Provide the name of the Principal Investigator.
Sponsor: If applicable, provide the name of the sponsor funding the research study.

1. Explanation of the study (Why is this study being done?): Provide a brief non-technical explanation of the purposes of the research. Explain why the participant is being asked to participate in the study (e.g., you are being asked to participate in this research study because…).

2. Number of participants in the study (How many people will take part in this study?): Include approximate number of participants; if multi-center, include total study number and number expected at the study site.

3. Study procedures (What will happen if I take part in this study?): Provide a complete description of procedures, including the order in which they occur, and specifically identify and distinguish any procedures that are experimental or being performed solely for research purposes. Describe what the participant will be expected to do using lay language and fully explain any medical terms or abbreviations.

4. Duration of participation (How long will I be in the study?): Provide expected duration, including frequency of re-contact and follow-up, of the participant’s participation. Ensure that the proposed duration is realistic for the procedures to be performed.

5. Study withdrawal (Can I stop being in the study?): Indicate that the participant may choose to discontinue participation without penalty or prejudice.

Explain potential outcomes of a participant’s decision to withdraw from the research. If applicable, insert the following language and describe the procedures for orderly termination, explaining why the tests, visits, etc. are necessary for the participant’s welfare:

You may be asked to follow certain procedures or undergo additional testing to safely leave the study.

If applicable, also insert the following language and explain anticipated circumstances under which the participant’s participation may be terminated:

There may also be reasons why your study participation can be stopped without your consent.

Note: Do not state that the investigator may withdraw participants if they do not follow study procedures, as participants are not able to know all of the study procedures.

Regarding participant withdrawal from FDA-regulated clinical trials, explain the following:

  • According to FDA regulations, data collected about the participant up to the time of withdrawal remains part of the study data and may not be removed;
  • Participants may be asked if they wish to provide informed consent for continued follow-up and data collection subsequent to their withdrawal from the interventional portion of the study (Note: Distinguish between previous study-related interventions and the continued follow-up of associated clinical outcomes and address the maintenance of privacy and confidentiality of the participant’s data);
  • Data collected about the participant prior to withdrawal may be reviewed by the researcher and research team (including review of public records, such as survival status) even if the participant does not provide consent to continued follow-up. 

6. Description of the risks (What risks, side effects or discomforts can I expect from being in the study?): Provide a description of any reasonably foreseeable risks or discomforts. Explain the likelihood and seriousness of the risks, including potential physical, social, economic, psychological, and legal harms. Describe the precautions that will be taken to minimize the risks.

When appropriate (e.g., for studies involving investigational drugs), include a statement that the treatment or procedure may involve risks to the participant (or embryo or fetus, if the participant is or may become pregnant) that are currently unforeseeable. If drugs or devices are being studied, ensure that the risks described are based on the protocol, investigator’s brochure, package labeling and/or previous research reports.

When appropriate (e.g., for studies involving genetic testing), include the following language:

A federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:

  • Health insurance companies and group health plans may not request your genetic information from this research;
  • Health insurance companies and group health plans may not use your genetic information when making decisions about your eligibility or premiums;
  • Employers with 15 or more employees may not use your genetic information from this research when deciding to hire, promote, or fire you or when setting the terms of your employment.

​All health insurance companies and group health plans must follow this federal law. This law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. Under MD law, health insurance companies cannot ask about the results of a genetic test or use any information obtained from genetic testing to make decisions about providing coverage or benefits for health care services http://www.dbm.maryland.gov/benefits/Pages/GINAPolicy.aspx.

7. Description of the benefits (What benefits can I expect from being in the study?): Provide a description of any benefits to the participant or to others that may reasonable to expect from the research, distinct from benefits participants may receive if not participating. Consider potential benefits that may accrue to science or society in general because of the planned research. Assess the likelihood of benefits based on the protocol and ensure they are realistic for the research. Do not overstate potential benefits.

If applicable, insert the following language when no direct benefits to participants are expected:

You will not benefit directly from participating in the study.

Note: Describe any payments to participants in the incentives (Will I be paid for taking part in this study?) section.

8. Alternatives (What other choices do I have if I do not take part in the study?): Disclose appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant. Include the full range of available options for the participant. Also state that participants may choose not to participate without penalty or loss of benefits.

9. Additional costs to participants (What are the costs of taking part in this study?): Explain any additional costs to the participant that may result from participation in the research. When medical care is delivered in the context of the study, distinguish between costs of procedures performed for research purposes and those performed as part of standard care.

If applicable, insert the following language when there will be no additional costs to participants:

There will be no additional costs to participate in the study.

10. Description of the incentives provided (Will I be paid for taking part in this study?): Explain payments or other incentives to participate, including amount and schedule of payments. Compensation should be pro-rated (e.g., per visit) and not contingent upon study completion.

If payments will be offered, also state that payments are considered taxable income.

If payments will not be offered, insert the following language:

You will not be paid to participate in the study.

11. Compensation/medical treatments for injury (What happens if I am injured because I took part in this study?): Explain any compensation or medical treatments available if injury occurs. Use non-exculpatory language to describe the availability of compensation.

Include any information regarding whether participants or their insurance companies will be billed for any costs.

When compensation for injury will be provided by the sponsor, also insert the following language:

{Insert sponsor’s name}, the study sponsor, plans to pay for necessary medical treatment not covered by your insurance if you are injured by the drugs or devices being studied or any procedures required by the study, as described above in this consent form. The sponsor does not plan to pay for treatment or other complications or illness that did not result from your study participation, or for injuries that result from your failing to follow instructions given to you by the researcher or study doctor.

12. Participants’ rights (What are my rights if I take part in this study?): State that participants do not give up any personal legal rights by agreeing to participate. The following statements must also be included: participation is voluntary and refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled; participants may discontinue participation at any time without penalty or loss of benefits;  and any significant new findings developed during the research that may relate to participants’ willingness to continue participation will be provided.

13. Confidentiality of records (Will my study-related information be kept confidential?): Add the following to the consent template: A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. Do not interchange the terms “confidential,” “anonymous,” and “de-identified.” Discuss the disposition of participants’ records following conclusion of the research.

14. For research involving protected health information (PHI), provide a HIPAA research authorization or request for waiver.

15. For applicable clinical trials, also state that participant information from studies involving drugs, biologics, or devices will be entered into the publicly available databank at ClinicalTrials.gov.

WAIVER OR ALTERATION OF THE INFORMED CONSENT PROCESS
The GA IRB ensures that provisions are made to obtain legally effective informed consent prospectively from each research participant or permission from his/her legally authorized representative. Per 32 CFR 219.116d, the IRB may approve a consent procedure, which does not include, or which alters, some or all the required elements of informed consent, or waive the requirements to obtain informed consent entirely, provided the IRB finds and documents that:

  • The research involves no more than minimal risk to the participant; AND
  • The waiver or alteration will not adversely affect the rights and welfare of the participants; AND
  • The research could not practicably be carried out without the waiver or alteration; AND
  • Whenever appropriate, the participants will be provided with additional pertinent information after participation.

The Principal Investigator is responsible for providing detailed justification that these four criteria are met.

Note: The criteria listed above for waiver or alteration of informed consent are now applicable to FDA-regulated research per an amendment to the Federal Food, Drug and Cosmetic Act (FD&C Act) prepared by the Office of Good Clinical Practice, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health at the Food and Drug Administration (FDA), passed on December 13, 2016, known as the 21st Century Cures Act (Cures Act) (P.L. 114-255). This law provides FDA with the authority to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human participant and includes appropriate safeguards to protect the rights, safety, and welfare of the human participant.

DOCUMENTATION OF INFORMED CONSENT FOR HIMAN PARTICIPANTS RESEARCH
Unless specifically waived or altered by the GA IRB, there are several options for documentation of informed consent. The IRB will determine which of the procedures described below is appropriate for documenting informed consent in research applications that it reviews.

  • Written consent form signed and dated by the participant or legally authorized representative;
    • In most circumstances, the GA IRB will require that informed consent is documented using a written consent form approved by the IRB and signed by the participant or the participant's legally authorized representative;
    • This consent form must embody, in language understandable to the participant, all the required elements necessary for legally effective informed consent. The required elements of informed consent, in addition to any applicable additional elements that are required by the federal regulations must be included;
    • The consent form may be read to the participant or the participant’s legally authorized representative. However, the Investigator should allow the participant or the legally authorized representative adequate opportunity to read and consider the consent document before it is signed;
    • A copy of the informed consent document must be given or made available to the person signing the form.
  • Oral presentation using short form. As an alternative to standard written informed consent documents, oral presentation of informed consent information may be used (e.g., with illiterate participants);
    • The participant must be provided with both a short form written informed consent document stating that the required elements of consent have been presented orally to the participant or the participant’s legally authorized representative; and a written summary of the information that is presented orally;
    • A witness to the oral presentation is required. The witness must sign and date both the short form written informed consent document and a copy of the written summary;
    • The participant or the legally authorized representative must sign and date the short form written consent document;
    • The person obtaining consent (e.g., the Principal Investigator or study coordinator) must sign and date a copy of the written summary of the information
    • that is presented orally;
    • The person obtaining consent may not be the witness to the consent. The GA IRB may approve alternate processes for obtaining informed consent documentation.

The IRB will determine, on a protocol case-by-case basis, the exact process appropriate for documenting informed consent in research applications that it reviews. Two examples are given:

  • Consent conducted by telephone. The GA IRB may approve a process that allows the informed consent document to be delivered by mail or facsimile to the potential participant or the potential participant’s legally authorized representative and to conduct the consent interview by telephone when the participant or the legally authorized representative can read the consent document as it is discussed. All other applicable conditions for documentation of informed consent must also be met when using this procedure;
  • E-Consent. Electronic-Consent (e-Consent) is a newly evolving platform for consenting patients either on site or at home using a computer based consent form rather than traditional paper documentation. Consent forms can be implemented in a technology platform that enables secure and efficient interactions between research sites and patients. (e.g. REDCap). Such technology utilizes a secure, web-based interface that allows both secure data collection for research sites and permits patients access to study information, documents, consent forms, etc via computer, mobile phone, or tablet, and to e-sign, date, download and print forms. If properly reviewed and approved by the GA IRB, e-Consent may be used for adults, children, and vulnerable populations, as well as, for minimal and greater than minimal risk studies. The most optimal process is for the investigator/sponsor to provide in writing to the IRB a complete description of the electronic consent process. GA IRB suggests IRB approval of the consent text prior to developing the electronic consent, to avoid revising the electronic consent because of inappropriate wording. Thus, investigators are advised to submit a Word doc or paper version of the consent to the IRB in advance of creating the finalized eConsent interface to get IRB approval of the general document and avoid extra expense. The IRB will approve and issue a stamped/approved version of (any) scripts and the final PDF form of consent text for use in the on-line platform. The final product must meet the regulatory requirements for the elements and documentation of consent. It is the investigator’s responsibility to ensure that the version signed by participants matches the version approved by the IRB.

Verbal agreement (e.g., consent obtained over the telephone) to participate in a research study is not permitted unless the documentation or process of informed consent is waived or altered by the IRB.

WAIVER OF DOCUMENTATION OF INFORMED CONSENT
The GA IRB may waive the requirement for the Investigator to obtain a signed consent form for some or all participants. A waiver of documentation means that the requirement to obtain a signed consent document is waived, however, a consent process must still take place. The waiver of documentation is appropriate when telephone contact will be made with the participant or surveys will be sent to participant’s (email/computer, postal service). The basic elements of informed consent (32 CFR 219.116 (a-b)) must be communicated to the participant verbally (if contact occurred by telephone) or in writing (as part of survey or information sheet provided to the participant), but a signed consent form is not required. To waive the requirement for documentation of informed consent the IRB must find either:

  • That the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (32 CFR 219.117(c)(1)); OR
  • That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context (32 CFR 219.117(c (2)).

For FDA-regulated research, this condition cannot be used to justify waiver of documentation.

In cases in which the documentation requirement is waived, the GA IRB may require the Principal Investigator to provide participants with a written statement regarding the research (e.g.”Information Sheet”).

INFORMED CONSENT AND NON-ENGLISH-SPEAKING PARTICIPANTS
It is preferable that the written informed consent documents for non-English speaking participants embody, in a language understandable to the participant, all the required elements necessary for legally effective informed consent. Alternatively, the regulations permit oral presentation of informed consent information in conjunction with a short form written consent document (stating that the elements of consent have been presented orally) and a written summary of what is presented orally (32 CFR 219.117(b)(2)).

During the consent process an individual who is knowledgeable about the study and who can answer questions in the participants’ language or through a translator should be present. A witness to the oral presentation is required, and the participant must be given copies of the short form informed consent document and the summary. When this procedure is used with participants who do not speak English, the following are required:

  • The oral presentation and the short form written informed consent document should be in a language understandable to the participant;
  • The IRB-approved English language informed consent document may serve as the summary; AND
  • A witness who is fluent in both English and the language of the participant should be present.

When consent will be obtained in a language other than English, documentation that the foreign language version of the consent form is an accurate translation of the English version of the consent form must be provided to the GA IRB. Documentation from a qualified translator certifying the translation must be provided along with the English and foreign language version of the consent forms. The documentation of translation should include the following statement, “I certify that this is an accurate and true translation” as well as the signature, name, address, and phone number, of the translator. The GA IRB may also request a certified back-translation.

Twitter icon
Facebook icon
LinkedIn icon
Google+ icon
YouTube icon
RSS icon

4301 Connecticut Ave NW, Suite 404, Washington DC 20008-2369 | Tel: 202.966.5557 | Fax: 202.966.8553 | EIN 52-1571905

Except where otherwise noted, content on this site is licensed under a Creative Commons Attribution 3.0 License.