The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research

This section of the toolkit offers some strategies for those who seek to serve as change agents in their organizations to improve the informed consent and authorization process.

Raise Awareness

• Share examples of readable informed Health Insurance Portability and Accountability Act (HIPAA) consent and authorization documents that have been used succesfully by other institutional review boards (IRBs).
• Educate IRB members, institutional lawyers, and researchers on regulatory requirements.
• Identify sections of documents that are not required and distract from the primary purpose of the documents.
• Host experts on health literacy, informed consent, and research ethics to educate the research and IRB communities.
• Conduct interactive workshops and online training on writing understandable documents and how to conduct the informed consent and authorization discussion.
• Create a forum to discuss ways to identify and address liability concerns outside the informed consent and authorization process.
• Share research findings regarding malpractice and communication.

Identify Leaders and Partners

• Invite researchers and IRB officials from other communities or accrediting institutions such as the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP, www.aahrpp.org) to model new approaches and demonstrate that changing the process for obtaining informed consent and authorization is feasible and worthwhile.
• Identify opinion leaders who can advocate change among their colleagues.
• Enlist technical assistance from the Department of Health and Human Services (HHS) Office for Human Research Protections to resolve questions on whether informed consent document simplification complies with regulations.
• Review the Web site of the HHS Office for Civil Rights for general HIPAA Privacy Rule information, as well as specific information related to the HIPAA Privacy Rule and research.
• Review the Web site of the National Institutes of Health (NIH) regarding research and the HIPAA Privacy Rule.
• Solicit ideas from outside resources such as Public Responsibility in Medicine and Research (PRIM&R; www.primr.org), the Association of American Medical Colleges (AAMC; www.aamc.org), and AAHRPP (www.aahrpp.org) for ideas and support.

Identify Mechanisms for Change

• Post AHRQ sample documents on your IRB Web site and encourage researchers to use them as templates.
• Establish a mechanism that researchers can easily use to test their documents and processes with potential research subjects.
• Create a community advisory board to review template language at your institution.
• Have the IRB office sponsor catered training, education, and feedback meetings that include topics related to evaluation and integration of methods to promote comprehension.
• Significantly increase the training and participation of IRB members who can represent the perspectives of research subjects, who are unaffiliated with the institution, and who are not scientists.

Address Common Concerns About the Proposed Changes

Common concerns appear below, along with responses that can be used to educate the community.

1. Objection: Legal clauses protect our institution against lawsuits. Response: Including legalistic clauses does not afford protection against lawsuits. On the contrary, complex consent forms have been the basis of legal action by research subjects even in the absence of physical harm. 14
2. Objection Regulations require use of technical terms. Response: Regulations require the use of language that is understandable to the potential subject. 15
3. Objection: A small font and long paragraphs keep the documents short. Response: Well-written documents do not have to be long. Also, documents that use large fonts, short lines, lots of white space, bulleted lists, and headings to break the text into manageable pieces are easier to read than short, dense documents.
4. Objection: Most people are familiar with common medical and research terms. Response: Most people who participate in research do not understand common medical and research terms. 16-17
5. Objection: These documents have been used for years, so they must be fine. Subjects would not sign the documents if they didn't understand. Response: Research has shown that most research subjects did not understand all the information contained in consent documents they had signed. 18
6. Objection: It will take too long to verify comprehension. Response: This is possible; however, assessing comprehension can identify subjects who need further instruction to participate.
7. Objection: There is no reason to focus too much on the written materials because informed consent is a process and investigators will communicate what is needed. Response: High-quality consent materials can lead to an improved consent process and provide information that subjects, family, and friends can refer to as the study continues to help ensure continuing comprehension and consent.

Improving the Informed Consent and Authorization Process

AHRQ recommends the following process for all study personnel who will be obtaining written informed consent and authorization. The objective is to teach potential subjects about research protocols and confirm their comprehension.

Create a Research Culture To Promote the Process

Many of the safeguards that have been put in place to protect subjects' rights can be easily subverted if research personnel are not motivated to perform their duties with integrity. Professionalism needs to be modeled. In addition, some of the activities needed to promote the consent process require preparation and training. If the activities described below are presented in a fashion that exhibits the ethical and regulatory importance of the consent process, investigators will be able to communicate these values to their staff.

Staff Training

• Create a teaching version of your Informed Consent and Authorization documents. These are educational materials. Researchers can create a companion teaching version with embedded prompts (e.g., "stop here and ask for questions") to serve as a teacher's guide. Give a copy of this teaching version to personnel in contact with subjects and potential subjects. Use the teaching version in a supervised simulation of the consent process and give feedback about what worked well and what did not work well.
• Review the Informed Consent and Authorization Certification document prior to beginning the discussion with a potential research subject. It serves as a reminder of the topics to discuss with the potential subject. When supervising a simulated or actual consent process, use the certification document as a checklist to keep track of what was or was not done.
• Take steps to differentiate between clinical care and research. Research personnel need to approach the informed consent and authorization process in a fashion that helps potential subjects understand that they can freely refuse to participate. Research personnel should avoid activities that falsely impart the impression of a therapeutic relationship, such as wearing a white coat. Investigators who are clinicians need to be especially careful to separate their clinical and research roles and, whenever possible, should not be directly involved with the consent and authorization process.

Physical Environment

• Conduct the discussion in a private and quiet place. The informed consent discussion should be held in a private setting, unless the potential research subject would like to include other people (e.g., family, friend). An exception may be made when providing information to a group of potential subjects at the same time, as is frequently the case when focus groups are conducted.
• Be prepared to accommodate potential subjects with disabilities. For example, people with visual impairment often can benefit from materials with large font, high contrast, adequate illumination, and reduced glare. People with hearing impairment benefit from interactions in private quiet environments and may need sign language interpreters. The physical route people take to interact with research staff should be accessible. Research staff should be taught about accommodating disabilities and should prepare in advance for these possibilities.

Communication To Promote Comprehension

• Plan for potential subjects with limited English proficiency. If the researcher anticipates that a portion of potential subjects will not be fluent in English, translated forms and bilingual staff are needed. In such circumstances, care should be taken that informed consent not only meets appropriate standards, but also ensures that all survey instruments will provide valid data for such subjects.
  • In some settings, if no study personnel are fluent in the appropriate language, a qualified interpreter can be used.
  • For any subject who does not understand English, the consent form to be signed by the subject must be translated into a language understandable to the subject. Under the Office for Human Research Protections' guidance titled "Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English," this can be a short-form written consent document stating that the elements of informed consent required by 45 CFR 46.116 have been presented orally to the subject or the subject's legally authorized representative.
  • Translation does not ensure that the materials are readable by the potential subject. Care needs to be taken to ensure that translated materials are not overly complex.
  • Study personnel who are fluent in the appropriate language or an interpreter should be used for any potential research subjects who request one, even if they appear to speak and understand English well.
  • If you cannot communicate with potential subjects, they may not be enrolled.

  Teach-Back: Part 1

  • "I want to make sure we have the same understanding about this research. Can you tell me what this project is about in your own words?"
  • "It's my job to explain things clearly. To make sure I did this I would like to hear your understanding of the research project."

  Teach-Back: Part 2

  • Goal of the Research and Protocol
    • "Tell me in your own words about the goal of this research and what will happen to you if you agree to be in this study."
    • Benefit and Compensation
      • "What do you expect to gain by taking part in this research?"
      • Risks
        • "What risks would you be taking if you joined this study?"
        • Voluntariness
          • "Will anything happen to you if you refuse to be in this study?"
          • Discontinuing Participation
            • "What should you do if you agree to be in the study but later change your mind?"
            • "What will happen to information already gathered if you change your mind?"
            • Privacy
              • "Who will be able to see the information you give us?"
              • Contact Information
                • "What should you do if you have any questions or concerns about this study?"

                Teach-Back: Part 3

                Correct any misinformation until potential research subjects indicate that they have understood by correctly answering all the questions. Make clear that the need to repeat is due to the complexity of the material rather than the "fault" of the potential research subject.

                • Potential research subjects should not be enrolled if they cannot comprehend the study protocol, despite repeated attempts to explain the details.
                • Document completion of the teach-back process on the Researcher's Certification of Consent and Authorization.
                • Ask the potential research subjects what questions they still have.
                  • Avoid yes or no questions such as, "Do you have any questions?" and "Do you understand?"
                  • Ask instead, "What questions do you still have?" and "What would you like to hear more about?"
                  • If the potential research subject signs the document (unless written consent and authorization have been waived), make a copy for him or her. Alternatively, have two copies and give one to the subject.
                    • Emphasize that subjects should keep the document since it has important phone numbers in case they have any questions or concerns later.
                    • Complete and sign the Researcher's Certification of Consent and Authorization.

                    Using the Tool for Researcher's Certification of Consent and Authorization

                    The Researcher's Certification of Consent and Authorization document is a tool to be completed by the person conducting the consent and authorization discussion. It can serve as:

                    • A checklist of all aspects of the process.
                    • Documentation that the correct process was used with each prospective research subject.
                    • A tool to help train research assistants.
                    • Protection for subjects in protocols that deserve special scrutiny. 13

                    Improving the Forms

                    Sample Documents for Informed Consent and HIPAA Authorization (English and Spanish versions)

                    AHRQ has developed sample documents in both English and Spanish. They are written to maximize readability. Researchers should check with their IRB about combining the informed consent and authorization documents into a single document for both purposes.

                    • Sample Informed Consent Form (English)
                    • Sample HIPAA Authorization Forms (English):
                      • For investigators who are in the same covered entity as the protected health information (PHI) of interest.
                      • For investigators who are in an institution that is covered by HIPAA but is not in the same covered entity as the PHI of interest.
                      • For investigators who are not in an institution that is covered by HIPAA to use PHI from a covered entity.
                      • For investigators who are in the same covered entity as the protected health information (PHI) of interest.
                      • For investigators who are in an institution that is covered by HIPAA but is not in the same covered entity as the PHI of interest.
                      • For investigators who are not in an institution that is covered by HIPAA to use PHI from a covered entity.
                      • For investigators who are in the same covered entity as the protected health information (PHI) of interest.
                      • For investigators who are in an institution that is covered by HIPAA but is not in the same covered entity as the PHI of interest.
                      • For investigators who are not in an institution that is covered by HIPAA to use PHI from a covered entity.
                      • For investigators who are in the same covered entity as the protected health information (PHI) of interest.
                      • For investigators who are in an institution that is covered by HIPAA but is not in the same covered entity as the PHI of interest.
                      • For investigators who are not in an institution that is covered by HIPAA to use PHI from a covered entity.

                      The Sample Informed Consent Document is designed for use when researchers only need to conduct informed consent and do not need HIPAA authorization to use protected health information (PHI).

                      The Sample HIPAA Authorization Documents are designed for use when researchers only need authorization to use PHI. There are three versions. Two are for researchers in institutions that are covered by HIPAA. The difference between these two documents depends on whether the researcher works at the same covered entity that has the PHI. The last version is for researchers in institutions that are not covered by HIPAA but want to use PHI from a covered entity.

                      The Sample Combined Informed Consent and Authorization Documents are designed for use with studies requiring both informed consent and HIPAA authorization. There are three versions. Two are for researchers in institutions that are covered by HIPAA. The difference between these two documents depends on whether the researcher works at the same covered entity that has the PHI. The last version is for researchers in institutions that are not covered by HIPAA but want to use PHI from a covered entity.

                      Highlighted brackets are used in the sample documents to provide instructions to researchers to guide their customization of the template.

                      These documents were developed for use in survey research and other types of minimal-risk research. They are templates that need to be adapted according to specific State, institutional, and protocol parameters and may need to be revised based on any applicable State privacy laws. There are many opportunities, such as pictures and simple tables to make the final consent and authorization forms that are derived from these templates even more engaging and easy to read. However, the addition of complex medical or legal jargon could easily subvert the goal of promoting informed consent. When complex terms are absolutely necessary, appropriate explanation in language understandable to the potential subjects should be included.

                      A significant portion of these templates is also relevant for research that involves more than minimal risk. Researchers who are implementing an intervention as part of their research (e.g., clinical trials) will need to add information to identify which procedures are experimental and alternatives. Researchers and IRBs can consult the National Cancer Institute's Informed Consent Documents for Cancer Clinical Trials. The report includes templates and samples of simplified informed consent documents for research trials.

                      In addition, researchers who are doing research that involves intervention (e.g., clinical trials) should consult the HIPAA Privacy Rule for additional requirements that may apply with respect to their authorizations for such research. For example, there is a prohibition on combining authorizations for multiple purposes where one of the authorizations conditions the research participant's receipt of research-related treatment on the participant signing the HIPAA authorization. 19

                      Adapting and Testing AHRQ Sample Documents

                      AHRQ's sample documents are designed to be used as a template that researchers and IRBs can adapt according to the needs of State and local laws and regulations. While the sample documents were developed with minimal-risk health services research in mind, they can be adapted for use in other types of research settings.

                      Several publications listed in the Resources section of this toolkit can be helpful in adapting documents. When adapting the materials in the toolkit, keep in mind the following writing principles used to create easy-to-read materials.

                      Write in Plain Language

                      • Keep the reading level of consent documents low (Note: Grade level can be checked using one of several readability formulas. However, the main benefit of such formulas is to identify text that is overly complex. A low reading level on a readability formula does not ensure that potential research subjects will be able to read and understand the text. For example, most readability formulas involve counts of the number of syllables per word and the number of words per sentence, so these tests would find no problem with the sentence, "The argot was quite arcane.")
                      • Use the active voice.
                      • Use simple sentence structures.
                      • Use short sentences. Aim for no more than 8 to 10 words.
                      • Keep the object of the sentence close to the subject of the sentence.
                      • Do not use jargon. Ask people in your target audience to identify jargon and technical terms.
                      • When technical terms or abbreviations are essential, provide clear definitions.

                      Format to Promote Reading

                      • Use at least 14-point fonts if there is a chance that a potential subject is visually-impaired.
                      • Do not use ALL CAPS.
                      • Do not use italics.
                      • Break up text into manageable chunks using headings and subheadings.
                      • Use wide margins. A line length of 50 characters and spaces or fewer is easier to read.

                      AHRQ recommends that before use, all adapted consent and authorization documents be tested with a diverse set of potential research subjects similar to those who will be approached to enroll in the study. Researchers are still responsible for ensuring that their documents meet the requirements of their IRB.