Informed consent

Beginning July 19, 2018, informed consent documents for federally-funded research must begin with a concise and focused presentation which provides the key information most likely to assist a prospective subject in understanding why they may or may not want to participate in the study.  See below for more information.

For all research requiring informed consent, including verbal consent, the following elements must be presented to subjects and be included in the informed consent document or study information sheet. The informed consent document template provides a guideline for language which might be acceptable; however, language should be customized carefully for your study. 

• Statement that the study involves research, explanation of the purposes of the research and the expected duration of participation, description of the procedures, and identification of any procedures which are experimental
• Description of reasonably foreseeable risks or discomforts
• Description of any benefits that may be reasonably expected
• Disclosure of appropriate alternative procedures or courses of treatment, if any
• Statement describing the extent to which confidentiality of records identifying the subject will be maintained
• 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
  • For studies that do not have a source of compensation for injury, language in the informed consent document template should be used.
  • For studies that do have a source of compensation, the sponsor will generally provide template language for the consent describing the parameters of compensation available. Carefully check the language proposed by the sponsor to ensure it is consistent with the language in the clinical trial contract and does not include conditional payment language (i.e., language which limits the sponsor’s compensation to only subjects who are uninsured or whose insurance will not pay for research-related injury).
• Explanation of whom to contact to obtain information or offer input about the research, to discuss problems, concerns, and for questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury
• Statement that participation is voluntary, refusal to participate will not result in penalty or loss of benefits, and subjects may withdraw without penalty
• Statement that identifiers might be removed and deidentified information/biospecimens used for future research studies or distributed to another investigator for future research studies without additional consent OR statement that subject’s information/biospecimens will not be used or distributed for future research

The following elements must be included, when applicable. Please note that additional elements may be required for research subject to VA, DOD, or DOJ regulations – see the IU HRPP Policy on Informed Consent.   

• Statement that treatment may involve risks to the subject or fetus that are currently unforeseeable
• Anticipated circumstances in which subjects’ participation may be terminated
• Statement describing details and conditions of payment, if any
• Any additional costs to the subjects
• Consequences of the subject’s decision to withdraw
• Statement that significant new findings that may relate to the subject’s willingness to participate will be provided
• For greater than minimal risk research, approximate number of subjects involved in the study
• Statement that the subject’s biospecimens may be used for commercial profit and whether the subject will/will not share in those profits
• Statement regarding whether clinically relevant research results will be disclosed to subjects and, if so, under what conditions
• For research involving biospecimens, whether the research will involve whole genome sequencing

The following elements should be included, when applicable.  You must use the mandatory language provided in the informed consent statement template for these sections, unless otherwise approved by the IRB and Human Subjects Office.  

• ClinicalTrials.gov (21 CFR 50.25[c])
• Certificate of Confidentiality, if NIH-funded or a Certificate has been granted
• Genetic Information Nondiscrimination Act (GINA) notification
• Financial interest disclosure, if an investigator on the protocol has a related financial interest
• Radiation risk language, if radiation/radioactive materials are used for research purposes (Required language will be provided by Radiation Safety Office as part of review)

In addition to the above elements, the following information should be provided to subjects as appropriate:

• For genetic studies, if family contact is requested, the subject must specifically agree to the contact and all family members must provide individual consent.

The revised Common Rule (effective 2019) requires that the consent begin with a concise and focused presentation of key information that participants need to make a decision, and which explains why a potential subject might or might not want to participate.

The goal of this concise presentation is to provide a high-level summary of the research first, so potential participants can more easily understand the research and the consequences of participation, both positive and negative. The requirement applies to the informed consent process, meaning that researchers should begin the consent conversation with the concise presentation.

For studies with an informed consent document or study information sheet, a written concise summary should be added to the beginning of the informed consent document. The summary does not replace the usually-required consent document, but is an addition to the already-required elements of consent.

When the concise presentation is needed

The concise presentation is required for all federally-funded and VA research, unless the IRB can determine that the consent form is concise enough already. If the consent form is already short and concise, adding summary pages only serves to make the consent document longer and doesn’t provide value to human subjects. The IRB will consider whether the consent document is concise as written on a case-by-case basis. If you are unsure whether your consent can be considered concise as written, contact the HRPP.

What information to include

The concise presentation is a high-level summary of the key information that potential participants need to make a decision. The key information may be different for every study, so it’s important to think carefully about your study, then write a custom concise presentation which addresses that information. Feel free to be creative with format and language, and consider including non-text elements like pictures or icons to describe your study.

Generally, the concise presentation should include:

• Statement that the project is research and that participation is voluntary
• Summary of purpose, duration, procedures, risks, discomforts, and benefits
• Other key information as appropriate, such as summary of cost and payment information or alternatives to participation in the research (especially for treatment studies)

Since the concise presentation is an addition to the consent document, it should only include a summary of this information, and participants can see the relevant section of the consent document for additional details. If all information relevant to a particular topic is included in the concise presentation, it should not be repeated elsewhere.

Effective January 25, 2015, NIH-funded research must comply with the NIH Genomic Data Sharing Policy. For NIH-funded research that generates large-scale human or non-human genomic data, the informed consent document should include the following statements:

• Genomic and phenotypic data, and any other data relevant for the study (such as exposure or disease status) will be generated and may be used for future research on any topic and shared broadly in a manner consistent with the consent and all applicable federal and state laws and regulations.
• Prior to submitting the data to an NIH-designated data repository, data will be stripped of identifiers such as name, address, account and other identification numbers and will be de-identified by standards consistent with the Common Rule. Safeguards to protect the data according to Federal standards for information protection will be implemented.
• Access to deidentified participant data will be controlled, unless participants explicitly consent to allow unrestricted access to and use of their data for any purpose.
• Because it may be possible to re-identify deidentified genomic data, even if access to data is controlled and data security standards are met, confidentiality cannot be guaranteed, and re-identified data could potentially be used to discriminate against or stigmatize participants, their families, or groups. In addition, there may be unknown risks.
• No direct benefits to participants are expected from any secondary research that may be conducted.
• Participants may withdraw consent for research use of genomic or phenotypic data at any time without penalty or loss of benefits to which the participant is otherwise entitled. In this event, data will be withdrawn from any repository, if possible, but data already distributed for research use will not be retrieved.
• The name and contact information of an individual who is affiliated with the institution and familiar with the research and who will be available to address participant questions.

For more information, visit NIH Genomic Data Sharing.

Informed consent documents provide information to research subjects to ensure they can understand the research and make an informed, voluntary decision whether to participate.  HRPP staff and IRB members will carefully review the informed consent document to ensure that all required elements and language are included. 

You are strongly encouraged to utilize sponsor-created consent templates. If an informed consent template is available for your study, please use it. Add any site-specific language, checking the HRPP guidance on informed consent for required language, then submit the final document to the IRB for review.

General tips

• Use simple language, no higher than 8th grade level, or language that is appropriate to the specific subject population. Consider the environment and context in which the consent is presented to a potential research subject.
• As much as possible, avoid the use of, or replace, complicated or medical/technical language with lay language to ease subject comprehension. For instance, use action instead of intervention and high blood pressure instead of instead of hypertension.
• Write in second person so as not to be interpreted as suggestive or coercive.
• Define any abbreviations and acronyms.
• Use short, simple, and direct sentences.
• Be sure that formatting and grammar are consistent throughout the document. Font choice and size are up to you and should be chosen based on your specific subject population; however, please be sure both are consistent throughout.  Be careful not to use font in specific sections to over or underemphasize the information provided.  For example, don’t use bold or larger font in the payment section, or smaller font in the risks section.

Tips for using the IU HRPP Templates

The IU HRPP offers several informed consent templates which are offered only as tools and are NOT required.  The templates are designed to help you draft and finalize an informed consent document which is compliant with federal regulations and institutional expectations.

• The templates and the suggested language within are suggestions only (in most cases), meant to provide a guideline for language which might be acceptable. Where the suggested language does not adequately address your study or uses more complex words than is appropriate for your subject population, please customize the language carefully.
• Templates and language should be customized carefully for each individual study to facilitate subjects’ clear understanding of the research.
• Instructions are in brackets and are highlighted in gray.  Be sure to address each highlighted item and to remove all bracketed/highlighted template instructions before submission.
• If a section does not apply to your study, please remove the section.
• Make use of images, lists, and tables, where appropriate, to clarify procedures.
• Review your final version carefully for consistency with other study documents (e.g., IRB application forms, protocol document).
  

Resources

The following resources are publicly available for suggested lay terms and testing the readability of consent forms:

1. CDC Everyday Words for Public Health Communication
2. Federal Plain Language Guidance
3. Document Checklist for Plain Language
4. Readability calculator

Investigators may conduct the consent conversation in person or via phone or electronic means such as Skype or Zoom. These methods are allowable for all research and do not require protocol-specific approval, as long as the study team follows the procedures outlined in the IU HRPP Policy on Informed Consent.

In addition, documentation of informed consent (i.e., obtaining signature from individuals providing consent) can be completed in a variety of ways, allowing for flexibility in the consent process. In general, the study team needs to have confirmation that the individual providing consent has signed a consent document prior to research procedures. The following methods of doing so are acceptable, in order of preference:

• In person: Consent document is signed in the presence of the person obtaining consent. Research procedures may begin upon signature.
• Fax: Consent document is signed and faxed to the study team. Research procedures may begin when the study team receives the fax and confirms signature.
• Email or text message: Consent document is signed and a scanned copy or photograph of the signature page (at least) is sent to the study team. A signature using Adobe Reader via smartphone may also be acceptable for some studies. Research procedures may begin when the study team receives the email or photograph and confirms signature.
• Courier/overnight mail: Consent document is signed and mailed via courier or overnight mail. Research procedures may begin when the study team receives the document and confirms signature.

The study team should document the timing and venue of the consent conversation, as well as the time/date of receipt of the signature.

Signatures documenting consent (e.g., person obtaining consent, subject, both parents, LAR, etc.) do not need to be contained on the same document as long as the study team retains documentation for all individuals.

When subjects cannot consent for themselves, study teams must identify the appropriate individual per IU HRPP Policy to provide consent for those individuals. In some cases, this identification requires consideration of whether an appropriate individual is reasonably available. If not, consent from that person is not required or acceptable. Consideration of whether an individual is reasonably available is most often necessary for the following research:

• For research with children approved under Categories 406/407, both parents must provide consent for the child to participate (unless consent is waived), unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
• For research with adults lacking consent capacity, a legally authorized representative (LAR) must provide consent when a subject does not have capacity to consent. Under Indiana law, the LAR is the individual with the highest priority based on the statutory-defined list and is reasonably available. If an individual at one priority is not reasonably available, the study team can identify a LAR at the next priority level.

The IU HRPP Policies indicate that a study team can find that an individual isn't reasonably available after the study team has made repeated attempts to contact the individual over a reasonable time period with no response. Study teams must make at least 3 attempts over at least 48 hours. Attempts to contact may include phone calls, emails, registered letter, etc. If this guideline is not appropriate (e.g., required timeline for enrollment does not allow 48 hours), investigators can propose a protocol-specific standard for finding that individuals are not reasonably available, and the IRB will consider the proposal with their review.

When investigators are aware that an individual exists, that person should be considered reasonably available until the study team can complete and document the required contact attempts.

Reasonable availability should not be confused with a person's ability to physically meet with the study team. Inability to meet face-to-face should never be a barrier to obtaining informed consent, and study teams should consider utilizing the flexible consent procedures described above.

If a parent or higher priority LAR was considered not reasonably available at the time of enrollment but later contacts the study team and does not wish the subject to participate, the subject should be withdrawn.

Some studies may require subjects to perform activities prior to their first study visit (e.g., fasting, refraining from smoking or drinking, keeping a food journal, etc.). Subjects are still required to give informed consent before engaging in the activities; however, a waiver of documentation of consent may be requested if obtaining signature at that time is not possible.

Research records must be sufficient to demonstrate that research is conducted in accordance with relevant policies and requirements and, in the event of an audit, to allow the auditor to reconstruct the research process. This is especially important for research requiring informed consent. The research record should document, for each subject, that the consent process occurred prior to participation and was conducted in accordance with the IU HRPP Policy on Informed Consent. In addition to the requirements in section 3.3 of the policy, such documentation might also include:

• Time/date of consent
• Method of consent (e.g., in person, via phone or Skype, etc.)
• Additional research personnel or other individuals (such as family or friends of the subject) in attendance during the consent conversation
• Notations indicating that the study was explained to the subject, the subject was given an adequate opportunity to read the document and ask questions, and a copy of the information was given to the subject
• Description of any special circumstances (e.g., witness, LAR consent, minor assent, parent consent, etc.)

The IU HRPP Policy on Informed Consent allows study teams to use the short form in lieu of a translated consent document when enrolling subjects who do not read English. When using the short form, the procedures outlined in section 3.4 of the policy must be followed. In addition, when identifying an appropriate witness to the oral consent presentation, study teams are strongly encouraged to identify an individual who is impartial (i.e., not affiliated with the study team or the subject) whenever possible.

Ethics and regulations both require that subjects be provided a consent document in the language understandable to them. The short form process is an exception meant to ensure that subjects are not excluded from research simply because a translated version of the consent isn’t available. Study teams are strongly encouraged to have the informed consent document translated prior to enrolling the subject, and should carefully consider whether use of the short form adequately protects subjects in the situation. The short form may not be appropriate for all research, especially that which is complicated and difficult for subjects to understand.