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Building Your Consent Document

This document provides an outline of text and information that may need to be included in your consent form. Use your creativity to develop a functional format based on your study population. You may wish to use section titles, question/answer, letter, or other presentation formats. There is no required order (except when adding Key Information) and this guidance is designed as a resource. Suggested wording is displayed in italics. Some topics may not apply to your study and can be excluded. Remember you can use photos or diagrams to help comprehension.

The first page should be on letterhead or space provided to print on letterhead. It is highly recommended to start from a blank document in Word. This is because left-over formatting such as text boxes, fonts, etc., may conflict with the PittPRO footer and the finalization process. Ensure that you leave at least 0.6 inches of blank space at the bottom of each page. PittPRO will add a one-line footer with the approval date stamp. If there is text or formatting in the space, it may overlap with this approval footer.

Ensure that the formatting is as you would like it to appear. Remember to allow space for the PittPRO footer. NOTE: HRP staff DO NOT have the ability to make changes to the consent document in PittPRO. It is essential that the consent document is in its final form in order to avoid having to submit an additional modification to make a correction.

Increasing Readability

Use the same font, size 12, throughout the document. Some experts say simple fonts, called “san serif”, like Arial, Calibri, Tahoma are better for reading than Times New Roman. Use a minimum of 1-inch margins on all pages. Write with left justified, right ragged text alignment.

After each consent form is drafted, but before submitting the application, it is recommended to review the consent form for consistency with the application, and to combine any information that may be duplicated throughout the consent form. The preferred reading level is 8th grade. Technical terms and acronyms should be defined. A helpful resource for defining medical terms is plainlanguage.gov. It is often useful to have an individual who is not involved with writing the consent form and perhaps does not have a science background review it for clarity and consistency.

Do not use the medical or scientific term and then define it. Simply include only the lay language description. For example,

DON’T SAY: The study drug carries a common risk of hyperglycemia (high blood sugar).
INSTEAD: The study drug has a common risk of high blood sugar.

Use personal pronouns, and/or “subject/participant”, not “patient”, and use active voice. Active voice means the subject performs the action, rather than the subject receiving the action. For example,

DON’T SAY:  Patients will be asked to record their daily food intake.
INSTEAD:    We will ask you to record your daily food intake. OR, “You will record your daily food intake.”

Sections of a Consent Document

Header

Include one of the following headings: CONSENT TO ACT AS A PARTICIPANT IN A RESEARCH STUDY or CONSENT TO ACT AS A PARTICIPANT IN A RESEARCH REGISTRY

Study Title

Add the study title, consistent with the application. If the title of the protocol is sensitive in nature, the IRB will consider use of an alternative title with appropriate justification.

PRINCIPAL INVESTIGATOR

Include the name of the PI and contact information which may include the professional address, Pitt or UPMC email address, telephone number, and possibly pager number of the PI. This should be a number where participants can reach the principal investigator in the event of a question, concern, or emergency. Do not use any personal contact information, such as cell phone number or personal email address.

CO-INVESTIGATORS & OTHERS

You are not required to list any co-investigators on the consent but do make sure that those listed on the consent are also listed in the application. If you choose to list investigators, list those who are qualified to address the participant’s questions and include contact information consisting of the professional email address and/or telephone number/pager number. You may also choose to include others that can be contacted about the study, such as primary coordinators or faculty mentors, but ensure that roles are listed consistently with the application.

QUESTIONS ABOUT THE STUDY

Depending on the nature of the study (e.g., a treatment study of a medically ill patient/subject), it may be necessary to provide a phone or pager number so the research participant can contact a member of the research team as soon as possible. Suggested wording may include:

You can contact the study investigator if you have any questions about the study, concerns or complaints.  Contact Principal Investigator, Dr. _________ at ___________ pager _____________ or the Study coordinator at _______________.

SOURCE OF SUPPORT

List all sources of support, consistent with the “Funding Sources” section of PittPRO.

RESEARCH CONSENT SUMMARY (KEY INFORMATION)

If your study is federally funded and submitted to the IRB after 1/20/2019, the inclusion of a summary of key information at the beginning of the consent document is required. For all other studies, a consent summary can be utilized if you believe it will assist a potential research participant in understanding the key points of the study.

The content of the key information should be customized to the specifics of the study, and it should be organized in a way to facilitate comprehension. Although what is determined to be “key information” varies by study, this generally consists of a short paragraph, chart or list of bullet points briefly addressing the study purpose, risks, voluntary participation, and procedures, but can also include payment. This section is not necessary for shorter consent forms. Consent forms that are 5 or fewer pages are generally deemed short enough to not require this section, but this will be determined on a case-by-case basis depending on the length of the form, amount of information, and whether a key information section may be beneficial to the subject’s understanding. Learn more about Key Information in the A-Z Guidance section of the HRP website.

SIGNIFICANT FINANCIAL CONFLICT OF INTEREST

If an investigator has a significant financial conflict of interest, the conflict must be disclosed to the research participants, consistent with the COI Management Plan developed by the investigators with advice from the COI office, and approved by the IRB.

INTRODUCTION

  • Explain why the research is being conducted and provide a brief discussion of the research. Specific procedures will be addressed later in the consent document.
  • Indicate why the potential participant is being asked to participate (basic eligibility criteria).
  • Indicate the approximate number of particpants to be enrolled at this site and total number if multi-centered. This is not required for all studies but should be included when it might affect the participants’ willingness to participate.
  • Indicate the expected length of a subject’s participation

WHEN THE INVESTIGATOR IS ALSO THE CARE-PROVIDER

Include the following suggested language: Your doctor may be involved as an investigator in this research study. Before agreeing to participate, or at any time during your study participation, you may discuss your care with another doctor who is not associated with this research study. You are not obligated to be a part of any research study offered by your doctor.

Research Activities

  • Define all activities in lay language. Present them in a way in which an 8th grader can understand.
    • Consider using bullets, tables, and picture; pictures are especially good when the study involves a device.
    • Use bold font or italics to emphasize the ‘MUST READ’ sections.
    • Indicate the approximate duration of the research activity, where the procedures will be performed, the number of visits, and who will be performing the procedures.
    • Describe the research activities to be completed for research purposes only, including medical record review and genetic analysis. Do not address procedures performed for the participant’s routine medical care.
    • If your study requires intensive screening procedures, it may be appropriate to develop a separate screening consent form to lessen possible confusion due to the length of the document.
  • Drug studies:
    • Indicate the phase of the study and provide an explanation. For example, “This is a phase 1 study which means the researchers are trying to find out the right dose of the drug and if it is safe.”
    • Include the FDA status of all drugs or devices used in this study for research and whether approved for the current use in this study. Drugs provided as a part of routine care do not need to be included since they are not being administered for research purposes. If participants are randomized into arms of the study, ALL drugs and devices used in each arm become research-related and must be listed.
    • Specify the route of administration, dose, frequency, and duration.
    • If the research involves a Phase I study to determine the maximum tolerated dose of an experiment drug, it should also be stated that participants are expected to experience significant adverse effects based on the design of the study.
    • Specify if the experimental intervention will be available to the participant following study completion.

Study Risks

  • Include the risks for all research procedures during screening, experimental intervention, and follow-up. List the risks by importance and frequency to the subject, e.g., experimental drug/device risks first.
  • Include this statement for studies involving greater than minimal risk: As with any experimental procedure, there may be adverse events or side effects that are currently unknown and some of these unknown risks could be permanent, severe or life-threatening.
  • If a risk exists to either the mother or fetus sufficient to exclude pregnant women from participation and avoid pregnancy or fathering a child during a study, refer to the Guidance for Reproductive Risk Language for Consents for suggested language.
  • Radiation risks language: Refer to Radiation Safety, Human Use Research for standard language regarding risks.
  • Genetic testing risks sample language:
    • Include the following when the study involves or may involve genetic testing: The risk of doing genetic studies includes the potential for a breach of confidentiality, which means someone could see your genetic testing results who is not authorized. The information could be used to affect what insurance or jobs you may be able to get. Or it could affect your decision to have children. It could also cause stress and conflict in your family relationships, as it can confirm who is a child’s father, identify a risk for a certain disease, or cause you or other people to have negative feelings if the results show you may be more likely to get certain diseases.
    • In addition, the following suggested sample language should be included in the consent document, if appropriate:  A federal law, called the Genetic Information Nondiscrimination Act (GINA), helps to reduce the risk of discrimination by health insurers and most employers based on your genetic information. This law will protect you in the following ways:
      • Health insurance companies and group health plans may not request your genetic information that we get from this research.
      • Health insurance companies and group health plans may not use your genetic information that we get from this research when making decisions regarding 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.
    • Be aware that this federal law does not protect you against genetic discrimination by companies that sell life insurance disability insurance, or long-term care insurance, nor does it protect you against genetic discrimination by all employers. GINA also does not protect you against discrimination based on an already-diagnosed genetic condition or disease.
    • Consider adding the following, when applicable:
      • You may learn something about your genome that relates to the health of your relatives.  If so, your relatives might want to know so that they can decide whether to get tested or follow up in other ways. It is also possible that they might not want to know. Before joining the study, you may want to discuss your plans and this study with your family members.
      • Because certain conditions and traits run in families and are inherited through genes, this study is recruiting biologically related family members. This study will compare family members who have [condition] and family members who do not.

STUDY BENEFITS

  • Do not overstate the potential benefits of study participation. When a study will provide no potential direct benefit, this must be stated.
  • Do not state that participants may benefit if there is no potential direct benefit listed in the protocol.
  • If it is possible that participants may benefit directly from study participation, disclose this to the participant.
  • If the research study involves a placebo-controlled arm, state that individuals assigned to the placebo group are expected to receive no direct benefit from study participation.
  • Payment/compensation can never be considered a benefit and should always be separated from the benefits section.

ALTERNATIVE TREATMENTS: (Do not include this section if the only alternative is not to participate)

  • Disclose any currently available treatments or procedures that may be of potential benefit to the participant in lieu of participation in the research study.
    • Subjects should be made aware of the full range of options available to them which may include no further or additional treatment or supportive care.
    • The investigators should offer their availability to discuss alternatives to research study participation and answer all questions. 
  • If the research study involves the evaluation of a currently approved drug or device, indicate whether that the study drug or device is available outside of study participation

NEW INFORMATION

Include the following language when each subject’s participation extends over multiple sessions, and the study is more than minimal risk: We will tell you about any new information that we learn that may cause you to change your mind about staying in the study.

CONFIDENTIALITY

  • Specify the procedures (e.g., coding of research data, storage of linkage code information in separate locked files, firewalls) that will be used to protect the confidentiality of the research subjects. Do not describe this information in multiple sections.
  • Access to Research Record: Specify who will have access to research records, which may include medical records. For each, specify whether they may access identifiable records or only de-identified records, and also be consistent regarding who may access identifiable specimens or de-identified specimens. Examples of groups that may be included are:
    • University of Pittsburgh Office of Research Protections (always applicable – no need to list in application). Suggested language: Authorized representatives of the University of Pittsburgh Office of Research Protections may review your identifiable research information for the purpose of ensuring the appropriate conduct of this research study.
    • Study Sponsor: list name of sponsor and/or external auditors
    • U.S. Food and Drug Administration (FDA)
    • UPMC hospitals or other affiliated health care providers. Suggested language: Authorized representatives of the UPMC hospitals or other affiliated health care providers may have access to identifiable information (which may include your identifiable medical information) related to your participation in this research study for the purpose of (1) fulfilling orders made by the investigators for hospital and health care services (e.g., laboratory tests, diagnostic procedures) associated with research study participation; (2) addressing correct payment for tests and procedures ordered by the investigators; and/or (3) for internal hospital operations (i.e. quality assurance).
  • Address sharing for future research. Restrictive language is not recommended. If the study is federally funded (or if it makes sense based on the nature of the study), include one of the following statements:
    • At some point, your identifiers might be removed from the private information and/or biospecimens. This de-identified information and/or biospecimens may be used by other researchers for future research studies. If this happens, we will not contact you for additional consent
    • At some point, your identifiers might be removed from the private information and/or biospecimens collected during the study. Even after the identifiers are removed, we will not use or distribute them for future research studies.
  • There are circumstances when the investigators might have to release identifiable information due to state law or another circumstance. Examples include:
    • Court order – Suggested language: In unusual cases, the investigators may be required to release identifiable information related to your participation in this research study in response to an order from a court of law.
    • Mandatory reporting of harm – Suggested language: If the investigators learn that you or someone with whom you are involved is in danger or potential harm, they will need to inform, as required by Pennsylvania law, the appropriate agencies.
    • Mandatory reporting of communicable disease – Suggested language: If you test positive for certain diseases, we are required to report to the Pennsylvania Department of Health.
  • If the protocol involves the collection of any specimens, add the following:
    • A statement that the participant's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit. Suggested language: Your data and specimens used in this research study may contribute to a new discovery or treatment.  In some instances, these discoveries or treatments may be of commercial value and may be sold, patented, or licensed by the investigators and the University of Pittsburgh for use in other research or the development of new products. You will not retain any property rights, nor will you share in any money that the investigators, the University of Pittsburgh, or their agents may realize.
    • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to participants, and if so, under what conditions.
    • Whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
  • Regardless of current funding, for studies proposing to use genomic data from cell lines or clinical specimens, NIH Genomic Data Sharing policy expects that informed consent for future research use and broad data sharing will have been obtained even if the cell lines or clinical specimens are de-identified. For both currently planned, and currently unplanned yet potential sharing, with national repositories, or other studies that may later share with national repositories, this language should be included, and should include reference to federal or national repositories.  An excellent resource for genomic research considerations and model consent language may be found at NIH's Special Considerations for Genomics Research page. More information can be at the NIH Genomic Data Sharing page. Sample language: We will store your samples and data (including genetic data) indefinitely. Information will be shared with other researchers in the future but those researchers will not be able to identify you. Your data (including genetic data and samples) may be used in any type of research. Your samples, data, and genetic data generated from these samples may be shared with others, including federal repositories, and will be shared without identifiers. 

  • Indicate that per University of Pittsburgh policy all research records must be maintained for at least 7 years following final reporting or publication of a project. However, you can add that the records may be kept indefinitely. For projects involving children, records must be maintained until child participants reach the age of 25 if one of the following applies: 1) the research activities will result in the generation of a medical record OR the results of research will be put into an existing medical record; 2) the research activities involve procedures such as collection of blood, MRI, etc.; or 3) the research activities include measures (such as the SCID) which are generally used for clinical care but are being done for research purposes. All other records for studies involving minors can be retained for the standard 7 year period as required by University policy. 

  • If your study is NIH-funded, it is automatically covered by a Certificate of Confidentiality under certain conditions. See additional information about Certificates of Confidentiality on the HRP website under A-Z Guidance. Example Informed Consent Language that can be used in consent documents can be found on the NIH website. 

  • It is recommended to avoid text committing to destroy data and/or specimens at any specific timepoint, as this often becomes problematic if this destruction of data/specimens becomes impractical for any reason.

  • Similarly, it is recommended to avoid text limiting the sharing of de-identified materials in the future unless prohibited by the contract or agreement.

Subject Access to Research Results

  • There may be studies that require the inclusion of research-related results in the medical record. Subject-patients can request access to those results through a medical record request if not provided by the study team.
  • When results are generated purely for research purposes and not recorded in the medical record, a decision must be made about whether results will be provided to the subject. There are several factors that are relevant when making that decision such as whether: 1) the results were generated in a CLIA-approved lab, 2) providing the results prematurely might break a blind, 3) the testing is being done in a research only facility such as the MR Center.
  • Suggested wording: The results of testing performed under this research study [will/will] not be included in your medical record. You have the right to access information that is in your medical record. However, results from testing done purely for research purposes may not be put into your medical record and [will/will not] be provided to you because [study team to provide language specific to why or why not].

HIPAA

If the consent form is also serving as a HIPAA Authorization to allow access to / recording of protected health information (Pitt and/or UPMC medical records) for research purposes, the form must be HIPAA compliant.  Include the following, ensuring consistency with the protocol. Customize text in brackets to the specific study.  This can be in one section, or divided as appropriate:

As part of this research study, we are asking your permission to use your medical records to [customize these examples for your study: see if you are eligible to be in this study, to compare your earlier test results to the findings from this study, and if possible, to use your previous exam results in place of, or in addition to, some of the exams needed for this study, as well as to support other data collected in the study.] This permission does not expire. We will collect the following information: [customize these examples for your study: your diagnosis, age, past medical history, tests that were done to diagnose your condition, and results of any tissue biopsies or blood tests, including results of genetic tests that were already done as part of your standard medical care.]

As part of this study, some research results from testing we do with you (and/or a copy of this consent form) will be placed into your medical records held at UPMC. These tests include [customize these examples for your study: the results of pregnancy tests (for women of childbearing potential) and other medical tests.
This medical record information, which includes your name, is available to members of the research team for an indefinite period.

We will protect the confidentiality of your records. This means we will keep your records secure and do all we can to prevent people who have not been given permission to be able to access it. We cannot guarantee the confidentiality of your information from this study including from your medical records once people outside UPMC or the University have viewed it.

You can withdraw your permission to allow the research to team use your information from your medical records. You can do this by sending a request in writing to Dr. _______ listed on the first page. If you do so, you will be withdrawn from this study since your medical information is a critical part.  The research team will continue to use information collected from you or your records up to that point.

FDA CLINICAL TRIAL REGISTRY [21 CFR 50.25]

The FDA requires language for “applicable” clinical trials. These are clinical trials that are registered on www.clinicaltrials.gov AND are conducted under a U.S. IND or are otherwise subject to FDA regulations. Required verbatim: A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by US Law.  This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.

COSTS:

Research participants must be told if there are costs associated with study participation. If there are none, this section does not have to be included.

For studies not involving a drug or device, use the following suggested text: To be part of the study, you will need to pay for [indicate what costs participants will have to pay (such as parking)].

For studies involving a drug or device, use the following suggested text, if there are any potential costs: If you participate in this research study, the cost of the experimental (indicate the device or drug, as applicable) and/or the costs of some research procedures may be billed to your health insurance provider. You will be told ahead of time if your health insurance provider refuses to cover some or all these research costs and if any of these uncovered research costs will be billed directly to you. If this happens, you will be given a price estimate for the uncovered research costs and you will have to meet with a hospital financial counselor to set up a payment plan. You can also decide that you no longer want to participate.  

Payments

  • Describe all payments a subject may receive, consistent with the recruitment section of PittPRO. It is important that the total payment for study completion or the payment schedule for partial study completion not be coercive to initial or continuing participation. It is acceptable, however, for the payment schedule to include a non-coercive, payment bonus for the completion of all parts of the study.
  • If subjects may receive more than $600/year, cumulative, for participation in studies from one entity (e.g. the University of Pittsburgh or UPMC), include the following language: Payment to participants is considered taxable income regardless of the amount. If a participant receives $600 or more in a calendar year from one organization, that organization is required by law to file a “Form 1099 – Miscellaneous” with the IRS and provide a copy to the taxpayer. We are required to give your name and social security number to the Accounting Office. Participants who do not provide a social security number may still participate in the research, but the IRS requires that 26% of the payment be sent by the institution to the IRS for ‘backup withholding;’ thus you would only receive 74% of the expected payment.

Compensation for Injury

  • Include the following language if the research is NOT commercially sponsored but is conducted at Pitt or UPMC facilities: If you believe that the research procedures have resulted in an injury to you, immediately contact the Principal Investigator who is listed on the first page of this form. Emergency medical treatment for injuries solely and directly related to your participation in this research study will be provided to you by the hospitals of UPMC. Your insurance provider may be billed for the costs of this emergency treatment, but none of those costs will be charged directly to you. If your research-related injury requires medical care beyond this emergency treatment, you will be responsible for the costs of this follow-up care. At this time, there is no plan for any additional financial compensation.  You do not waive any rights by signing this form.
  • Include the following language if the research is NOT commercially sponsored and NOT conducted at Pitt or UPMC facilities: If you believe you have been injured as a result of the procedures that are performed for research purposes, immediately contact the Principal Investigator or one of the researchers listed on the first page. Emergency medical treatment for injuries solely and directly related to your participation in this research study will be provided by UPMC hospitals. If you do not have access to a UPMC facility, you should seek emergency care from your local hospital and contact the study team. It is possible that UPMC or our local hospital may bill your insurance provider for the costs of this emergency treatment, but none of these costs will be charged directly to you. If your research-related injury requires medical care beyond this emergency treatment, you will be responsible for the costs. At this time, there is no plan for any additional financial compensation. You do not waive any rights by signing this form.
  • For research that is commercially sponsored, and the protocol is provided by the sponsor, the sponsor should, at a minimum, provide adequate compensation for subject harm directly resulting from the research intervention that requires any emergency care. Some sponsors have plans for monetary compensation for non-emergency treatment, and, if they do, that additional compensation for harm should be included in the informed consent, but it is the responsibility of the investigator to ensure that the compensation for injury statement is consistent with the signed sponsor’s agreement. The IRB will be provided a copy of the contract language related to subject injury from the University of Pittsburgh Office of Sponsored Programs in order to ensure consistency in the language.

Withdrawal From Study Participation

  • Suggested language if the subject decides to withdraw from the study: You can withdraw from this research study at any time. Any identifiable research information obtained as part of this study prior to the date that you withdrew your consent will continue to be used by the investigators for the purposes described above. If you want to withdraw, notify the study team. Your decision to withdraw will have no effect on your current or future relationship with [the University of Pittsburgh or UPMC].
  • Suggested language if the investigator removes subject from study: It is possible that you may be removed from the research study by the researchers if, for example, [be consistent with item 7 of the risk and benefits section of the protocol]
  • If the investigator may request follow-up after withdrawal (valid only for safety reasons), indicate what steps will be taken to ensure the subject’s safety upon his/her termination from study participation: If you are withdrawn from participation in this research study, you will be asked to continue [specify procedures] because [reason], or If you decide to withdraw from study participation after you have received the study drug, you should participate in additional monitoring follow-up procedures that are being conducted to measure the safety of the study drug.
  • Address other study termination requests such as the return of unused study drug or supplies
  • Indicate the steps that will be taken with regard to continued treatment of the subject’s disease or condition should s/he be withdrawn from study participation, if applicable

Signature Section

Consent to Participate

(This may be customized if necessary)

The above information has been explained to me and all my current questions have been answered. I understand that I am encouraged to ask questions, voice concerns or complaints about any part of this research study during this study. Any future questions, concerns or complaints will be answered by a qualified individual or by the investigator(s) listed on the first page of this consent document at the telephone number(s) given. I understand that I may always request that my questions, concerns or complaints be addressed by a listed investigator. I understand that I may contact the Human Subjects Protection Advocate of the Human Research Protection office, University of Pittsburgh (1-866-212-2668) to discuss problems, concerns, and questions; obtain information; offer input; or discuss situations that occurred during my participation. By signing this form, I consent to participate in this research study [Include if HIPAA applies: and provide authorization to use and share my medical records]. A copy of this consent form will be given to me.

___________________________________                             ______________________________
Printed Name of Participant                                        Date [add time if copy will be in medical record]

___________________________________
Signature of Participant

Investigator Certification

Include the following: I certify that I have explained the nature and purpose of this research study to the above-named individual(s), and I have discussed the potential benefits and possible risks of study participation. Any questions the individual(s) have about this study have been answered, and we will always be available to address future questions, concerns or complaints as they arise. I further certify that no research component of this protocol was started until after this consent form was signed.

___________________________________                                       ______________________________
Printed Name of Person Obtaining Consent                       Role in Research Study

___________________________________                                       ______________________________
Signature of Person Obtaining Consent                               Date [add time if copy will be in medical record]

 

v. 6/1/2021