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Consent Document Checklist

The Common Rule sets forth general requirements for documentation of informed consent. An informed consent form approved by the IRB and signed by the participant or the participant’s legally authorized representative should be used to document informed consent. A written copy should be given to the person signing the informed consent document.

Written Informed Consent Document

In some cases, the IRB may grant a waiver of documentation of consent – a consent process is still used but documentation of that consent process not required. There are specific circumstances when a waiver of documentation may be used which is explained below. Finally, as an alternative to standard written informed consent documents, oral presentation of informed consent information is allowed and documented using a short form which is explained below. In all circumstances, required elements of informed consent are still required as described below.

In the past, the University of Utah provided consent templates to assist creating consent documents. However, in an effort to allow more flexibility, the University of Utah IRB has created this expandable checklist to assist investigators and research staff when creating consent documents. Not all elements of informed consent will be required for every study, and for some studies, there will be additional elements of informed consent that must be added. 

doc checklist     checkmark You may print a simplified checklist here. Or, click below to read more about each of the requirements. 

Basic Elements of Informed Consent

The following basic elements of informed consent are described in the Common Rule, FDA, and International Conference on Harmonization (ICH). Additional elements of informed consent necessary under other regulations, such as Veterans Health Administration (VHA), Department of Defense (DoD), or HIPAA will have an additional checklist.

Is there a statement that the study involves research and an explanation of the purposes of the research?

 

An explanation that the study involves research and the purpose of the research should be included. Briefly tell the participant why this research is being done, why the individual is being invited to participate and how this study will address the problem.

Informed consent should begin with a concise and focused presentation of the key information. It is expected that a statement that consent is being sought for research and the purpose of the research should be a part of that concise summary. For more about the concise summary, please see the Consent Process Checklist page.

  • "You are being asked to take part in a research study. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether you want to volunteer to take part in this study."
  • "The purpose of the study is <<explain purpose of the research using simple, accurate language>>. This study is being conducted by <<insert sponsor, granting agency, investigator, etc.>>."
  • 45 CFR 46.116(b)(1)
  • 21 CFR 50.25(a)(1)

  • ICH GCP 4.8.10(a) and (b)

Is the expected duration of participation stated?

 

The expected duration of participation should be stated. If applicable, include the total length of time that the participants will be involved both in the active study and for follow-up.

Informed consent should begin with a concise and focused presentation of the key information. It is expected that a statement with the expected duration should be a part of that concise summary. For more about the concise summary, please see the Consent Process Checklist page.

  • "The anticipated time for your participation in this research is approximately <<insert time, e.g. 1 hour, 3 hours, 1 day>>."
  • "The length of time you may spend in the study may be for as long as you are receiving benefit and will depend on your response to the treatment and whether you are having any side effects."
  • 45 CFR 46.116(b)(1)
  • 21 CFR 50.25(a)(1)

  • ICH GCP 4.8.10(s)

Is there a description of the procedures to be followed including the identification of any procedures that are experimental?​

 

Participants should be informed about what they will have to do, undergo or experience in the study. A description of the study procedures involved should be given to the participant. Additionally, any treatments or procedures that are experimental should be identified and described. For some studies, it may be helpful to provide participants with a time-line description (e.g. week 1, week 2, 4 weeks later, etc.) or a chart of the procedures that will be performed, the drugs that will be administered, all hospitalizations, and all outpatient visits, etc.

If a clinical trial includes standard therapy as part of the study protocol, it should be described to the participant.

For clinical trials following ICH GCP, the following should also be explained 1) the trial treatments and the probability for random assignment to each treatment, and 2) the participant’s responsibilities.

Informed consent should begin with a concise and focused presentation of the key information. It is expected that a statement that a description of the procedures should be a part of that concise summary. For more about the concise summary, please see the Consent Process Checklist page.

The following are suggested lay definitions which may be used, if applicable:

  • Randomized Trial: A research trial usually involves comparing different treatments. In a trial, one group will get one treatment and another group will get a different treatment. In a “randomized trial” people are put in one group or the other by random chance. This means that a computer will decide by chance which group a person is in, not the doctors running the trial.

    Patients should be told what chance they have of getting the study drug/treatment e.g. a one in four chance, a 50:50 chance, etc.
  • Single Blind Trial: In a blind trial you will not know which treatment group you are in.
  • Double Blind Trial: In this trial, neither you nor your doctor will know which treatment group you are in (although, if your doctor needs to find out for important medical reasons, he/she can do so).
  • 45 CFR 46.116(b)(1)
  • 21 CFR 50.25(a)(1)

  • ICH GCP 4.8.10(c-f)

Is there a description of any foreseeable risks or discomforts to the participant?

 

Describe any reasonably foreseeable risks, discomforts or side-effects the participant may experience for each procedure and drug (including the possibility that an experimental treatment may be ineffective). List all side effects which are life-altering or potentially life-altering, no matter how rare. Minor risks such as the possible breach of confidentiality should be listed.

For studies involving placebo or withheld treatment, potential risks must be adequately explained, including any risks of non-treatment.

For studies involving possible reproductive risks, participants should be informed of any known risks in pregnancy, either to mother or child. For clinical trials adhering to GCP, risks to an embryo, fetus, or nursing infant must also be explained, as applicable. Acceptable methods of birth control that may be used during the research should be described. Finally, the informed consent should include a description of what action will occur in the event of pregnancy (i.e., follow-up of pregnancy outcome, immediate withdrawal from the study, etc.).

Informed consent should begin with a concise and focused presentation of the key information. It is expected that a statement that the risks should be a part of that concise summary.

For some studies, with greater risks and more procedures, the key information to be presented in a concise and focused will differ greatly from those simple studies with limited risks. For example, a complicated clinical trial for cancer patients may have a consent document that is 20-25 pages. The concise summary would ideally be no more than a few pages. The most important foreseeable risks to participants could be summarized at the beginning of the informed consent, while the more comprehensive and detailed description of foreseeable risks would be presented later with the body of the informed consent.

For more about the concise summary, please see the Consent Process Checklist page.

  • "The risks of this study are minimal. You may feel upset thinking about or talking about personal information related to <<insert topic>>. These risks are similar to those you experience when discussing personal information with others. If you feel upset from this experience, you can tell the researcher, and he/she will tell you about resources available to help."
  • The following can be used for studies involving possible reproductive risks: "It is possible that if the treatment is given to a pregnant woman it will harm the unborn child. Pregnant women must not take part in this study, nor should women who plan to become pregnant during the study. Women who are at risk of pregnancy will be asked to have a pregnancy test before taking part to exclude the possibility of pregnancy. If you could become pregnant must use an effective contraceptive during the course of this study. Acceptable methods of birth control include <<list acceptable methods>>.  If you become pregnant while taking part in the study, you must immediately tell your research doctor. Options will be discussed with you at that time. Whether or not you remain on study treatment, we will follow the outcome of your pregnancy and we will continue to follow you according to the study plan."
  • 45 CFR 46.116(b)(2)
  • 21 CFR 50.25(a)(2)
  • ICH GCP 4.8.10(g)

Is there a description of any benefits to the participants or others?

 

A description of any benefits to the participants or to others that may be reasonably expected from the research should be included. Do not imply that compensation to be offered to participants is a benefit. The description of benefits to the participant should be clear and not overstated to avoid coercion. If no direct benefit is anticipated, it should be stated.

For clinical trials adhering to GCP, if there is no intended clinical benefit to the participant, the participant should be made aware of this.

Informed consent should begin with a concise and focused presentation of the key information. It is expected that the benefits that may be reasonably be expected should be a part of that concise summary. For more about the concise summary, please see the Consent Process Checklist page.

  • "We cannot promise any benefits to you from your being in the study. However, possible benefits may include <<list benefits>>."
  • "There are no direct benefits for taking part in this study. However, we hope the information we get from this study may help develop a greater understanding of <<insert topic>> in the future."
  • "We hope that this study will help you, however, this cannot be guaranteed."
  • 45 CFR 46.116(b)(3)
  • 21 CFR 40.25(a)(3)
  • ICH GCP 4.8.10(h)

Is there a disclosure of any alternative procedures or courses of treatment?

 

The informed consent process should describe any alternative procedures or courses of treatment that might be advantageous to the participant. To enable a rational choice about participating in the research study, individuals should be aware of the full range of options available to them including palliative or comfort care, if applicable. If standard therapy is part of the study protocol, the participant must be told that he/she can receive standard treatment outside of the study.

For clinical trials adhering to GCP, the important potential benefits and risks of any alternative procedures or courses of treatment should also be stated.

Informed consent should begin with a concise and focused presentation of the key information. It is expected that a statement with appropriate alternative procedures or courses of treatments (if any) should be a part of that concise summary. For more about the concise summary, please see the Consent Process Checklist page.

  • "You may choose not to be in this study. If you do not want to take part in the study, there are other choices such as <<list alternatives>>. You may discuss these options with your doctor."
  • "If you do not want to be in the study, you may earn research participation credit by <<list alternatives>>."
  • 45 CFR 46.116(b)(4)
  • 21 CFR 50.25(a)(4)

  • ICH GCP 4.8.10(i)

Is there a statement describing the confidentiality of records?

 

A statement describing the extent, if any, to which confidentiality of records identifying the research participant will be maintained must be included. This should include information about storage of the records and data pertaining to the participant and how confidentiality will be protected. Please note who may have access to the data.  Inform participants if you collect social security numbers. Tell participants whether they can withhold their social security number and still participate. 

If your research is subject to FDA regulations, please include a statement that the FDA may inspect research records at any time.

If applicable, a description of the Certificate of Confidentiality and any voluntary disclosure plans by the Investigator(s) should be explained to the participant.

For clinical trials adhering to GCP, the participant should be informed that the monitor(s), the auditor(s), the IRB, and the regulatory authority(ies) will be granted direct access to the participant’s original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by applicable laws and regulations. Additionally, participants should be informed that records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the participant’s identity will remain confidential.

When seeking informed consent for applicable clinical trials, a statement should be provided to each clinical trial participant notifying the participants that clinical trial information has been or will be submitted for inclusion in the clinical trial registry (www.ClinicalTrials.gov).  Follow this link to help you determine if your study is an applicable clinical trial. Additionally, the NIH expects that all NIH-funded awardees and investigators conducting clinical trials, funded in whole or in part by the NIH will include the same language in the consent document.

Often, when HIPAA authorization is obtained for the use of medical records, it is explained to the participant in conjunction with the description of confidentiality. However, it is not required to combine confidentiality and authorization language. For more about HIPAA authorization language, please see the HIPAA Authorization Checklist.

  • "We will keep all research records that identify you private to the extent allowed by law."
  • "Your name <<will/will not>> be kept with your responses from <<the interview, focus group, questionnaire, etc.>>.  In publications, your name will be <<used, removed, protected, etc.>>."
  • Verbatim language if the research is a clinical trial that must be registered on www.ClinicalTrials.gov:  "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 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."

For an example of combined confidentiality language and HIPAA authorization section, please see the HIPAA Authorization Checklist.

  • 45 CFR 46.116(b)(5)
  • 45 CFR 45.164 (HIPAA Privacy Rule)

  • 21 CFR 50.25(a)(5)

  • ICH GCP 4.8.10(n) and (o)

  • 21 CFR 50.25(c)

For research involving more than minimal risk, is there a statement about what options are available if injury to the participant occurs?

 

For research involving greater than minimal risk, participants should be informed as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

If the study is conducted at the University of Utah, Primary Children’s Hospital or Shriners, there is specific language that should be used and can be found below under “Example”. If a sponsor or other party who is assuming responsibility for research-related injury, the language should also be included. For any questions, please contact the IRB office for guidance.

If the study is conducted at the VA, there is specific language that should be used. You may refer to the VA checklist for more information. The language has been provided below for your convenience.

  • If the study is conducted at the University of Utah or Primary Children’s Hospital, include the following statements verbatim: If you are injured from being in this study, medical care is available to you at the <<insert appropriate institution(s) e.g. University of Utah or Primary Children's Hospital >>, as it is to all sick or injured people. The University of Utah <<and Primary Children’s Hospital (if applicable)>> has not set aside any money to pay the costs for such care. The University <<and Primary Children’s Hospital>> will work with you to address costs from injuries. Costs would be charged to you or your insurance company (if you have insurance), to the study sponsor or other third party (if applicable), to the extent those parties are responsible for paying for medical care you receive. Since this is a research study, some health insurance plans may not pay for the costs. By signing this consent form you are not giving up your right to pursue legal action against any parties involved with this research.
  •  If you have a sponsor or other party who is assuming responsibility for research-related injury, please include the language here.
  • Insert the following language verbatim: The University of Utah is a part of the government. If you are injured in this study, and want to sue the University or the doctors, nurses, students, or other people who work for the University, special laws may apply. The Governmental Immunity Act of Utah is a law that controls when a person needs to bring a claim against the government, and limits the amount of money a person may recover. See sections 63G -7-101 to -904 of the Utah Code.
  • If your study takes place at Shriners, please add the following additional language: In the case of injury or illness resulting from this study, medical treatment is available. To the extent the Shriners Hospitals for Children provides medical services at its facility, those will be at no cost. If you get that care somewhere else, your usual healthcare coverage would apply.  Shriners Hospitals for Children is not able to offer financial compensation for a research- related injury or other problems. Although no funds have been set aside to pay you for injury or illness.
  • 45 CFR 46.116(b)(6)

  • 21 CFR 50.25(a)(6)

  • ICH GCP 4.8.10(j)

Is the necessary contact information provided?

 

Explain whom participants should contact with any questions, complaints, and concerns about the research or related matters. If the study involves serious risks, a number with 24-hour availability must be provided. If the number is a pager or the hospital operator include further instructions for contacting the appropriate individual. 

Give specific information about who the participant should contact in case of a research-related injury. This should include name(s), telephone number(s), and when the person(s) listed may be contacted. If applicable, provide information about who to contact if the participant has questions about the billing of costs in the study.

  • "If you have questions, complaints or concerns about this study, you can contact <<insert name>> at <<insert phone number>>. If you think you may have been injured from being in this study, please call <<insert name>> at <<insert phone number>>. <<Insert name>> can be reached at this number during <<specify hours or state it is a number available 24-hours a day>>."
  • If the study is conducted at the University of Utah, include the following statement verbatim:  Contact the Institutional Review Board (IRB) if you have questions regarding your rights as a research participant. Also, contact the IRB if you have questions, complaints or concerns which you do not feel you can discuss with the investigator. The University of Utah IRB may be reached by phone at (801) 581-3655 or by e-mail at irb@hsc.utah.edu. 
  • If the study is conducted at University of Utah Health, include the following statement verbatim: Research Participant Advocate:  You may also contact the Research Participant Advocate (RPA) by phone at (801) 581-3803 or by email at participant.advocate@hsc.utah.edu.
  • 45 CFR 46.116(b)(7)

  • 21 CFR 50.25(a)(7)

  • ICH GCP 4.8.10(q)

Is there a statement that participation is voluntary?

 

A statement that participation is voluntary should be included.

Informed consent should begin with a concise and focused presentation of the key information. It is expected that a statement that participation is voluntary should be a part of that concise summary. For more about the concise summary, please see the Consent Process Checklist page.

If there are any possible consequences of a participant’s decision to withdraw from the research, it should be explained. For example, if the participant decides to withdraw from the study, describe any adverse effects on the participant’s health or welfare, or any extra follow-up that may be requested.

  • "Research studies include only people who choose to take part.  You can tell us that you don’t want to be in this study.  You can start the study and then choose to stop the study later.  We will still give you medical care and answer any questions you have.  Your decision will not affect your relationship with your doctor or the study team in any way."
  • "If you want to stop being in this study, please let the research doctor know. That way you can find out what should be done about your normal medical care outside of the study."
  • 45 CFR 46.116(b)(8)

  • 21 CFR 50.25(a)(8)

  • ICH GCP 4.8.10(m)

Is there a statement that individuals may refuse to participate or discontinue participation without penalty or loss of benefits?

   

The informed consent process should include a statement that the refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.

  • “If you decide to take part, you are still free to withdraw at any time and without giving a reason. Refusal to participate or the decision to withdraw from this study will involve no penalty or loss of benefits to which you are otherwise entitled. If you don’t take part, you can still receive all standard care that is available to you. This will not affect the relationship you have with your doctor or other staff, nor decrease the standard of care that you receive as a patient."

  • “If you do not want to be in the study or want to stop being in the study, you will not receive a penalty and you will not lose any benefits.  Your decision will not affect your relationship with the researcher or the study team in any way.”

  • 45 CFR 46.116(b)(8)
  • 21 CFR 50.25(a)(8)
  • ICH GCP 4.8.10(m)
  • VHA Handbook 1200.05(2), 15(b)(8)

Is there a statement about the collection of identifiable private information or identifiable biospecimens?

 

For any research that involves the collection of identifiable private information or identifiable biospecimens, there must be either:

  1. A statement that the participant’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies, OR

  2. If identifiable private information or identifiable biospecimens could be used for future research studies or distributed to another investigator for research studies without additional informed consent, please review the Future Use of Private Information or Biospecimens checklist. You will need to include specific information in the informed consent document.

  • "The <<information and/or specimens>> collected about you for this study will not be used for future research studies."

  • “Your name and information that can directly identify your <<specify what biospecimens are collected>> will be removed from the sample. The <<specify what biospecimens are collected>> will not be used for future research studies.”

For an example of language for future use of private information or biospecimens, please see the Future Use of Private Information or Biospecimens Checklist.

  • 45 CFR 16.116(b)(9)

 Additional Elements of Informed Consent

The following are additional elements of informed consent. Generally, the University of Utah does not require that the additional elements of informed consent as described below be provided for studies that are no more than minimal risk. However, the IRB may determine that any of the additional elements of informed consent be required.

If a study is greater than minimal risk (as determined by the IRB), the additional elements of informed consent are generally required. However, the IRB may determine if any of the additional elements of informed consent may be omitted.

Is there a statement that the treatment or procedure may involve risks to the participant that are currently unforeseeable?

 

A statement that the particular treatment or procedure may involve risks to the participant that may be unforeseeable should be included in the informed consent process. Also, if the participant is or may become pregnant, there should be a statement that there may be unforeseeable risks to the embryo or fetus.

It makes the most sense to include this statement when discussing risks (see above).

  • "In addition to the risks listed above, you may experience a previously unknown risk or side effect."
  • 45 CFR 46.116(c)(1)

  • 21 CFR 50.25(b)(1)

Is there a description of anticipated circumstances under which the investigator may terminate participation?

 

If applicable, the informed consent process should describe anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent. This section may be omitted if there are no anticipated circumstances under which the subject’s participation may be terminated. If withdrawal of a participant by the investigator may occur, possible reasons should be listed.

Any procedures required for an orderly termination of participation should be described. Include a description of any adverse effects on the participant’s health or welfare, or follow-up that may be requested if the participant is withdrawn from the study.

  • "The investigator can withdraw you without your approval. Possible reasons for withdrawal include <<list reason(s) why the participant may be withdrawn>>."
  • 45 CFR 46.116(c)(2)

  • 21 CFR 50.25(b)(2)

  • ICH GCP 4.8.10(r)

Is there a description of any additional costs to the participant?

 

Any additional costs to the participant that may result from the research should be clearly indicated. Costs related to standard of care and costs related to research procedures should be separated and explained.  If applicable, state that the participant may want to check whether their health insurance will cover research-related costs. When costs may be billed to the participant, the insurance company, or both, statements such as “will be billed to you or your insurer in the ordinary manner” are preferred.

  • "All costs associated with this study will be billed to you or your insurance company in the ordinary manner. Your insurance company may not pay for the costs associated with research. Therefore, these costs <<state who will be responsible e.g. “will be your responsibility” or “will be paid by the sponsor” or “the sponsor has agreed to pay $XX”, etc.>>."
  • "You will not be charged, nor will your insurance company be charged, for any test or visit that is completed solely for the purpose of this study. "
  • "The parts of your care that would normally be done as standard treatment such as <<list procedures or refer to the procedures identified as standard of care in the “Procedures” section>> will be billed to you or your insurance company."
  • 45 CFR 46.116(c)(3)

  • 21 CFR 50.25(b)(3)

  • ICH GCP 4.8.10(l)

Is there a description of any compensation given to the participant, including the anticipated prorated payment, if any?

 

Explain whether participants will be compensated. If not, please state. Specify the overall amount, schedule of payment(s) and any plan for prorating payments if a participant does not complete the study. It should not be implied that compensation is a benefit to participants. Therefore, it is best to explain compensation separately from the description of benefits.

  • "You will not receive payment for taking part in this study."
  • "You will also be provided <<insert amount per visit>> per visit as compensation for your time. If all study visits are completed, the maximum total you may receive is <<insert total amount>>. This money is meant to help pay for things like travel costs, child care costs, missed hours from work, that you may have because you are taking part in this study. You will only be paid for each visit that you complete. If you discontinue early from the study, you will receive a pro-rated (partial) reimbursement amount based on how many study visits you completed."
  • ICH GCP 4.8.10(k)

Is there a description of the consequences of a participant’s decision to withdraw and procedures for withdrawal?

 

The consequences of a participant’s decision to withdraw from the research and procedures for orderly termination of participation should be explained in the consent process.

Describe any adverse effects on the participant’s health or welfare, or any extra follow-up that may be requested, if the participant decides to withdraw from the study. Explain the procedures for an orderly termination of participation. Such an explanation may be omitted if there are no adverse consequences to withdrawal.

  • "If you want to stop being in this study, please let the research doctor know. That way you can find out what should be done about your normal medical care outside of the study."
  • 45 CFR 46.116(c)(4)

  • 21 CFR 50.25(b)(4)

  • ICH GCP 4.8.10(m)

Is there a statement regarding significant new findings?

 

The informed consent process should include a statement that new findings developed during the course of the research that may affect to the participant’s willingness to continue in the study will be provided to the participant. This section may be omitted if new information could not reasonably be used to alter participation (e.g. one-time interventions).

If study may reveal clinically relevant research results or incidental genetic findings, the participant should be informed what information will be provided and how that information will be provided. For more about incidental genetic findings, please see Supplemental Elements of Informed Consent.

  • "Sometimes during the course of a research project, new information becomes available about the <<treatment/drug>> that is being studied. If this happens, your research doctor will tell you about it and discuss with you whether you want to continue in the study."
  • "If you decide to withdraw at that time, your research doctor will make arrangements for your medical care to continue. If you decide to continue in the study, you may be asked to sign an updated consent form. Also, on receiving new information your research doctor might consider it to be in your best interests to withdraw you from the study. He/she will explain the reasons and arrange for your medical care to continue."
  • 45 CFR 46.116(c)(5)

  • 21 CFR 50.25(b)(5)

  • ICH GCP 4.8.10(p)

Is there a statement with the approximate number of participants involved in the study?

 

If applicable, state the approximate number of participants to be enrolled. Indicate whether this study is part of a national study.

  • "We expect to enroll <<enter number>> participants at the <<University of Utah, PCH or Shriner’s Hospital>>. We also expect to enroll <<enter number>> participants at <<enter number>> other medical centers. "
  • 45 CFR 46.116(c)(6)
  • 21 CFR 50.25(b)(6)
  • ICH GCP 4.8.10(t)
 

Is there a statement about whether the participant’s biospecimens may be used for commercial profit?

   

If applicable, a statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit should be included. The statement should be clear of whether the participant will or will not share in any commercial profit.

This statement should be addressing any biospecimens collected and used during the research project that is currently being conducted. It should be noted that if the study will be banking any biospecimens for future use, the University of Utah similarly requests that a statement be made regarding commercial profit. You may find more details on the Future Use of Private Information or Biospecimens checklist.

  • "Tissue or blood samples obtained from you in this research may help in the development of a commercial product by <<specify who will conduct future research on the sample, e.g. the University of Utah, the study sponsor, etc.>> or its research partners.  There are no plans to provide financial compensation to you should this occur."
  • 45 CFR 46.115(c)(7)

Is there a statement about whether clinically relevant research results will be disclosed to participants?

 

If applicable, include a statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects and, if so, under what conditions.

If your study may reveal incidental genetic findings, the participant should be informed of what information will be provided and how that information will be provided. 

It makes sense to include this when describing the disclosure of new findings.

  • "We do not have plans to tell you about any of the results from this study.”
  • “During the study, we may learn something about your health that could help you and your doctors make decisions about your healthcare.  If this happens, we will tell you about these results. We will contact you and make arrangements to discuss this with you."
  • Include the following verbatim statement if incidental genetic findings may be disclosed to participants: “In this research, we are only looking for changes in your genes that are related to <<condition under study>>. But it is possible that we may come across changes in your genes that are related to other health conditions.  These other findings may be important to your health care or the health care of your family members.

    If this happens, we may contact you to give you a choice about learning about these findings.  We will also refer you to a genetic counselor who can help you make a decision and talk to you about how you might use the results in your health care.

    Although it is possible we may find gene changes related to other health conditions, it is important to emphasize that we are focused on gene changes associated with <<condition under study>>.  This means that you might have changes in your genes related to other health conditions that we will not identify in this study.

    In most cases we may need to retest your original blood sample or obtain a new sample for clinical testing.  We may refer you to clinical specialists where retesting could be done to verify results.  If you choose to receive results, the cost of clinical retesting may be billed to your insurance or you.”"
  • 45 CFR 46.116(c)(8)

For research involving biospecimens, is there a statement about whether the research may include whole genome sequencing?

 

For research involving biospecimens, the informed consent process should describe whether the research will (if known) or might include whole genome sequencing. For example, sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen.

  • “Your <<specify type of sample>> that are collected for this research study will not include whole genome or whole exome sequencing. This means that the researchers have no plans to look at or try to “read,” the protein information that makes up your genes (DNA) from your sample.”
  • For potential testing: "We <<may or will>> perform a whole genome or whole exome analysis on your <<specify type of sample>>. In whole genome or whole exome analysis, all or most of your genes are studied and used by researchers to find causes of <<indicate whether the sequencing data will be limited to the disease under study and related disorders or "many diseases or conditions">>. It is also possible that this type of testing will discover a gene that you do not know about that may indicate you or a relative is at risk for a genetic disorder in the future."
  • Example for non-disclosure: “In whole genome or whole exome analysis, all or most of your genes are studied and used by researchers to find causes of <<indicate whether the sequencing data will be limited to the disease under study and related disorders or "many diseases or conditions">>. We will not give you any individual results from your whole <<genome and/or exome>> sequencing. This is because it will probably take a long time for this project to produce health-related information that we will know how to interpret accurately.”
  • Example for disclosure: “In whole genome or whole exome analysis, all or most of your genes are studied and used by researchers to find causes of <<indicate whether the sequencing data will be limited to the disease under study and related disorders or "many diseases or conditions">>. When we have useful results from the genome sequencing we have done, we will contact you and ask you if you want to learn the results. We will ask you to meet with us to learn the results. You will meet with professionals with the expertise to help you learn more about the risks, benefits and limitations of learning your research results.  If you then decide to receive your results, the research team will explain the meaning of these results and any implications for your and/or your family’s health.”"

45 CFR 46.116(c)(9)

HIPAA Authorization

Will your study require HIPAA authorization for the use of medical records?

 

To protect patient privacy, “covered entities” (all health plans, health care “clearinghouses,” and health care providers) must obtain specific, written Authorization from a patient to use or disclose protected health information (PHI). An authorization may be combined with an informed consent document or other permission to participate in research. The University of Utah accepts either an authorization combined with the informed consent document or a separate authorization form as long as all the elements and required statements of a valid authorization are met.

The authorization must be written in plain language and a copy of the authorization must be provided to the individual signing.

Often, when authorization is obtained, it is done in conjunction with the description of confidentiality. However, it is not required to combine confidentiality and authorization language.

The VA Salt Lake City Health Care System uses VA Form 10-0493, Authorization for Use & Release of Individually Identifiable Health Information for VHA Research to document authorization. This authorization may not be embedded in the consent form. Please see VA Form 10-0493.

You will find the language for both confidentiality and the authorization in an informed consent document provided in the example below. However, you may use the checklist with the following questions to ensure that all elements of a valid authorization are met.

 The following example combines both confidentiality and an Authorization in an informed consent document. 


AUTHORIZATION FOR USE OF YOUR PROTECTED HEALTH INFORMATION

Include the Authorization and Confidentiality information as outlined:

Signing this document means you allow us, the researchers in this study, and others working with us to use some information about your health for this research study.


This is the information we will use and include in our research records: Modify the following list as appropriate – delete or add items as necessary.

Demographic and identifying information like <<name, address telephone number, and email address>>

<<Social Security Number – Tell participants whether they can withhold their social security number and still participate>>

Related medical information about you like <<family medical history, allergies, current and past medications or therapies, and information from physical examinations, such as blood pressure reading, heart rate, temperature, and lab results>>

All tests and procedures that will be done in the study

How we will protect and share your information:

We will do everything we can to keep your information private but we cannot guarantee this. Study information will be kept in a secured manner and electronic records will be password protected. Study information may be stored with other information in your medical record. Other doctors, nurses, and third parties (like insurance companies) may be able to see this information as part of the regular treatment, payment, and health care operations of the hospital. We may also need to disclose information if required by law.

If applicable, please provide a description of the Certificate of Confidentiality and any voluntary disclosure plans by the Investigator(s). For more information regarding Certificates of Confidentiality, please refer to the IRB website.

If this research represents a clinical trial that must be registered on ClinicalTrials.gov, you must include the following statement verbatim: A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 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.

In order to conduct this study and make sure it is conducted as described in this form, the research records may be used and reviewed by others who are working with us on this research:

Members of the research team and << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>;

The University of Utah Institutional Review Board (IRB), which reviews research involving people to make sure the study protects your rights;

Modify the list below as appropriate - delete or add items as necessary. The examples below are suggestions and may be used as applicable.

 

Other local hospital(s) that we are working with: <<list VA Salt Lake City Health Care System or any other local hospitals where information could be shared>>

Other academic research centers we are working with: <<list all other academic centers including those at the University that may not be within UUHSC, and explain their roles in project>>

The study sponsor: <<Name of sponsor>>

A research coordinating office: <<Name of group or company>>

<<Name of federal oversight agencies, i.e. the Food and Drug Administration, Centers for Disease Control, etc.>>

<<Name any other groups that will receive data>>

Include this statement if you will share PHI outside of the University of Utah Health Sciences Center, Primary Children’s Hospital, the VA Salt Lake City Health Care System, and/or Shriners Hospital: If we share your identifying information with groups outside of << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>, they may not be required to follow the same federal privacy laws that we follow.  They may also share your information again with others not described in this form.

Include this statement if you will not share PHI outside of the University of Utah Health Sciences Center, Primary Children’s Hospital, the VA Salt Lake City Health Care System, and/or Shriners Hospital: If we share your information with groups outside of << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>, we will not share your name or identifying information.  We will label your information with a code number, so they will not know your identity.

If testing is performed as a result of study participation for any communicable or infectious diseases reportable by Utah State law, the following must be addressed in this section (refer to http://health.utah.gov/epi/report.html for a current list of Utah’s reportable diseases):

Tell the participant about the state reporting.

Describe how results will be given to the participant to comply with state reporting requirements.

Describe the methods or opportunities participants will be given for appropriate counseling and medical care.

If you do not want us to use information about your health, you should not be part of this research. If you choose not to participate, you can still receive health care services at << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>.

 

What if I decide to Not Participate after I sign the Consent and Authorization Form?

You can tell us anytime that you do not want to be in this study and do not want us to use your health information.  You can also tell us in writing.  If you change your mind, we will not be able to collect new information about you, and you will be withdrawn from the research study. However, we can continue to use information we have already started to use in our research, as needed to maintain the integrity of the research. 


This authorization does not have an expiration date. 


Include the following paragraph if participants will not have access to their information during the study:

You have a right to information used to make decisions about your health care. However, your information from this study will not be available during the study; it will be available after the study is finished.


CONSENT

Please include a consent and authorization statement written in first person such as the following:


I confirm that I have read this consent and authorization document and have had the opportunity to ask questions. I will be given a signed copy of the consent and authorization form to keep.  

I agree to take part in this research study and authorize you to use and disclose health information about me for this study, as you have explained in this document.

Does the authorization include a description of the information to be used or disclosed?

 

A meaningful description or identification of the information to be used or disclosed should be included in the authorization.

  • “The health information that we may use or disclose (release) for this research includes: <<Insert a description of information to be used or disclosed for the research project. This may include, for example, all information in a medical record, results of physical examinations, medical history, lab tests, or certain health information indicating or relating to a particular condition.>>”
  •  45 CFR 164.508(c)(1)

Does the authorization include the name or identification of the recipient of the information and describe the purpose of the requested use or disclosure?

 

The authorization should include the name or other identification of the recipient of the information. It is acceptable to state that the information will be used by the “researchers and their staff” rather than use the name of the researcher.

The authorization should include a description of each purpose of the requested use or disclosure. The authorization may be obtained from an individual for uses and disclosures of protected health information for future research purposes, as long as the authorization adequately describes the future research.

  • “In order to conduct this study and make sure it is conducted as described in this form, the research records may be used and reviewed by others who are working with us on this research:
    • Members of the research team and << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>;
    • The University of Utah Institutional Review Board (IRB), which reviews research involving people to make sure the study protects your rights
    • [Modify the list below as appropriate - delete or add items as necessary. The examples below are suggestions and may be used as applicable.]
      -Other local hospital(s) that we are working with: <<list VA Salt Lake City Health Care System or any other local hospitals where information could be shared>>
      -Other academic research centers we are working with: <<list all other academic centers including those at the University that may not be within UUHSC, and explain their roles in project>>
      -The study sponsor: <<Name of sponsor>>
      -A research coordinating office: <<Name of group or company>>
      -<<Name of federal oversight agencies, i.e. the Food and Drug Administration, Centers for Disease Control, etc.>>
      -<<Name any other groups that will receive data>>”
  • 45 CFR 164.508(c)(1)

Does the authorization include a description of expiration?

 

The authorization should include a description of the expiration. Unlike other authorizations, an authorization for a research purpose may state that the authorization does not expire, that there is no expiration date or event, or that the authorization continues until the “end of the research study”.

  •  “This authorization does not have an expiration date.”
  • “This authorization expires at the end of the research study.”
  • “This authorization will remain valid unless and until it is revoked by the individual.”
  • 45 CFR 164.508(c)(1)

Is there a statement about the revocation of authorization?

 

The authorization should include an explanation of the individual's right to revoke his/her Authorization in writing and either (1) the exceptions to the right to revoke and a description of how the individual may revoke Authorization or (2) reference to the corresponding section(s) of the covered entity's Notice of Privacy Practices.

  • “You can tell us anytime that you do not want to be in this study and do not want us to use your health information.  You can also tell us in writing.  If you change your mind, we will not be able to collect new information about you, and you will be withdrawn from the research study. However, we can continue to use information we have already started to use in our research, as needed to maintain the integrity of the research.”
  •  45 CFR 164.508(c)(2)

Is there a statement describing authorization and the ability or inability to condition enrollment on the Authorization?

 

Notice of the covered entity's ability or inability to condition treatment, payment, enrollment, or eligibility for benefits on the Authorization, including research-related treatment, and, if applicable, consequences of refusing to sign the Authorization.

  • “If you do not want us to use information about your health, you should not be part of this research.  If you choose not to participate, you can still receive health care services at << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital>>.”
  •  45 CFR 164.508(c)(2)

Is there a statement about the potential of PHI being re-disclosed?

 

The authorization must include a statement about the potential for the PHI to be re-disclosed by the recipient and no longer being protected by the Privacy Rule. This may be a general statement that the Privacy Rule may no longer protect health information.

  • Include this statement if you will share PHI outside of the University of Utah Health Sciences Center, Primary Children’s Hospital, the VA Salt Lake City Health Care System, and/or Shriners Hospital: “If we share your identifying information with groups outside of << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>, they may not be required to follow the same federal privacy laws that we follow.  They may also share your information again with others not described in this form.”
  • Include this statement if you will not share PHI outside of the University of Utah Health Sciences Center, Primary Children’s Hospital, the VA Salt Lake City Health Care System, and/or Shriners Hospital:  “If we share your information with groups outside of << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>, we will not share your name or identifying information.  We will label your information with a code number, so they will not know your identity.”
  • 45 CFR 164.508(c)(2)
 

Does the authorization include the name of the person authorized to make the requested disclosure and obtain a signature?

 

The name of the individual or name of the person authorized to make the requested disclosure. The name of the individual is typically printed by the participant at the end of the document along with the signature.  So, there may be a line to allow for the printed name of participant or the participant’s authorized representative.

The authorization should be signed by the individual and dated. If the authorization is signed by an individual's personal representative, a description of the representative's authority to act for the individual should also be indicated.

 I agree to take part in this research study and authorize you to use and disclose health information about me for this study, as you have explained in this document.

 

 

 

Participant’s Name

 

 

Date

 

 

 

Participant’s Signature

 

 

 

 

 

Name of Person Obtaining Authorization and Consent

 

 

 

Signature of Person Obtaining Authorization and Consent

 

Date

  • 45 CFR 164.508(c)(1)

Supplemental Elements of Informed Consent

Investigators should provide participants with information that a reasonable person would want to have in order to make an informed decision. Use this checklist to help ensure that, if necessary, important information is shared with participants.

Does your study involve the possible disclosure of confidential information (e.g. reportable diseases, disclosure of abuse, or self-harm)?

 

This section discusses information that should be shared with participants during the informed consent process. This covers the 1) disclosure of confidential information of reportable diseases; 2) disclosure of abusive situations; and 3) disclosure of information about harming others or themselves. It makes the most sense to explain these possible disclosures when discussing confidentiality.  If there is a test for a reportable disease and is explained with the rest of the study procedures, it makes the most sense to tell the participant about the reporting as well.  

If testing is performed as a result of study participation for any communicable or infectious diseases reportable by Utah State law, the following must be addressed in this section (refer to http://health.utah.gov/epi/report.html for a current list of Utah’s reportable diseases):

  1. Tell the participant about the state reporting.
  2. Describe how results will be given to the participant to comply with state reporting requirements.
  3. Describe the methods or opportunities participants will be given for appropriate counseling and medical care.

In some cases, a statement about mandatory reporting of confidential information such as when the researcher is legally obligated to reveal instances of child abuse, elder abuse, or abuse of the disabled should be given during the informed consent process. If your study involves the possibility of disclosure of abusive situations, mandatory language from the Department of Health and Human Services must be inserted (click on “Example” below to find the mandatory language). 

It is recommended that this discussion be paired with your confidentiality section.

  • Use the following statement verbatim if your study involves the possibility of disclosure of abusive situations: “If you disclose information that gives study staff a reason to believe that a child or disabled or elderly adult has been subjected to abuse or neglect, study staff will report that information to Child Protective Services, Adult Protective Services, or the nearest law enforcement agency to the extent required by law.”
  • “There are some cases in which a researcher is obligated to report issues, such as serious threats to public health or safety.”
  • Example for reporting of communicable or infectious diseases:   

    When explaining procedures: The tests that may be performed include <<type of test>>.

    Positive <<communicable or infections disease>> test results are required to be reported to local health authorities.

     When explaining confidentiality: You may be tested for <<communicable or infections disease>>. You will have appropriate counseling regarding this testing if the results are positive for <<communicable or infections disease>>.  The results of your tests will be confidential, but will appear in your medical records.

     Utah State law requires the test results to be reported to the Utah Department of Health (UDOH).  In this instance the Study Doctor will offer you information relevant to your health and advise you on the next steps regarding your medical care and appropriate counseling.  Confidentiality of your data will be respected at all times.

Coming soon.

Is there a possibility of the disclosure of incidental genetic findings?

 

If the study may reveal incidental genetic findings, the participant should be informed what information will be provided and how that information will be provided.

It makes the most sense to include this when describing the disclosure of new findings. See the Additional Elements of Informed Consent.

  • Include the following verbatim statement if incidental genetic findings may be disclosed to participants:
    “In this research, we are only looking for changes in your genes that are related to <<condition under study>>. But it is possible that we may come across changes in your genes that are related to other health conditions.  These other findings may be important to your health care or the health care of your family members. 

    If this happens, we may contact you to give you a choice about learning about these findings.  We will also refer you to a genetic counselor who can help you make a decision and talk to you about how you might use the results in your health care.

    Although it is possible we may find gene changes related to other health conditions, it is important to emphasize that we are focused on gene changes associated with <<condition under study>>.  This means that you might have changes in your genes related to other health conditions that we will not identify in this study.

    In most cases we may need to retest your original blood sample or obtain a new sample for clinical testing.  We may refer you to clinical specialists where retesting could be done to verify results.  If you choose to receive results, the cost of clinical retesting may be billed to your insurance or you.”

Coming soon.

Does your study involve placebo or withheld treatment?

 

For studies involving placebo or withheld treatment, the informed consent process should include:

  1. The reason for the placebo or withheld treatment must be explained;
  2. “Placebo” should be defined in lay terms;
  3. Any withheld treatment must be detailed;
  4. If applicable, describe any plan for rescue therapy, special monitoring, or crossover to placebo;
  5. For studies involving placebo or withheld treatment, potential risks must be adequately explained, including any risks of non-treatment.
  • Example definition of placebo: “A placebo is a dummy treatment such as a pill which looks like the pill that contains the study drug but is not. Placebos contain no drugs or active ingredients. Study participants are given placebos so that the effects of a drug can be compared against no drug.  Use of placebos also prevents the participant and the doctor from knowing whether or not the subject is getting the drug.”

Coming soon.

Additional Elements Required by the VA

Is there a statement about the investigators’ conflict of interest?

 

Any real or apparent conflict of interest by investigators where the research will be performed should be described in the informed consent process. If there are no conflicts of interest, it can be stated but is not required.

Briefly describe the financial interest in the consent form. You may also disclose the nature of any financial or proprietary interests, though it can be general in terms.

  • “<<Investigator’s name>> <<describe real or apparent conflict of interest, e.g., receives payments for lecturing for, has an equity interest in, receives royalty from a patent associated with, or serves in an executive position with>> <<sponsor name>>, a sponsor of this research study. This conflict has been reviewed and managed by the VASLCHCS Conflict of Interest in Research Committee.”
  • “A company called <<insert name of sponsor>>, who is the sponsor of the study, is paying for this study. The study doctor, the non-profit corporation for the VASLCHCS, and members of the study team receive compensation from (sponsor) for your participation in the study as well as for the time and materials used to track your progress in the study.”
  • “<<Name of person with conflict>>, who is << describe role>> on this multi-center study, is <<describe potential conflict, e.g., the inventor of a biochemical test / author of a book>> used in the study. The <<name of institution>> where <<name of person with conflict>> works, owns the test.  Both <<name of institution>> and <<name of person with conflict >> receive money on sales of the <<test/book>> when used in general clinical practice; however, neither <<name of person with conflict>> nor the <<name of institution>> will receive any money for the use of the <<test/book>> as part of this study. The financial interests have been reviewed and managed in accordance with the policies of the VALSCHCS.”
  • VHA Handbook 1200.05(2), 15(c)(2)

Is there a statement that the VA will provide treatment for research related injury?

 

The VA must provide necessary medical treatment to a research subject injured as a result of participation in a research study approved by the VA and conducted under the supervision of a VA employee.

If the study has a third party sponsor, the participant may have other options for treatment. The options should be explained in a separate section.  The investigator will need to provide a copy of the relevant contract to the VA research office so consistency can be verified.

  • Include the following statement verbatim: The VA has the authority to provide medical treatment to participants injured by participation in a VA study.  If you are injured as a result of being in this study, the VA will provide the necessary medical treatment in accordance with federal law. If you want to make a legal claim against the VA or anyone who works for the VA, special laws may apply. The Federal Tort Claims Act (28 U.S.C. 1346(b), 2671-2680) is a federal law that controls when and how a person can bring a claim against the U.S. Government. If you sign this document, you are not giving up your right to make a legal claim against the United States. 
  • VHA Handbook 1200.05(2), 15(c)(3)

When appropriate, is there a statement that informs VA subjects that insurance will not be charged for costs related to the research?

 

Include a statement that veteran-participants will not be required to pay for care received as a participant in a VA research project except as follows: Certain veterans are required to pay co-payments for medical care and services provided by the VA. Veterans receiving medical care and services from the VA that are not rendered as part of the VA-approved research study, must pay any applicable co-payment for such care and services.

  • “A veteran participant will not be required to pay for care and services (treatment) received as a subject in a VA research project. However, some veterans are required to pay co-payments for medical care and services provided by the VA. These co-payment requirements will continue to apply to medical care and services provided by the VA that are not part of this study.”
  • VHA Handbook 1200.05(2), 15(d)(7)

Is there a description of the use of photographs, video, and/or audio recordings to be taken for research purposes?

 

The informed consent for research must include information describing any photographs, video, and/or audio recordings to be taken or obtained for research purposes. Describe how the multimedia will be used for the research.  For more information about this topic, please see the Investigator Guidance Series: Multimedia Recordings.

State whether the multimedia images/recordings will be disclosed outside of the VA.  A HIPAA Authorization is necessary if the images/recordings will be disclosed outside the VA.

An informed consent to take a photograph, video, and/or audio recordings cannot be waived by the IRB.

  • “Interviews may be audio recorded. Recordings will help with accurately documenting your responses.  You have the option of refusing the audio recording.”
  • VHA Handbook 1200.05(2), 16(f)

If applicable, is the VA Authorization for Use & Release of Health Information prepared?

 

To protect patient privacy, “covered entities” (all health plans, health care “clearinghouses,” and health care providers) must obtain specific, written Authorization from a patient to use or disclose protected health information (PHI).

The VA Salt Lake City Health Care System uses VA Form 10-0493, Authorization for Use & Release of Individually Identifiable Health Information for VHA Research to document authorization. The authorization may not be embedded in the consent form. The form includes all the elements and required statements of a valid authorization.

The investigator should complete all blank fields and checkboxes on the VA Form 10-0493, specific to the study, prior to submission to the IRB.

  • See VA Form 10-0493.
  • VHA Handbook 1200.05(2), 23

 

Future Use of Private Information or Biospecimens

Prior to the implementation of the revised Common Rule (effective date January 19, 2019), the University of Utah policy required tissue banking language to be included in the informed consent document. The University of Utah has expanded this guidance for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens (collected for research studies other than the proposed research). The University of Utah tissue banking guidance has been updated and to include data repositories. The University of Utah IRB does not utilize the option for broad consent (54 CFR 46.116(d)).

For more information about tissue and specimen use, please see the Tissue/Specimen Use & Repositories page.  

If collection of identifiable private information or identifiable biospecimens is a sub-component to a larger study, the University of Utah will accept either a separate consent document or the following requirements may be included into the main consent document. If the following requirements are incorporated into a main consent document, there should be a separate heading that notes the tissue bank or data repository.

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Is there a description of what is collected, the purpose(s), and the type(s) of future research?

 

The purpose for collecting the identifiable private information or identifiable biospecimens should be explained. If biospecimens are collected, state the type of sample (e.g., blood, urine, tissue, etc.).

The level of specificity for the purpose and types of future research is determined case-by-case. Authority is given to the IRB to determine how specific a consent form should be, based upon the following regulatory requirements and guidelines.

  • Sample language for a locally-managed bank: “As part of this study, we would like to put some of your blood in a tissue bank so that other researchers can use it in the future.  Future research about <<insert disease or condition>> may be done on your blood and it may help us learn more about the disease.  Your blood will be kept by Dr. <<insert name>> who manages the tissue bank at the University of Utah.”
  • Sample language for a sponsor-managed bank:  “As part of this study, we would like to put some of your blood in a tissue bank so that other researchers can use it in the future.  We don’t know what kind of future research will be done, but we hope to learn more about diseases and how to treat them. Your blood will be kept by the study sponsor, <<insert sponsor name>>, who manages the tissue bank.”
  • 45 CFR 164.508(c)(1)(iv)
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Is the option to participate in banking biospecimens or the data repository thoroughly explained?

 

Some studies are designed exclusively for the purpose of banking biospecimens or creating a data repository.  If collecting identifiable private information or identifiable biospecimens for future research is the sole purpose of the study, this must be made clear to the participant.

Other studies are designed to include the collection of identifiable private information or identifiable biospecimens as a sub-study to a larger study. For these studies, it should be clear whether or not it is mandatory to participate in the biospecimens banking or the data repository if the participant wants to be in the full study. 

You may not condition participation in a treatment/interventional trial upon mandatory participation in a tissue bank or data repository.  Participation in the tissue bank or data repository must be optional for treatment/intervention trials. 

  •  Sample text with tissue banking options: You do not have to participate in the tissue bank to be in the main part of this study. No matter what you decide to do, your decision will not affect your medical care.  You can tell us your choice by initialing one of the choices below:

___ YES,

(initial)

my sample(s) may be saved for future <<specify a specific condition/disease>> research.

 

___ NO,

(initial)

my sample(s) must be destroyed at the end of this research project.

 

  • Sample text for mandatory tissue banking:  If you do not want your blood to be saved for future research, you should not participate in this study.  No matter what you decide to do, your decision will not affect your medical care.
  • 45 CFR 46.116(2)
  • 45 CFR 46.116(a)(8)
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Is there a description of whether personally identifiable information will be collected with the biospecimens?

 

State whether or not personally identifiable information will be collected with the sample.  Include the type of identifiers (name, date of birth, etc.) that will be collected. 

If identifiers are collected, state who will have access to the identifiable information (i.e. the Investigator, the sponsor, the other future investigators, etc.). 

In order to allow maximum flexibility for sharing samples and identifiers with future researchers, the IRB encourages you to state that samples and identifiers may be shared within the local institution, as well as the local affiliate institutions.  Local affiliate institutions include the University of Utah, VA SLCHCS, and Primary Children’s Medical Center. [N/A if the bank is managed exclusively by the sponsor on an external institution.]

If identifiers are collected, state whether or not participants can choose to have their samples de-identified (de-identified means no identifiable link back to the participant exists). 

  • Sample text for coded samples: "Your sample will be coded so that your name is not on the sample.  <<insert name>> and the University of Utah will keep your name in a separate place so that we can link your sample back to you later if we need to."
  • "Your sample may be shared with researchers at the University of Utah and at other institutions. Dr. <<insert name>> will not give your name to other researchers who want to use your sample, but will only give them information like your age and what disease you have."
  • Sample text for de-identified samples:  "Your sample will not have your name or other personal information linked to it.  No one will be able to tell that you gave us the sample.  Your sample may be shared with researchers at the University of Utah and at other institutions. The only information we will keep with the sample is information like your age and what disease you have."
  • Sample text with option to de-identify samples: "We would like to code your sample so that your name is not on it.  <<insert name>> and the University of Utah will keep your name in a separate place so that we can link your sample back to you later if we need to.  But if you do not want us to keep your name or any other identifying information with the sample, you can chose to have your sample remain anonymous.  You can tell us your choice by initialing one of the choices below:

 

___YES,

(initial)

my personal identifiers can be kept with my sample(s). All information will be kept secure and confidential.

 

___NO,

(initial)

my name and identifiers must be removed from my sample(s).  My sample(s) cannot be linked back to me.

 

Your sample may be shared with researchers at the University of Utah and at other institutions."

 Coming soon.

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Is there a description of the procedures that participants should follow if they want to withdraw samples or information?

 

Describe the procedures that participants should follow if they want to withdraw their biospecimens from the tissue bank or remove their information from a repository.

  • Sample text for coded samples: “You can have your blood sample removed from this tissue bank later.  You will need to contact <<insert name>> at <<insert contact information>>.”
  • Sample text for de-identified samples: “Because we will not keep your name or other identifying information when we store your blood, you will not be able to have the sample removed from the bank later.” 
  • Sample text with option to de-identify samples: “You can have your blood sample removed from this tissue bank later.  You will need to contact <<insert name>> at <<insert contact information>>.  If you decide to have your identifiers removed from your sample, you will not be able to withdraw your sample later because it cannot be linked back to you.”

 Coming soon.

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Is there a statement about whether the future use of the participant’s biospecimens may be used for commercial profit?

 

The participant should be informed about the potential for development of a commercial product. Use the example language below verbatim.

It should be noted that this statement addresses the future use of the participants biospecimens.

  •  “Tissue or blood samples obtained from you in this research may help in the development of a commercial product by <<specify who will conduct future research on the sample, e.g. the University of Utah, the study sponsor, etc.>> or its research partners.  There are no plans to provide financial compensation to you should this occur.”
  •  45 CFR 46.116(c)(7)
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Is there a description of whether future results or findings will be given to the participants?

 

State whether or not the future results or findings will be given back to the participant.  If results or findings will be disclosed, describe the process for this interaction.

  • Sample text for not disclosing future results: Because the results from future research will not directly affect your health care, we will not share the results from future studies with you or your doctors.
  • Sample text for not disclosing future result because of de-identification: Because your sample cannot be linked back to you, we will not share the results from future studies with you or your doctors.  
  •  45 CFR 46.116(c)(8)

 

 


Additional Resources

Consent Models

Click here to see examples of consent documents for research.

translation

Translated Documents

Click here for the translated Short Forms.

 

 

Last Updated: 5/14/19