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)

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of any adverse effects on the participant’s health or welfare, or follow-up that may be requested if the participant is withdrawn from the study.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list reason(s) why the participant may be withdrawn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)

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)

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.

Depending on the amount of compensation and the method used to make the payment, tax information may need to be collected from participants and shared with Accounts Payable. Please review the guidance on the Accounts Payable website or contact the Research Accounting Department (801-581-6976) to determine whether your participants will have to complete a Federal W-9 Form to be compensated for their participation.

• "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."
• If collecting tax information for Accounts Payable: “Since you will be paid for participating in this study, it is necessary for us to collect your Social Security Number. You will provide this information for a Federal W-9 Form that is filed with our Accounts Payable department.  The amount you receive for taking part in this study will be turned into the Internal Revenue Service (IRS) as taxable income.  You can choose not to provide us with your Social Security Number for this form and still participate in this study; however, we will not be able to pay you as outlined in this consent form.”

• ICH GCP 4.8.10(k)

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.

For research subject to FDA regulations, the data collected on participants to the point of withdrawal remains a part of the study database and may not be removed. Generally, this is stated along with the authorization to use protected health information. The consent document should not give participants the option of having that data removed. For additional guidance regarding data retention when participants withdraw from FDA-regulated clinical trials, click here.  

• "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."

• For FDA-Clinical Trials: “If you withdraw from this study, the information collected about you up until the point of withdrawal must be retained to maintain the integrity of the research.” Note: This statement is often included with the authorization to use protected health information language. It does not need to be repeated if it is already included elsewhere in the consent document.  

• 45 CFR 46.116(c)(4)

• 21 CFR 50.25(b)(4)

• ICH GCP 4.8.10(m)

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)

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)

Final Common Rule (2018 Common Rule) requirement

For research involving biospecimens, a statement should be included clarifying that the biospecimens may be used for commercial profit, even if identifiers are removed. The statement should clearly indicate 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 collecting biospecimens for future use (i.e., secondary research), the University of Utah similarly requests that a statement be made regarding commercial profit. If a single statement is used to address both the use in the current resarch project and the future/secondary research use, it must clearly acknowledge both aspects. You may find more details on the Future Use of Private Information or Biospecimens checklist.

If research participants will receive any payments related to products with commercial or product development, adjust the sample language as needed.

• “The use of your data and biospecimens may lead to new tests, drugs, devices, or other products or services with commercial value. These products or services could be patented and licensed. There are no plans to provide any payment to you should this occur.”

• 45 CFR 46.115(c)(7)

Final Common Rule (2018 Common Rule) requirement

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)

Final Common Rule (2018 Common Rule) requirement

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)

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. Please see VA Form 10-0493.  Alternatively, the authorization may be combined with the consent document in certain circumstances. See the “Additional Elements Required by the VA” tab of this checklist for required language.

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.

• ICH GCP 4.8.10(n)
• 45 CFR 45.164 (HIPAA Privacy Rule)
• Health Information Privacy in Research
•  Guidance on HIPAA and Individual Authorization of Uses and Disclosures of Protected Health Information for Research

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)

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)

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)

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)

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)

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)

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)

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 https://health.utah.gov/epi/reporting/ 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). 

Under University of Utah policy, most University employees (including researchers) are required to report situations involving sexual misconduct and discrimination to the Office of Equal Opportunity and Affirmative Action (OEO/AA) https://oeo.utah.edu/. This includes research activities that may result in a participant who is a University of Utah student disclosing alleged sexual violence. The PI/study team member to whom incidents of this alleged sexual violence is disclosed is considered a “mandatory reporter” and has an obligation to report these incidents to the University of Utah Office of Equal Opportunity, Affirmative Action, and Title IX (OEO), https://oeo.utah.edu/.

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 or authorized by law to report issues, such as serious threats to public health or safety.”
  
  
• It is important to note that should you disclose certain conduct (e.g., child abuse) during this research, the study team would be required to report it to law enforcement officials consistent with requirements under state and/or federal law.
  

 

• 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.

 

• Example for mandatory reporting of situations involving sexual misconduct (Only include this language if research participants are adult students (18+ years of age) at the University of Utah and the research is such that participants may divulge experiences with sexual violence):
  
  

  During this research, you may be asked about your experiences with sexual violence. University of Utah policy requires its employees to report situations involving sexual misconduct and discrimination to its Office of Equal Opportunity and Affirmative Action (OEO/AA). OEO/AA can provide support for your safety and ensure you have information about your options.
  
  It is important to note that should you disclose certain conduct (e.g., child abuse) during this research, the study team would be required to report it to law enforcement officials consistent with requirements under state and/or federal law.

• https://www2.ed.gov/about/offices/list/ocr/docs/tix_dis.html

• https://sexualassault.utah.edu/reporting/mandatory-reporters/

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.

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.

The conflict of interest committee may require a disclosure of conflicts of interest to all potential research participants in the informed consent document. The informed consent document should 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 University of Utah Conflict of Interest Committee.”
• “A company called <<insert name of sponsor>>, who is the sponsor of the study, is paying for this study. The study doctor and members of the study team receive compensation from <<sponsor name>> 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 by the University of Utah Conflict of Interest Committee.”

• Policy 1-006: Individual Financial Conflict of Interest Policy

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)

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)

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)

HIPAA authorization for VA studies may be included within the consent document or as a separate document. If the study includes optional tissue/data banking or impaired decision making individuals (using LAR) the consent document should not include any mention of authorization and the VA Form 10-4093, Authorization for Use & Release of Individually Identifiable Health Information for VHA Research should be submitted.

If the authorization is intended to be combined with consent, include the following language verbatim (modify as indicated):

Health Information Portability and Accountability Act (HIPAA)

There are rules to protect your private health information.  Federal and state laws and the federal medical law, known as the HIPAA Privacy Rule, also protect your privacy.  By signing this form, you provide your permission called your ‘authorization,’ for the use and disclosure of information protected by the HIPAA Privacy Rule.

The research team working on the study will collect information about you.  This includes things learned from the procedures described in this consent form.  They may also collect other information including your name, address, date of birth, and information from your medical records such as <<list information to be collected such as medical history, allergies, lab results, HIV status, drug, alcohol or STD treatment, genetic test results or mental health treatment>>.

The research team may also need to disclose your health information and the information it collects to others as part of the study progress.  Others may include the <<add or remove as appropriate: VA Cooperative Studies Program (CSPCC), CSP Clinical Research Pharmacy Coordinating Center (CSPCRPCC), CSP Site Monitoring, Auditing and Review Team (SMART), CSPCC’s Human Research Committee (HRC), add entities such as sponsor, contractors, affiliates as appropriate>>  Institutional Review Board, Food and Drug Administration Office (FDA), Office of Human Research Protections (OHRP), the VA Office of Research Oversight (ORO), and the Government Accountability (GAO). 

 

Your health information disclosed pursuant to this authorization may no longer be protected by Federal laws or regulations and may be subject to re-disclosure by the recipient.

 

You can revoke this authorization, in writing, at any time.  To revoke your authorization, you must write to the Release of Information Office at this facility or you can ask a member of the research team to give you a form to revoke the authorization.  Your request will be valid when the Release of Information Office receives it.  If you revoke this authorization, you will not be able to continue to participate in the study.  This will not affect your rights as a VHA patient to treatment or benefit outside of the study.

If you revoke this authorization, <<insert name of Site Investigator>> and his or her research team can continue to use information about you that was collected before receipt of the revocation. The research team will not collect information about you after you revoke the authorization.

Treatment, payment or enrollment/eligibility for benefits cannot be conditioned on you signing this authorization.  This authorization will expire at the end of the research study unless revoked prior to that time.

• VHA Handbook 1200.05(2), 23

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.

• We would like to keep [insert specific biospecimen, e.g., blood, urine, tissue, etc. and/or description of information].

  Option for specific disease/condition:Your [sample and/or information] may be used in future research about [insert specific disease or condition] to help us learn more.

  Option for no specific disease/condition: 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.

  Option for University of Utah-managed biospecimen bank or data repository: Your [sample and/or information] will be kept by Dr. [insert name] who manages the [biospecimen bank or data repository] at the University of Utah.

  Option for a sponsor-managed biospecimen bank or data repository: Your [sample and/or information] will be kept by the study sponsor, [insert sponsor name], who manages the [biospecimen bank or data repository]. 

• 45 CFR 164.508(c)(1)(iv)

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. 

• Option for mandatory biospecimen banking or data repository (e.g., sole purpose of research study is to save samples or information for future research): If you do not want your [samples and/or information] 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.
• Option when choice given to bank biospecimens or information (note: participation in a biospecimen bank or data repository must be optional for treatment/intervention trials):You do not have to participate in the [biospecimen bank or data repository] 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) or information] may be saved for future [specify a specific condition/disease] research.
___ NO, (initial)	my [sample(s) or information] must be destroyed at the end of this research project.

 

• 45 CFR 46.116(2)
• 45 CFR 46.116(a)(8)

State whether 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 participants can choose to have their samples de-identified (de-identified means no identifiable link back to the participant exists). 

• Option 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 without additional informed consent from you or your legally authorized representative. The only information we will keep with the sample is information like your age and what disease you have. 

• Option for de-identified data: The information we collect from you will not have your name or other personal information linked to it.  Your de-identified information may be shared with researchers at the University of Utah and at other institutions without additional informed consent from you or your legally authorized representative. The only information we will keep is information like your age and what disease you have.

• Option for coded data: Your information will be coded so that your name is not kept with the rest of the collected data.  Dr. [insert name] and the University of Utah will keep your name in a separate place so that we can link back to the rest of your data later we need to.  Your information may be shared with researchers at the University of Utah and at other institutions without additional informed consent from you or your legally authorized representative. Dr. <<insert name>> will not give your name to other researchers who want to use your information and will only give them the data without identifiers. 

• Option for coded samples: Your sample will be coded so that your name is not on the sample.  Dr. [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 without additional informed consent from you or your legally authorized representative. Dr. [insert name] will not give your name to other researchers who want to use your sample and will only give them information like your age and what disease you have. 

• Option when choice offered regarding removal of identifiers from samples: We would like to code your sample so that your name is not on it.  Dr. [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 choose 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 without additional informed consent from you or your legally authorized representative.

• Option when choice given to de-identify data: We would like to code your information so that your name is not on it.  Dr. [insert name] and the University of Utah will keep your name in a separate place so that we can link your data 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 your data, you can choose to have your data remain anonymous.  Your data may be shared with researchers at the University of Utah and at other institutions without additional informed consent from you or your legally authorized representative. You can tell us your choice by initialing one of the choices below:

___ YES, (initial)	my personal identifiers can be kept with my data. All information will be kept secure and confidential.
___ NO, (initial)	my name and identifiers must be removed from my data.  My data cannot be linked back to me.

 Coming soon.

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.

• Option for de-identified samples: Because we will not keep your name or other identifying information when we store your sample, you will not be able to have the sample removed from the bank later.
  
  
• Option for de-identified data: Because we will not keep your name or other identifying information when we store your data, you will not be able to have your information removed from the data repository later.
  
  
• Option for coded samples: You can have your sample removed from this biospecimen bank later.  You will need to contact [insert name] at [insert contact information].
  
  
• Option for coded data: You can have your information removed from this data repository later.  You will need to contact [insert name] at [insert contact information].
  
  
• Option when choice offered regarding removal of identifiers from samples: You can have your sample removed from this biospecimen 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.
  
  
• Option when choice given to de-identify data: You can have your information removed from this data repository later.  You will need to contact [insert name] at [insert contact information].  If you decide to have your identifiers removed from your data, you will not be able to withdraw your data later because it cannot be linked back to you.

 Coming soon.

The participant should be informed about the potential for development of a commercial product.

This statement should address any biospecimens collected for future use (i.e., secondary use). It should be noted that if the study will be collecting biospecimens for use in a main study (i.e., the study uses biospecimens for both the main study and also collects biospecimens for future/secondary research), a statement must be made regarding commercial profit for the main study if subject to the Final Common Rule (2018 Common Rule). If a single statement is used to address both the use in the current research project and the future/secondary research use, it must clearly acknowledge both aspects.

If research participants will receive any payments related to products with commercial or product development, adjust the sample language as needed. 

• “The use of your data and biospecimens may lead to new tests, drugs, devices, or other products or services with commercial value. These products or services could be patented and licensed. There are no plans to provide any payment to you should this occur.”

•  45 CFR 46.116(c)(7)

State whether 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.

• Option 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.

• Option for not disclosing future result because of de-identification: Because your [information/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)