Hebrew SeniorLifeResearch Consent Form Study Participant ID: __________

SAMPLE ADULT CONSENT FORM for Revised Common RuleThis document is a sample of a consent form to be used with adults. It includes recommended as well as required language under institutional policies, as well as federal regulations (OHRP, OCR, NIH and FDA). To use this form insert applicable information about the study into the sections below. Remove all of the text in red and highlighted in yellow before submission to the IRB. If you have formatting difficulties, please call the IRB office.

Study title:

Principal Investigator: Primary Affiliation:

Co-Investigators:

Version Date:

Concise Summary of Key InformationThe revised Common Rule requires that consent forms contain a concise presentation of key information. The intention of this section is to provide potential research participants with a better understanding of the project scope, including major risks and benefits, so they can make a more fully informed decision about whether to participate.

This section should include a summary of the purpose of the study, duration of participation, major requirements of the study and any potential benefits. This section should also contain any significant risks of participating in the study. The information presented in this section may be discussed in greater detail later in the consent form.

About this Consent FormPlease read this form carefully. This form provides important information about participating in a research study. As a research participant, you have the right to take your time in making decisions about participating in this research and you are encouraged to discuss your decision with your family and your doctor. If you have any questions about the research or any part of this form, please ask us. If you decide to take part in this research, you will be asked to sign this form, and a copy will be provided for you.

What you should know about a Research StudyParticipation in research is voluntary, which means that it is something for which you volunteer. It is your choice to participate in the study, or to decline participation. If you choose to participate now, you may change your mind and stop participating at a later date. Refusal to participate or withdrawal of participation will not result in any penalty or loss of benefits to which you are otherwise entitled.

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Study Funding and Disclosure of any Special Interests This study is being conducted by Insert Name of Investigator(s). The study is funded or sponsored by Insert Sponsor Name(s). Include any investigators with special interests or conflicts of interest related to the

research and list the interests/conflicts Include whether HSL has any special interests or conflicts of interests related to the

research and list the interests/conflicts

Purpose of the ResearchYou are being asked to participate in a research study that is being conducted to State Purpose of the Research. Include the purpose of the research The reason the person was selected to participate Expected total enrollment Duration of participation Include information about the study design (randomization, placebo, blinding) and the

chances of being assigned to any one group. If there are normal controls, describe why controls are needed. If a placebo is being used, explain how that will work in the research context.

If an investigational drug, biologic, device or procedure is being used, indicate if the product/procedure has FDA approval and that ‘investigational’ means that the product/procedure is still being tested.

Include a statement regarding whether clinically relevant research results, including individual research results, will be disclosed to participants, and if so, under what conditions.

Research ProceduresIn this research study, you will be asked to participate in the following procedures: List and describe each procedure (e.g. interview, medical history, physical exam,

blood draw, study intervention). If procedures will be conducted to confirm eligibility, list this information and these procedures first. Detail any interventions, and list amounts (of blood in terms of teaspoons or tablespoons, exposure to radiation in relation to normal daily exposure, etc.).

If you are conducting procedures that are standard of care, the consent must explain which standard of care procedures (1) would be part of usual medical care (would occur even if the subject did not participate in the study), (2) which are standard procedures that will take place during the research and (3) which are the procedures/interventions being tested as part of the study (the research procedures).

If the research involves multiple procedures and visits, please provide a table (see example below) that includes:o study visit numbero procedures to take place at each visit; o expected time commitment of each visit o location of the study visit(s) and who they will see at each visit (research

assistant, radiation technologist, etc.)

Visit Purpose Procedures Study Duration Location

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PersonnelVisit 1 Screening

visit Blood tests, MRI scan Study nurse 2 hours HRC to

BIDMCVisit 2, Day 0

Start study drug

Distribute medication Study doc 30 minutes

Home visit

Visit 3, Day 28

Routine Visit Lab tests, distribute medication

Study nurse 1 hour HRC

Visit 4, Day 56

End of Study Return unused drug and Quality-of-Life Survey

Study nurse 1 hour Home visit

Provide any information that participants will need to be aware of before/during/after study visits or procedures (e.g. medications, exercise, food consumption, etc.)

For research involving biospecimens, include whether the research may be used for commercial profit and whether the participant will or will not share in this commercial profit

Include information about the product (drugs or devices) being used in the research

If the Project involves an investigational drug or device, the following wording must be used: This study involves testing an investigational drug/device. This means the drug/device has not yet been approved by the Food and Drug Administration (FDA) and has not yet been proven safe or effective for the purpose we are studying. Information from this research will help determine whether the drug/device should be approved by the FDA in the future. If the drug or device has been approved, but for another use, you may use the following statement: [name of drug/device] is approved by the Food and Drug Administration (FDA) for [ ] purpose. In this study, the use of [drug or device name] is investigational. This means that drug/device has not yet been approved by the FDA for the purpose we are studying, the treatment of [ ].

If the study involves questionnaires or assessments: provide a brief description of the type of questions that will be asked.

If cell lines will be created, the following statement must be used: The blood or tissue collected in this research may be used to create a “cell line” that can be grown in the laboratory. A cell line can continue to grow and make more cells indefinitely. This allows researchers to have an unlimited supply of your cells in the future without asking for more samples from you. The researchers will use these cells to try to learn more about [disease/condition].

If iPS cells will be created, the following wording must be used: We may use the cells taken from your [specify source of cells, e.g. skin] to create a type of cell known as a pluripotent stem cell. Stem cells can be used to create other types of cells and tissue, including [specify type of cells, e.g. cardiac, muscle, etc.] cells. Your cells might be used to study genetic changes .The researchers will use your cells to try to learn more about [disease/condition].

If cells will be used in animal models include the following sentence, the following wording must be used: Your cells [will/may] be mixed with other human cells, mixed with animal cells, or grown in lab animals like mice. [Provide a brief explanation, in lay terms, as to why cells will be used in animal models for the purposes of this study].

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If whole exome or whole genome sequencing studies (i.e. sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen) will be done for this research, the following wording must be used: We (may/will) perform a whole genome or whole exome analysis on your sample. Some research involves just studying a few genes that are linked to a disease or condition. In whole genome or whole exome analysis, all or most of your genes are studied and used by researchers to find causes of [signify here whether the sequencing data will be limited to the disease under study and related disorders or "many diseases or conditions". Note if your research is subject to the NIH Genomic Data Sharing policy and submitted to dbGaP you must indicate “many diseases and conditions” and cannot limit uses].

If the samples/data will be sent to NIH (e.g. dbGaP) or other repositories, the following working must be used: Note this is required for any research subject to the Genomic Data Sharing policy and submitted to dbGaP. In order to allow researchers to share results, the National Institutes of Health (NIH) and other central repositories have developed special sample/data (information) “banks” that collect the results and analyze samples/data from research studies, including genetic studies. These central banks may also analyze and store samples and health information form research conducted by Hebrew SeniorLife. These central banks will store your genetic and health information and/or samples and give them to other qualified and approved researchers to do more studies. We do not think that there will be further risks to your privacy and confidentiality by sharing your health information, samples and/or genetic information with these banks. However, we cannot predict how genetic information will be used in the future. The samples and data will be sent with only your research code number attached. Your name or other directly identifiable information will not be given to these central banks. There are many safeguards in place to protect your privacy.

Return of Research ResultsState whether clinically relevant research results will be returned, and if so, under what conditions. If such results will not be returned, this needs to be specified. If clinically relevant results will be shared, the following wording must be used:

During this research we may learn information from the study results which could be important for your health or your treatment. This information will be made available to (insert you, your health care provider). The information we may share is (insert statement as to what may be shared and the conditions of how it will be shared).

If not reporting research results, the following wording must be used: During this research we may learn information from the study results which could be important for your health or your treatment; however, we will not share this information with you.

Risks and Discomforts of Participating in the ResearchList the risks and discomforts related to the research procedures, including: Include the risks for all study-related procedures and interventions

o Risks/discomforts that are expected (likely), possible (less likely), and unexpected/rare

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o Risks/discomforts that are physical, psychological/emotional, legal, social, economic, and/or related to privacy

o If the risks are unknown or unforeseeable, include a statement that the risks of the procedure or treatment are currently unknown

o List any special risks to female and male participants Describe any measures to minimize risks/discomforts If there is a risk to uncovering unreported elder abuse, the following statement must

be included: If, during your participation in this study, the researcher has reasonable cause to believe that previously unreported abuse is occurring, he/she must comply with state law by filing an elder abuse report with the Department of Social Services. Study material might be court ordered for use in a court hearing. The researcher will make every reasonable effort to protect the confidentiality of the information, though it is possible that a civil or criminal court might demand the release of the material obtained.

If there is a risk of discovering that a participant is suicidal, the following statement must be included: If, during the study, we have reason to believe that you/your family member are at risk for being suicidal or otherwise harming yourself, we are required to take the necessary actions. This may include notifying you, your family member, your therapist(s) if applicable, or other individuals. If this were to occur, we would not be able to assure confidentiality.

If the study is FDA-regulated, the following statement must include the following statement: All records associated with you/your family member’s participation in this study will be confidential. However, because the use of this drug/device is regulated by the Food and Drug Administration (FDA) and (INSERT NAME OF SPONSOR) agents of the FDA and (INSERT NAME OF SPONSOR), (INSERT NAME OF OTHER ORGANIZATIONS, CROS) may have access to these records during the course of their duties.

Consent forms must include the following statement: You will be informed of any significant new findings developed during the course of this research which may affect your willingness to continue participation.]

If multiple products/procedures include risk, consider using a risk chart such as the following:

Possible Side Effects

Common Happens to >21 adults out of every 100

Occasional Happens to 5-20 adults out of every 100

Rare Happens to <5 adults out of every 100

Drug 1 Stomach pain Nausea or vomiting Dizziness Drowsiness Headache

Back pain Blurred vision Constipation Diarrhea Dryness of the mouth Heartburn Increased sweating Trouble sleeping

Chest pain Hives or itching Joint pain Swelling of the legs Flu like symptoms Memory loss

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Drug 2 Stomach pain Nausea or vomiting Dizziness Drowsiness Headache

Back pain Blurred vision Constipation Diarrhea Dryness of the mouth Heartburn Increased sweating Trouble sleeping

Chest pain Joint pain Flu like symptoms Memory loss Acute liver failure

In Case of Injury while Participating in the ResearchIf the research involves more than minimal risk, consent forms must include the following paragraphs:We will offer you the care needed to treat any injury that directly results from taking part in this research study. If we cannot provide the care directly, we will arrange for the care to be provided to you at a nearby institution.  We (and/or the treating provider, as appropriate) reserve the right to bill your insurance company or other third parties, if appropriate, for the care you get for the injury. We will try to have these costs paid for, but you may be responsible for some of them. For example, if the care is billed to your insurer, you will be responsible for payment of any deductibles and co-payments required by your insurer.

[THE SPONSOR MAY REQUEST TO INCLUDE A STATEMENT ABOUT THE INJURY COVERAGE THE SPONSOR WILL OFFER.  WHEN THE SPONSOR REQUESTS TO INCLUDE SUCH A STATEMENT, THE STATEMENT MAY BE ENTERED HERE, AFTER THE INSTITUTION'S COMMITMENT TO PROVIDE CARE FOR THE INJURY.  FOR EXAMPLE, "In this study, [Sponsor] will pay for medical treatment for any injury that is not paid for by your health insurer if the injury is a direct result of your taking part in the study."] IF THERE IS NO SPONSOR INJURY STATEMENT YOU MAY DELETE THIS PARAGRAPH.

Injuries sometimes happen in research even when no one is at fault. There are no plans to pay you or give you other compensation for an injury beyond what is described above, should one occur. However, you are not giving up any of your legal rights by signing this form.

If you think you have been injured or have experienced a medical problem as a result of taking part in this research study, tell the person in charge of the study as soon as possible. The researcher's name and phone number are listed at the end of this consent form. Benefits to Participating in the ResearchDescribe any reasonably expected benefits to the participant(s). If there are no benefits to the participant directly, but there may be a benefit to others with a similar condition in the future as a result of this research, you may include a statement such as: You may not directly benefit from this study, but others may benefit from the knowledge gained in connection with your participation.

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Alternative Treatments or Procedures to those Conducted in the ResearchDisclose any appropriate alternative procedures or treatments that might be available to the participant (e.g. drug alternatives to an IND under study), or state: We know of no other similar treatment or service. If the study does not involve treatment, please state: There are no treatments in this study. If the only alternative to participating in this study is not to participate, this section may be left out of the consent document.

Confidentiality of Information Collected as Part of the ResearchDescribe the methods used for maintaining confidentiality of subject-related materials. Include the location of study materials, how the materials will be secured, whether materials will be stored with personal identifiers, or if these identifiers will be removed, for example: All personal information obtained in the study will be kept confidential, and this information will only be available to the research staff. The records identifying your name will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. The results of the study will only be published or presented as group data. No individual participants will be identified. Forms to collect data will be identified with a unique study number and kept locked in the study office.

Your records may be reviewed in order to meet federal or state regulations. Reviewers may include representatives from the Study Sponsor, the Food and Drug Administration, and the HSL Institutional Review Board, or others in order to meet regulatory requirements.

Note: If the consent form will be placed in the participant’s medical record/s (at HSL or any facility) this information must be included.

Certificate of ConfidentialityFor NIH Funded Research after October 1, 2017 and any other Research/Investigator that has obtained a Certificate of ConfidentialityThe National Institutes of Health (NIH) has issued a Certificate of Confidentiality to further protect your privacy.  With this Certificate, the investigators may not disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings, unless you have consented for this use. Research information protected by this Certificate cannot be disclosed to anyone else who is not connected with the research unless: there is a law that requires disclosure (such as to report child abuse or communicable diseases, but not for legal proceedings); you have consented to the disclosure, including for your medical treatment; or the research information is used for other scientific research, as allowed by federal regulations protecting research participants. 

Disclosure is required, however, for audits or program evaluations requested by the agency that is funding this project or for information that may be required by the Food and Drug Administration (FDA). Any research information that is placed in your medical record would not be covered under this Certificate.  You should understand that a Certificate of Confidentiality does not prevent you or a

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member of your family from voluntarily releasing information about yourself or your involvement in this research. If others obtain your written consent to receive research information, then the researchers may not use the Certificate to withhold that information.

Finally, you should understand that the investigator is not prevented from taking steps, including reporting to authorities, to prevent serious harm to yourself or others.

Future Use of Biological Specimens or DataPossible future use of collected identifiable samples/data/information, the following wording must be used:Identifiable samples and/or identifiable private information collected from you during this study may be used for future research studies or shared with other researchers for future research. The identifiable samples and/or identifiable private information may be used for future research of [signify here whether the data/sample will be limited to the disease under study and related disorders or "many diseases or conditions”]. (Note if your research is subject to the NIH Genomic Data Sharing policy and submitted to dbGaP you must indicate “many diseases and conditions” and cannot limit uses). If the research investigator distributes your samples and/or information to other researchers or institutions, your samples and/or information will be labeled with a research code without identifiers so that you cannot be identified. No additional consent will be requested for the future use of your samples or information.

If you have questions about storing samples or would like to request that samples be removed from storage, please let us know. It is not always possible to remove samples from storage or to retrieve samples from which identifiers have been removed and/or that have already been sent to other investigators.

No future use of collected identifiable samples/data/information, the following wording must be used:Samples and private information collected from you during this study will NOT be used for future research studies or shared with other researchers for future research, even if the information identifying you are removed from the sample and/or private information.

Compensation for Participating in the ResearchDescribe any type of compensation. If money is offered for participation, it should be pro-rated across study visits and not require completion of the entire study. If there is no compensation, you may either delete this section or state, for example ‘There will be no compensation for taking part in this study’.

Costs to Participating in the ResearchDescribe any additional costs to the subject (e.g. parking, co-payments, etc.) that may result from the Research. If there are no costs, you may either delete this section or state, for example, ‘There are no costs to you for participating in this study.’

Withdrawal from the Research List the consequences of a subject’s decision to withdraw from the research, for example:

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Your participation in this research is completely voluntary. If you chose not to participate or withdraw from the study, you will incur no penalty or loss of usual benefits. You may withdraw your consent and discontinue participation at any time without affecting your employment, job evaluations, health care or other services you may be receiving. If you choose to take part in the study, you have the right to stop at any time.

Include the circumstances, if any, in which the Investigator may terminate the subject’s participation in the research, for example: Your participation in this research project may be terminated if the procedure is determined to be inappropriate or potentially harmful for you.

Authorization for Use and Disclosure of Your Protected Health InformationHIPAA requires that each subject who participates in a research study sign an informed consent form as well as written authorization for the use and disclosure of their Protected Health Information. The following sections encompass the required authorization language. As part of this study, we will be collecting and sharing information about you with others. Please review this section carefully as it contains information about the federal privacy rules and the use of your information.

Protected Health Information (PHI)By signing this informed consent document, you are allowing the investigators and other authorized personnel to use and disclose health information about you. This may include information about you that already exists such as: Include all that apply, such as medical records, demographic information, laboratory results, etc. as well as any new information generated as part of this study through Include all that apply, such as questionnaires, tests, procedures that we may ask you to undergo. This is your Protected Health Information, or PHI.

People/Groups at HSL Who Will Use Your Protected Health InformationYour Protected Health Information, PHI, may be shared with the investigators listed on this consent form as well as the supporting research team (i.e. research assistants, statisticians, data managers, laboratory personnel, administrative assistants). Your PHI may also be shared with the Institutional Review Board of Hebrew SeniorLife as it is responsible for reviewing studies for the protection of the research subjects.

People/Groups Outside of HSL with Whom Your Protected Health Information Will Be SharedWe will take care to maintain confidentiality and privacy about you and your Protected Health Information, PHI. We may share your PHI with the following groups so that they may carry out their duties related to this study:

The sponsor of this study name Sponsor here and their clinical research organizations Other researchers and centers that are part of this study name institutions here – if none,

remove this bullet Other hospitals and medical centers taking part in this study name Institutions here - if

none, remove this bullet and research collaborators at those institutions Laboratories not affiliated with HSL name labs here - if none remove this bullet

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Statisticians and other data monitors not affiliated with HSL name here – if none, remove this bullet

People or groups that are hired to provide services related to this research name such people/groups here – if none, remove this bullet

Your health insurance company, for portions of the research and related care that are considered billable.

Federal and state agencies that oversee or review research information, such as the Food and Drug Administration, the Department of Health and Human Services, the National Institutes of Health, and public health and safety authorities include any other agency that may have regulatory oversight for your study

Data and Safety Monitoring Board(s) that oversee this study if there are no DSMBs, remove this bullet

Those who receive your PHI may make further disclosures to others. If they do, your information may no longer be covered by the federal privacy regulations.

Why We Are Using and Sharing Your Protected Health InformationThe main reason for using and sharing your Protected Health Information is to conduct and oversee the research as described in this Informed Consent Document.

No Expiration Date - Right to Withdraw AuthorizationYour authorization for the use and disclosure of your Protected Health Information, PHI, in this Study shall never expire. However, you may withdraw your authorization for the use and disclosure of your PHI at any time by notifying the Principal Investigator in writing. If you would like to withdraw your authorization, please send a letter notifying the Principal Investigator to name of Principal Investigator at 1200 Centre Street, Boston, MA 02131 or other address, if applicable. Please be aware that the investigators in this study will not be required to destroy or retrieve any of your PHI that has already been used or disclosed before the Principal Investigator receives your letter.

Right to Access and Copy Your PHIIf you wish to review or copy your Protected Health Information, PHI, as it is made part of your medical record, you may do so after the completion or termination of the study by sending a letter to the Principal Investigator. You may not be allowed to inspect or copy your PHI until this study is completed or terminated.

Notice of Privacy PracticesIn addition to signing this document, you may also be asked to sign an HSL Acknowledgement Received Notice of Privacy Practices form to acknowledge that you have received the HSL Notice of Privacy Practices.

ClinicalTrials.GovFor studies that qualify as “applicable clinical trials” [studies of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the United States, involves a drug, biologic, or device that is manufactured in the United States (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE)], the following statement must be included, word

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for word, as notification that clinical trial information has been/will be submitted for inclusion in the clinical trial registry databank: A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Important Contact Information For questions about the research, or your participation in the research, please use the below information.

You may call… Contact Information

For questions about…

Principal Investigator:

Name Provide Phone Number

General questions about the research

Research related injuries or emergencies

Any research related concerns or complaints

Research Contact

Name Provide Phone Number

General questions about the study Research-related injuries or

emergencies Any research-related concerns or

complaintsInstitutional Review Board

Main Office

Dr. Madhuri Reddy, Chair

617-971-5415

617-678-7592

Rights of a research participant Use of protected health

information Compensation in event of

research-related injury Any research-related concerns or

complaints

Signature SectionThe consent form must be signed and dated by the participant or a legally authorized representative (LAR) at the time of consent. The participant/LAR must be given adequate opportunity to read or have the form read to them before signing. A copy shall be given to the person who signs the form. If the participant/LAR is unable to read, the consent may be read in the presence of a witness who must co-sign the consent. The FDA suggests that patients with dementia be informed about a clinical trial to the extent compatible with their understanding, and if capable, sign their assent to participate.

Documentation of Informed Consent and Authorization:

I have read this consent form and was given enough time to consider the decision to participate in this research.

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This research has been satisfactorily explained to me, including possible risks and benefits.

All my questions were satisfactorily answered. I understand that participation in this research is voluntary and that I can withdraw at

any time. I am signing this consent form prior to participation in any research activities. I give permission for participation in this research and for the use of associated

protected health information as described above (HIPAA).

Research Participant

__________________ _______________________________________________Date (MM/DD/YEAR) Signature of Research Participant

If the participant(s) does not have capacity to provide informed consent, the following sections for Legally Authorized Representative/Guardian and Adult Assent must be completed. If only competent adults will be consenting to the research, you may remove the following LAR and Assent sections.

Legally Authorized Representative/Guardian:I give permission for the person I am authorized to represent to participate in this research study and for the use of associated protected health information as described above (HIPAA).

___________________ ________________________________________________Date (MM/DD/YEAR) Legal Guardian Signature

________________________________________________Legal Guardian Name

Relationship to Subject *(This order must be followed. If there is a court appointed guardian, this is who needs to provide consent. If not, a health care proxy, followed by durable power of attorney and lastly, family members)

Court-Appointed Guardian Health Care Proxy (Attach Proxy and ensure there is express authority to make health care decisions inclusive of research.)

Durable Power of Attorney (POA) (Durable POA may be limited to specific areas. Attach Durable POA and ensure it covers research.)

Family Member/Next of Kin, (in order of preference: spouses, parents and adult children). Specify relationship: ___________________________________________

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Adult Assent:

___________________ ________________________________________________Date (MM/DD/YEAR) Signature of Participant

Check if assent is not obtained and specify the reason here: _____________________

Investigator or Associate’s Statement & Signature:

I have fully explained the research described above, including the possible risks and benefits, to all involved parties (participant /legal guardian as applicable).

I have answered and will answer all questions to the best of my ability. I will inform all involved parties of any changes (if applicable) to the research

procedures or the risks and benefits during or after the course of the research. I have provided a copy of the consent form signed by the participant /guardian and a

copy of the hospital’s privacy notification (if requested).

__________________ _______________________________________________Date (MM/DD/YEAR) Signature of Investigator or Associate

Witness Statement & Signature:

Required ONLY IF (check which one applies):

Consent document needs to be read to subject or legal representative, or Communication impairments limit the subject’s ability to clearly express consent, or Other reason: please specify: ___________________________________________

I confirm that the information in this consent form was accurately explained to, and understood by the subject and/or legally authorized representative as required, and that informed consent was given freely.__________________ ________________________________________________Date (MM/DD/YEAR) Signature of Witness

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