sample - usuhs.edu web viewin the event of an emergency, ... necessary medical care does not include...

Subject/LAR Initials ____________

INFORMED CONSENT DOCUMENT and AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION FOR VOLUNTARY PARTICIPATION IN A RESEARCH STUDY

{IDCRP-xxx: Enter protocol title}

PRINCIPAL INVESTIGATORS (Study Doctor):

Brian Agan, MD Uniformed Services University (USUHS)Christina Schofield, MD Madigan Army Medical Center (MAMC)Jason Maguire, CAPT, USN, MC Naval Medical Center Portsmouth (NMCP)Mary Bavaro, CDR, USN, MC Naval Medical Center San Diego (NMCSD)Timothy Whitman, LCDR, USN, MC National Navy Medical Center (NNMC)Jason Okulicz, Maj, USAF, MC San Antonio Military Health System (SAMHS)Tomas Ferguson, LTC, MC, USA Tripler Army Medical Center (TAMC)Timothy Whitman, CDR, USN, MC Walter Reed National Military Medical Center

(WRNMMC)

1. DESCRIPTION/PURPOSE OF RESEARCH :

You are being asked to consider participation in this research study. Taking part in this research is entirely voluntary. If you choose not to participate in this research study, your decision will not affect your eligibility for care or any other benefits to which you are entitled. Please read the information below, and ask questions about anything you do not understand, before deciding whether to take part in the study.

The purpose of this study is to ___________________. (Provide any background information and the need for conducting this study, e.g., explanation of disease/condition under investigation. Some other examples are: This research is being done because currently there is no effective treatment for…. OR The goal of this study is to see if there is a difference between….)

AND ( for single site studies )

This study will enroll approximately ___________subjects over a period of ______ (number of days/months/years).

OR ( for multicenter studies )

This study is called a multi-site study because participants from several hospitals will be in the study. There will up to ____ at NMCP, ____ at NMCSD, ____ at MAMC, ______at SAMHS, _____at WRNNMC, _____at Ft. Benning, and _____ at TAMC taking part in this study. A total of _______ people will be enrolled in the study from all of the hospitals involved over a period of ______ (number of days/months/years).

AND

Your participation in the research study will last for ______ (number of days/months/years).

Version 0.0 dated 1 January 2013 of 16


{IDCRP-xxx: enter protocol title}

AND (for studies with LAR )

If you are unable to actively participate in this informed consent process, your legally authorized representative (LAR) will do that on your behalf. If your LAR consents on your behalf and you later become capable of consent, you will be approached to give your informed consent.

AND (for outpatient studies )

During your participation in this study, you will be asked to make approximately ______ outpatient visits. It may be necessary for you to return every ________ (number of days/months/years). Each visit will last approximately ______ (minutes, hours).

OR ( for inpatient or other types of studies )

During your participation in this study, you will __________________ (explain the expected duration of the subject’s participation in the study, e.g., how much time and number of visits).

AND

You have been selected to participate in this study because you meet the following criteria: (list inclusion criteria).

Add if appropriate You will not be able to participate if you have: (list exclusion criteria).

AND Add if appropriate: (Identification of any experimental procedure, device, or pharmaceutical).

This study involves the use of an investigational (pick one) drug/device called _____________ (name). This means that the (pick one) drug/device has NOT yet been approved by the Food & Drug Administration (FDA) for (pick one: treating/preventing/diagnosis) _____________ (disease or condition). However, the FDA has approved it for use in research studies to find out its the safety and effectiveness of the (pick one) drug/device.

AND ( for Phase I studies ) NOTE: This language may be modified as needed by the Investigator if certain statements do not apply or are not accurate for the Drug being studied.

This drug is in the first stage of testing in people called a Phase I (one) study. This means that the drug has been tested in the laboratory and in animals. It has not been adequately tested in people. You are one of the first to participate in this study. We do not know how the drug works in people. We do not know the best dose or best way of giving this drug (for example, by mouth or into a vein) to people. We do not know if the drug is active against your disease. We do not know the side effects of this drug in people. We do not know how long it takes the body to break down and get rid of the active drug. The goal of a Phase I study is to begin collecting this information about the drug by testing the drug in people. Given the nature of a Phase I study, you are unlikely to benefit from treatment with this drug.

OR ( for Phase II studies ) NOTE: This language may be modified as needed by the Investigator if certain statements do not apply to the Drug being studied

Version 0.0 dated 26 March 2013 of 16



This drug is in the second stage of testing in people called a Phase II (two) study. This means that the drug has been tested in the laboratory, on animals, and in people. Some information about the dose, the way of giving the drug (for example, by mouth or into a vein) and many short-term side effects is known for people. We are looking to see if this drug is effective against your disease. We are also trying to learn more about the side effects of this drug and how the drug is broken down and removed by the body in patients with your disease.

OR ( for Phase III studies ) NOTE: This language may be modified as needed by the Investigator if certain statements do not apply to the Drug being studied

This drug is in the final stage of testing in people called a Phase III (three) study. This means that the drug has been tested in the laboratory, on animals, and in many people. Much information about the dose, the way of giving the drug (for example, by mouth or into a vein) and many side effects is known for people. In a Phase III study, the drug is given to a large number of patients to find out its safety, effectiveness, and the best dose. The treatment being used in this research study will be compared with the current standard treatment for your disease.

2. PROCEDURES:

As a participant, you will undergo the following procedures: (Describe in reasonable detail all procedures the subject will undergo. Describe any screening procedures used to qualify or select subjects for enrollment. List/table research procedures versus standard of care procedures).

AND (If applicable: this paragraph is for studies using randomization )

As a participant, you will be randomly assigned to one of ______ (number) treatment plans. Neither you nor the research staff will be able to choose the treatment plan to which you are assigned. Randomization is a process like flipping a coin and means you will have a chance of being assigned to (pick one) any/either of the plans. (Describe each of the treatment plans).

(If applicable: this paragraph is for studies using PLACEBO )

You will have a one in ____ chance of being in the placebo group. A placebo is an inactive, harmless substance, like a sugar pill, that looks like the other study medications.

AND (If applicable, pick either single or double blind )

Single Blind : This study is a single blind study, which means that you will not know whether you are receiving the study medication or a placebo.

OR

Double Blind:This study is a double blind study, which means that neither you nor your study doctor will know whether you are receiving the study medication or a placebo. In the event of an emergency, there is a way to determine which you are receiving.




AND(for studies with blood draws)

For this study, there will be about _____ blood draws. (Describe a breakdown of the blood draws here). The total amount of blood drawn will be about _______ mL (___oz or ____Tbsp) while you are participating in this study. For comparison, the standard blood donation is about 16 ounces (2 cups).

AND

If you need a procedure requiring additional informed consent, a separate consent form will be given to you before that procedure.

3. RISKS OR DISCOMFORTS:

The risks or discomforts which are possibly related to your participation in this study are as follows: (Describe in lay language the risks that are reasonably foreseen related to subject's participation in the project, including estimates of expected frequency and severity of risks (e.g., 10% nausea, rare vomiting, etc. List only risks related to participation in the research study, not on risks or discomforts attendant to a subject's underlying medical condition or to standard health care received coincident with participation in the research project. ) Add as appropriate: (for venipuncture ) You may experience discomfort, bleeding, bruising, soreness, swelling, light-headedness and in rare cases, fainting or infection at the site where blood is drawn. (Add if applicable: Excessive blood loss is also a risk with serial blood draws. However, when drawing blood from existing catheters or directly from your vein, the research staff will use a sterile technique to minimize the blood draw related risks.)

If there are minimal or no risks anticipated, insert Minimal or no risks or discomforts are anticipated related to your participation in this study. This means that risks or discomforts, beyond those risks associated with any underlying medical condition which you might have or associated with standard health care which you might be receiving during the course of your participation in this study, are felt to be no greater than the "normal" risks of day-to-day life.

If there are no risks, state There are no known risks associated with this study.

AND

Another risk of your participation in this study is that someone may accidentally release information from your medical records without your permission. However, the investigators make every effort to protect your confidentiality through secure data management and de-identification of data as soon as possible.

AND/OR

Since this study involves standard of care procedures, pregnancy will not affect your participation in this study.

OR

This study may involve risks, if applicable, to your unborn baby if you are or become pregnant. You should promptly advise your doctor and the study researcher identified below if you are now pregnant, if




you contemplate becoming pregnant, or if you become pregnant during your participation in the study. Further, you should promptly advise your doctor and the study researcher if you are now breastfeeding or contemplate breastfeeding your child during the course of this study.

OR

As a FEMALE OF CHILD BEARING POTENTIAL wishing to volunteer for this project, you must understand that this research study and/or___________________ (list the drug/procedure) might be harmful to (1) an unborn child if you are pregnant; or (2) an infant if you are breast-feeding. Therefore, you may not be pregnant and will take a pregnancy test before you participate in this study. You must also agree to take precautions to prevent pregnancy during the course of this study due to the possible severe harm the drug/procedure may cause your unborn child. The only completely reliable methods of birth control are total abstinence or surgical removal of the uterus. Other methods, such as the use of condoms, a diaphragm or cervical cap, birth control pills, IUD, or sperm killing products are not totally effective in preventing pregnancy. Also, you may not breast-feed and participate in this study.

If you become pregnant or feel you might be pregnant, contact your provider and the study investigator listed in the voluntary participation section.

AND/OR(If applicable: use this paragraph if there is a risk to the fetus through male subjects)

As a MALE who wishes to volunteer for this project, you must understand that this drug/procedure might be harmful to an unborn child if your partner(s) should become pregnant. Therefore, you must agree to ensure that precautions are taken to prevent pregnancy from occurring during the course of this study due to the possible severe harm the drug/procedure may cause the unborn child.

AND

If applicable: (If animal and/or human data is available on mutagenicity and teratogenicity, it should be presented so those subjects will understand the danger of taking the drugs).

The medication under investigation in this study (pick one) has/has not shown to cause birth defects. (Add as appropriate, delete if not needed). The following birth defects have been observed:___________________

OR

If there are no data on mutagenicity and teratogenicity, use the following statement.

Studies evaluating the capability of the medication under investigation to produce birth defects in an unborn child have not been completed/conducted.

AND

There may also be unforeseen risks associated with this study.

4. BENEFITS:




The possible benefit of your participation in this study is ____________________. (List if there is/are defined direct benefit(s). Take care not to misrepresent the value ascribed to an experimental therapy of unknown efficacy. If a placebo controlled trial, ensure that the possibility of receiving no direct benefit is included in this section.)

(If your study involves minors or use of legal authorized representative consent, 10 USC 980 requires that the intent to benefit each subject be addressed.)

OR

Taking part in this study may or may not make your health better. While study investigators hope (drugs, interventions, devices) will be more useful against _______________ compared to the standard treatment, there is no proof yet. We do hope that information gained from this study will help us learn more about (procedures, drugs, interventions, devices) as a treatment for ________________.

OR

There is no guarantee you will receive any benefit from this study other than knowing that the information may help future patients.

5. PAYMENT (COMPENSATION):

(Please note that active duty may be reimbursed for participating in the study only for having blood drawn,but may not participate during duty hours AND must have supervisor’s approval.)

You will not receive any payment (compensation) for being in this study.

OR

If you are eligible for care at military hospitals, but are not an active duty member of the military, you will receive payment (compensation) of $__________ upon ______. (Explain the payment plan for this study, e.g enrollment, completion of the study, at each visit, etc.”)

AND/OR

If you are an active duty member of the military and you are taking part in this study outside your normal duty hours, you will receive $50.00 per blood draw for being in this study not to exceed $250.00. You will receive your payment (compensation) upon ______. (Explain the payment plan for this study, e.g enrollment, completion of the study, at each visit, etc.”)

AND (If applicable)

The sponsor of this study has agreed to reimburse _____________ (enter name) for some of the costs related to your participation in this study.

AND (If applicable)




Your participation in this study will provide financial benefit to the corporate sponsor and to the research program of this/these institution(s).

AND (If applicable)

There is no charge to you for taking part in this study.

OR

The additional cost to you for taking part in this study is $____________ for _________.

6. ALTERNATIVES TO PARTICIPATION:

Alternatives may be available to you should you decide not to participate in this research study (list all alternative treatments - these may include other treatments, e.g. chemotherapy, radiation therapy, or hormonal therapy).

OR

You may receive standard medical treatment that may or may not include any one of the procedure(s) or treatment(s) that are part of the planned research study.

OR

This research study is not designed to treat any medical condition that you may have. Therefore, there are no alternate procedure(s) or treatment(s) that would be advantageous to you.

OR

Supportive care to reduce symptoms rather than treat underlying causes may be the only alternative treatment available for you.

AND

Choosing not to participate in this study is your alternative to volunteering for the study.

AND (If applicable)

There may be other research studies involving experimental treatments that could be helpful to your condition.

AND ( If applicable for drugs with FDA approved indications )

The medication involved in this study may also be available through your family doctor without the need for you to volunteer to participate in this study.

7. BLOOD & TISSUE SAMPLES:




If biologic specimens (blood, fluid or tissue samples) will not be taken, add the following : No blood or tissue samples will be taken as part of this study.

If biologic specimens (blood, fluid or tissue samples) will be taken, add the following : You are in a study where ______ (list as applicable: blood, urine, cells, tissue, organs, hair, nail clippings or other specimens) will be collected as part of the research study.

If specimens will be maintained on site or sent to a contract laboratory, include the following paragraph : All specimens kept at ___________ will be handled and disposed of in accordance with federal regulations. Outside laboratories will not have permission to use the samples for any additional research. (Add if Applicable: The specimens will be coded with a unique identifier (i.e. Personal Identification Number (PIN)). The research coordinator and database manager will have access to the key that links your personally identifiable information with this code.)

AND/OR (If applicable)

Samples will be destroyed after completion of the study.

AND/OR (If applicable)

After all of the required tests are finished, if the investigator decides to save the samples for possible use in future research, you will be asked if you want to sign a separate consent form for your leftover samples to be used or available for another study. This future research may be in the same area as your study, or it may be for a different kind of study.

If specimens will be stored for future use (tissue bank) or in possible substudies, use the following language for Use of Biologic Specimens - delete if not needed )

Use of Biologic Specimens: The investigators are asking for your permission to store your biological specimens for future use in research studies. The specifics of these research studies are unknown at this time, but these studies will frequently be in the area of _______________ (insert disease). Your samples will be stored with information such as _____________________ (insert the data fields that will be included in the bank). This is considered (pick one) identifying/not identifying information and (pick one) can/cannot be traced back to you as the donor.

The storage (bank) area is maintained at _____________________________ (insert name & location of tissue bank). Other research investigators requesting portions of tissue samples from the bank must have the approval of the Tissue Bank Manager and also must have a research protocol for this newly proposed study approved by an Institutional Review Board (IRB) (a committee responsible for protecting research subjects). It is possible researchers will request approval from an IRB to contact you in the future.

Some research studies may include genetic testing of your samples. Since storage (banking) of tissues, organs and other biologic specimens for future genetic testing is still undergoing development, the risks or genetic testing are unknown.

(GINA defines genetic information as information about:

An individual's genetic tests (including genetic tests done as part of a research study);




Genetic tests of an individual's family members (defined as dependents and up to and including 4th degree relatives);

Genetic tests of any fetus of an individual or family member who is a pregnant woman, and genetic tests of any embryo legally held by an individual or family member utilizing assisted reproductive technology;

The manifestation of a disease or disorder in an individual's family members (family history); or

Any request for, or receipt of, genetic services or participation in clinical research that includes genetic services (genetic testing, counseling, or education) by an individual or an individual's family members.)

It is believed that the risks are very low. Using new technology, information about your DNA structure (genetic information) can be used to indicate risk for developing certain diseases. This genetic information is unique to you and may indicate changes in your future health status or life expectancy, or that of your children and other relatives. These discoveries could be stressful and cause psychological difficulties or family problems. It is also possible that during this research, people of your ethnic background may be found to be at more risk for certain diseases. Release of this information could stigmatize your ethnic or cultural group and may pose a possible risk of discrimination or increased difficulty in obtaining health insurance, life insurance, or employment. These risks would occur if the confidentiality of data is breached. A Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. Be aware that this law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. Every effort will be made to protect the confidentiality of your medical information. Procedures to protect the confidentiality of the data include: ___________________________(state protections, which may include: coded data, removal of personal information, computer password protection, creation of firewalls around the data, locking of drawers and offices. A lay definition of firewall is: A firewall is a protection or barrier within a computer to protect the information from being viewed by unauthorized people.)

Generally, you will not be provided with the results of the studies using your tissue from this bank. Any results from stored specimens would be of unclear value and unknown clinical meaning.

You may request that your specimen be withdrawn from the tissue bank at any time if you decide you no longer want to participate. This can be done by calling the research staff or investigator.

_____ I do not authorize the storage of my biological specimens for future use in research studies. (If subject does not want specimens to be stored they may not be able to participate depending of the study design)

_____ I authorize the storage of my biological specimens for future use in research studies.

8. VOLUNTARY PARTICIPATION:

The decision to participate in this study is completely voluntary on your part. You want to participate without being coerced or intimidated into participating in this project. The Study Doctor or one of his/her associates has adequately answered any and all questions you have about this study, your




participation, and the procedures involved. You will be informed, if significant new findings develop during the course of this study that may affect your decision to continue participation.

You may withdraw this consent at any time and discontinue further participation in this study without affecting your eligibility for care or any other benefits to which you are entitled. Should you choose to withdraw, you must ______________ (Ex: contact the research staff or investigator. Also state withdrawal procedures to include returning all study material. NOTE: If further testing is recommended after the subject’s request for withdrawal, you must explain why the tests are necessary for the subject’s welfare. State: Some testing or period of observation by the investigators may be recommended for you in order for you to safely stop taking part in this study.). If you do not follow these procedures, you may experience ___________ (state health risks if study withdrawal procedures are not followed). Your condition will continue to be treated in accordance with acceptable standards of medical treatment.

The Study Doctor may terminate your participation in this study at any time if he/she feels this to be in your best interest. The Study Doctor may also terminate your participation in this study for the following reasons: List possible indications for involuntary termination of subject's participation, e.g., subject's failure to comply with study procedures, investigator's determination that the assigned treatment is ineffective or unsafe, appearance of unacceptable side effects in the subject, pregnancy

AND (if applicable: study involves experimental medication )

The sponsor of this study may terminate the study and/or your participation in this study for safety reasons or if the drug receives FDA approval. There is no guarantee that the drug you received during this study will continue to be available through the military system.

9. CONFIDENTIALITY OF RECORDS OF STUDY PARTICIPATION:

Records of your participation in this study may only be disclosed in accordance with federal law, including the Federal Privacy Act, 5 U.S.C.552a, and its implementing regulations. DD Form 2005, Privacy Act Statement - Military Health Records, contains the Privacy Act Statement for the records.

By signing this consent document, you give your permission for information gained from your participation in this study to be published in medical literature, discussed for educational purposes, and used generally to further medical science. You will not be personally identified; all information will be presented as anonymous data.

Your records may be reviewed by the U.S. Food & Drug Administration (FDA), other U.S. government agencies, Uniformed Services University of the Health Sciences (USUHS) Infectious Disease Institutional Review Board (ID IRB), Infectious Disease Clinical Research Program (IDCRP), Madigan Army Medical Center (MAMC), Naval Medical Center Portsmouth (NMCP), Naval Medical Center San Diego (NMCSD), San Antonio Military Health System (SAMHS), Tripler Army Medical Center (TAMC), Walter Reed National Military Medical Center (WRNMMC), authorized members of the Regulatory Affairs Division of the Henry M. Jackson Foundation, National Institute of Allergy and Infectious Disease (NIAID) and their representatives as well as other DoD and Federal regulatory agencies are eligible to review research records as part of their responsibility to protect human subjects in research. (List any other internal or external agencies that may review records.)

Complete confidentiality cannot be promised, particularly for military personnel, because information regarding your health may be required to be reported to appropriate medical or command authorities.




******************************************************************************

10. AUTHORIZATION TO USE AND/OR DISCLOSE PROTECTED HEALTH INFORMATION FOR RESEARCH (HIPAA):

You are being asked for permission to use or disclose your protected health information for this research study.

The Health Insurance Portability & Accountability Act of 1996, Public Law 104-109 (also known as HIPAA), establishes privacy standards to protect your health information. This law requires the researchers to obtain your authorization (by signing this form) before they use or disclose your protected health information for research purposes in the study discussed in this form.

(a).Your protected health information that may be used and disclosed in this study includes:

Names Address Dates except year Ages over 89 (can be grouped as age 90 or

older) Phone numbers Fax numbers E-mail addresses Social security numbers Medical record numbers Account numbers Certificate/license numbers

Health plan beneficiary numbers Vehicle identifiers and serial numbers, or license

plate numbers Device identifiers and serial numbers Web Universal Resource Locators (URLs) Internet Protocol (IP) address numbers Biometric Identifiers, including finger and voice

prints Full face photographic images and any

comparable images Any other unique identifying number,

characteristic, or code

(b).Your protected health information will be used for:

The disclosure of your protected health information is necessary in order to be able to conduct the research project described. Records of your participation in this study may only be disclosed in accordance with state and federal law, including the Privacy Act (5 U.S.C. 552a) and the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (45 CFR 160 & 164). Note: Protected health information of military service members may be used or disclosed for activities deemed necessary by appropriate military command authorities to ensure the proper execution of the military mission.

By signing this authorization, you give your permission for information gained from your participation in this study to be published in medical literature, discussed for educational purposes, and used generally to further medical science. You will not be personally identified; all information will be presented as anonymous data.

(c).The Study Doctor may use and share your health information with: The Institutional Review Board (USUHS ID IRB) Infectious Disease Clinical Research Program (IDCRP),




State and Federal Government representatives, when required by law Representatives of the Department of Defense (DoD) and/or the different components of the DoD

involved in monitoring the research Regulatory Affairs Division of the Henry M. Jackson Foundation National Institute of Allergy and Infectious Disease (NIAID) and their representatives (List any collaborators, outside laboratories, etc., AND what each is, i.e., research collaborator or

outside laboratory, etc.) (If applicable -list the sponsor's name, AND what it is, i.e., pharmaceutical manufacturer or medical

device manufacturer, etc) (List any other groups with whom the information may be shared, AND what that group is)

The researchers and those listed above agree to protect your health information by using and disclosing it only as permitted by you in this Authorization and as directed by state and federal law.

You need to be aware that some parties receiving your protected health information may not have the same obligations to protect your protected health information and may re-disclose your protected health information to parties not named here. If your protected health information is re-disclosed, it may no longer be protected by state or federal privacy laws.

(d). You do not have to sign this Authorization. If you decide not to sign the Authorization:

It will not affect your treatment, payment or enrollment in any health plans or affect your eligibility for benefits.

You will not be allowed to participate in this research study because your health information is required in order for you to take part in this study.

(e). After signing the Authorization, you can change your mind and:

Notify the researcher that you have withdrawn your permission to disclose or use your protected health information (revoke the Authorization).

If you revoke the Authorization, you will need to send a written letter to the Study Doctor at your medical site (name and complete mailing address in the Contact section of this form) to inform him/her of your decision.

If you revoke this Authorization, researchers may only use and disclose the protected health information already collected for this research study and also with instances related to an adverse event.

If you withdraw your Authorization, you may not be allowed to continue to participate in some or all aspects of the study.

Note: the following paragraph must be included if the protocol is blinded, or the early release of participant’s information would adversely affect the study.During your participation in this study, you will not be able to access your research records. This is done to ensure the study results are reliable. After the completion of this study, you have the right to see or copy your research records related to this study. A Request for Access must be made in writing to the




Study Doctor at your medical site (name and complete mailing address in the Contact section of this form).

If you have not already received a copy of the brochure entitled “Military Health System Notice of Privacy Practices,” you may request one. DD Form 2005, Privacy Act Statement - Military Health Records (located on your medical records jacket), contains the Privacy Act Statement for the records. If you have any questions or concerns about your privacy rights, you should contact:

Uniformed Services University Office of Research (301) 295-9534MAMC Institutional Review Board (253) 968-0149NMCSD Privacy Officer (619) 532-5296NNMC Privacy Compliance Office (301) 319-4775NMCP Privacy Officer (757) 953-7754SAMHS SAMMC Privacy Officer (210) 916-1029

WHASC Privacy Officer (210) 292-4599TAMC Privacy Officer (808) 433-2237WRNMMC Privacy Compliance Office (301) 319-4775

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11.ENTITLEMENT TO CARE IF INJURED:

You will not receive any payment should you be injured as a direct result of being in this study. You do not give up your legal rights by signing this form. Please discuss this issue thoroughly with the principal investigator before you decide to participate in this study. Medical care is limited to the care normally allowed for DoD health care beneficiaries (patients eligible for care at military hospitals and clinics). Necessary medical care does not include in-home care or nursing home care.

OR

Should you be injured as a result of your participation in this study, you will be given medical care for that injury at no cost to you. If you need to be hospitalized, you may have the normal fees for subsistence (hospital meals), as per standard regulations.

OR

In the event of injury resulting from this study, the extent of medical care provided is limited and will be within the scope authorized for DoD health care beneficiaries.

ANDYour entitlement to medical and dental care and/or compensation in the event of injury is governed by federal laws and regulations, and if you have questions about your rights as a research subject or if you believe you have received a research-related injury, you may contact:

Uniformed Services University Office of Research (301) 295-9534MAMC Center Judge Advocate (253) 968-1525NMCSD Legal Department (619) 532-6475NMCP Head, Clinical Investigation and Research

Department(757) 953-5939or DSN 377-5939




SAMHS SAMMC Protocol Coordinators (210) 916-2598

SAMMC Judge Advocate General (210) 808-4075

WHASC Clinical Research Squadron Commander

(210) 292-7069

WHASC Risk Manager (210) 292-6004

TAMC Department of Clinical Investigation (808) 433-6709WRNMMC HPA (301) 295-8273

Legal Office (301) 400-2152

12. CONTACT INFORMATION:

Study Doctor/Principal Investigator (PI)The Study Doctor is the Principal Investigator of this study and he/she or a member of the research staff will be available to answer any questions concerning procedures throughout this study.

Brian Agan, MD 301-816-8446 Uniformed Services University (USUHS)4301 Jones Bridge Road, Bldg 28 Room 201Bethesda, MD 20814

Christina Schofield, MD

253-291-2574 Madigan Army Medical Center (MAMC) Infectious Diseases, 9040 Fitzsimmons Drive Tacoma, WA 98431

Jason Maguire, CAPT, USN, MC

757-953-5182 Naval Medical Center Portsmouth (NMCP)620 John Paul Jones Circle, Building 3, 1st FloorPortsmouth, VA 23708

Mary Bavaro, CDR, USN, MC

619-532-7480 Naval Medical Center San Diego (NMCSD)34800 Bob Wilson Drive, Suite 201San Diego, CA 92134

Timothy Whitman, CDR, USN, MC

301-295-6400 Walter Reed National Military Medical Center (WRNMMC)8901 Wisconsin Avenue, Building 7,1st FloorBethesda, MD 20889

Jason Okulicz, Maj, USAF, MC

210-916-3369 San Antonio Military Health System (SAMHS)3551 Roger Brooke Drive, MCHE-MDIFt. Sam Houston, TX 78234

Tomas Ferguson, LTC, MC, USA

808-433-6513 Tripler Army Medical Center (TAMC)1 Jarrett White Road, MCHK-DMITripler AMC, HI 96859

Institutional Review Board (IRB) The USUHS Institutional Review Board is the IRB committee responsible for safeguarding your rights as a research subject. If you have any questions about your rights as a research subject or any other concerns that cannot be addressed by the Study Doctor you can contact the Director of the Human Research Protections Program at, (301) 295 3836. In addition, if you have any comments, questions, concerns or complaints, you may also contact the Chairperson of the IRB, at (301) 295-3637.




Under 21 CFR 50.25(c), include the following statement word-for-word in the informed consent document for applicable clinical trials: ( “Applicable clinical device trial” means: (I) the trial prospectively compares a device-based intervention subject to FDA regulation against a control in human subjects; or (II) the trial is a pediatric post-market surveillance trial. 42 U.S.C. § 282(j)(1)(A)(ii).

The trial is an “applicable clinical drug trial” if the trial is a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to FDA regulation. 42 U.S.C. § 282(j)(1)(A)(iii)(I). For the purposes of this definition, a “clinical investigation” is “any experiment in which a drug is’ administered or dispensed to, or used involving, one or more human subjects.” 21 CFR § 312.3.)

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.

13. SIGNATURE PAGE:

Your signature is voluntary consent to participate in this study. Your signature also acknowledges that you authorize personnel to use and disclose your Protected Health Information (PHI) collected about you for research purposes as described above.

A signed and dated copy of this form will be given to you. This document is effective until completion of the protocol and will be kept for at least 6 years after the study is closed.

______________________________________________ Printed Name of Subject

______________________________________________ ___________________Subject's Signature Today’s Date

( Use the following only if applicable for the type of research study, otherwise delete )

The subject, ______________________________________________ (name), has verbally consented to participate in the study as described and also authorizes the use and disclosure his/her health information as described. The subject is coherent, determined to be able to understand and in the opinion of the advising research staff, the subject has understood the nature and consequences of participation in the study, but the subject is physically disabled and is unable to sign.

The consent and authorization information were accurately explained. The subject was given the opportunity to ask questions. All questions were answered before giving verbal consent and authorization. The subject apparently understood the information. The informed consent and authorization were given freely by the subject.

*******************************************************************************( Use the LAR section only if applicable for the type of research study, otherwise delete )

_______________________________________________ ___________________Printed Name of Legally Authorized Representative (LAR) Relationship to Volunteer




_______________________________________________ ___________________Signature of LAR Today’s Date

(If the legal representative has a copy of the power of attorney or court appointment, attach it to this consent document.)******************************************************************************

_______________________________________________ Printed Name of Advising Research Staff

_______________________________________________ ____________________Signature of Advising Research Staff Today’s Date

******************************************************************************

_____________________________________________ Printed Name of Witness

_____________________________________________ ____________________Signature of Witness Today’s Date


sample - usuhs.edu web viewin the event of an emergency, ... necessary medical care does not include...

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