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Participate in Clinical Studies

Back to: Clinical Center Home Page > Participate in Clinical Trials > Patient Information
 
Legal, Ethical, and Safety Issues
Your Rights and Responsibilities (Informed consent, Patient bill of rights, Advance directives, more)

Your Privacy (Your medical records, Information about previous transfusions, Uses of information)

Your Safety (Preventing infection, Emergency procedures, High security access, Hospital accreditation)


Your Rights and Responsibilities

Informed consent. While you receive medical care here, information gained from studying your condition will help us to better understand your illness and to develop or improve treatments or methods of prevention.

Because you consented to take part in research, we have a responsibility to inform you about the procedures we use and what you can expect from your stay.

Your doctors and nurses will explain treatments and tests, and very often, your written consent is required before they are administered. If a treatment is relatively new and not yet generally used, or if it is a test mainly for research and not for your immediate benefit, your doctor will make this clear and will ask for your written consent. However, you may have questions later even after you have given your consent. Please do not hesitate to discuss these questions with your doctor, nurse, social worker, chaplain, or Patient Representative (301 496-2626). We want you to understand exactly what is being done and why.

If at any time you wish to withdraw from the research study, you may do so. The Clinical Center will provide short term medical care for any physical injury resulting from your participation in research here until such time that the NIH has determined that you can be safely discharged.

Although data from the studies in which you participate may be used widely in medical research, information about you as an individual is confidential. Generally, access to this information is restricted to NIH staff involved in the patient care and research programs. Your doctor and other physicians or organizations you specify will also receive your medical information.

You are entitled to receive a copy of the protocol consent form you signed. Ask for this when you sign the consent form.

Patients' Bill of Rights. Whether you volunteer to participate in a research protocol as a healthy subject or as a patient, you are protected by the Clinical Center Bill of Rights for patients who are volunteer subjects. We, at the Clinical Center, believe that personal concern for every volunteer is indispensable to the quest for knowledge about disease. The most important person in medical research is the patient. The Clinical Center provides hospital facilities and professional care, but the patient is the essential element without which health and disease could not be observed or response to treatment measured.

Clinical Center patients' rights are safeguarded by procedures to ensure that all patients know their medical choices, and are aware of any risks from the procedures and understand how research may affect them.

Members of the hospital staff have a responsibility to assure the following:

  • The patient receives information necessary to make decisions about taking part in any research procedures.
  • Care is given in a manner consistent with the patient's beliefs.
  • Those rights basic to human dignity are observed.

This Bill of Rights for Clinical Center patients has been adapted from a similar document developed by the American Hospital Association for use by general hospitals.

Pain Management. Every patient has the right to appropriate assessment and relief of pain.

Advance directives for medical care. The rights of Clinical Center patients to participate in decisions concerning their medical care are preserved even if they lose the ability to communicate directly with their caregivers. One method of exercising these rights is to prepare an "advance directive."

An advance directive is a document in which a person gives advance directions about medical care or designates who should make medical decisions for that person if he or she loses the ability to make such decisions. There are two types of advance directives: treatment directives, the most common example being the living will, and proxy directives, the most common example being the durable power of attorney for health care.

A treatment directive, such as a living will, is a written statement expressing the forms of medical treatment a person wishes to receive or forgo when unable to make decisions in stated medical conditions. Such medical conditions may include irreversible unconsciousness, terminal illness, or severe and irreversible brain disease.

A proxy directive, such as durable power of attorney, is a person's written statement naming another to make medical decisions for that person if he or she becomes unable to make such decisions.

In 1990, the Congress approved legislation called the "Patient Self-Determination Act." This law requires all medical facilities reimbursed by Medicaid and Medicare to educate patients about advance directives and to help them make advance directives if they choose to do so. Although the Clinical Center does not receive such financial reimbursement, there has been, and continues to be, a commitment to consistent and thoughtful attention to the ethical aspects of patient care, including advance directives.

The Clinical Center has guidelines for using durable power of attorney for patients in certain research studies. Work is in progress to expand the Clinical Center's ability to educate and help patients make advance directives. If you have any questions about advance directives, please speak with your doctor, your nurse, the Patient Representative (301 496-2626), or the Department of Clinical Bioethics staff (301 496-2429).

DNR (Do Not Resuscitate) orders. At the Clinical Center of the National Institutes of Health, all members of the health care team are dedicated to your care and well-being. We believe that one of our most important responsibilities is to preserve and maintain the life and vigor of our patients. We also believe that patients have the right and responsibility to participate in decisions about their health care.

In this hospital, it is understood that if a patient has cardiopulmonary arrest (sudden stoppage of heart or lung function), every effort will be made to restore these vital functions. Cardiopulmonary resuscitation, or CPR, refers to the technique used to restore these functions. These efforts will take place routinely, unless an order to the contrary has been written in the patient's medical record.

When a patient's heart or breathing stops and CPR is started, a multi-step process begins. CPR may include such procedures as chest compression, administration of various medications, electrical shocks to restart the heart, placement of a breathing tube (intubation), and placement on a breathing machine (ventilator). Patients receiving successful CPR will usually be transferred to an intensive care unit (ICU) for continued treatment and observation.

Although our hope is to restore health in all our patients, there are times when this will no longer be possible. In certain situations, it is important to discuss whether we should even try CPR. CPR may not be appropriate for patients with a progressive and terminal condition from which recovery is no longer possible. Making this decision should be a joint process in which the patient, the physician, the nurse, and the patient's family are involved. Other persons on the health care team experienced in discussing these matters with patients include chaplains, social workers, and the patient representative. The decision to write the DNR (Do Not Resuscitate) order, however, rests with the competent patient and his or her physician. If the patient is not competent, the decision rests with the patient's surrogate and physician.

If the patient, in consultation with his or her attending physician, decides that CPR is not appropriate, at least at that particular time, the attending physician will write a DNR order, or a "No Code," in the patient's records. A DNR or No Code order means that CPR will not be started.

It is important to remember two points about a DNR order:

  • The DNR order will be reviewed regularly. Entering a DNR order into a medical record does not mean that the DNR order is permanent. A DNR order can be reversed if it becomes medically appropriate. If a patient changes his or her mind about the DNR order, this should be discussed with the attending physician.
  • Even if the DNR order is written, this does not mean that other lifesaving treatments, such as antibiotic administration, will be withheld. All treatments related to pain management, or other treatments agreed to by the patient and the physician, will be given.

We hope this information will help familiarize you with choices related to your health care. We encourage you to discuss this, or any aspect of your care, with your family and your physician and with other members of your health care team.

Patient Responsibilities. In the spirit of working together toward our common goal, our patients (and their parents, guardians, or surrogates) also have certain responsibilities as participants in medical research and as patients at the Clinical Center. Patient Responsibilities explains them.

Your Privacy

Information concerning previous transfusions and the risk of AIDS virus infection. In March 1985, the nation's blood supply was first screened for the presence of HIV, the virus that causes AIDS. Between 1977 and 1985, however, patients were at risk for exposure to the AIDS virus if they had received unscreened blood and blood products.

About 12,000 people who were infected with HIV through blood transfusions given during those years are alive. If you received a blood transfusion between 1977 and 1985, there is a small, but real, risk that you were exposed to HIV by the transfusion. This risk will vary depending on where you received the transfusions and how many units you received. Most people exposed to HIV by transfusions do not develop symptoms of AIDS in the years immediately following the transfusion, yet they may be able to pass the virus to their offspring (via childbirth) or to their sexual partners. For these reasons, the NIH Clinical Center recommends that HIV testing be offered to all patients transfused between 1977 and 1985. When your medical history is taken by the admitting physician, you will be asked if you have ever received blood transfusions. If you inform the physician that you were transfused between 1977 and 1985, the doctor will recommend that a test be performed to detect the presence of HIV antibody in your blood. This test is a very reliable indicator of exposure to the AIDS virus. Please note that AIDS virus testing is recommended, but not mandatory. You will be asked to sign an informed consent form that gives us permission to test your blood for HIV. These tests are carried out promptly and confidentially at the Clinical Center.

If you cannot remember or are uncertain if you received transfusions, your physician can ask the Clinical Center Department of Transfusion Medicine to check its records to see if you received a transfusion here. This information will be accurate and complete for transfusions given at the Clinical Center but will not include a record of transfusions given elsewhere.

Medical record information. If you have questions about access to your medical record or the release of information contained in it, please call the Medicolegal section of the Medical Record Department at 301-496-3331 or stop by room 1N216.

Photographing fellow patients. If you wish to take a photograph of your fellow patients, please ask their verbal permission. You may photograph patients in their rooms or in the unit lounge, solaria, or outside the Clinical Center. Please refrain from taking photographs in gathering places such as cafeterias and lobbies.

Photographs and recordings. Some types of medical information cannot be recorded completely in writing. Photography, tape recording, and other audiovisual methods are sometimes much better. Audiovisual records which could reveal your identity are never made unless you have given your prior written permission on a special form, which states the particular uses that will be made of the records.

Uses of information. Patients who give information about themselves or their families to the doctors and other workers in a hospital expect the information to be kept confidential. We will do this to the best of our ability. However, you should be aware that neither the Clinical Center nor any other medical institution can absolutely guarantee confidentiality.

In 1974, the US Congress passed a law called the Privacy Act. This law puts strict limits on how Federal agencies may use and disclose personal information, including medical information. It requires every agency to inform each individual why he or she is asked for information and how it will be used.

Physicians and other scientists at the National Institutes of Health conduct research by authority of the US Congress, Section 301 of the Public Health Act (42 United States Code 241). The research in which patients or volunteers participate - clinical research - takes place mainly in the Clinical Center in Bethesda, Maryland.

The medical and other personal information you are asked to give, as well as the information from various tests, is gathered for two purposes: to provide the best care and treatment for you as a patient, and for research to increase understanding of health and illness. Both good treatment and good research depend on accurate and complete information. However, just as your coming to the Clinical Center as a patient is voluntary, your giving the information we request and participating in various tests and research procedures is also voluntary.

Publications
Some of the information obtained from you may appear in scientific publications or be presented to professional audiences at meetings. It may be used for the purpose of teaching health professionals or students in the health professions. Under these circumstances, measures are taken to conceal your identity.

Release of patient information to the media
Occasionally, we receive media requests for information about patients who are being treated at the Clinical Center. Inquiries may be made especially if a patient is a public figure or celebrity. These requests are handled by Clinical Center Communications, the public affairs office for the hospital. Our primary concern is patient welfare, but we also have an obligation to cooperate with the media.

The only information that may be released to the media without the patient's prior written permission is verification that the person is a current Clinical Center patient. Medical records, including diagnosis, are confidential and will not be released to the media.

If you are contacted by the media while you are a patient here, or if you have questions about Clinical Center media policies, please call Clinical Center Communications at 301-496-2563.

Religion and social security number
At the time of your admission, you were asked to give your social security number and your religion. Giving this information is strictly voluntary, and the admissions clerk will emphasize this. If your social security number is required for any financial transactions, this will be explained to you. Knowing your religion enables the hospital chaplains to offer spiritual service, which for many patients is an essential part of their care.

Uses of information at NIH
The information needed for care and treatment, and much of the research information, is recorded and stored in your written medical record and in a computer system. In addition, records containing some of the same or similar information are maintained by the many departments and offices essential in a modern hospital. These include admissions, anesthesiology, transfusion medicine, dental clinic, nursing, nutrition, pharmacy, reception desk, recreation therapy, social work, spiritual ministry, and travel office. These also include the departments and offices that perform electrocardiograms, electroencephalograms, metabolic rates, pathological anatomy, pulmonary function, radioisotope studies, and x-rays.

NIH scientists and their technical assistants maintain research records in their offices and laboratories. These may be records of clinical research procedures carried out in each laboratory, or they may be compilations of data abstracted from the medical records of many patients, some of whom may have no personal contact with the scientist. Such records are essential to prepare the hundreds of clinical research reports published in scientific journals each year.

Students in the health professions, particularly medicine and nursing, are regularly assigned to the NIH as part of their formal training. They may be unpaid volunteers, but they are under the direct supervision of the NIH staff. They have access to medical information as necessary to carry out their training assignments. For the purposes of the Privacy Act, they are regarded as NIH employees.

Uses of information outside NIH
Generally, access to medical information is restricted to NIH employees who need it to carry out their official duties. There are, however, occasions when confidential information is shared with individuals or organizations that are not part of the NIH. These are as follows:

  • The physician(s) or organization(s) that the patient specifies to receive reports (which are identified in MIS) get the following:
    • reports summarizing each patient admission
    • letters dictated by the patient's primary care physician(s).
  • The Social Work Department may share pertinent information with community agencies that may assist the patient. Providers may also be given the information needed for obtaining special individualized devices such as braces, artificial limbs, or cosmetic aids.
  • The travel office may inform public carriers such as airlines of the special requirements of some patients, for example, "heart condition" or "wheelchair required."
  • Information about diagnostic problems or having unusual scientific value may be shared with consultants other than NIH employees. For example, bacterial specimens may be sent to the Centers for Disease Control and Prevention of the Public Health Service in Atlanta; tissue specimens may be sent to the Armed Forces Institute of Pathology in Washington, D.C.; x-rays may be sent for the opinion of a radiologist with extensive experience in a particular kind of diagnostic radiology. Pertinent parts of your medical history may be shared with such consultants. NIH scientists may collaborate with colleagues at institutions such as medical schools. They may share information so that the number of patients under combined study will be sufficient, or they may exchange samples of material such as blood so that samples can be analyzed uniformly in the laboratory best equipped to do so.
  • Representatives of the Joint Commission on the Accreditation of Healthcare Organizations or of the government's General Accounting Office occasionally have access to representative medical records. Such inspections ensure that the quality of our record-keeping meets established standards.
  • Records may be released to Congress or to committees and subcommittees of Congress for matters within their jurisdiction, and information may be used to respond to congressional inquiries for contituents concerning their admission to the NIH Clinical Center.
  • Certain diseases or conditions, including infectious diseases, may be reported to appropriate representatives of the State or Federal Government as required by law.
  • Records may be released for statistical research or reporting if the information is transferred in a form that does not identify anyone individually. For example, medical information may be disclosed to tumor registries for maintaining health statistics.
  • The Department of Health and Human Services may contract with a private firm for transcribing, updating, copying, or otherwise refining records it uses. Relevant records will be disclosed to such a contractor. The contractor(s) will be required to comply with the requirements of the Privacy Act regarding such records.
  • If a government employee is involved in a lawsuit, records may be released that facilitate the employee's defense.
  • The Bureau of the Census may request records for census or survey purposes, and records may be released for archival purposes to the National Archives.
  • Records may be released for law enforcement purposes to a law enforcement agency, and records may be released in response to a court order.
  • Whenever medical information about you as an identifiable individual is disclosed to anyone who is not an employee of the Department of Health and Human Services, notation of the reason for the disclosure and the identity of the recipient of the information is made in your medical record. When such disclosures are for one of the reasons described above, or if disclosure is otherwise required by law, the NIH does not seek your written permission to make the disclosure.
  • Except for the uses described here, medical information about a patient is not given to anyone without the specific written permission of the patient or a legally authorized representative. However, there is one additional exception to that rule: if at some later time, a hospital or physician who is caring for you needs information immediately, and if waiting to obtain your written release of the information would endanger your health, the information will be released immediately, and you will be notified of the release later.

Compensation
The NIH compensates study participants for their time and, in some instances, for the inconvenience of a procedure. There are standard compensation rates for the participant's time; the study's principal investigator determines inconvenience rates. NIH reports compensation of $600 or more to the Internal Revenue Service and sends a "Form 1099-Other Income" to the participant at the end of the year. Please be aware that some or all of that compensation may be garnished if the participant has outstanding debts to the federal government.

Your Safety

High Security Access. Due to heightened security measures, Patients and Visitors arriving at the main entrance to the Clinical Center will be asked for a valid photo ID (drivers license, state ID, passport, high school/college ID, etc.). Bags and luggage will be inspected. You will be issued a Visitor Pass that should be worn at all times in the Clinical Center and while on the campus. If you are unable to wait in line for this procedure, please inform the security staff who will notify a member of the Clinical Center's Hospitality Staff to come and assist you.

Accreditation. The Joint Commission is an independent, not-for-profit organization that sets the standards by which healthcare quality is measured both nationally and internationally. It evaluates the quality and safety of care for more than 17,000 healthcare organizations. To maintain and earn accreditation, organizations must have an extensive onsite review by a team of Joint Commission healthcare professionals at least once every three years. The review's purpose is to evaluate the organization's performance in areas that affect patient care.

Emergency Procedures. The Clinical Center has implemented an official Emergency Preparedness Plan, which seeks to ensure that disasters or hazardous circumstances are managed in a manner that minimizes injury to persons and damage to property. It also provides written procedures for a safe building evacuation process, needed medical care, and appropriate containment and management of hazards.

Precautions against Infection.

HIV testing and reporting of infectious diseases
As a Clinical Center patient, you may be asked to provide a blood sample to be tested for antibodies against the human immunodeficiency virus (HIV), the virus that has been identified as the cause of AIDS (the acquired immune deficiency syndrome). If testing is indicated for you, your primary caregiver at the Clinical Center will ask for your permission to do the test. Further information about HIV testing is available in the booklet, "Testing Your Blood for HIV, the Virus That Causes AIDS."

The Clinical Center may report certain communicable diseases, including HIV infection, to appropriate State and Federal government agencies. If you have any questions about HIV testing or this policy, you can discuss them with your caregivers in the Clinical Center or the Clinical Center HIV Counseling Coordinator. The HIV Counseling Coordinator may be reached at 301-496-2381 or through the page operator at 301-496-1211.

If you would like more information or counseling before or after HIV testing, you may contact the Clinical Center HIV Counseling Coordinator at 301 496-2381. Counseling may cover issues such as the meaning of a positive test, the confidentiality of test results, and the potential risks to family members or sexual contacts if a positive result is found. The results of the HIV screening test will have no impact on the quality of care you receive at the Clinical Center.

Universal precautions/isolation precautions
One of the goals of the Clinical Center is to provide a safe and healthy environment for patients and staff. Universal precautions are used to reduce the risk of transmission of blood-borne infections, as well as infections from moist body substances. If exposure to a patient's blood, body fluids or other infectious materials is likely, hospital staff members will use some type of personal protective equipment.

Gloves are the most frequently used personal protective equipment, but the actual equipment used will depend on the procedure involved. You may notice health care members wearing gloves while drawing your blood. Masks, gowns and protective eyewear might also be used when performing a procedure where blood or other infectious materials might splash on a health care worker's skin, eyes, or mouth. Housekeeping staff wear gloves and gowns when changing soiled linens and wear gloves when handling trash. Hospital staff should observe universal precautions with all Clinical Center patients.

Isolation precautions
Isolation precautions are recommended practices used in hospitals to prevent the spread of certain infections. Different isolation precautions may be used depending on how a particular infection is spread. Isolation precautions usually require health care staff to use protective equipment to prevent exposure to substances such as blood or other potentially infectious materials. Examples of this equipment are gloves, gowns, masks, and protective eyewear.

Rarely, some isolation precautions may restrict the patient's contacts with other patients or health care staff. If you have an infectious disease that requires isolation precautions, your nurse or doctor will explain this to you. Patients requiring isolation precautions are identified by signs attached to their hospital room doors and medical charts. These signs remind staff to use appropriate precautions. To protect the patient's confidentiality, the signs do not identify the infection requiring the isolation precautions.


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