Clinical Studies Unit

Manual & Application

CSU Manual - MS-Word Doc

This is the complete manual for the Clinical Studies Unit. The user can view, print or download this MS-Word document. Content by manual section is listed below.

CSU Application

Manual Sections

Mission

The mission of the Clinical Studies Unit (CSU) is to advance nursing science and provide research training for School of Nursing students. This is achieved by providing research space for the conduct of human research that can be shared by a number of investigators throughout the SCHOOL OF NURSING under the supervision of the Associate Dean for Research.

Governing Body

The CSU is directed by the SCHOOL OF NURSING Associate Dean for Research in concert with an advisory committee. The CSU Advisory Committee includes faculty members from School of Nursing departments plus a staff member representing the interests of the affiliated CSU research projects. The CSU Advisory Committee recommends policy and reviews applications for use of CSU space.

CSU Application

CSU space is restricted to research projects approved by the CSU Advisory Committee. Investigators interested in using CSU space for a research project must submit a CSU application to the Office for Nursing Research in T643. There are two types of CSU application forms.

Letter of Intent

The CSU Advisory Committee uses this form for long-range planning. CSU space is limited and investigators are encouraged to inform the CSU Advisory Committee of their intent or interest to use CSU space well in advance of submitting the formal application. While the letter of intent does not guarantee space, it does help the CSU Advisory Committee plan and enhance the possibility that space will be available when the formal application is submitted. The Letter of Intent is to be submitted to the Office for Nursing Research in T643.

Application

The CSU application should be complete and include all required documents. The review process will not begin until all required information has been submitted to the Office for Nursing Research. Please include the following documents.

Complete CSU application
Copy of human subjects application
Copy of human subjects approval letter
Copy of letter verifying human subject training of PI
Copy of biohazard assessment form submitted to UW Environmental Health & Safety
Copy of safety certification from UW Scientific Equipment for all equipment planned for use with human subjects

After the Office for Nursing Research has received the CSU application and all required documents, copies will be sent to the CSU Advisory Committee for review. Comments are taken from committee members and the PI may be asked for further clarification or documents. The PI will be notified by e-mail when the final decision is made.

Room Assignments & Scheduling

Research space is not assigned until the CSU application has been approved by the CSU Advisory Committee. The PI is asked to be as clear as possible when describing the type of research space needed in the CSU application. This information will be used to assign research space.

The PI will be contacted by the Office for Nursing Research informing them which research space has been assigned. The Office for Nursing Research manages research space. The PI should contact the Office for Nursing Research in T643 for help with keys and other facility issues.

Certain rooms in the CSU are considered shared research space. Schedule books are maintained to coordinate the use of these rooms by multiple research projects.

Equipment & Supplies

Research projects using the CSU are expected to fund their own equipment and supplies. The CSU does not have available funds to purchase equipment or supplies for a research project. Funding is available from the Office for Nursing Research for minor repair, or modification to CSU space based on project need.

While the CSU does not fund equipment for research projects, the School of Nursing has a small inventory of scientific equipment for loan. A researcher can contact the Office for Nursing Research if interested in the type of equipment available.

Specimen Storage

If human body fluids will be collected during the research and require long-term storage by the School of Nursing laboratories, the PI will need to consult with the School of Nursing lab manager prior to completing the CSU application to determine if long-term storage space will be available. A refrigerator/freezer is available in CSU T429 for temporary storage of human body fluids (i.e., urine, blood, and saliva). The samples must be moved to the Biobehavioral laboratory within 24 hours for permanent storage.

Investigators who plan to collect blood or urine specimens in the CSU must also file a "Research Project Hazard Assessment" form with Environmental Health and Safety (Biosafety Supervisor Environmental Health and Safety, Box 354400).

Use of Scientific Equipment

All scientific equipment that will come in contact with research subjects must be approved by UW Scientific Instruments before it can be used in research. If the PI intends to use scientific equipment with research subjects, a Scientific Instrument approval report must be submitted with the CSU application. If the scientific instrument approval report has not been completed before submitting the CSU application, the Office for Nursing Research must receive a copy before the equipment can be used with a subject.

Storage of Equipment-Supplies

General CSU storage space is minimal. Research projects can store equipment or supplies only in their assigned rooms. Nothing should be stored in shared CSU rooms. All equipment or supplies stored must be clearly marked with project title and PI name. All equipment and supplies must be removed by the PI when the project completes its use of CSU space.

Ethics & Confidentiality

Ethics

Sexual Misconduct Prohibited (WAC 246-840-740) Reproduced from The Nursing Commission Newsletter Winter 1998
What is the nursing commission's intent in prohibiting this type of misconduct?

Sexual or romantic conduct with a client or the client's family is serious misconduct because it harms the nurse/client relationship and interferes with the safe and effective delivery of nursing services. A nurse does not need to be assigned” to the client in order for the nurse/client relationship to exist. The role of the nurse in the nurse/client relationship places the nurse in the more powerful position and the nurse must not abuse this power. Under certain circumstances, the nurse/client relationship continues beyond the termination of nursing services. Not only does sexual or romantic misconduct violate the trust and confidence held by health care clients towards nursing staff, it also undermines public confidence in nursing. Nurses can take measures to avoid allegations of misconduct by establishing and maintaining professional boundaries in dealing with their clients.

What conduct is prohibited?

Nurses shall never engage, or attempt to engage, in sexual or romantic conduct with a client, or a client's immediate family members or significant others. Such conduct does not have to involve sexual contact. It includes behaviors or expressions of a sexual or intimately romantic nature. Sexual or romantic conduct is prohibited whether or not the client, family member significant other initiates or consents to the conduct. Such conduct is also prohibited between nursing educator and student. Regardless of the existence of a nurse/client relationship, nurses shall never use patient information derived through their role as a health care provider to attempt to contact a patient in pursuit of a nurse's own sexual or romantic interests or for any other purpose other than legitimate health care.

What should a nurse do to avoid allegations of sexual or romantic misconduct?

Adopting and maintaining professional boundaries is critical to avoiding even the appearance of sexual or romantic misconduct. Nurses can take certain preventive steps to make sure safeguards are in place at all times, such as:

Setting appropriate boundaries with patients, physically and verbally, at the outset of professional relationships, and documenting such actions and the basis for such actions
Consulting with supervisors regarding difficulties in establishing and maintaining professional boundaries with a given client
Seeking reassignment to avoid incurring a violation of these rules.

What about former clients?

A nurse shall not engage or attempt to engage a former client, or former client's immediate family member or significant other, in sexual or romantic conduct if such conduct would constitute abuse of the nurse/client relationship. The nurse/client relationship is abused when:

a nurse uses and/or benefits from the nurse's professional status and the vulnerability of a client due to the client's condition or status as a patient.
Due to the unique vulnerability of mental health and chemical dependency clients, nurses are prohibited from engaging in or attempting to engage in sexual or romantic conduct with such former clients, or their immediate family or significant others For a period of at least two years after termination of nursing services.
After two years, sexual or romantic conduct may be permitted with a former mental health or chemical dependency client, but only if the conduct would not constitute abuse of the nurse/client relationship.

Factors which the commission may consider in determining whether there was abuse of the nurse/ client relationship include, but are not limited to

The amount of time that has passed since nursing services were terminated
The nature and duration of the nurse/client relationship, the extent to which there exists an ongoing nurse/client relationship following the termination of services
whether the client is anticipated to become a client of the nurse in the future
The circumstances of the cessation or termination of the nurse/client relationship
The former client's personal history
The former client's current or past mental status and whether the client has been the recipient of mental health services
The likelihood of an adverse impact on the former client and others
Any statements or actions made by the nurse during the course of treatment suggesting or inviting the possibility of sexual or romantic conduct
Where the conduct is with a client's immediate family member or significant other, whether such a person is vulnerable to being induced into such relationship due to the condition or treatment of the client or the overall circumstances

Are there situations where these rules do not apply? These rules do not prohibit:

The provision of nursing services on an urgent, unforeseen basis where circumstances will not allow a nurse to obtain reassignment or make an appropriate referral
The provision of nursing services to a spouse, or family member, or any other person who is in a preexisting, established relationship with the nurse where no evidence of abuse of the nurse/client relationship exists

Sexual Misconduct Prohibited (WAC 246-840-740) Reproduced from The Nursing Commission Newsletter Winter 1998

What conduct is prohibited?

What should a nurse do to avoid allegations of sexual or romantic misconduct?

Setting appropriate boundaries with patients, physically and verbally, at the outset of professional relationships, and documenting such actions and the basis for such actions
Consulting with supervisors regarding difficulties in establishing and maintaining professional boundaries with a given client
Seeking reassignment to avoid incurring a violation of these rules

What about former clients?

a nurse uses and/or benefits from the nurse's professional status and the vulnerability of a client due to the client's condition or status as a patient
Due to the unique vulnerability of mental health and chemical dependency clients, nurses are prohibited from engaging in or attempting to engage in sexual or romantic conduct with such former clients, or their immediate family or significant other For a period of at least two years after termination of nursing services. After two years, sexual or romantic conduct may be permitted with a former mental health or chemical dependency client, but only if the conduct would not constitute abuse of the nurse/client relationship

Factors which the commission may consider in determining whether there was abuse of the nurse/ client relationship include but are not limited to:

The amount of time that has passed since nursing services were terminated
The nature and duration of the nurse/client relationship, the extent to which there exists an ongoing nurse/client relationship following the termination of services, and whether the client is anticipated to become a client of the nurse in the future
The circumstances of the cessation or termination of the nurse/client relationship
The former client's personal history
The former client's current or past mental status and whether the client has been the recipient of mental health services
The likelihood of an adverse impact on the former client and others
Any statements or actions made by the nurse during the course of treatment suggesting or inviting the possibility of sexual or romantic conduct
Where the conduct is with a client's immediate family member or significant other, whether such a person is vulnerable to being induced into such relationship due to the condition or treatment of the client or the overall circumstances

Are there situations where these rules do not apply? These rules do not prohibit:

The provision of nursing services on an urgent, unforeseen basis where circumstances will not allow a nurse to obtain reassignment or make an appropriate referral
The provision of nursing services to a spouse, or family member, or any other person who is in a preexisting, established relationship with the nurse where no evidence of abuse of the nurse/client relationship exists

Priviledged Communication & Confidentiality

Care in maintaining confidentiality is an important professional responsibility.

Reporting Abuse

As health professionals, we are required by law to report suspected abuse or neglect of children, developmentally disabled persons and dependent adults. The report must be made verbally to Child Protective Services (all abuse) within 48 hours (721-4852) and followed by a written report upon request. Before reporting a suspected abuse, always consult with your supervisor first. CPS officials are also available to answer your questions about whether a specific case needs to be reported. Document the time and date of your call to CPS, who you spoke to and what they recommended. Put a copy of your written report in the research patient’s file. Whenever possible, discuss your need to report with your client before actually contacting CPS. All clients should have read and signed the “Informed Consent” form explaining our obligation to report abuse.

The Regulation of Services

Licensure

Research investigators are responsible for obtaining a copy of the Washington State licenses of all research staff working in a position that requires such credentials.

Washington State Patrol Clearance

The Washington State Patrol Identification and Criminal History Section is the statewide repository for fingerprint-based criminal history record information (CHRI). Local criminal justice agencies are required by law to submit felony and gross misdemeanor arrest and disposition information to the State Patrol, where it is included in a CHRI database.

Who May Request CHRI?

Certified criminal justice agencies may request and receive unrestricted CHRI from the Identification and Criminal History Section for criminal justice purposes. The public may request and receive CHRI for non-criminal justice purposes, but it is limited to conviction information only. Conviction CHRI is defined in the Revised Code of Washington (RCW) 10.97.030, and it relates to an incident that has led to a conviction or other disposition adverse to the subject. In addition to the conviction CHRI, non-criminal justice requestors (the public) may receive a record showing pending arrest offenses under one year old without disposition, and if the subject is a registered sex offender or kidnapper.

Two Types of Criminal History Requests

Depending on the purpose, the Identification and Criminal History Section responds to non-criminal justice inquiries under two different statutes.

Criminal Records Privacy Act (Chapter 10.97 RCW)
Child and Adult Abuse Information Act (RCW 43.43.830-.845)

On-line information from WATCH is immediate. However, it takes from 3 to 10 weeks for us to respond to written requests.

Criminal Records Privacy Act

Under the Criminal Records Privacy Act, conviction CHRI may be made public to anyone without restriction and without the consent of the subject of the record. The requestor must submit either a Request for Conviction Criminal History Record (using Form 3000-240-569 or WATCH) or a full set of the subject's fingerprints.

Instructions for Completing Form 3000-240-569

Part A - Write in the applicant's (subject's) full name, date of birth, and alias names--including birth and married names. The subject's sex, race, social security number, and driver's license number are helpful in searching for CHRI.
Part B - Print your (the requestor's) full name, telephone number, and complete address. Be sure to fill in the date and sign your name.

Responses

Each written response takes from 3 to 10 weeks to complete. If a record exists, a copy of the record will be attached to the returned form. It will include all state of Washington conviction CHRI and pending arrest offenses under one year old without disposition. If the subject is a registered sex offender or kidnapper, it will be disclosed on the record you receive. If our search reveals that no CHRI exists, the form will be returned to you and the "WSP Use Only" box will be stamped. Secondary dissemination of the CHRI is prohibited, unless in compliance with RCW 10.97.050.

Child and Adult Abuse Information Act

Under the Child and Adult Abuse Information Act, requests for CHRI are limited to businesses or organizations licensed in the state of Washington; any agency of the state; or other governmental entities that educate, train, treat, supervise, house, or provide recreation to developmentally disabled persons, vulnerable adults, or children under 16 years of age. The requestor may submit either a Request for Criminal History Information Child/Adult Abuse Information Act (using Form 3000-240-430 or WATCH) or a full set of the subject's fingerprints.

Supervision

PI Responsibility

The Principal Investigator (PI) is responsible for orienting the staff members to the CSU (e.g., the manual, keys, and safety features).

RA Responsibility

The Research Assistant (RA) or any other research staff is responsible for obtaining an orientation from the PI (e.g., the manual, keys, and safety features).

Management of Emergency Situations

During the conduct of clinical research with human participants, there is always the potential that an emergency situation will arise. The general categories of emergency situations that might arise include: (1) medical emergencies, (2) suicidal subjects/substance-using subjects and (3) dangerous/disruptive subjects. Neither the Clinical Studies Unit (CSU) nor the research projects operating under its auspices are authorized or prepared to provide crisis or emergency services to subjects/study participants. The following guidelines are designed to support project personnel in the management of emergency situations. Specifically, these policies and procedures are designed to assist project personnel with identifying and contacting the health care agencies/resources that are the most appropriate for providing crisis or emergency services in specific instances. In all emergency situations, project personnel should contact project administrators and faculty investigators as soon as possible, so that they can assist in the management of the emergency situation.

Medical Emergencies

Any project personnel who are working directly with study participants will be required to have current CPR training. It is the responsibility of each project to ensure current CPR training for project personnel who work directly with study participants.

In the event of a medical emergency (e.g. cardiac arrest, sudden loss of consciousness), School of Nursing project personnel should dial 9-911 on the nearest phone. Campus police will triage the call to get emergency personnel on their way. They will then forward your call to the Seattle Fire Department. You will then be responsible for communicating with the fire department to arrange for appropriate help (i.e., ambulance, paramedic, etc.) and to assure that the emergency personnel can respond to the scene. If appropriate, study personnel should initiate CPR until the emergency team arrives. If immediately accessible, other personnel in the CSU should be recruited to help manage the emergency situation and if possible assist in escorting emergency teams to the precise location from the street.

Suicidal Subjects

Subjects expressing thoughts of suicide or death during an interview, a treatment session or in response to a questionnaire should be immediately assessed with regard to suicidal risk. Any interview or questionnaire item that might indicate suicide intent/risk should be evaluated by qualified project personnel before the subject leaves the CSU. The Suicide Risk Assessment Decision Chart (see below) is provided as a guide for assessment of suicide risk.

Subjects at moderate risk for suicide should be seen within 24 hours by a mental health professional. If the individual is currently working with a therapist, he/she should meet with that therapist within 24 hours. If the individual does not currently have a therapist he/she should be directed to the Crisis Line, 206-461-3222. The Crisis Line will conduct a suicide risk assessment and, as appropriate, provide mental health referrals. As indicated, study personnel should facilitate the contact between the subject and a significant other or between the subject and the therapist/Crisis Line.

Subjects at imminent risk for suicide need to be evaluated by a mental health professional immediately. Emergency psychiatric evaluation is available at Harborview Medical Center, 206-731-2649, or the University Hospital Emergency Room, 206-548-4000. Students who are currently enrolled at the UW may be evaluated by crisis services available at Hall Health Center, Monday-Friday from 9AM-5PM by calling 206-583-1551. As a precaution, you may wish to have the University Police escort the subject to the University Hospital Emergency Room or to Hall Health. Under other circumstances you may wish to call University Police 9-911 (for an emergency) or 206-543-9331 (for other assistance). Under no circumstances should project personnel transport individuals at risk for suicide. Transport includes driving an individual or walking with the person to either the UW or Harborview Emergency Rooms or Hall Health.

In the State of Washington, only a designated mental health professional (MHP) can hospitalize someone involuntarily. Hospital emergency rooms at Harborview and University of Washington Hospital will have personnel available to decide on the question of commitment and will know the procedures to follow. In instances when a research subject or potential subject arrives and you suspect that he or she is under the influence of ETOH or other substance(s), provision should be made for safe transport to his or her home. Options for safe transport to home would include contacting a relative or friend of the individual for transport home or the use of a taxi. If you suspect that an individual who is under the influence of drugs or alcohol is a lethality risk transport to UW Emergency Room or Harborview Emergency Room is indicated.

Dangerous or Disruptive Subjects

When managing a situation with a violent subject, your safety is primary. When interviewing new or potentially threatening subjects, always place yourself so that your exit from the room can be executed quickly and safely, and can not be blocked. If you are in a therapy/interview room with a subject who becomes threatening or violent, leave the room immediately. Locate any phone and dial 9-911 to contact the UW Police. Another option is to remove yourself from the threatening situation and go to a safe/locked area, preferably with a phone so that you can contact University Police by calling 9-911. If you are unable to reach a phone, yell for help. Under no circumstances should you attempt a physical confrontation with a violent, armed or threatening subject. If a violent or threatening subject leaves the CSU, do not follow them, but let them go and call the University Police with a description of the individual and the direction where they were going.

Under less threatening circumstances (i.e., when a subject becomes agitated but is not directly threatening or endangering you), you can ask the subject to leave the room or leave the CSU temporarily. Seek consultation immediately from project administrative personnel or faculty investigators. Contact UW police at 9-911 at any time you feel that the situation is unsafe.

If a research subject or potential subject informs you of his or her intent to injure or kill another individual you should contact UW Police immediately. As a health care professional, you are also required by law to work with University Police to inform the potential victim of the threat made by the research subject or potential research subject. Seek consultation immediately from project administrative personnel or faculty investigators.

In any of the above circumstances, when it becomes necessary to call the UW Police, the following procedures will be in effect: When the police arrive, they should ask you to ask the disruptive subject (or non-subject), in the presence of the police, to leave the CSU. If the person refuses to leave, the police should then advise the person of the statute regarding criminal trespass and ask again for the person to leave the CSU voluntarily. If the person still refuses to leave, the police will escort the disruptive person out of the CSU and depending on the circumstances may arrest the disruptive person. If, for any reason the police do not follow these procedures, or do not seem to take your request seriously, call 206-543-9331 immediately and ask to speak to a supervisor. Do not call the campus escort service. This is a service provided for the safety of students walking the campus at night.