Department of Medicine
Center for Cost and Outcomes Research
Campus Box 359736
325 Ninth Ave
Seattle WA 98104
Patient toll free line (800) 246-8142
Fax (206) 744-9889
niams@u.washington.edu
Follow-up Unit IRB application information.
Follow up data collection for this study will be performed by the UW Follow-up Unit, a group affiliated with the
Center for Cost and Outcomes Research dedicated to data collection for clinical research studies. The Follow-up
Unit will charge the study budget on a per patient-interview basis (variable cost, dependent on recruitment) at a rate
which will include printing of surveys, computing, telephone charges, long distance communications, and
administration. The Follow-up Unit operates off of a program income budget and has developed a pricing structure
in accordance with the Management Accounting and Analysis office at the UW. The administrator of the Follow-up
Unit is:
Brook Martin, MPH
Research Scientist
Division of General Internal Medicine
bim@u.washington.edu
(206) 744-1803
Participant contact information
The Follow-up Unit uses a centralized computer server application which stores data and systematically generates
follow-up monitoring tasks across all projects. The participant contact information will be entered by the study team
into this computer which will then be used to assign each subject to an interviewer working for the Follow-up Unit.
Since the Follow-up Unit is primarily responsible for contacting study participants in order to collect research data,
identifiable information is a necessity. Once a study participant has completed the study protocol, the participant’s
contact information will be permanently removed from the Follow-up Unit records. The study data collected on
behalf of the researcher will be delivered to the researcher either as hardcopies or electronic data identified only by
the participants’ research identification number initially provided by the researcher. It is necessary to retain the
study ID number within data that is delivered to the researcher so that they could match the collected Follow-up Unit
survey data to other forms of data, such as laboratory results or imaging reports, for the same subjects. Once the
research data has been delivered to the researcher, all records of the data will be removed from the Follow-up unit
systems. The Follow-Up unit will not retain data indefinitely, will not retain it as a data repository, and will not
maintain it as a backup service for the researcher.
Data stored in the Follow-Up Unit System
The information that the Follow-up Unit collects and maintains includes:

Contact information received from the researcher at the time that a patient enrolls in a study. This
information includes participant name, phone number(s), mailing address, e-mail address, and alternate
contacts. The Follow-up Unit has developed a standardized contact information form which is used to
capture the information needed by the Follow-up Unit;

Information collected directly from study participants in response to a research study survey, specific for
each study;

Information received from the researchers or from outside organizations offering public information which
can be used to find study participants in order to conduct a survey (such as motor vehicle records, USPS
mail forward service, and third party directory searches); and

Information we have recorded in our system regarding attempts we have made to contact study participants
in order to perform a research study interview.
IRB statement
Created by Brook Martin, MPH
Created on: 12/14/05
Department of Medicine
Center for Cost and Outcomes Research
Campus Box 359736
325 Ninth Ave
Seattle WA 98104
Patient toll free line (800) 246-8142
Fax (206) 744-9889
niams@u.washington.edu
Follow-up data collection procedures
The Follow-up Unit will be responsible for contacting patients through phone, mail and e-mail (if written into
protocol) in order to collect follow-up research data on study participants.
At the start of the study, all patients will be provided a letter introducing them to the data collection service provided
by the Follow-up Unit. This letter will include a toll free number for participants (800-246-8142), an e-mail
(niams@u.washington.edu), and the address for contacting the Follow-up Unit (Center for Cost and Outcomes
Research, Box 359736 psb5076, 325 Ninth Ave., Seattle WA 98104). In addition, the Follow-up Unit will provide a
privacy statement to all study participants as they begin the study (see privacy policy attached.)
At the beginning of each interview time point, the Follow-up Unit will send a letter and e-mail (if allowed by
protocol) to the participants to explain that we are about to begin efforts to contact them for a research interview.
Throughout the interview window, multiple attempts to contact the patient via telephone and e-mail (if allowed by
protocol) will be made by the Follow-up Unit, who will vary the days and times of their attempts. The Follow-up
Unit makes approximately five telephone attempts per week while the patient is in the interview window. In
addition, they will attempt to collect survey material via mail if we are unable to reach them via phone. Mailed
surveys will be sent in an opaque envelope which will not include information on the outside that would identify the
study condition, and will also include a postage paid return envelope.
If a participants’ phone numbers or address becomes insufficient (e.g. returned mail or disconnected phone number)
the Follow-up Unit will make an additional effort to find them. These efforts include utilizing the USPS mail
forwarding service, calling the alternate contacts that were provided by the participant, checking third party phone
and mail tracking databases (such as through the department of licensing, reverse directories, or www.5551212.com), and informing the researcher to check their medical records for updated contact information.
Interviewer Training
Research interviewers working for the Follow-up Unit are trained in telephone interviewing skills, HIPAA
compliance, ethical treatment of subjects participating in research, best practices for computer security, and how to
respond when a study participant raises concerns of self-harm. The Follow-up Unit provides feedback on an
ongoing basis to the researcher of key monitoring variables as well as collaborates on research monitoring issues.
Mental Health
In asking research survey questions, it is possible that a subject may reveal intentions for self-harm. In such cases, it
will not be the responsibility of the Follow-up Unit to deal directly with subjects in order to deal with the crisis.
Rather, in the event that a study participant provides an answer to a survey question which suggests that they may
have intentions of self-harm, appropriate actions for a non-clinician interviewer will be taken. Initially the purpose
of the interviewers’ actions will be limited to assessing whether there is an immediate, serious crisis. If this is the
case, the first action will be to immediately contact the researchers or a researcher designee, who should then deal
with the crisis. If the researcher or designee is not immediately available, the interviewers working for the Followup Unit will take the following actions:
a) Determine if the participant is seeing any provider (such as a mental health professional) for the feelings of selfharm in order to suggest that the participant be seen.
IRB statement
Created by Brook Martin, MPH
Created on: 12/14/05
Department of Medicine
Center for Cost and Outcomes Research
Campus Box 359736
325 Ninth Ave
Seattle WA 98104
Patient toll free line (800) 246-8142
Fax (206) 744-9889
niams@u.washington.edu
b) Determine is they are willing to speak to a mental health provider regarding the feelings of self harm.
d) Offer the local crisis hotline.
e) Inform the researcher of the self-harm response.
System security
The Follow-up Unit uses a centralized computer server application which stores data and systematically generates
follow-up monitoring tasks across all projects. The Follow-up Unit uses compatible technologies (Microsoft
products) and exercises proper security protocols, to assure that only authorized people have access to information in
the system. The Follow-up Unit’s data server is housed in a physically secured location within the department of
biostatistics at the UWMC. This server hosts a SQL server database with a hardware firewall and virus protections,
is backed up regularly to two separate locations, and uses web application which interfaces study data to a user over
the internet. Authorized users can only access this data over a secure internet connection called Secure Socket Layer
(SSL). Information sent from the server to the client or vice versa is encrypted with a 128-bit encryption algorithm.
This is the standard technology for protecting electronic information. To gain access to our web application, user
must provide strong passwords (passwords that cannot be computer generated in a timely manner). These
passwords are subject to approval before a user is allowed to access our system and will lock out a user profile if
three failed attempts are made to enter a password. These policies are in place in order to prevent unauthorized
and/or malicious attempts at accessing our data. Once in our system, a user’s access to data retrieval/ manipulation
is governed by the principles of least privilege, separation of duties and minimum necessity. These policies ensure
that users are given only the minimal amount of permissions and information needed to perform their job function.
Our computing practices exceed the regulations set forth in the Code of Federal Regulations, Title 21 Part 11,
pertaining to electronic records used in research. In addition, our computing system adheres to the standards set
forth in the School of Medicine’s Security Infrastructure Team’s Informal Compliance Review.
IRB statement
Created by Brook Martin, MPH
Created on: 12/14/05