**COMBINE Data Set**

**Data Access Agreement**

***As a recipient of the COMBINE data, the undersigned users and
institutional official agree to act in accordance with the following
policies***:

1\. Access to COMBINE data files will be restricted to the persons
listed below. Data files will not be released to anyone else (including
new employees or associates of the user) without the approval of NIAAA.
In the event that the investigator changes institutions, a new
application must be submitted to indicate concurrence of the new
institution with the policies in this agreement. Data remaining in the
former institution is to be destroyed, or a new Data Access Application
submitted naming a new requestor/principal investigator.

2\. Data must be kept physically and electronically secure and must not
be directly accessible from the internet (i.e. must be behind a firewall
or not connected to a larger network). Use of portable media (e.g. CD,
flash drive or laptop) is discouraged and, if used, should be encrypted.
Individual level data may not be sold under any conditions.
Applicant/P.I. agrees that his/her name, collaborators and institution
may be listed on the COMBINE website.

3\. By approving and submitting the Data Access Agreement the requestor
and his/her authorized institutional official certify that all relevant
institutional policies (including IRB approval if necessary) have been
followed and that other relevant organizations within the institution
(e.g. Human Subjects Protection Office, Information Technology Office)
have reviewed the access application and data access agreement and are
in agreement with the policies stated.

4\. Dr. Raye Litten of NIAAA (phone 301-443-0636; <rlitten@mail.nih.gov>
) or Dr. Patricia Thomson of CSR (phone 703-741-7179;
<pthomson@CSRIncorporated.com> ) will be notified immediately of any
problems or anomalies found within the data set or its accompanying
documentation.

5\. The COMBINE data will only be used for legitimate research purposes.
The anonymity of research participants will be protected and no attempt
to identify or contact individual participants will be made. In the
unlikely event that the identity of an individual becomes known, this
information will be withheld from others and NIAAA will be notified
immediately. Any other breaches in security (e.g. inadvertent release of
data, unauthorized use, and electronic data system breach) will likewise
be immediately reported to NIAAA. Approved users who may have access to
personal identifying information for research participants in the
original study may be required by their institution to have IRB approval
for their research plan.

6\. Investigators, at least yearly, will send citation information on
publications, presentations, abstracts, theses, dissertations, as well
as in press papers, using the COMBINE data set to Dr. Raye Litten, so
that this information can be posted on the COMBINE website.

7\. All presentations, papers, published articles, theses, abstracts,
dissertations and other written materials that report results based on
the COMBINE Data Set must include the following acknowledgement and
disclaimer, in writing, as appropriate:

> *"The author(s) acknowledge(s) that the reported results are, in whole
> or in part, based on analyses of the COMBINE Data Set. These data were
> collected as part of a multisite clinical trial of alcoholism
> treatments supported by a series of grants from the National Institute
> on Alcohol Abuse and Alcoholism, NIH, DHHS. This presentation
> (paper/article/chapter/document) has not been reviewed or endorsed by
> NIAAA or the COMBINE Research Group and does not necessarily represent
> the opinions of its members or NIAAA, who are not responsible for the
> contents."*

8\. For the purposes of bibliographic citation, the recommended citation
format is:

> COMBINE Research Group. The Combined Pharmacotherapies and Behavioral
> Interventions Study (COMBINE), 2001--2004 (data files and
> documentation). Sponsored by the National Institute on Alcohol Abuse
> and Alcoholism, National Institutes of Health, DHHS.

9\. The NIH or NIAAA may terminate this agreement and revoke access at
any time if the applicant/PI is found to be no longer in agreement with
the data access policies and procedures of the NIH and NIAAA.

**Applicant/P.I.**

Name (please print)

Date

Signature

**Authorized Institutional Official**

Name (please print)

Date

Signature

**Collaborators/Students/Data Analysts/Other Users**

Name (please print)

Date:

Signature

Name (please print)

Date

Signature

Name (please print)

Date

Signature

Name (please print)

Date

Signature

(Add additional names, dates, and signatures as necessary)