Memo Operating Guidance
ARCHIVE. See Memo 05-01 for current guidance at http://www.ucop.edu/raohome/cgmemos/05-01.html
January 30, 1986
Subject: Confidentiality of Information Clause--DHHS
Enclosure I is a copy of the "Confidentiality of Information" clause which appears in the DHHS Acquisition Regulations (HHSAR) at 48 CFR 352,224-70, as required under certain circumstances by 48 CFR 324.70. Although this clause has been in existence for almost two years, a recent query from one campus suggests that the following guidance, which has received legal review, may be helpful. A copy of the clause and the related CFR subpart are enclosed. The following analysis assumes that all of the information in question is unclassified.
Paragraphs (b), (f), and (g) of the clause are cause for concern because, taken together, they seem to give the agency the right of prior approval before certain research results may be published. There is no problem when it comes to patient names or other personal data, since both the government and the University have the same interest in restricting the dissemination of such information, and the scope of the agency restrictions are well defined by law. When it comes to "information which might require special consideration with regard to the timing of its disclosure," however, the interests of the two parties may conflict and there is no statutory recourse. With respect to the clause in question, there are basically three options for preserving the right of the University to disseminate non-personally identifying research findings:
(1) Deletion. Paragraphs (b), (.f), and (g) could be negotiated out of the signed contract on the grounds that they are inappropriate given the type of research being done.
(2) Advance Understanding. It may be possible to reach agreement that the only information to be considered confidential or subject to special consideration is the identity of subjects. Such an understanding should be explicitly stated either in the contract or in a covering letter, using language such as: "Contracting Officer and Contractor are agreed that the category of information to be considered confidential or subject to special consideration, as it pertains to Article ---,'Confidentiality of Information', is restricted to the identity of subjects."
(3) Subject to Interpretation. It may be possible to sign the contract if paragraphs (b), (f), and (g) would have no practical effect. That is, the paragraphs may be de facto not applicable if the Principal Investigator knows in advance that the conditions under which (b), (f), and (g) might pose a barrier to publication would never arise. It can be argued that in most cases the academic standards for publication of results precludes "public disclosure of preliminary unvalidated findings (which) could create erroneous conclusions which might threaten public health or safety if acted upon." Because there are no stipulated standards for judging such acts, the University could claim that, in our judgment, disclosure of the results did not fall within the scope of the clause or require prior approval.
The preferred option is (3), since under the interpretation outlined in that option a contract containing the clause could simply be signed without further ado. However, once attention is focused on the clause in a contract negotiation, then option (2) is appropriate. Given past experience in dealing with DHHS, it is very unlikely that the agency would agree to option (1).
This Memo supersedes and cancels Contract and Grant Memo No. 1-79, dated July 11, 1978, on the same subject.
Refer: Bill Sellers
Subject Index: 1, 17, 18
Organization Index: F-350
Cancel C& G Memo: 1-79
David F. Mears
University Contracts and Grants Coordinator
C& G Memo 86-2
January 30, 1986
Title 41--Federal Acquisition Regulations
Chapter 3--Department of Health and Human Services
352.224-70 Confidentiality of Information.
[see clause in CFR]
Title 48---Federal Acquisition Regulations System
Chapter 3--Department of Health and Human Services
Subpart 324.70--Confidentiality of Information
In the performance of certain HHS contracts, it is necessary for the contractor to generate data, or be furnished data by the Government, which is about individuals, organizations, or Federal programs. This subpart and the accompanying contract clause require contractors to prudently handle disclosure of certain types of information not subject to the Privacy Act or the HHS human subject regulations set forth in 45 CFR Part 46. This subpart and contract clause address the kinds of data to be generated by the contractor and/or data to be furnished by the Government that are considered confidential and how it should be treated.
It is the policy of HHS to protect personal interests of individuals, corporate interests of non-governmental organizations, and the capacity of the Government to provide public services when information from or about individuals, organizations, or Federal agencies is provided to or obtained by contractors in performance of HHS contracts. This protection depends on the contractor's recognition and proper handling of such information. As a result, the "Confidentiality of Information" contract clause was developed.
(a) The "Confidentiality of Information" clause, set forth in 352.324-70, should be inserted in solicitations and resultant contracts whenever the need exists to keep information confidential. Examples of situations where the clause may be appropriate include:
(1) Studies performed by the contractor which generate information or involve Government-furnished information that is personally identifiable, such as medical records, vital statistics, surveys, and questionnaires;
(2) Contracts which involve the use of salary structures, wage schedules, proprietary plans or processes, or confidential financial information of organizations other than the contractor's; and
(3) Studies or research which may result in preliminary or unvalidated findings which, upon disclosure to the public, might create erroneous conclusions which, if acted upon. could threaten public health or safety.
(b) With regard to protecting individuals, this subpart and contract clause are not meant to regulate or control the method of selecting subjects and performing studies or experiments involving them. These matters are dealt with in the HHS regulation entitled "Protection of Human Subjects, 45 CFR Part 46. If a system of records under contract, or portions thereof, is determined to be subject to the requirements of the Privacy Act, in accordance with FAR 24.1 and 324.1 and Title 45 CFR Part 5b, the procedures cited in those references are applicable and the Privacy Act contract clause shall be included in the contract, If the contract also involves confidential information. as described herein, which is not subject to the Privacy Act, the contract shall include the "Confidentiality of Information" clause in addition to the Privacy Act.
July 11, 1978
The following policy and procedure item remains in effect u incorporated into the Contract and Grant Manual, or until subsequently specifically canceled.
CONFIDENTIALITY OF INFORMATION CLAUSE--DHEW
Over the past several years you have been cautioned against accepting a DHEW contract article entitled "Confidentiality of information" (refer to Attachment 1). The wording in that clause is sufficiently vague and broad that it can be used by DHEW to prohibit publication of research data. (For further background refer to C& G Memo 10-74 which contains Associate Counsel Marchand's three page legal opinion on that article.)
When recently the Berkeley campus was unable to negotiate deletion of the "Confidentiality" article from a NIMH agreement, the campus successfully negotiated an additional article which serves to negate the objectionable
aspects of the subject clause. For your information the Berkeley campus/NIMH
contract language appears in Attachment 2. An April 28, 1978, memo from
Assistant Counsel Alderman which reaffirms the unacceptability of the original
article appears as Attachment 3.
You should continue to negotiate the deletion of the Confidentiality article and to request inclusion of the Berkeley article only when necessary.
Refer: W. Archie, 2-2593
Terms and Conditions of Contracts
Terence A. Feuerborn
Acting University Coordinator,
Contracts and Grants
Confidentiality of Information Article
May 11, 1978
At the request of Mr. Archie we are writing to advise you of negotiations we recently completed with National Institute of Mental Health on the contract article "Confidentiality of Information".
Associate Counsel Marchand, in an opinion dated March 20, 1974, advised Mr. Archie that the article was unacceptable unless there was a formal commitment from the sponsor that it would not use the article to prohibit publication.
In our negotiations with NIH we were unable to have the article deleted or modified. The contracting officer stated that such deletion or modification would constitute a deviation from the HEW Procurement Regulation which would require Secretarial approval.
We then pointed out to the contracting officer that paragraph 3-7.5010 of the HEW Procurement Regulations requires the contracting officer to designate in the contract what information is considered confidential. On that basis we were successful in negotiating an additional contract article as follows:
"ARTICLE - INFORMATION CONSIDERED CONFIDENTIAL
For the purpose of the Article of this contract entitled "Confidentiality of Information" only the identity of subjects shall be considered to be confidential information and Contractor shall be free to publish any material or information based upon the work of this contract so long as the identity of subjects is not revealed. For the purpose of this Article, identity shall include name, identifying number, symbol or other identifying particular assigned to the individual such as finger or voice print or a photograph."
We believe that addition of an article such as the foregoing is a facile mechanism for rendering the "Confidentiality of Information" article acceptable which you may want to pass on to the other campuses.
cc: Assistant Counsel Alderman
April 28, 1978
ASSISTANT MANAGER ROBERT C. EDWARDS Berkeley Campus
Re: Confidentiality of Information Clause--41 CFR Chapter 3
This is in response to your memorandum to General Counsel Reidhaar requesting legal review and an opinion as to the acceptability of the above-referenced clause, and to Research Coordinator Peter Tietjen's memorandum transmitting the regulation under separate cover.
You note that in 1974 Senior Associate Counsel George Marchand advised Willie Archie of the Systemwide Contract and Grant Office that the clause is not acceptable if the sponsor intends to prevent disclosure or dissemination of research results should the project officer not agree with the investigator's interpretation. The opinion further advised that the acceptability of the clause was a matter of policy if the sponsor intended to assert restraints short of prohibition. You ask whether Senior Associate Counsel Marchand's 1974 opinion remains in effect.
1974 was a good year for opinions. I know of no change in University publication policy which would permit
acceptance of the regulation as written. First, it gives
-the contracting officer the unilateral right to identify confidential data to be furnished by the government or generated by the contractor (University) in performance of research. It then prohibits the University from disclosing such information or material based on such information, and gives the government's project officer the right to review such material.
As a general rule, The Regents have accepted contracts containing publication restraints where (1) a precise time limit for government review of proposed material is set forth, and permission to publish is deemed granted unless the government advises the University to the contrary within that time period, and (2) material whose publication is prohibited is limited to classified information, in the case of the government, and to clearly identified proprietary or confidential information in the case of private industry. With these changes, a contract incorporating the regulation would be acceptable from a legal standpoint, and I believe it would conform to University publication policy.
Please call if you have any questions or if I can be of further help.
Kate K. Alderman
Principal Administrative Analyst Archie (w/attach.) Manager Manza
Research Coordinator Tietjen
April 5, 1974
I-2. Office of Education, Contract Provisions -
Confidentiality of Information
The following provision appeared in a Request for Proposal recently issued by the Office of Education to the Riverside campus,
ARTICLE 26. CONFIDENTIALITY OF INFORMATION
The contractor shall not disclose any confidential information obtained in the performance of this contract. Any presentation of any statistical or analytical material or reports based on information obtained from the studies covered by this contract will be subject to review by the Government s project officer
before publication or dissemination for accuracy of factual data, interpretation, and safeguards of privacy.
Pursuant to Associate Counsel George L. Marchand's March 20, 1974 memo
(see attachment) the above language is objectionable in that its intended scope should be clarified before it is agreed to on behalf of the University. Until such time that we can negotiate improved language with Mr. John Thorsley of OE, you should take exception to this language in responding to OE's RFP's. You are cautioned to note your exception in the RFP document, as well as in your transmittal letter.
Refer: Willie Archie, 2-2598
Confidentiality - Research
Terms & Conditions of Contracts
PRINCIPAL ADMINISTRATIVE ANALYST WILLIE C. ARCHIE Contracts and Grants
RFP No. 74-27 - DHEW/Office of Education - Special Provisions
Yesterday, you asked for my comments about Articles 21, 22 and 26 of the Special Provisions of the Office of Education Solicitation and Offer No. 74-27, which is under consideration at UCR.
With respect to Articles 21 and 22, if compliance by UCR is impossible, the terms should not be agreed to. If, on the other hand, compliance is costly, time consuming, etc., the issue is whether UCR wants the award badly enough to comply with the contract. The answer to this question is primarily an administrative one. The legal aspect is that if the terms are agreed to, the University will be obligated to comply with them, even if such compliance is inconvenient and expensive.
The scope of Article 26 is uncertain in two particulars. I recommend that its intended meaning be clarified before the University commits itself to be bound by the provision. The first uncertainty arises from the fact that the term "confidential information" is not defined. Under Article 26, the contractor agrees not to disclose "any confidential information" obtained in the performance of the contract. Article 26 does not define the term or indicate who will decide what information will be classified as confidential. Although there are three possible classifiers, the source, the University or the government, the implication is that the classification will be made by the latter. This uncertainty could cause considerable difficulty because an acceptable definition of confidentiality to the principal investigator might not be agreed to by the project officer, or, in the alternative, a subject of the study might assert that information given the investigator was intended to be confidential, precluding its disclosure. On the other hand, there would seem to be no objection to nondisclosure of "confidential information" if that term were defined to mean information acquired in confidence by the investigator in the course of his research and not open or officially disclosed to the public prior to the time that the claim of confidentiality is asserted. The suggested definition is taken from California Evidence Code Sec. 1040, which confers a privileged status on data obtained by a public agency if it meets the stated standard. A typical application would be that research data obtained after a pledge that the source of the material would not be disclosed could not be published if the source were identified. The second sentence in Article 26 implies that the term "confidential information" will be broadly interpreted by the project officer and may be asserted to preclude publication if the officer concludes that factual data is inaccurate, determines that "any statistical or analytical material or reports based on information obtained from the studies covered by this contract . . ." are invasions are privacy, or the contracting officer disagrees with the interpretation of the products of the research. Because of the breadth of the possible restraints on publication, the issues of academic freedom and University policy on the publication of research are clearly raised. Even if the scope of the second sentence is acceptable from a policy standpoint, as you have noted, there is no time period stated within which the project officer must conclude his review. In the absence of a stated time, the law would imply a reasonable period, but it would be preferable if a time was stipulated in Article 26 to preclude the possibility of future misunderstanding. As you have suggested, a second possible modification which would limit the government's ability to delay or prevent publication would be to add a third sentence to Article 26, to the effect that if the project officer found inaccuracies, violations of privacy, or disagreed with the interpretation of data, the University would have the right to publish but would be required to disclaim DHEW endorsement of the content of the research. If DHEW were to confirm that its intention was to prevent publication if the project officer disagrees with the "interpretation" contained in the research, the clause could not be accepted because the University could not categorically agree to nondisclosure in light of California Gov. Code Sec. 6250 et. seq. These statutes, also known as the California Public Records Act, require the University to permit inspection and copying of its business records on request, subject to certain exceptions, none of which would categorically authorize nondisclosure of interpretations contained in research data. The Act does confer a privileged for "...files the disclosure of which would constitute an unwarranted invasion of personal privacy" [Sec. 6254 (c) ] and for "information received in confidence by" a state agency [Sec. 6254(d) (4)], but neither exception is as broad as the possible scope of Article 26.
In conclusion, (1) Articles 21 and 22 should only be agreed to if UCR can and is willing to comply with the requirements stated because such requirements will be contractual obligations unless they are modified and agreed to by the Office of Education; (2) the intended scope of Article 26 should be clarified before it is agreed to on behalf of the University.
If the Office of Education formally advises that-it intends to prevent disclosure or dissemination of research results should the project officer not agree with the investigator's interpretation, Art. 26 may not be agreed to. If the Office of Education formally indicates its intention to assert restraints on publication short of prohibition, the acceptability of Art. 26 is a matter for determination on policy rather than legal grounds.
Should you wish to make a counter proposal for these provisions, and will indicate the details, I will prepare an appropriate text.
George L. Marchand Associate Counsel
Vice President Perkins
Manager of Contracts and Grants Wolfe
Assistant Vice Chancellor-Research Johnson, UCR Administrative Analyst Thornburg, UCR