either of the primary procedures for obtaining informed consent would surely invalidate objectives of considerable immediate importance, and (3) that any reasonable alternative means for attaining these objectives would be less advantageous to the subjects. The committee's reasons for permitting the use of modified procedures must be individually and specifically documented in the minutes and in reports of committee actions to the files of the organization. All such modifications should be regularly reconsidered as a function of continuing review and as required for annual review, with documentation of reaffirmation, revision, or discontinuation, as appropriate. § 46.11 Certification, general assurances. (a) Timely review. Unless the Secretary otherwise provides, all proposals involving human subjects submitted by organizations having approved general assurances must be given review and, when found to involve subject at risk, approval, prior to submission to DHEW. In the event the Secretary provides for the performance of organizational review of a proposal after its submission to DHEW, processing of such proposal by DHEW will under no circumstances be completed until such organizational review and approval has been certified. Unless the organization determines that human subjects are not involved, the proposal or application should be appropriately certified in the spaces provided on forms, or one of the following certifications, as appropriate, should be typed on the lower or right hand margin of the page bearing the name of an official authorized to sign or execute applications or proposals for the organization. Human Subjects: Reviewed, Not at Risk, (date) Human Subjects: Reviewed, At Risk, Approved.--. (date) (b) Proposals not certified. Proposals not properly certified, or submitted as not involving human subjects and found by the operating agency to involve human subjects, will be returned to the organization concerned. § 46.12 Certification, special assurances. (a) An applicant organization not having on file with DHEW an approved general assurance must submit for each application or proposal involving human subjects a separate special assurance and certification of its review and approval. (b) Such assurance and certification must be submitted within such time limit as the Secretary may specify. An assurance and certification prepared in accordance with this part and approved by DHEW shall be considered to have met the requirement for certification for the initial grant or contract period concerned. If the terms of the grant or contract recommend additional support periods, certification shall be provided by the organization with applications for continuation or renewal of support in the manner prescribed in § 46.11(a). § 46.13 Proposals lacking definite plans for involvement of human subjects. Certain types of proposals are submitted with the knowledge that subjects are to be involved within the support period, but definite plans for this involvement would not normally be set forth in the proposal. These include such activities as (a) institutional type grants where selection of projects is the responsibility of the institution, (b) training grants where training projects remain to be selected, and (c) research, pilot, or developmental studies in which involvement depends upon such things as the completion of instruments, or of prior animal studies, or upon the purification of compounds. Such proposals shall be reviewed and certified in the same manner as more definitive proposals. The initial certification indicates organizational approval of the applications as submitted, and commits the organization to later review of the plans when completed. Such later review and certification to the DHEW should be completed prior to the beginning of the budget period during which actual involvement of human subjects is to begin. Review and certification to the DHEW must in any event be completed prior to involvement of human subjects. § 46.14 Proposals submitted with the intent of not involving human subjects. If a proposal does not anticipate involving or intend to involve human subjects, no certification should be included with the initial submission of the proposal. In those instances, however, when later it becomes appropriate to use all or part of awarded funds for one or more activities which will involve subjects, each such activity shall be reviewed and approved in accordance with the assurance of the organization prior to the involvement of subjects. In addition, no such activity shall be undertaken until the organization has submitted to DHEW: (a) a certification that the activity has been reviewed and approved in accordance with this part, and (b) a detailed description of the proposed activity (including any protocol or similar document). Also, where support is provided by project grants or contracts, subjects shall not be involved prior to certification and organizational receipt of DHEW approval and, in the case of contracts, prior to negotiation and approval of an amended contract description of work. § 46.15 Evaluation and disposition of proposals. (a) Notwithstanding any prior review, approval, and certification by the organization, all grant and contract proposals involving human subjects at risk submitted to the DHEW shall be evaluated by the Secretary for compliance with this part through such officers and employees of the Department and such experts or consultants engaged for this purpose as he determines to be appropriate. This evaluation may take into account, among other pertinent factors,the apparent risks to the subjects, the adequacy of protection against these risks, the potential benefits of the activity to the subjects and to others, and the importance of the knowledge to be gained. (b) Disposition. On the basis of his evaluation of an application pursuant to paragraph (a) of this section and subject to such approval or recommendation by or consultation with appropriate councils, committees, or other bodies as may be required by law, the Secretary shall (1) approve, (2) defer for further evaluation, or (3) disapprove support of the proposed activity in whole or in part. With respect to any approved grant or contract, the Secretary may impose conditions, including restrictions on the use of certain procedures, or certain subject groups, or requiring use of specified safeguards or informed consent procedures when in his judgment such conditions are necessary for the protection of human subjects. § 46.16 Cooperative activities. Cooperative activities are those which involve organizations in addition to the grantee or prime contractor (such as a contractor under a grantee or a subcontractor under a prime contractor). If, in such instances, the grantee or prime contractor obtains access to all or some of the subjects involved through one or more cooperating organizations, the basic DHEW policy applies and the grantee or prime contractor remains responsible for safeguarding the rights and welfare of the subjects. (a) Organization with approved general assurance. Initial and continuing review by the organization may be carried out by one or a combination of procedures: (1) Cooperating organization with approved general assurance. When the cooperating organization has on file with DHEW an approved general assurance, the grantee or contractor may, in addition to its own review, request the cooperating organization to conduct an independent review and to report its recommendations on those aspects of the activity that concern individuals for whom the cooperating organization has responsibility under its own assurance to the grantee's or contractor's committee. The grantee or contractor may, at its discretion, concur with or further restrict the recommendations of the cooperating organization. It is the responsibility of the grantee or contractor to maintain communication with the committees of the cooperating organizaion. However, the cooperating organization shall promptly notify the grantee or contracting organization whenever the cooperating organization finds the conduct of the project or activity within its purview unsatisfactory. (2) Cooperating organization with no approved general assurance. When the cooperating organization does not have an approved general assurance on file with DHEW, the DHEW may require the submission of a general or special assurance which, if approved, will permit the grantee or contractor to follow the procedure outlined in the preceding subparagraph. (3) Interorganizational joint review. The grantee or contracting organization may wish to develop an agreement with cooperating organizations to provide for a review committee with representatives from cooperating organizations. Representatives of cooperating organizations may be appointed as ad hoc members of the grantee or contracting organization's existing review committee or, if cooperation is on a frequent or continuing basis as between a medical school and a group of affiliated hospitals, appointments for extended periods may be made. All such cooperative arrangements must be approved by DHEW as part of a general assurance, or as an amendment to a general assurance. (b) Organizations with special assurances. While responsibility for initial and continuing review necessarily lies with the grantee or contracting organization, DHEW may also require approved assurances from those cooperating organizations having immediate responsibility for subjects. If the cooperating organization has on file with DHEW an approved general assurance, the grantee or contractor shall request the cooperating organization to conduct its own independent review of those aspects of the project or activity which will involve human subjects for which it has responsibility. Such a request shall be in writing and should provide for direct notification of the grantee's or contractor's committee in the event that the cooperating organization's committee finds the conduct of the activity to be unsatisfactory. If the cooperating organization does not have an approved general assurance on file with DHEW, it must submit to DHEW a general or special assurance which is determined by DHEW to comply with the provisions of this part. $46.17 Investigational new drug 30-day delay requirement. Where an organization is required to prepare or to submit a certification under §§ 46.11, 46.12, 46.13, or 46.14 and the proposal involves an investigational new drug within the meaning of The Food, Drug, and Cosmetic Act, the drug shall be identified in the certification together with a statement that the 30-day delay required by 21 CFR 130.3 (a) (2) has elapsed and the Food and Drug Administration has not, prior to expiration of such 30-day interval, requested that the sponsor continue to withhold or to restrict use of the drug in human subjects; or that the Food and Drug Administration has waived the 30-day delay requirement; provided, however, that in those cases in which the 30-day delay interval has neither expired nor been waived, a statement shall be forwarded to DHEW upon such expiration or upon receipt of a waiver. No certification shall be considered acceptable until such statement has been received. § 46.18 Organization's executive responsibility. Specific executive functions to be conducted by the organization include policy development and promulgation and continuing indoctrination of personnel. Appropriate administrative assistance and support shall be provided for the committee's functions. Implementation of the committee's recommendations through appropriate administrative action and followup is a condition of DHEW approval of an assurance. Committee approvals, favorable actions, and recommendations are subject to review and to disapproval or further restriction by the organization officials. Committee disapprovals, restrictions, or conditions cannot be rescinded or removed except by action of a committee described in the assurance approved by DHEW. § 46.19 Organization's records; confidentiality. (a) Copies of all documents presented or required for initial and continuing review by the organization's review committee, such as committee minutes, records of subjects's consent, transmittals on actions, instructions, and conditions resulting from committee deliberations addressed to the activity director, are to be retained by the organization, subject to the terms and conditions of grant and contract awards. b) Except as otherwise provided by law information in the records or possession of an organization acquired in connection with an activity covered by this part, which information refers to or can be identified with a particular subject may not be disclosed except: (1) with the consent of the subject or his legally authorized representative or; (2) as may be necessary for the Secretary to carry out his responsibilities under this part. § 46.20 Reports. Each organization with an approved assurance shall provide the Secretary with such reports and other information as the Secretary may from time to time prescribe. § 46.21 Early termination of awards; evaluation of subsequent applications. (a) If, in the judgment of the Secretary an organization has failed materially to comply with the terms of this policy with respect to a particular DHEW grant or contract, he may require that said grant or contract be terminated or suspended in the manner prescribed in applicable grant or procurement regulations. (b) In evaluating proposals or applications for support of activities covered by this part, the Secretary may take into account, in addition to all other eligibility requirements and program criteria, such factors as: (1) whether the offerer or applicant has been subject to a termination or suspension under paragraph (a) of this section, (2) whether the offerer or applicant or the person who would direct the scientific and technical aspects of an activity has in the judgment of the Secretary failed materially to discharge his, her, or its responsibility for the protection of the rights and welfare of subjects in his, her, or its care (whether or not DHEW funds were involved), and (3) whether, where past deficiencies have existed in discharging such responsibility, adequate steps have in the judgment of the Secretary been taken to eliminate these deficiencies. § 46.22 Conditions. The Secretary may with respect to any grant or contract or any class of grants or contracts impose additional conditions prior to or at the time of any award when in his judgment such conditions are necessary for the protection of human subjects. [FR Doc. 74-12269 Filed 5-29-74; 8:45 am] Dr. J. R. NEW BROUGH, U.S. SENATE, COMMITTEE ON GOVERNMENT OPERATIONS, Center for Community Studies, George Peabody College, DEAR DR. NEWBROUGH: Thank you for your letter of July 2, 1974 containing your views on record systems and registries for children. The information will be most helpful in our development of privacy legislation. Hearings have been conducted, but I shall include your letter and enclosure in the printed record. Enclosed are reprints describing the Committee investigation. As you will see, S. 3418 would apply to federal, state, local and private record-keeping while S. 3633 would cover federal, intergovernmental and other information systems receiving federal support. If, after reviewing the text of S. 3418 contained in the May 2nd Congressional Record excerpt, you wish to offer further comments, the Committee would welcome your expert advice. With all kind wishes, I am Sincerely yours, SAM J. ERVIN, JR., Chairman. CENTER FOR COMMUNITY STUDIES, Hon. SAM ERVIN, Senator from North Carolina, Senate Office Building, Washington, D.C. DEAR SENATOR ERVIN: I notice from the newspapers that you are currently holding hearings on the matter of records systems. I have been particularly interested in them and wished to share two ideas about safeguards that I have developed. The background for these was a project on the Classification of Exceptional Children directed by Dr. Nicholas Hobbs, Provost, Vanderbilt University, Nashville, Tennessee. I prepared a memorandum to Dr. Hobbs (which I attach for your information) on the matter of Records Systems and Registries for children. The two final recommendations, however, are appropriate for all citizens. They are: 1. Recommendation for registers and name-linked systems. In order to protect the person, the contents of the information held in the computer or linkage system should be periodically (yearly) printed out and provided to the person in complete detail. The system should also record the name, agency, date and content of information shared for each time the person's file is accessed and information removed. 2. General recommendation. All information should be reviewed by the person and the agency, institution or system each ten years (keyed to the person's dicennial birthdays). Any information to be retained must have the joint agreement of the person and the agency. All other information is to be destroyed. If I may provide further information, I should be happy to do so. Sincerely, J. R. NEWBROUGH. To: Nicholas Hobbs. CENTER FOR COMMUNITY STUDIES, MEMORANDUM From: J. R. Newbrough. Date: November 28, 1973. Subject: Section for Final Report on Records and Registries. I. I based the following on your section, Lister's paper, the sources cited in the draft, and some of my own thoughts. It is now in First draft form for your, the staff's, and Bert Brim's review. Would you collect the replies and suggestions for alteration? If you want, I will then work it over again. II. Records and Record-keeping.-Records are kept on all children as part of their contacts with service organizations. The schools maintain a cumulative student record that serves as a dossier. The exceptional child is particularly exposed to the risks of record-keeping since the characteristics which prompt the institution to help or to control also lead them to create and retain records (Baker, Lister, & Milhous, 1973). Three problems are contained in the record-keeping matter which represents threats to the civil liberties of the child: (1) Privacy. This involves the collection of information not actually needed for service purposes. This same information may become information which limits opportunities of the child in the future. (2) Confidentiality.—This involves the protection of information so that only those with a need and a right to know can have access to the information. (3) Due process.-This refers to the extent to which the record content, sharing and interpretation is visible to the person and is subject, at least in part, to his or her control. Record-keeping serves an archival and a communication function in institutions. The records are a by-product of the service and are often handled by staff not in direct service work. Specialists (librarians or clerks) manage the records as if they were impersonal information collections (like books). Procedures to protect confidentiality and to provide due process represent complicating aspects of the procedure which requires more procedures and rules and manpower. Further, the professional or the agency regards the record as his property, to be managed as seen appropriate for their professional purposes. The individual person is then in no position to protect his own interests. In addition to these institutional practices which present threats to individual civil liberties, there is the status of the child legally and socially that complicates the picture, particularly as regards due process (taken from Baker, Lister, & Milhous, 1973). (1.) The child is not regarded as a full-member of society with the same rights as a citizen. (2.) Whatever rights the child is understood to have is nearly always exercised through the child's parents. (3.) With no citizens' rights of privacy and confidentiality clear under existing law, the exceptional child is often in a special status created by the view of him as an inferior child. These three aspects make it difficult for there to be proper safeguards established for exceptional children, or children in general. And were they established, the procedures necessary to ensure that the parents were acting in the best interests of (or as an agent for) the child would represent a major challenge. Recommendation for agencies and institutions. In order to insure responsible and ethical practices in record-keeping, each agency establish a Records Policy Board composed of appropriate professional people, of legal counsel on civil rights matters and of parents or their representatives. The Records Policy Board would: |