Application for Human Subjects Review

Investigator's Name: Joseph Janes
Date: 9/25/94
Address: 304 West Engineering, (550 East University, University of Michigan, Ann Arbor, MI 48109-1092)
Phone: 764-9376
University affiliation: School of Information & Library Studies
Title of Study: User Evaluation of the University of Michigan Digital Library

Basic Elements of Informed Consent (1)

Informed consent in the policy of the University of Michigan means the knowing consent of an individual or his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other forms of constraint or coercion. The written informed consent statement shall be in language which is understandable to the subject or his representative.

The basic elements of information necessary to such consent include:

  1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental or novel.

  2. A description of any reasonable foreseeable risks or discomforts to the subject.

  3. A description of any benefits to the subject or to others which may reasonably be expected from the research.

  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subjects.

  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. (In the case of protocols relating to the Federal Food and Drug Administration Regulations [1981 Federal Register, Vol. 46, No. 17, pg 8951], this statement will also note the possibility that the Food and Drug Administration may inspect the records.)

  6. For research involving more than minimal risk of physical harm, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

In general, if there is a chance of physical harm to persons who take part in a project, the following statement must be used (in accordance with 1978 Federal regulations) when requesting the consent of the subjects:

"I understand that the University will provide first aid medical treatment in the unlikely event of physical injury resulting from research procedures. Additional medical treatment will be provided in accordance with the University's determination of its responsibility to do so. The University does not, however, provide compensation to a person who is injured while participating as a subject in research."

  1. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
  2. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

When appropriate, one or more of the following additional elements of information for consent shall also be provided to each subject.

  1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.

  2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.

  3. Any additional costs to the subject that may result from participation in the research.

  4. The consequences of the subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.

  5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.

  6. The approximate number of subjects involved in the study.

Retention of Consent

The investigator, where appropriate, shall retain in his file a complete set of written consent forms signed by the subject(s) or his (their) authorized representative(s). This treatment of informed consent records may be altered when written consent may be more appropriately retained in clinical files. A copy of the written consent form shall be given by the investigator to all persons who will be signing it.

Endnote

This information is taken from The University of Michigan's General Institutional Assurance of Compliance with Regulations of the Department of Health and Human Services for the Protection of Human Research Subjects dated June 17, 1983.

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Summary of Study

Summary of Study. To assist the Human Subjects Review Board in evaluating your proposal, describe as clearly as possible the purpose and rationale for the study the experimental design to be used. Describe the potential benefits of the study.

The University of Michigan plans a coordinated program of experimental research and development to gain insight into the creation, operation, and use of advanced digital libraries. It uses the term "digital library" as the generic name for federated structures that provide humans both intellectual and physical access to the huge and growing world- wide networks of information encoded in multi-media digital formats.

The University research team will focus particularly on mechanisms to support humans in the timely, relevant, and economic harvesting of information that they need and want in a vast and growing "information wilderness." Their ultimate goal is to help create an environment in which people (working alone or in groups) have on a desktop a personalized ("special") library built upon collections of world wide information sources.

The project is organized around the synergistic intersection of three sub-activities: relevant basic research in computer, information, and social science; design and construction of an evolving testbed system; and its deployment, use, and assessment. These activities are built upon the complementary strengths of multiple groups, both internal and external to the University.

Relevant Basic Research

Beginning from the perspective of the desktop (or other personal information appliance), the researchers will explore the creation and evaluation of 1) information viewers and query facilities; 2) supporting search and retrieval services; 3) data and document structures; and 4) collection and access management services.

The basic research team includes: Faculty in the Department of Electrical Engineering and Computer Science with expertise in distributed, intelligent systems including: federation of heterogeneous systems, distributed AI, object-oriented databases, and collaboration systems; faculty in the School of Information and Library Studies with expertise in information organization and retrieval, reference services, and user needs assessment/system evaluation; faculty and senior staff in computer science, economics, and the Michigan University Press with expertise in information economics and intellectual property issues; and technical staff, research programmers, and system builders at Michigan, American Math Society, and Bellcore with expertise in human computer interface design, segmentation of continuous media, and experience in creating and deploying experimental electronic library/publishing systems.

Design and Construction of a Testbed

The proposed research is focused and grounded by the goal to design, construct, deploy, and evaluate a digital library testbed Although much of the research will be generic with respect to information subject area, our testbed, the University of Michigan Digital Library (UMDL) will focus on the subject domain of earth and space science (ESS) .

Deployment, Use, and Assessment

The user communities for the testbed will include expert researchers, graduate, undergraduate, and high school students, and the general public. The research team will build a microcosm of content levels and media types ranging from page images to interactive, compound documents and real-time interaction with real time scientific data, replays of collaborative sessions, and human expertise. It will also be addressing issues about how users of the UMDL add content back into it the digital library.

II. Participation of Human Subjects

[A. Describe the subjects to be used in the study. Include age range and criteria for selection or exclusion.]

Subjects will be:

[B. Describe specifically what subjects will be asked to do and how much time will be involved. Include with the application copies of questionnaires, standardized tests, interview schedules, and other materials which are already prepared. Describe any equipment to be used. If materials and/or equipment are being designed, describe them as fully as possible. (NOTE: Whenever materials are prepared after approval for a project has been granted, a copy should be forwarded to the chair of the Human Subjects Review Board to be included with the file for that project.) .]

To help in the development of the library, we will ask some subjects to participate in focus groups to help us to identify and understand their basic information seeking skills, especially their most recent use of a library catalog.

As subjects use the digital library, they will be asked some simple demographic questions to allow the system to better respond to their questions. As they retrieve information, they will further be asked to rate the value of items they find by clicking a mouse on a 100mm line. Some subjects will also be interviewed more in depth, and will be asked what particular features of items affected their decisions, and what criteria they used in making those decisions. The interviews will also include questions regarding their opinions of the overall system, the types and frequencies of information sources they are using, and factors which affect their use of different kinds of information sources.

[C. Describe the setting in which data will be collected. If data are collected under the auspices of an agency such as a school system, clinic, government office, professional association, etc., attach a letter of permission from an authorized representative of that agency.]

Evaluative data will be collected via use of the system over the Internet as well as personal interviews at the sites (high schools, public libraries, faculty offices). Focus group interviews will be conducted at the sites as well.

III. Protection of Human Subjects.

[It is the responsibility of the Human Subjects Review Board to determine for each activity as planned and conducted whether: (a) The costs and risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept those costs and risks; (b) The rights and welfare of any such subject will be adequately protected; and (c) Legally effective informed consent will be obtained by adequate and appropriate methods.

A. Describe any potential costs or risks to the subjects. Costs should include both monetary and time factors; risks include possible physical, psychological, social, or legal risks to the subject.]

Costs: Time

Risks: Privacy

[B. Describe the procedures by which you will do the following:

1. Ensure voluntary participation by subjects. ]

All subjects will signal consent to participate either through signed forms or validation within the system itself (see #4 below).

[2. Protect subjects' identity and confidentiality of records. ]

Although the system will create and maintain profiles of users' prefereances and information needs, only members of the evaluation and research teams will have access to names and other identifying information. Codes will be used in other settings, including interviews and focus groups.

[3. Minimize costs and risks to the subjects. ]

See answer to #2 above regarding threats to privacy; interviews and system procedures will be made as efficient and brief as possible to minimize time requirements.

[4. Ensure that the subject is fully informed about the purpose of the experiment, the duration of his/her participation, the procedures to be followed, and the possibility of risk or discomfort. ]

The system will employ an introductory message explaining the nature of the research enterprise and that use of the system indicates consent to participate. Subjects involved in longer-term studies and focus groups will read and sign additional consent forms explaining additional aspects of these protocols.

IV. Informed Consent.

Using language which will be understandable to the subject his/her representative, prepare an informed consent form, using the guidelines presented in the document "Basic Elements of Informed Consent" which is appended to this application. (We have included a set of sample informed consent forms/cover letters with the application material which you may find helpful in a consent form or cover letter.)

Written informed consent must be obtained from either the subject or his/her authorized representative. A parent or legal guardian must sign for all subjects under 18 years of age. It is suggested, but not required, that children who are enough to read and understand the consent form be given an opportunity to sign it as well.

In the case of survey research, where the subject's only participation consists of returning a questionnaire anonymously, and no identification of the subject is possible, the purpose of the study and the procedures for protection of human subjects may be explained in a cover letter and the subject may demonstrate consent by returning the questionnaire. The cover letter should accompany the human subjects application.

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Comments or questions may be sent to: UMDL.INFO@umich.edu