Investigational Drugs -
Investigational Devices -
Radiation exposure
Administration of Alcohol or Illegal Drugs -
Research using records and stored biological specimens
Confidentiality -
Compensation for adverse events -
Subject recruitment -
Grants and Contracts -
Subject Compensation -
Deception -
Electrical equipment -
DNA -
Genetic research -
Research at or with Other Sites -
DEFINITION OF TERMS -
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All drugs intended for interstate commerce are regulated by the U.S. Food and Drug Administration (FDA) Federal Food, Drug and Cosmetic Act. With few exceptions, the research use of any drug or biologic substance that is either not approved for marketing by the FDA or is not approved for the research indication is prohibited without prior Human Subjects Review Committee approval. The researcher is obligated to file an "Investigational New Drug (IND)" application with the FDA. The FDA will review the application and, if approved, will issue an IND number.
The FDA regulations protecting human subjects in research are substantially equivalent to 45 CFR Part 46. However, FDA regulations (21 CFR Parts 50 and 56) do not allow for a waiver of documentation of informed consent when the principal risk of harm to the subject would result from breach of confidentiality.. Likewise, the FDA regulations do not allow for an alteration in or waiving of the required elements of informed consent.
Human Subjects Review Committee review and approval is required for all research uses of investigational drugs and biological substances. This includes industry-sponsored protocols, investigator-initiated protocols, protocols for off-label use of an approved drug or biologic, treatment uses of unapproved drugs and biologics, as well as emergency uses of unapproved products.
Medical devices are regulated by the Federal Food, Drug and Cosmetic Act, as amended by the Medical Device Amendments of 1976. In accordance with this Act, the Food and Drug Administration (FDA) has established procedures for obtaining an "Investigational Device Exemption" (IDE), which applies to investigations conducted to determine the safety and effectiveness of medical devices.
The IDE regulations distinguish between "significant risk (SR) devices" and "non-significant risk (NSR) devices." Use of either kind of device in research requires Human Subjects Review Committee approval and use of informed consent.
Significant risk devices are those which present a potential for serious risk to the health, safety, or welfare of subjects, and are subject to FDA control and approval. To obtain FDA approval, the Human Subjects Review Committee must first review and approve; then the sponsor, i.e., the person or firm which initiates the investigation, submits an application for an IDE to the FDA. Examples of significant risk devices are implants and life-supporting equipment.
Non-significant risk devices include such items as crutches, elastic knee braces, bed boards, bedpans, medical chairs, and tongue depressors. In order to obtain approval to use a non-significant risk device for research purposes, the investigator must present the Human Subjects Review Committee with a brief explanation as to why the device is not a significant risk device. If the Human Subjects Review Committee concurs with the determination that a device involves a non-significant risk and approves the research, the investigator is automatically considered to have an IDE without submitting an application to the FDA.
The following categories of medical device investigations are exempted from the IDE requirements but are subject to other FDA requirements;
In addition, two categories of devices have a temporary exemption by FDA from IDE requirements;
Any activities involving procedures which expose subjects to a radiation hazard (e.g., a chest X-ray or a radioactive tracer), either during screening prior to a study or during the study itself, require the approval of the Radiation Safety Committee (RSC). This is true of radiation that results from standard clinical exposures, as long as they are performed for purposes of the study. In those cases where approval by the RSC has not been given prior to Human Subjects Review Committee review, Human Subjects Review Committee approval will be contingent upon RSC approval. Approvals from the Radiation Safety Committee are congruent in time with approval from the Human Subjects Review Committee. Therefore, renewal requests to the Radiation Safety Committee should be made at the same time as renewal requests to the Human Subjects Review Committee.
Investigators whose research requires the administration of alcohol or illegal drugs to human subjects should take special care to screen out inappropriate subjects, to provide information about the administration of alcohol or illegal drugs to subjects in the informed consent statement, to protect subjects against risks that may be entailed in experimentally induced intoxication, and to protect subjects against post-experimental risks.
Investigators should be very cautious about including members of populations for whom alcohol or illegal drug use may be contraindicated. In applying for human subjects approval, investigators should show sensitivity to this issue and provide cogent justification for the inclusion of members of high risk populations such as the following:
When alcohol or illegal drugs are administered the consent process should include the following:
For additional information and assistance on the administration of alcohol and illegal drugs and the protection of subjects, contact Human Subjects Division, Office of Sponsored Programs (543-0098) or the Alcoholism and Drug Abuse Institute (543-0937).
Humans Subjects Review Committee approval must be obtained in most cases in which research activities include the use of data from records or stored specimens (blood, urine, tissue, and other human products). For purposes of this discussion, health care information records (including financial records, pharmacy records, x-rays, CT scans, MRI and other images and recordings), diagnostic specimens, pathological specimens and residual specimens are treated as health care information.
State law requires that explicit written consent is obtained from the patient/subject before his or her records or materials (specimens, x-rays, billing information, etc.) are used for research purpose. This law applies to all researchers including health care professionals unless the information is being used to provide direct patient care. The consent must state the name of the person(s) who want to use the information, the purpose for which the information is to be used, and must be dated. This release may be included in a standard consent form as long as all the necessary elements are included.
If the research otherwise qualifies as exempt (information to be used must "exist" at the time the research proposal is formulated) from University-level review by the Human Subjects Review Committee, and the patient's explicit written consent is obtained for the use of health care information, the research may be reviewed at the department level, using the Certification of Exemption form. Departments would be well advised to review the consent forms to make sure they include all the necessary elements of consent.
State law does allow a waiver of the requirement to obtain written consent to use health care information, provided that the research has been reviewed by the Human Subjects Review Committees and that a Confidentiality Agreement has been negotiated between the investigators and the Committees.
Although explicit written consent is always preferred, such a waiver should be requested if it is truly not feasible or practicable to obtain written consent for the use of health care information. The researcher must complete a Human Subjects Review Committee application form so that the Human Subjects Review Committee may determine that the benefits of the research outweigh the risks posed by waiving the requirement for written consent -- invasion of privacy and breach of confidentiality.
If the research activity consists solely of the use of health care information, or if its other components also qualify, the application will be reviewed as "minimal risk." A subcommittee of the Human Subjects Review Committee will review the application and, if it is approved, will draft a Confidentiality Agreement to be signed by the researchers and by the authorized University official.
Confidentiality of records. There are several special laws concerning access to records. The most important of these is a State of Washington law enacted in 1985, which deals with research records, and Acts concerning educational and medical records. Academic records are excluded from this statute because their use is restricted by the Buckley Amendment to the Federal Family Educational Rights and Privacy Act. Psychiatric records are further protected by the State Involuntary Treatment Act.
For additional information on this legislation, investigators may consult with the personnel of the Office of Sponsored Programs, Human Subjects Division, or with the Attorney General's Division.
Confidentiality of the identity of subjects and of information from subjects is an important part of any research activity. Especially in behavioral research, but also in bio-medical research, breach of confidentiality and invasion of privacy may pose the greatest risks of harm associated with the research. Wherever possible, research data should be retained without any identifiers. When this is not possible, as in the case of longitudinal research or research which links data from several sets of data, investigators must take steps to protect the confidentiality of the subjects and the data.
Any unintentional but identifying data or information on data collection forms, questionnaires, and other records usually should be removed, stricken, or otherwise made indecipherable as soon as noted by the investigator.
In those instances where it is necessary to identify respondents, identification on data collection forms, questionnaires, and other records should be by code, with the code translation to be kept separate from the data. The code should not be an identifiable number such as a hospital's patient number, a student identification number, or a Social Security number; rather, a code should be established solely for the purpose of the study. Both the code translation and the data should be kept in a secure place, such as a locked file cabinet, accessible only to the investigator, to his or her authorized staff, and to others identified in the Human Subjects Review Committee application.
Where information will be computerized, no names or other identifying information should be entered. The study code number should be the only computerized identifier. The code translation should not be entered into the computer.
Exceptions to this policy may be made when it is necessary for the conduct of the study to collect and link data on the same individual from more than one source. In such instances the procedures for maintaining confidentiality of both the paper and computerized records should be clearly described and justified in the Human Subjects Review Committee application form.
Social Security numbers need to be collected from subjects who may receive monetary inducements exceeding $50.00 during a calendar quarter. The list of subjects, Social Security numbers, and payments should be kept in a secure place separate from the data.
Because subject anonymity is an important part of exempt research, a brief discussion of it is in order. The phrase "identifiers linked to the subject" appears in the Federal regulations. This means any name, code, or reference that could be used to identify the subject outside of the context of the research setting. Names, student numbers, and Social Security numbers are obvious examples of identifiers. An identifier that links a subject to a list of names or identifiers kept elsewhere is also an "identifier linked to the subject." For instance, numbering data records and keeping a list of subject names and record numbers creates an identifier linked to a subject, even if the list is well guarded. Similarly, if records are linked to a second set of records (e.g., test scores linked to school grades) and the second set of records is identified, then the first set would also be identified. The key question is, "Is there any way that anyone, including the investigator, could start with a data record and trace it back to the person being studied?" If the answer is yes, then there is an identifier linked to the subject.
Records may be numbered so that they can be associated with each other without creating an identifier linked to the subject. For example, if a study extends over several sessions, the data from one subject can be assigned a unique number without creating an identifier providing that there is no way that the record number can be associated with a person.
Investigators frequently have to know a participant's identity in order to schedule appointments and otherwise arrange for data collection. Ordinarily this sort of temporary identification does not create an identifier providing that the data collected cannot be traced back to an individual subject. In certain cases, however, the information that the subject participated in the research at all might be considered confidential and sensitive. For instance, this situation would occur if the study were of persons who have committed illegal acts. When the fact of participation is itself sensitive, any record identifying the subject is considered sensitive and confidential.
Investigators who collect sensitive information from subjects who may be identifiable as study participants may apply for a federal Certificate of Confidentiality. The Certificates are available to all investigators, whether or not their research is funded by the federal government, and regardless of the kind of sensitive information being collected. The Certificate is intended to protect identifiable research data from disclosure through subpoena, warrant, or court order. There are exceptions to the Certificate's coverage. For further information about Certificates, please contact the Human Subjects Division.
The University's policy on compensation for adverse events to human subjects is intended primarily to provide necessary medical care to subjects who sustain bodily injury as a direct result of participation in a research project.
"Adverse Effect" is defined to mean bodily injury. Except in special circumstances, the term does not include impairment of mental processes or emotional distress, nor does it encompass effects resulting from: (1) injuries from diagnostic or therapeutic procedures, either standard or experimental, performed as part of patient management; (2) the normal course of a disease or condition; or (3) non-compliance with study procedures.
The program operates on a "no-fault" basis; that is, the claimant does not need to establish negligence. Rather, the claimant or the investigator must demonstrate only that the subject has suffered an adverse effect as a result of participation in a University-sponsored study. The program is included as part of the University's overall general liability self-insurance program.
If an investigator believes an adverse effect has occurred, he or she should immediately prepare a report summarizing the background, nature, and result. A form for this purpose may be obtained by telephoning the Human Subjects Division. The report will be submitted to the Human Subjects Division and the Office of Risk Management, which may consult with the Attorney General's Division and the Human Subjects Review Committee in making a determination as to the applicability of the compensation program.
A report must be submitted within one year of the occurrence of the adverse effect, but as soon as possible after the researcher becomes aware of the event. In a case of latent disability, the time for filing the report does not begin until the subject or the subject's legal representative is aware or reasonably should be aware of the causal relationship of the disability to his or her participation in the research. This allowance takes into account an adverse effect to a fetus.
The compensation program for adverse effects may not apply to research carried out by investigators under grants administered through other institutions; and it is not effective for research carried out in foreign countries. However, adverse effects should be reported to the HSD whether or not the investigator believes that the compensation plan may be applicable.
It is the position of the University of Washington that subjects and their third party payers or governmental programs should not be held accountable for the costs of treating adverse effects incurred as a result of taking part in clinical trials sponsored by commercial companies.
The terms of the agreement under which the trial is conducted shall determine whether the sponsor or the University of Washington is financially responsible for the treatment of adverse effects. With rare exception, the agreement will specify that the University will hold the sponsor harmless from adverse effects resulting from the negligence of University employees, including failure to adhere to the protocol, while the sponsor will hold the University harmless from adverse effects resulting from the prescribed use of the test article or protocol. It is possible, though unusual, that both University negligence and sponsor negligence could concurrently cause an adverse effect, in which both parties share financial responsibility.
The consent form should include information that physical injuries to the subject that are a direct result of study procedures will be treated at no cost to the subject. Wherever possible, the consent form should state that the sponsor is the responsible party. For example:
"If you have a physical injury as a direct result of this study, we will treat you or refer you for treatment. The X company, the sponsor of this study, will pay for this treatment."
In cases in which the sponsor does not wish to be named, acceptable wording is as follows:
"If you have a physical injury as a direct result of this study, we will treat you or refer you for treatment. The treatment will be given at no cost to you."
In rare instances in which the University's compensation plan does not apply, or when the sponsor has made no provision for treating adverse events, the subject or the subject's health insurer may be the payer of last resort. In this case, the consent process should include this information, along with the proviso that insurers may not be willing to pay for treatment of adverse events resulting from treatment provided in the research context. The Human Subjects Review Committee may request a pre-approval procedure to make sure that the insurer will pay for these costs before the subject is enrolled in the study.
To minimize coercion, investigators should stress the voluntary nature of participation in diagnostic or therapeutic experimental procedures involving patients, and should avoid, whenever possible, the use of their own patients, clients, employees, and students in procedures which are neither therapeutic nor diagnostic. In these latter situations, investigators should solicit subjects through means such as bulletin board notices, advertisements in newspapers, and announcements in classes other than their own.
In order to avoid an invasion of privacy, it may be necessary for an investigator to enlist the cooperation of other professionals and organizations as intermediaries. This is appropriate when an investigator has not had prior contact with prospective subjects and does not have access to their names and addresses or telephone numbers from a publicly available source. The intermediary does not obtain consent from the prospective subject to participate in a research activity; rather the role of the intermediary is to obtain consent from the prospective subject to release his or her name and address or telephone number to the investigator. The investigator then would make the contact regarding the study and obtain consent. The intermediary who is willing to assist an investigator in this way should not take a strong advocacy position in favor of a particular research activity.
In some instances, the investigator may already have access to the participant's name and other identifiers through a non-public source such as a disease registry (e.g., an area-wide cancer registry) with which the investigator is affiliated. Such sources should be used to identify prospective subjects for study only if their own operations have been reviewed and approved by the appropriate IRB. Subjects identified from such sources may be contacted directly by investigators without the use of intermediaries if they can be reasonably expected to know their names are listed in the registry and that the registry will be used for research purposes.
Voluntariness begins with recruitment. Potential subjects must not feel that they have been coerced into participating, nor must they fear the loss of some benefit to which they are otherwise entitled if they choose not to participate. The researcher must stress the voluntary nature of research participation to potential subjects when they are first approached. In many cases this requirement is easily met. For instance, people who respond to a recruiting notice placed in a newspaper or on a bulletin board are obviously volunteers.
Special care must be taken if the person doing the recruiting (normally but not necessarily the principal investigator) is a person who is in a relationship of authority or service provision with respect to potential participants. Such a situation can arise if a teacher recruits his or her students, or if a health practitioner recruits patients as research subjects. If possible, it is best to avoid such situations, but there can be cases where this is not possible. It is the investigator's responsibility to ensure that a person's decision to participate or not will not have any effect on any other practitioner-client, employer-employee, teacher-student or similar relationship. Furthermore, this must be clear to the potential subjects. Human Subjects Review Committees will require assurance that the voluntary nature of participation has been explained to subjects in those situations where this is a consideration. When appropriate, investigators should include in their application for approval a discussion of how voluntariness is ensured.
There are situations in which a potential subject's privacy might be invaded simply by being identified as a qualified participant for a study.
Members of "support groups" for problems such as alcoholism, drug dependency, or depression might justly feel their privacy had been invaded if they were identified to an investigator. In such situations investigators may ask persons who already have access to the necessary records, groups, or other information to approach subjects for them. When such a person serves as an intermediary for the investigator, that person must also stress the voluntary nature of research participation. The intermediary does not obtain consent from a prospective subject, the intermediary obtains permission to release the potential subject's name to the principal investigator, together with any other information that will allow the investigator to contact the potential subject. The intermediary may indicate his or her approval of the research, but should not take a strong position advocating participation.
In some instances investigators may have access to a potential participant's name and other identifiers through a non-public source, such as a registry of persons suffering from a particular disease. Such sources should be used to identify prospective participants in a study only if the use of this source has already been reviewed and approved by an appropriate Human Subjects Review Committee.
Advertisements, flyers, public service announcements (PSAs), and other forms of publicity may be used to inform potential subjects about a research activity. The content of each such method used must be approved before use. Text for advertising purposes must be straightforward and non-coercive. If investigational drugs or devices are to be used, this information must be included in the advertisement. The text should also include the name of the University of Washington and a contact person as well as a telephone number or address. National recruiting campaigns must be modified to include local references and information.
Sites at which advertisements are to be posted may have their own regulations about what can be displayed or printed. Approval from the Human subjects Review Committee does not superseded these institutional requirements.
All grants and contracts proposed by university faculty and staff must be submitted through Office of Sponsored Programs using the GC-1 form. On this form, the investigator is asked to provide information about the use of human subjects. Proposals will not be forwarded from the university to the proposed sponsor unless this information has been provided.
All federal agencies and many private sponsors require human subjects approval before reviewing proposals for funding. Therefore, the investigator must submit a Human Subjects Review Committee application so that it is pending review at the time the proposal is transmitted from the university to the sponsor. Most sponsors allow sixty days for review and approval. Once approval has been received, the investigator should notify the sponsor to that effect.
Center grants and program project grants typically involve more than one project involving human subjects. Before the proposal can be transmitted from the university, the investigator must document on the GC-1 that each of the projects has received human subjects approval or is pending review.
Training grants require no accompanying human subjects approval. It is the principle investigator's responsibility to assure that each of the trainees obtains approval for his or her project, or works with a mentor who already has human subjects approval for the project. the GC-1 accompanying a training grant proposal should include a statement that each trainee will obtain human subjects approval as soon as the research has been planned and before human subjects are approached to participate.
For proposals to sponsors who do not require human subjects approval before review, a simple letter of intent on file with the Human Subjects Division is all that is required by Office of Sponsored Programs to transmit the proposal. The letter of intent should include the name of the principle investigator, the title of the proposal, the name of the agency to which the proposal is being submitted, the proposed dates of funding, and a statement that the investigator will submit a Human Subjects Review Committee application at least sixty days before approaching human subjects if the proposal is funded.
Grant and contract proposals which are substantially similar to existing activities with human subjects approval may be added to those approvals (see section III.G.3., above).
Subjects may be compensated in a variety of ways for participating in research activities. These include financial remuneration, merchandise (gifts, toys, or vouchers), provision of services (parking fees, free meals, medical treatment), and educational credit. The terms of all types of compensation must be described in the consent form.
Compensation is intended to reimburse subjects for time and inconvenience, not for risk. The amount of compensation offered should not be such that it would be the sole motivation for a subject to participate in the research.
Compensation should be appropriate to the subject population. Adults may be offered, for example, a higher rate of compensation than children. The Human Subjects Review Committee will consider the compensation offered in the context of the subject population of the proposed study.
In most cases, compensation should be pro-rated for subjects who are not able to complete the study. The schedule of payments should be outlined in the consent form.
In most investigations the subject should be made aware of the major purposes of the research. In some investigations, however, there is some degree of deception involved. Usually deception consists of merely failing to tell the subject what the specific points of interest are in an attempt to prevent biasing the results. Deception of this kind is reasonable and acceptable as long as the investigator provides justification for its use, and debriefs the subjects after their participation, when appropriate.
Problems arise when major deception is involved. For example, if an investigator leads a subject to believe that he or she has committed a crime, or has a disease, or has some serious character flaw, then the merit of the investigation must clearly counterbalance the risk to the subject for the research to be approved. Similarly, if an investigator studies some closed group such as a secret society by becoming a member without revealing his or her purposes, deception is being practiced through omission of information. Because this might put the group members at risk, the merit of the investigation must counterbalance the risk for such a procedure to be approved.
Withholding information cannot be used as a means to secure the participation of subjects in research.
The use of deception imposes special responsibilities on the investigator. One of these responsibilities is to provide appropriate debriefing to the subjects. In each case, the Human Subjects Review Committee will require information sufficient to understand why deception is needed, how the potential benefits justify its use, and how debriefing will be done.
In order to assure the protection of human subjects in research involving electrical equipment to be performed under the auspices of the University of Washington, the Standards on Electrical Safety of the Joint Committee on Accreditation of Hospitals (see (4), below) and the Biomedical Electrical Safety Guidelines of the Department of Social and Health Services have been adopted. The following shall apply:
Research involving recombinant DNA requires the approval of the Recombinant DNA Committee. In those cases involving human subjects where approval by that committee has not been given prior to Human Subjects Review Committee review, approval will be contingent upon Recombinant DNA Committee approval.
Genetic information carries with it many possible risks, among them risks to insurability, risks to family life (for example, in incidentally generated information about paternity), and risks to life plans (for example, from discovery of previously unknown but possibly stigmatizing conditions). Investigators should provide the Human Subjects Review Committee with a full description of the kinds of testing which will be done, what kinds of data will be collected, how the data will be stored, and to whom they will be available (will they be entered in subjects' medical records?). The investigator should discuss the risks attendant on these procedures, and will be done to minimize them. These points should also be addressed in the consent forms under "Risks, Stress and Discomfort".
If genetic counseling will be available to subjects before and after testing, the investigator should explain who will do the counseling and describe the training and experience of the counselors.
If it is possible that the testing will provide evidence of previously undiagnosed or unrecognized illness, or susceptibility to illness, the investigator should describe how this
will be handled. Investigators should think in long-range terms about the potential risks posed by the research and how they will be handled.
The UW currently has Cooperative Interinstitutional Review Agreements for the Protection of Human Subjects with several local institutions. These Agreements recognize each institution's approved Multiple Project Assurance with the Department of Health and Human Services and generally provide for only one review by a Human Subjects Review Committee (either the UW or at the cooperating institution) on joint research projects. These Agreements are subject to change through negotiation and interested investigators should seek information on the current provisions of each Agreement from the Office of Sponsored Programs, Human Subjects Division.
When agencies or institutions cooperate in UW research by providing access to subjects, those organizations should be fully informed about the research and official approval should be obtained before any subjects are contacted. A copy of the letter(s) of cooperation should be submitted with the application for human subjects approval.
For UW research conducted at non-UW sites not covered by an existing interinstitutional agreement, duplicate review for the protection of human subjects will be avoided when feasible in accord with the following guidelines:
In order to use subjects in societies or cultures outside the United States, permission should be obtained from the host country (its government or delegated agency). Complete information about the study should be made available to the host government. Where written consent is appropriate, the form should be translated into the native language. Although a formal consent form may not be appropriate if contrary to national or local custom, full disclosure to subjects of all information as specified in the Federal regulations and by UW policy is required. A written statement containing the content of this disclosure should accompany applications for human subjects approval.
The university's compensation plan for adverse effects to human subjects does not apply outside of the United States.
Investigators conducting research in foreign countries under a grant or contract from a Federal agency should consult that agency concerning any special requirements which may apply.
"Minimal risk" means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (from Title 45, Code of Federal Regulations, Part 46.102(g)).
Note: There are different types of adverse effects to which human subjects may be at risk that are inherent in various research procedures. Risk is most obvious in medical and behavioral science research projects involving procedures which may induce a potentially harmful altered physical state or condition. Some examples of such procedures are: the removal of organs or tissues for study, reference, transplantation, or banking; the administration of drugs or radiation; the use of indwelling catheters or electrodes; or the requirement of strenuous physical exercise.
There is a wide range of medical, social, and behavioral projects in which no risk of immediate adverse physical effects for the subject is involved (e.g. those involving the use of personality inventories, interviews, questionnaires, observations, photographs, tapes, records, and stored data). However, some of these procedures could involve a potential risk of discomfort, harassment, or a threat to the subject's dignity. Also, the information, if not kept confidential, could present psychological, social, or legal risks.
There are also medical and biomedical projects concerned solely with organs, tissues, body fluids, and other materials obtained in the course of routine performance of medical services such as diagnosis, treatment, and care, or of an autopsy. The use of these materials obviously involves no element of physical risk to the subject. However, their use for research, training and service purposes, if known to unauthorized persons or the general public, could present psychological, social or legal risks. In these situations, review may be necessary to determine whether the circumstances under which the materials will be procured are appropriate, and whether appropriate consent should be, or can be, obtained for the use of these materials for project purposes, and that the confidentiality of individuals will be maintained.
In cases in which there would be moderate or high risk and in which there are problems in determining scientific merit, the Human Subjects Review Committee may use consultants in making this determination. The Human Subjects Review Committee will not approve research when the risk is significant and the project is judged to lack adequate scientific merit.
Special regulations apply to prisoners, residents of institutions for the mentally ill and the mentally retarded, as well as pregnant women, the viable fetus, the newborn, children, and the dead. See Part D.5. and Federal Regulations for a description of these regulations.
Note: This definition of "subject" excludes all accepted and established service relationships, such as the normal relationship of patients to physicians, students to professors, and other clients to professionals, in which the patient, student, or client is receiving aid or services intended only to meet his or her own personal needs. The professional-client relationship has the welfare of the client as the primary objective, whereas the investigator-subject relationship has the discovery of new knowledge as its primary objective.
The normal employee-employer relationship, in which legitimate services are exchanged for salary, wages, or remuneration in keeping with customary written or oral contracts, is also excluded from the definition of "subject." Payment of volunteers, however, does not alter their status as subjects. If doubt exists as to whether the procedures are within the normal limits of the employees' work scope, the employees should be considered to be participating as human subjects, and their rights and welfare must be protected.