DETERMINE WHETHER THE PROJECT NEEDS TO BE REVIEWED
COMPLETING THE PROTOCOL
REVIEW AND SIGNATURE OF FACULTY SUPERVISOR (student research only)
CHANGES IN APPROVED PROCEDURES (modifications)
CONTINUING PROJECTS AND TERMINATION OF PROJECTS
EDUCATION REQUIREMENT
CPHS/IRB REVIEW AND APPROVAL
APPEAL PROCESS
EXEMPTION CATEGORIES
EXPEDITED REVIEW CATEGORIES
FULL REVIEW
Physical risks
Psychological risks
Social/Economic risks
Loss of Confidentiality
Legal risks
OBTAINING INFORMED CONSENT
REQUIRED ELEMENTS FOR ALL INFORMED CONSENT FORMS
ADDITIONAL ELEMENTS IF APPROPRIATE
Explanation of compensation or medical treatment if injury occurs
DOCUMENTATION OF INFORMED CONSENT
WAIVER OF DOCUMENTATION OF INFORMED CONSENT
POLICY ON PASSIVE PARENTAL CONSENT - For Research in Elementary and Secondary Educational Settings
VERBAL CONSENT
WAIVER OR ALTERATION OF INFORMED CONSENT
RETENTION OF SIGNED CONSENT DOCUMENTS
CONFIDENTIALITY/ANONYMITY
SAMPLE CONSENT FORM: Written Consent, Adults
CONSENT AGREEMENT FOR VIDEO RECORDING
SAMPLE ASSENT FORM (young children)
SAMPLE CONSENT FORM: NON-SENSITIVE QUESTIONNAIRES
PSYCHOLOGICAL RISK LANGUAGE
VIII. SPECIAL SUBJECT POPULATIONS
Categories of exempt research when the subjects are children
Special considerations in research when subjects are children
Informed ConsentAssent of the children
Permission from parent(s) or guardian
Information that must be provided in requests for assent and permission; and documentation of informed consentCategories of exempt research when subjects are mentally disabled
Special considerations in research when subjects are mentally disabled
Informed consentAssent of the subjects
Permission from competent adults acting on behalf of the subjects
Information that must be provided in requests for assent and permission; and documentation of informed consentActivities Directed Toward Pregnant Women
Additional Consent Requirements
Research Directly Involving FetusesCPHS/IRB Membership Regarding Research with Prisoners
Types of Research Permitted
Funded Research
Additional Considerations
Guidelines for Research Using Classroom Subjects
Recruiting Clients of Social Service and Other Institutions
Advertising for SubjectsPROTOCOLS USING MAGNETIC RESONANCE IMAGING (MRI)
INFORMED CONSENT AND ABUSE REPORTING REQUIREMENTSINTERNATIONAL RESEARCH
TRANSPORTATION OF RESEARCH SUBJECTS
COMPENSATION FOR PARTICIPATION IN RESEARCH
INVESTIGATIONAL DRUGS/DEVICES REVIEW
CLASSROOM INITIATED RESEARCH OR TRAINING PROJECTS INVOLVING HUMAN SUBJECTS
REGULATIONS FOR RESEARCH WITH HUMAN SUBJECTS UNDER HIPAA
GENETIC RESEARCH AND COMPLIANCE WITH STATE LAW
RADIOLOGY DEVICES
DATA SAFETY MONITORING PLAN (DSMP)/DATA SAFETY MONITORING BOARD (DSMB)
(References include websites for federal documents)
In accordance with the Federal Policy on the Protection of Human Subjects (DHHS Policy 45 CFR Part 46; Department of Education Policy 34 CFR Part 97; FDA Policy 21 CFR Parts 50 and 56), University of Oregon assumes the responsibility for the protection of the rights and welfare of human subjects who participate in research and other activity projects conducted by, or under the supervision of, faculty, staff, or students. To conduct this responsibility effectively, the University maintains a Committee for the Protection of Human Subjects/Institutional Review Board (CPHS/IRB) competent to review research, training, and other activity protocols involving human subjects and to evaluate both risk and protection against risk for those subjects. It is the function of the Office for Protection of Human Subjects and the CPHS/IRB to 1) determine and certify that all projects reviewed by the CPHS/IRB conform to the regulations and policies set forth by DHHS regarding the health, welfare, safety, rights, and privileges of human subjects; and 2) assist the investigator in complying with DHHS and FDA regulations in a way that permits accomplishment of the research activity.
The University of Oregon assures that all of its activities related to human subjects research, regardless of funding source, will be guided by the ethical principles in the Belmont Report (1979): respect for persons, beneficence and justice. The application of the general principles lead to consideration of the following requirements: informed consent, risk/benefit assessment, and the selection of subjects in research (Appendix A).
The CPHS/IRB aims to provide a service to the University and the public by facilitating ethical treatment of research subjects while at the same time supporting the investigator's endeavor to advance knowledge. This manual is intended to assist investigators in their efforts to perform research and to protect the rights and welfare of human participants.
In accordance with the Americans with Disabilities Act (ADA), the Investigator's Manual On Research With Human Subjects (Manual) will be made available in accessible formats (e.g., large print) upon request. Contact the Office for Protection of Human Subjects at 346-2510. |
CPHS/IRB - The University of Oregon's Committee for the Protection of Human Subjects/Institutional Review Board, established for the purpose of review and approval of human subjects in research, in accordance with federal regulations governing the protection of human subjects in research.
OPHS - The Office for Protection of Human Subjects, administrative unit on campus (Riverfront Research Park, Suite 105, 346-2510/3106) which supports the CPHS/IRB and initiates certification of CPHS/IRB approval to funding agencies.
DHHS - U.S. Department of Health and Human Services, the federal agency which enters into agreement with institutions through a signed assurance of compliance for the protection of human subjects in biomedical or behavioral research. The University of Oregon's Federalwide Assurance (FWA) of Protection for Human Subjects number is FWA00005914. The University has two Institutional Review Boards (IRBs) designated under the assurance: IRB #1 - Social/Behavioral IRB; registration number: IRB00000190. IRB #2 - Biomedical IRB; registration number: IRB000005841.
45 CFR 46 - Code of Federal Regulations (Common Rule, Federal Policy for the Protection of Human Subjects, rev. August 19, 1991) implementing Public Law 93-348 (July 12, 1974) establishing institutional review boards and an ethics guidance program.
HIPAA - The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that has
several provisions affecting research that involves health information from human research participants. The Act includes a Privacy
Rule that restricts disclosure of protected health information (PHI) for individuals. (Effective April 14, 2003)
Human subject - "Human subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. "Intervention" includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. "Interaction" includes communication or interpersonal contact between investigator and subject. "Private information" includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Minimal risk - The risk to the subject is said to be minimal when the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Minimal risk is to be determined with regard to the state of vulnerability of the particular subject or subjects, especially if special populations are used as subjects.
Subject at risk - Any individual who is exposed to the probability of injury, physical or psychological, as a consequence of participation as a subject in a research procedure. A subject is beyond minimal risk when participating in a research endeavor in which the risks of harm are greater, considering either probability or magnitude, than those risks encountered in daily life. Refer to examples of risk.
Physical risk - Any strenuous or unusual physical activity or procedure required of a subject, use of compounds which might alter the subject's biochemical milieu, exposure to strong stimulation, placement in a situation which could lead to violence. The investigator is responsible for anticipating circumstances which might endanger the subject's physical well-being and for bringing these circumstances to the attention of the CPHS/IRB.
Psychological risk - Any experimental condition that induces personality change or intense changes in a subject's feelings or motivations, or that may induce such changes which extend beyond the experimental or debriefing period; subjection to deceit, to demeaning or dehumanizing procedures, to humiliation and embarrassment. The investigator has the responsibility to eliminate or minimize the effects of psychological risks to subjects and to bring these matters to the attention of the CPHS/IRB.
Confidentiality - Right of privacy and of non-release of disclosed personal information. The investigator should protect subjects against invasion of privacy and loss of confidentiality. Lack of secure handling of completed personality tests, questionnaires, interview protocols or data, and recorded materials, augments risk and must be avoided.
Informed consent - Informed consent means "knowing consent," the exercise of a free power of choice without undue inducement, force, fraud, deceit, duress, or other form of constraint or coercion. If the subjects are minors or are not capable of giving consent, parental, guardian or other legal representative consent is required. Use of a written consent form that includes all the basic elements of informed consent must be documented by a signature of the subject or legally authorized representative.
Anonymity - exists when there are no identifiers whatsoever on project materials which could link the data with individual subjects. Even the research investigator cannot know the identity of participants.
Protocol - A protocol is the researcher's plan of a scientific experiment or treatment. A full review or expedited protocol consists of a cover page, Investigator Agreement, Faculty Advisor Review and Agreement, Human Subjects Protocol Form, informed consent form(s), sample survey instrument(s) or questionnaire(s), and grant proposal, thesis or dissertation, or prospectus, so as to provide complete information regarding activities involving human subjects. Claim of Exemption from CPHS/IRB forms are also available.
Other definitions may be found throughout the manual in appropriate sections.
STEP 1 -- Design Research
Although scientific concerns are primary in the design of research involving human subjects, the rights of human subjects should be considered from the outset. The principles, policies, and procedures explained in this manual should be kept in mind throughout the design of any research project.
STEP 2-- Determine Whether the Project Needs to Be Reviewed
All research projects in which human subjects participate, whether funded or unfunded, are subject to the federal regulations governing such research, and to the policies and procedures outlined in the University's Federalwide Assurance of Protection for Human Subjects and this manual. Except for cooperative research projects which may be subject to review by another institution's IRB, all projects directed or co-directed by UO faculty, students or staff must be reviewed and approved by the UO CPHS/IRB. Such projects include individual or collaborative research projects, as well as any programmatic projects, class surveys or projects, and student government activities with a research component.
Some projects assigned to students in a class may have a research component or constitute training in research methodology. If such projects may contribute to generalizable knowledge (e.g., through publication or dissemination of the findings), they are subject to the regulations and must undergo review. The Committee is unable to give post facto approval. Classroom projects that are exclusively for instructional purposes need not undergo review by the CPHS/IRB; however, instructors and students are encouraged to follow federal and University regulations when designing and conducting class projects with human participants.
Cooperative research between the University of Oregon and other universities or research institutions will usually be reviewed by each institution's authorized Institutional Review Board. The lead institution is responsible for ensuring that all institutions and investigators engaged in the research operate under an appropriate federally-approved Assurance for the protection of human subjects. The lead institution is normally the primary grantee or contractor for funded projects and/or home institution of the principal investigator. The University of Oregon will need documentation of review and approval by another institution's IRB when appropriate. For example, students receiving their degree from another institution who are conducting research at the University of Oregon are required to document approval of the research project by the Institutional Review Board at their home institution. The investigator will need to complete the appropriate application for the University of Oregon for any research that has been approved by another Institutional Review Board other than the UO's CPHS/IRb. A copy of the approved protocol and/or IRB approval letter must be submitted with the UO application.
Certification of IRB approval is required when the research is supported by a federal department or agency. Certification should be submitted with the application or proposal or by the deadline prescribed by the department or agency to which the application or proposal is submitted. These deadlines vary depending on the funding agency. As part of the certification process, the National Institutes of Health (NIH) requires training on the protection of human subjects for all investigators/key personnel submitting applicatons for research involving human subjects. The UO curriculum in the Collaborative IRB Training Initiative meets this requirement and is available at http//humansubjects.uoregon.edu/citiprogram.htm.
Grant proposals lacking definite plans for involvement of human subjects (such as institutional bloc grants, training grants, or those projects in which the human subjects' involvement will depend upon completion of instruments, prior animal studies, etc.), or research undertaken without the intention of involving human subjects, shall be reviewed and certified, but the investigator will be required to submit a protocol to the CPHS/IRB once activities involving human subjects are formulated. In the case of multiple projects, the investigator must agree to take the responsibility for seeing that each individual project involving human subjects will be submitted to the CPHS/IRB for review.
If there are any questions or need of clarifications, the investigator is encouraged to consult with OPHS (346-2510/3106).
STEP 3 -- Complete the Protocol
The protocol provides the CPHS/IRB with the information that it needs to approve the proposed research. Copies of the protocol packet, with instructions for completing the forms, can be obtained from the researcher's department or from the Office for Protection of Human Subjects (6-2510). As indicated in the instructions, a sample informed consent form must be attached to the protocol. For funded projects and theses and dissertations, a copy of the proposal or thesis must be attached as well, although the material presented in the protocol should be complete in and of itself (i.e., do not refer to sections of the proposal to provide information to the CPHS/IRB).
The principal investigator signs the protocol cover sheet, indicating that s/he will comply with the federal and University regulations outlined in the Investigator's Manual on Research with Human Subjects.
STEP 4 -- Review and Signature of Faculty Supervisor (Student Research Only)
All student initiated research involving human subjects, whether dissertation, thesis, or other research projects, must be supervised by a faculty member to assure that human subjects are protected.
For thesis or dissertation research, the signature of the faculty advisor is required, unless there appears to be a conflict of interest (e.g., the advisor is also the chair of the unit review committee). If the faculty advisor is unable to sign, another member of the student's committee may sign. NOTE: The "Required Clearance for Master's Thesis/Project or Doctoral Dissertation" form must be completed, signed and on file in the Graduate School before you collect data. Forms are available at the Graduate School.
For student research other than thesis or dissertation projects, a faculty supervisor's signature is required and the student must be enrolled for at least one credit hour of research during that period of the project when human subjects are involved. Graduate students must meet the university requirements of continuous enrollment. The student must register for three graduate credits each term, excluding summer sessions, to be continuously enrolled.
The faculty signature on student research attests that the research procedures comply with federal and University policies with regard to the protection of human subjects. The faculty supervisor also is expected to monitor the research to assure that the approved protocol with human subjects is followed. When approved, the faculty member signs the appropriate section of the Faculty Advisor Review and Agreement (included in the protocol packet).
STEP 5 -- Submit the Protocol to OPHS
After the proposed project has been received by OPHS, a preliminary review of the protocol is done to determine whether (a) the project is exempt under the regulations or is to be reviewed under the expedited or full review process (see description of review categories); (b) the protocol meets the general requirements for review under the regulations; and (c) the informed consent form contains the required elements and is in satisfactory form for CPHS/IRB review. The OPHS will consult with the investigator (and/or faculty supervisor, if student research) when the proposal does not meet the general requirements, the informed consent form is missing required elements, or additional information or clarification is needed to determine the review category.
STEP 6 -- Review and Approval by CPHS/IRB
If the OPHS determines that the protocol is exempt under the federal regulations and everything is satisfactory, the OPHS will approve the protocol, indicating that the research may commence.
If the protocol requires expedited review the protocol and supporting documents will be reviewed by two members of the CPHS/IRB, who will have full authority of the CPHS/IRB except to disapprove a project. If either reviewer requests, the protocol will be referred to the full CPHS/IRB for consideration at their next meeting. If both reviewers approve the project, the chair of the CPHS/IRB will sign the cover sheet, indicating that the research may commence.
If the protocol is determined to require full review, the protocol and supporting documents will be reviewed by two members of the CPHS/IRB, who will make recommendations to the full CPHS/IRB.
The CPHS/IRB will consider all protocols requiring full review as well as protocols in the expedited category for which at least one of the reviewers determines that the procedures are unacceptable. The CPHS/IRB can approve the research, conditionally approve the research, or disapprove the research.
If the research is approved, the chair of the CPHS/IRB signs the cover sheet and the research may commence.
If there are correctable problems with the protocol, the OPHS will consult with the investigators to seek revisions in the protocol. Conditional approval indicates that problems with the protocol must be corrected before the research may commence; typically, determination of whether the changes made by the investigator satisfy the conditions set forth by the CPHS/IRB can be made by the OPHS or the chair, obviating further discussion of the protocol by CPHS/IRB. When the conditions have been satisfied, the chair of the CPHS/IRB will sign the cover sheet and research may commence.
If the protocol is disapproved, the researcher may not conduct the research and the CPHS/IRB will provide, in writing, the reason for its decision. Furthermore, the researcher will have the right to appeal the decision.
The OPHS will report concerns and outcomes of the CPHS/IRB to the investigator and to the faculty member supervising the research when the investigator is a student.
STEP 7 -- Research Commences or Decision is Appealed
Once the protocol is approved, research with human subjects may commence. It is the responsibility of the investigator (and faculty supervisor if investigator is a student) to monitor the research to insure that the approved procedures are being followed. Any harm to subjects should be reported to the CPHS/IRB immediately.
The CPHS/IRB will conduct continuing review of approved projects at intervals appropriate to the degree of risk, but not less than once per year. The CPHS/IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the CPHS/IRB requirements or that has been associated with unexpected serious harm to subjects. Any such termination will include a statement of the reason for action and shall be reported promptly to the investigator, to the faculty advisor if the investigator is a student, to the appropriate University officials, and to the appropriate federal officials. Furthermore, the CPHS/IRB has the authority to observe or have a third party observe the consent process and the research.
If for some reason an investigator is not satisfied with the decision of the CPHS/IRB or with the process by which a decision is rendered, the right to an appeal is maintained.
STEP 8 -- Changes in Approved Procedures (Amendments/Modifications)
Any changes in previously approved research must be approved by the CPHS/IRB. Minor changes may be submitted to the OPHS on the Amendment/Modification Form with a memorandum describing those changes and the effects of the requested modifications on risks, benefits and consent procedures. If the changes are determined to be substantial, the investigator will be informed that a new protocol must be submitted. All modifications must be reviewed and approved by the faculty advisor if the researcher is a student. Modifications need to be submitted on the Amendment/Modification Form.
STEP 9 -- Continuing Projects and Termination of Projects
At regular intervals (and at least once a year), the CPHS/IRB will conduct continuing reviews of projects in progress. When the current approval period is nearing an end, the CPHS/IRB will send the investigator a Continuing Review/Final Report Form. If there are no problems, adverse reactions, or changes in activities by the investigator, continuing review will be handled administratively. If any of these conditions are present, review of the project will be conducted by the CPHS/IRB and a revised protocol must be submitted.
An investigator may be granted up to four one-year renewals on each individual human subjects protocol. If the investigator wishes to continue conducting the research in question after the expiration of the fourth renewal, s/he will submit a new protocol application for Committee review.
According to NIH guidelines, proposals for noncompeting continuation support must have a current human subjects approval at the time the grant proposal is submitted. In other words, there is no "grace period" for certifying human subjects approval after the continuation proposal is submitted.
If the project is terminated (i.e., procedures involving human subjects are completed), the investigator should complete the Continuing Review/Final Report Form and send it to the CPHS/IRB. All consent forms must be kept by the investigator for three years after the research is completed.
Beginning February 15, 2007, all UO researchers (faculty, staff and students) conducting human subjects research and faculty advisors of students conducting human subjects research must complete the Collaborative IRB Training Initiative (CITI) program in order for applications to be approved by the Office for Protection of Human Subjects (OPHS). Any UO researcher who has already completed the NIH training module before February 15, 2007, will have a one-year grace period from the date of their NIH training certificate to complete the CITI modules. No NIH training certificates will be honored after February 15, 2008.
Completion of the CITI program is required by all UO researchers and research staff, regardless of whether the research is funded or not. "Research staff" includes investigators, researchers, key personnel, graduate or undergraduate students involved in faculty research projects, and faculty advisors on student research projects. Anyone on a research team responsible for the design and conduct of the study (e.g., the informed consent process and/or collecting data though intervention or interaction with an individual, or identifiable private information) need to complete the training. Outside investigators (those unaffiliated with the UO) conducting research at the University of Oregon or for any UO research team may submit documentation from their own institution, provided the training was completed within the last two years, or they may complete the University's CITI modules.
CITI is accessible via the OPHS research website at http://humansubjects.uoregon.edu/citiprogram.htm. The program was specifically chosen to provide faculty, staff and students with the greatest ease of access and flexibility to complete the training over multiple sessions according to your schedule. All CITI certificates expire two years from the completion date. At that time, researchers must take the refresher CITI course.
The CPHS/IRB may approve research when the following conditions are satisfied:
In the event that a protocol is disapproved by the CPHS/IRB, the investigator may appeal the decision as follows:
EXEMPTION CATEGORIES (Effective August 19, 1991)
For assistance determining review categories, see the regulations decision charts at the following link to the Office of Human Research Protections.
None of these exemptions apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization. It is the prerogative of the university to prohibit exemptions that are allowable under federal policy.
Exempt status applies to research activities in which the only involvement of human subjects will be in one or more of the following categories:
(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless;
(5) Research and demonstration projects which are conducted by or subject to the approval of [federal] department or agency heads, and which are designed to study, evaluate, or otherwise examine:
For assistance determining review categories, see the regulations decision charts at the following link to the Office of Human Research Protections.
Applicability
(A) Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
(B) The categories in this list apply regardless of the age of subjects, except as noted.
(C) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
(D) The expedited review procedure may not be used for classified research involving human subjects.
(E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.
(F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review.
Research Categories:
The University of Oregon accepts as a basic principle that it has an ethical and moral obligation to safeguard the rights and welfare of all subjects involved in research, training, educational development and other activities where subjects are exposed to a risk that could be detrimental to their health or well-being. In those cases where risk may exist, even with informed consent, approval of a research project will be made only if the risk to the individual is outweighed by a clear explanation of the potential benefit to the person (as in the case where an activity involves therapy, diagnosis, management, etc.). In evaluating risks and benefits, the CPHS/IRB shall consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies the subjects would receive even if not participating in the research), and shall not consider long-range effects of applying knowledge gained in the research as among those risks that fall within the CPHS/IRB's purview of responsibility.
The university shall be responsible for physical or psychological injury to human subjects attributable to university-sponsored research, development, and related activities, to the extent that the university may be found liable under federal and state laws. Therefore, the obligation of researchers to conduct activities in a manner and at such locations as will assure the proximity of adequate medical attention if warranted, and to provide appropriate referrals to subjects for adequate facilities and professional attention should subjects suffer physical, psychological or other injury, is of paramount importance when designing research involving human subjects. (Refer to additional elements if appropriate for further information on university liability.)
The seriousness of a risk to subjects is a function of the magnitude of the harm and the probability of the harm. A risk may be serious or significant because it has a probability (even a low probability) of great harm (e.g., a low probability of death), or because it has a high probability of slight harm (e.g., a near certainty of physical discomfort or psychological distress).
The risks of participation in research may be part of the research
design or may be a consequence of the research procedures, or both (e.g.,
the risks of an adverse reaction to an investigational drug are part of the
research design, while the risk of hematoma from blood drawn in the research
is not part of the design but a consequence of the research procedures).
Risks may be a consequence of the methods of recording, maintaining, or
reporting data, and they may be a consequence of methods of obtaining informed
consent.
Physical risks include physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research. A physical risk may result from the involvement of physical stimuli such as noise, electric shock, heat, cold, electric magnetic or gravitational fields, etc. Engaging a subject in a social situation which could involve violence may also create a physical risk.
Psychological risks include the production of negative affective states such as anxiety, depression, guilt, shock and loss of self-esteem and altered behavior. Sensory deprivation, sleep deprivation, use of hypnosis, deception or mental stresses are examples of psychological risks. (See risk language for sample informed consent language for research with psychological risks.)
Occasionally, some degree of deception is involved in a research study. Minor deception, such as failing to tell the subject what the specific points of interest are in an attempt to prevent biasing the results, can be acceptable provided the subject is fully debriefed after participating. Risks stemming from major deceptions, such as leading a subject to believe that s/he has committed a crime or has a disease, must be clearly counterbalanced by the benefits of the research. 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 CPHS/IRB will require information sufficient to understand why deception is needed, how the potential benefits justify its use, and how debriefing will be done.
If information was temporarily withheld from the subject during the study, or if deception was employed, a separate debriefing statement should be presented at the end of the procedure. This statement should clearly indicate why information was withheld during the study, and/or the purpose of the deception.
Social/Economic risks include alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling a subject in a way that will have negative consequences, or in some way diminishing those opportunities and powers a person has by virtue of relationships with others. Economic risks include payment by subjects for procedures not otherwise required, loss of wages or other income and any other financial costs, such as damage to a subject's employability, as a consequence of participation in the research.
Loss of Confidentiality: In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Subjects have the rights to be protected against injury or illegal invasions of their privacy and to preservation of their personal dignity. The more sensitive the research material, the greater the care that must be exercised in obtaining, handling, and storing data.
Investigators should be cognizant of the following guidelines to ensure confidentiality:
Identifiers linked to the subject can include name, code or reference that could be used to identify an individual outside of the context of the research setting. Names, student numbers, and social security numbers on the data are obvious examples. An identifier that links a subject to a list of names or identifiers kept elsewhere can also lead to loss of confidentiality. 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. A subject's privacy may be invaded simply by being identified as a qualified participant for a study (such as membership in Alcoholics Anonymous). The investigator should determine whether the information or data could be traced back to an individual subject, and make appropriate safeguards to ensure that confidentiality will be maintained (refer to confidentiality/anonymity for additional information on confidentiality/anonymity). Please refer to recruiting clients of social service institutions for information on accessing subjects' records.
Legal risks exist when the
research methods are such
that the subject or others will be liable for a violation of the law, either by revealing that the subject or others have or will engage in conduct for which the subject or others may be
criminally or civilly liable, or by requiring activities for which the subject or others may be
criminally or civilly liable.
Defining "minimal risk" in research involving human subjects is useful for both the investigator and the CPHS/IRB, in that research involving more than minimal risk requires additional elements in the informed consent documents, including the official liability clause (refer to additional elements if appropriate), and full review by the CPHS/IRB. Projects with minimal risk may be reviewed through the expedited process, or in some cases may be exempt from review altogether if the research so qualifies under the regulations.
The federal regulations governing research with human subjects define "minimal risk" as follows: "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
In broad terms, a project may be determined as involving minimal risk if:
Additional considerations for making this determination might include whether the project provides a novel environment for the subject, or whether the subject will be exposed to situations which would not be considered a risk for the general public but might be risky for a special population such as disabled, young or elderly subjects.
It is difficult to develop a rule that can be applied across all disciplines and in all situations, to determine whether a project involves minimal risk or more than minimal risk. It is assumed that the researcher will apply the customs and practices associated with his/her discipline, such as outlined in a published code of ethics, in making this initial determination. The CPHS/IRB will make the final determination as to the project's level of risk and the safeguards required to minimize risks for subjects.
Informed consent is the knowing consent of an individual or her/his legally authorized representative which is obtained without undue inducement or element of force, fraud, deceit, duress, or other forms of constraint or coercion. A consent form documents informed consent and is designed to protect the investigator and the institution against legal liability.
One of the most common reasons for delay of approval of a protocol is an inadequate consent form. The consent form should be a statement addressed to the subject and should read as such. Ordinarily, it is best worded in the second person. It must be in language the subject can understand (avoid or define technical terminology, adjust for educational background and ages, provide translations in other languages when subjects do not understand English). Separate forms may be required for different subject groups (parents, children, UO students, etc.), as well as for release of particular kinds of information (photographs, video recordings). (See this section ).
Templates for several types of informed consent forms can be found at
the end of this section. Researchers need not copy this language verbatim, so long as all required elements are included in the informed consent form. Sample protocols with examples
of well-written informed consent forms are on file at OPHS and may be
reviewed in that office.
Research investigators are responsible for obtaining informed consent and for insuring that no human subjects will be involved in the research prior to obtaining their consent. In obtaining informed consent, investigators must avoid the possibility of coercion or undue influence. Unless otherwise authorized by the CPHS/IRB, investigators are responsible for insuring that legally effective informed consent shall:
REQUIRED ELEMENTS FOR ALL INFORMED CONSENT FORMS
A written consent form must include the following items. In addition, special provisions are required when subjects are from special populations (refer to this section ).
ADDITIONAL ELEMENTS IF APPROPRIATE
If you are physically injured because of the project, you and your insurance company will have to pay your doctor bills. If you are a UO student or employee and are covered by a UO medical plan, that plan might have terms that apply to your injury. (revised 4/02)
If you experience harm because of the project, you can ask the state of Oregon to pay you. If you have been harmed, there are two University representatives you need to contact. Here are their addresses and phone numbers:General Counsel
Office of the PresidentUniversity of Oregon
Eugene, OR 97403(541) 346-3082Office for Protection of Human Subjects
University of OregonEugene, OR 97403
541) 346-2510A law called the Oregon Tort Claims Act limits the amount of money you can receive from the State of Oregon if you are harmed. The most you could receive would be $100,000, no matter how badly you are harmed. If other people are also harmed by the project, all of you together could only receive $500,000.
The consent form may be 1) a written document that contains the required
elements of informed consent, to be read by the subject or the subject's
representative or by the investigator to the subject; or 2) a short
written form stating that the basic elements of informed consent have been
presented orally to the subject or representative.
DOCUMENTATION OF INFORMED CONSENT
Investigators shall be responsible for insuring that informed consent
is documented by the use of a written consent form approved by the CPHS/IRB and signed by the subject or the subject's legally authorized representative, unless this requirement is
specifically waived by the CPHS/IRB. Each person signing the written consent form must be given a copy of that form.
WAIVER OF DOCUMENTATION OF INFORMED CONSENT
Under certain conditions, the CPHS/IRB can waive the requirement that the subject sign the consent form. However, waiver of documentation of informed consent does not constitute waiver of informed consent. The CPHS/IRB may waive the requirement to obtain a signed consent form for some or all of the subjects if one of the following conditions exists:
In cases where documentation is waived, the CPHS/IRB may require the investigator to provide subjects with a written statement regarding the research.
POLICY ON PASSIVE PARENTAL CONSENT FOR RESEARCH IN ELEMENTARY AND SECONDARY EDUCATIONAL SETTINGS
If the proposed study meets the conditions needed to obtain a waiver of
informed consent, use of a passive consent mechanism may be granted.
Where oral consent is allowable, investigators shall insure that:
WAIVER OR ALTERATION OF INFORMED CONSENT
The CPHS/IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to obtain informed consent, provided one of the following sets of conditions exists and is documented:
RETENTION OF SIGNED CONSENT DOCUMENTS
Investigators are responsible for placing the consent documents signed
by research subjects in a repository approved by the Office for Protection of Human Subjects and for retaining signed consent forms for three years
after termination of the project.
By current federal and University policies, subjects in research, evaluation, and training projects give their informed consent to participate. In the informed consent procedure, subjects are often given assurances of protection against loss of confidentiality or for total anonymity. Despite the assurances and subsequent efforts, subjects may yet be identifiable. Two legal conditions are at stake.
Refer to loss of confidentiality for additional information on safeguarding subject confidentiality.
This sample is a template from which a consent form can be
developed.
The language does not have to be repeated verbatim. THE CONSENT
FORM SHOULD BE WRITTEN IN TERMS UNDERSTANDABLE TO THE
SUBJECT (avoid or define technical terminology, adjust for
educational background and ages, provide translations in other languages
when subjects do not understand English). A
detailed description of the basic elements of consent is in the
Investigators with projects involving
more than minimal risk, and/or those working with special
populations (children, mentally disabled, prisoners, pregnant women) must
consult the
You are invited to participate in a research study conducted by [name of investigator], from the University of Oregon [departmental affiliation]. I hope to learn [state what the study is designed to discover or establish. If a student, indicate that results will contribute to thesis or dissertation]. You were selected as a possible participant in this study because [state why subject was selected].
If you decide to participate, [describe procedures, including their purpose, how long they will take, their location and frequency. If activities are to be audio or video recorded, indicate this].
The survey or interview [describe research activity] may [Describe risks, discomforts, inconveniences, and how these will be managed. Do not use definative statements regarding lack of risks. Describe any alternative procedures or courses of treatment, if applicable. Indicate costs of participating, if any.] [Describe benefits to subjects and humanity expected from the research]. However, I cannot guarantee that you personally will receive any benefits from this research. [If subject will receive compensation, describe amount and when payment is scheduled.] [If blood or urine samples will be collected and the samples will not be evaluated by a physician with results given to the subject, the following statement needs to be included in the consent form: "Blood (and/or urine, if applicable) samples are not being collected for diagnostic purposes. The results will not be reviewed by a physician and no action will be taken if a laboratory value falls outside of the normal range."]
[If project is more than minimal risk, the standard language regarding responsibility for medical expenses and liability must be included. See p. 18 of the Manual for this language. Other elements of informed consent may be required for a particular study. Refer to pp. 18 and 34-35 for this information.]
Any information that is obtained in connection with this study and that can be identified with you will remain confidential and will be disclosed only with your permission. Subject identities will be kept confidential by [describe coding procedures and plans to safeguard data]. [If information will be released to any other party for any reason, state the person/agency to whom the information will be furnished, the nature of the information, and the purpose of the disclosure.] [If protected health information (PHI) will be used, language referencing the authorization to access and use an individual's personal health information needs to be included in the form and an authorization form needs to be developed. Further information and a sample form may be found at HIPAA Instructions.]
Your participation is voluntary. Your decision whether or not to participate will not affect your relationship with [name of agency, school, etc. where subject was recruited]. If you decide to participate, you are free to withdraw your consent and discontinue participation at any time without penalty.
If you have any questions, please feel free to contact [provide name, phone number, and department address. If student, also provide advisor name and phone, and identify as your advisor.] If you have questions regarding your rights as a research subject, contact the Office for Protection of Human Subjects, University of Oregon, Eugene, OR 97403, (541) 346-2510. This Office oversees the review of the research to protect your rights and is not involved with this study.
Your signature indicates that you have read and understand the information provided above, that you willingly agree to participate, that you may withdraw your consent at any time and discontinue participation without penalty, that you have received a copy of this form, and that you are not waiving any legal claims, rights or remedies.
Print Name________________________________________________________
Signature ________________________________________________________ Date_________________________
(If subject is a child, indicate: Signature of Parent/Legal Guardian and include a space for name of child.)
NOTE: Language may be altered to obtain parental consent for participation of their child (e.g., "If you decide to allow you child to participate in this study, the child will be asked to..."). Children may also sign this form if they understand the information provided, or a separate assent form may be given to young children (see Manual for sample). If subjects are mentally disabled, the language should be appropriate to their understanding, and additional signatures are required (Manual - Special Subject Populations). The form should indicate that the "parent/legal guardian" is the appropriate person to sign the form.
For research projects that involve video recording, a video recording release form must be attached to the written consent form. If the investigator anticipates use of the recordings beyond the scope of the initial research project, the written consent form must indicate (a) who will view the recordings; (b) for what purpose(s); (c) when the recordings will be destroyed.
(to be attached to written consent form)
I have received an adequate description of the purpose and procedures for video recording sessions during the course of the proposed research study. I give my consent to be video recorded [If children will be video recorded, use the following: "I give my consent to allow _________ (child's name) to be video recorded..."] during participation in the study, and for those video recordings to be viewed by persons involved in the study, as well as for other professional purposes [clarify purposes] as described to me. I understand that all information will be kept confidential and will be reported in an anonymous fashion, and that the video recordings will be erased after the study has been completed [or a specified period of time, e.g., 7 years, etc.]. I further understand that I may withdraw my consent at any time.
Print Name_____________________________________________
Signature of parent/legal guardian___________________________Date_________
(if subject is a child)
Print Name____________________________________________
Signature of participant______________________________ Date_________
.
Child's name _______________________________
I am interested in [provide simple description of purpose of research], and I'd like you to help me. I'd like you to [describe activities]. All you'll have to do is [describe child’s participation in activities]. It will take [describe frequency and duration], but you can rest as much as you'd like, and you can stop the whenever you want.
If you want to rest, or stop completely, just tell me--you won't get into any trouble! In fact, if you don't want to [describe activity e.g., play the game, talk to me, etc.], you don't have to. Just say so. Also, if you have any questions about what you'll be doing, or if you can't decide whether to do it or not; just ask me if there is anything you'd like me to explain.
If you do want to try it, please sign your name on the line below. Your parent(s) have already told me that it is all right with them if you want to [describe activity e.g., play the game, talk to me, etc.]. Remember, you don't have to, and once you start you can rest or stop whenever you like.
Sign Your Name:____________________________________________ Date:______________________
You are invited to participate in a research project on [state purpose of research]. The project is being conducted by [name of investigator], from the University of Oregon [department affiliation and status, professor or if student, indicate that results will be used in thesis/dissertation]. The research will help me understand [state benefits to subjects and humanity expected from research].
All you need to do is complete this short questionnaire, which should take approximately [state time needed to complete questionnaire]. Your participation is voluntary. If you do not wish to participate, simply discard the questionnaire. Responses will be completely anonymous; your name will not appear anywhere on the survey. Completing and returning the questionnaire constitutes your consent to participate.
Keep this letter for your records. If you have any questions regarding the research, contact [give name, department, phone number, and department address if applicable. Include advisor name/phone if student, and identify as advisor]. If you have any questions regarding your rights as a research subject, please contact the Office for Protection of Human Subjects at the University of Oregon, (541) 346-2510. This Office oversees the review of the research to protect your rights and is not involved with this study.
Thank you again for your help.
Informed Consent/Cover Letter Statement:
If you feel uncomfortable answering any of the questions, you may discontinue at any time or skip to the next question. If you experience any stress, anxiety or psychological discomfort as a result of participation in this research, you may contact my advisor ___________________________, the University Counseling Center at x63227, or the University of Oregon Psychology Clinic, x64954.
Debriefing Statement:
Answering personal questions about one's life can be a disconcerting experience. If answering any of these questions has upset you, or made you think of your own questions, or if you have experienced any stress or discomfort as a result of participation in this research, you may contact the University Counseling Center at x63227, the University of Oregon Psychology Clinic at x64954, or you can call the investigator or his/her advisor for other names and numbers that may be helpful to you.
Child means any person younger than 18 years of age unless s/he has been legally emancipated. (However, college or university students 15-17 years of age may be considered adults for the purpose of participation in a research project with no more than minimal risk.)
Parent means a child's biological or adoptive parent.
Guardian means a person who is authorized by law to consent on behalf of a child or disabled individual to general medical care.
Permission means the agreement of the parent(s) or guardian to the participation of the child, disabled individual, or ward in the research.
Assent means an affirmative agreement to participate in research; mere failure to object does not
constitute assent.
When research subjects are children, additional considerations must be met by the researcher. Two limitations are that 1) some research which would fall in the exempt category if the subjects were all competent adults is not exempt, and 2) some research involving more than minimal risk to the subjects is prohibited. Additional requirements pertain to informed consent.
For the purpose of these rules, a "child" is any person younger than 18 years old unless he or she has been legally emancipated. A young person is legally emancipated if he or she is married or if a court has declared him or her emancipated. People
younger than 18 who are living independently of their parents are not for this reason alone legally emancipated. However, college or university students 15-17 years of age may be considered adults for the purpose of participating in a research project
with no more than minimal risk.
Categories of exempt research when the subjects are children
Some types of research are considered exempt even when children are subjects (refer to review categories for a list of exempt categories). However, some types of research considered exempt when subjects are competent adults are not exempt when children are subjects. Research involving survey or interview procedures is not exempt when children are subjects. Research involving observation of public behavior is exempt only if the researcher does not participate in the activities being observed. All other research with children must be reviewed by the CPHS/IRB.
In all cases, the assent of the children, and consent of parent(s)
or guardian, must be obtained prior to conducting
the research.
Special considerations in research when subjects are children
Research that poses only minimal risk to the subjects: Adequate provisions must be made for obtaining assent of the children and permission from their parent(s) or guardians, as described below.
Research that poses more than minimal risk but which promises to benefit the individual child directly or involves a monitoring procedure likely to contribute to the child's well-being will be permitted if:
Research that poses more than minimal risk and does not promise to benefit the individual child directly is permitted only if:
In addition, if the child is a ward of the state or any other agency, institution, or entity, he or she may be a research subject only if the research is 1) related to his or her status as a ward or 2) conducted in a school, camp, hospital, institution or similar setting in which the majority of the children involved as subjects are not wards. An advocate must be appointed for each child who is a ward. This advocate must be a person who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except as advocate or member of the CPHS/IRB) with the research, the investigator or the guardian organization. The requirement for an advocate is in addition to the requirement that permission be obtained from any other person acting on behalf of the child as guardian or in loco parentis.
Research with children which exposes the subjects to more than minimal risk and which does
not satisfy the conditions set out above cannot be approved by the CPHS/IRB. However, the federal regulations
governing research with human subjects provide a special procedure for seeking approval for such research that involves
getting approval of the Secretary of DHHS. The OPHS has information about
this process.
The federal regulations do not set a minimum age at which a child's assent must be solicited but instead say that assent is required whenever in the judgment of the CPHS/IRB the children are capable of providing assent, taking into account their ages, maturity, and psychological state. The CPHS/IRB has set this age at 7 years based on consultations with a child development expert on the University of Oregon faculty. Therefore, when research subjects are younger than 7, their assent does not have to be solicited, but the CPHS/IRB encourages researchers to explain to younger children what they will be asked to do in the course of the research and to secure their agreement to participation if possible.
Permission from parent(s) or guardian:If the research involves only minimal risk, or it poses more than minimal risk but promises to benefit the child directly, permission must be obtained from at least one of the child's parents, or the child's guardian. If the research poses more than minimal risk and no direct benefit to the child, both parents or the child's guardian must give permission for the child to participate in the research. However, the permission of a parent who is deceased, unknown, or incompetent, or not reasonably available, or who does not have legal responsibility for the care and custody of the child is not required.If a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the children (for example, neglected or abused children), the CPHS/IRB may waive the requirement that parental permission be sought, provided that there is an appropriate alternative mechanism for protecting the children which is not inconsistent with the law. The choice of an appropriate alternative mechanism depends on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the children, and their age, maturity, status and condition. In such cases the researcher should propose an alternative mechanism, explaining why it will protect the children. The CPHS/IRB will then review the adequacy of this proposal.
Information that must be provided in requests for assent and permission; documentation of informed consent: When parents or guardians are asked for permission and children are asked for assent, they must be given the same information that is generally required when informed consent for participation in research is sought, and their permission and assent must be documented in writing. The general requirements are discussed in informed consent.The assent form for children should, of course, be written in language appropriate to their age and understanding. (A sample form for use with younger children is available.) If the parents are not also research subjects themselves, it may be appropriate to have them sign the same form their children sign. If the parents are also research subjects, ordinarily a separate form should be drafted for them, addressing their own participation as well as that of their children.
In circumstances in which the CPHS/IRB may alter or waive the usual requirements for
securing and documenting informed consent when the subjects are
competent adults (refer to
documentation of informed consent), the CPHS/IRB
may waive or alter the requirements for seeking permission and assent
when children are subjects.
The CPHS/IRB has adopted special rules that apply when research subjects are mentally disabled. Most of the general requirements for approving research with human subjects apply, but with some exceptions and additions. The major exceptions are that 1) some research which would fall in the exempt category if the subjects were all competent adults is not exempt, and 2) some research involving more than minimal risk to the subjects is prohibited. Additional requirements pertain to informed consent.
For the purpose of these requirements, a "mentally disabled" person is a person who, because of mental illness, mental retardation, emotional disturbance, or senility, is incapable of giving informed consent.
Of course, some persons who have these conditions are also able to give
informed consent, but the CPHS/IRB cannot determine the capacity of persons
with these conditions on the basis of labels alone. Therefore, whenever
proposed research involves subjects who have been diagnosed with one of these
conditions or who may have such a condition, the researcher should explicitly
tell the CPHS/IRB whether the subjects are able to give informed consent
because of the condition. If the subjects are able to give informed consent,
the special rules in this section do not apply, and only the general
requirements for research with human subjects must be satisfied.
Categories of exempt research when the subjects are mentally disabled
Some types of research are considered exempt even when subjects are
mentally disabled (refer to
exemption categories). However, some types of research considered exempt
when subjects are competent adults are not exempt when subjects are mentally
disabled. Research in category 1 (conducted in established or commonly
accepted educational settings involving normal educational practices) is
exempt only if the research involves no changes in the content of instruction,
location of instruction, or procedures used during instruction from those a
subject would normally experience. Research involving survey or interview
procedures is not exempt. Research involving observation of public behavior
is exempt only if the researcher does not participate in the activities being
observed. All other research with mentally disabled subjects is subject
to review by the CPHS/IRB.
Special considerations in research when subjects are mentally disabled
Research that poses only minimal risk to the subjects: No special limits are placed on this type of research, except that adequate provisions must be made for obtaining assent of the mentally disabled subjects and permission from their representatives, as described below.
Research that poses more than minimal risk but which promises to benefit the individual subject directly will be permitted if:
In addition, if the mentally disabled subjects are wards of the state or any other agency, institution, or entity, they may be the subjects of research that poses more than minimal risk only if the research is 1) related to their status as wards or 2) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of the subjects involved are not wards. Furthermore, if the research poses more than minimal risk, an advocate must be appointed for each mentally disabled person who is a ward. The advocate must be a person who has the background and experience to act in, and agrees to act in, the best interests of the mentally disabled person for the duration of the person's participation in the research. The advocate cannot be associated in any way with the research, the investigator(s) or the guardian organization. A person can be the advocate for more than one person. The requirement for an advocate is in addition to any other person acting on behalf of the mentally disabled person as guardian.
Research that poses more than minimal risk and does not promise to benefit the individual subject directly will be permitted if:
In addition, if the mentally disabled subjects are wards the
requirements described previously apply.
Permission from competent adults acting on behalf of the subjects: Ordinarily, a mentally disabled person may not be the subject of research unless permission is obtained from the person's guardian. For purposes of these rules a guardian cannot be associated in any way with the research or the investigator(s). If the mentally disabled person is a ward of the state or any other agency, institution or entity, a person associated with the entity cannot be a guardian for purposes of these rules.
The parent of a mentally disabled person below the age of 18 is presumed to be the person's guardian. If the mentally disabled person is older than 18, the parent is not automatically the guardian. If the subjects are mentally disabled adults who have not formally had legal guardians appointed for them, the researcher should propose a procedure for securing permission from a competent adult acting solely in the interests of the mentally disabled person. This procedure must be consistent with federal, state, and local law.
Information that must be provided in requests for assent and permission and documentation of informed consent: Mentally disabled subjects and the competent adults acting on their behalf must be given the same information that is generally required when informed consent for participation in research is sought, and their permission and assent must be documented in writing. The assent form for the mentally disabled subjects should, of course, be written in language appropriate to their level of understanding.
In circumstances in which the CPHS/IRB may waive or alter the usual
requirements for securing and documenting informed consent when the subjects are competent
adults, the CPHS/IRB may waive or alter the requirements for seeking
permission and assent when subjects are mentally disabled.
Pregnancy encompasses the period of time from confirmation of implantation (as evidenced by
missed menses or a medically acceptable test) until expulsion or extraction of the fetus. Fetus means the product of
conception, from the time of implantation until a determination is made, following expulsion or extraction, that it is viable.
Activities Directed Toward Pregnant Women
No pregnant woman may be involved in a research activity unless a) the risk to the fetus is
minimal, or b) the purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to
the minimum extent necessary to meet such needs.
Additional Consent Requirements
Research activity permitted above may be conducted only after fully informing the mother and father of any possible impact on the fetus and obtaining informed consent from the legally competent mother and father. Consent by the father need not be secured if:
Research Directly Involving Fetuses
Any research directly involving fetuses requires consultation with the CPHS/IRB.
Prisoner means any individual involuntarily confined or detained in a penal institution. The term applies to those sentenced to such an institution, those detained in other facilities as alternatives to prosecution, and those detained pending arraignment, trial, or sentencing.
Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons, or may be untried persons who are detained pending judicial action, for example, arraignment or trial.
Common examples of the application of the regulatory definition of prisoner are as follows:
Prisoners may be under constraints because of their incarceration which could affect their
ability to make a truly voluntary decision whether or not to participate as subjects in research. Additional safeguards are
required, therefore, when prisoners are proposed as subjects. NOTE: The CPHS/IRB needs to be notified and a new protocol
will need to be submitted for review if currently enrolled subjects in a non-prisoner project become incarcerated. Additional
information is available at
http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm.
CPHS/IRB Membership Regarding Research with Prisoners
A majority of the CPHS/IRB shall have no association with the prison(s) involved. At least one member of the CPHS/IRB shall be a prisoner or prisoner representative, with appropriate background and experience. If the research is reviewed by more than one IRB, only one need have a prisoner representative.
When using prisoners as subjects, only the following types of research are allowable:
In all cases, the research is to present no more than minimal risk and inconvenience to subjects.
For research in the latter two categories above, consultation with the CPHS/IRB is necessary to determine
possible need for approval by experts in penology medicine and ethics. Any proposed biomedical research requires consultation
with the CPHS/IRB.
The institution responsible for conducting research involving prisoners that is supported by DHHS shall certify to the Secretary through the Office of Human Research Protections (OHRP) that the IRB has made the seven findings required under the regualations (45 CFR 46.305(a)). The institution must send to OHRP a certification letter to this effect, which should also include the name and address of the institution and specifically identify the research protocol in question and any relevant DHHS grant application or protocol. DHHS conducted or supported research involving prisoners as subjects may not proceed until OHRP issues its approval in writing to the institution on behalf of the Secretary under 45 CFR 46.306(a)(2).
Under its authority at 45 CFR 46.115(b), OHRP requires that the institution responsible for the conduct of the proposed research also submit to OHRP a copy of the research proposal so that OHRP can determine whether the proposed research involves one of the categories of research permissible under 45 CFR 46.306(a)(2), and if so, which one. The term "research proposal" includes the IRB-approved protocol, any relevant HHS grant application or proposal, any IRB application forms required by the IRB, and any other information requested or required by the IRB to be considered during initial IRB review.
When using prisoners as subjects the following additional concerns must be addressed:
Definition of Minimal Risk in Prisoner Research (45CFR 46.303(d)): "Minimal risk" is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
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 (such as on-going support by a social agency).
Special care must be taken if the person doing the recruiting is a person who is in a position of
authority (such as a teacher recruiting his or her own students) or makes decisions about the provision of services
(such as a director of a training clinic). It is the investigator's responsibility to ensure that a person's decision to
participate or not will have no other effect on an existing relationship.
Guidelines for Research Using Classroom Subjects
Students in University of Oregon classes are occasionally asked to participate in research. In such cases, the researcher should ask the instructor to give her/his permission to use class time to conduct a study. Because students in classrooms comprise a captive audience, care should be taken to respect their rights as subjects and as students.
If participation as a subject is part of the academic work of a student, it must not be a coercive requirement, and informed consent, if appropriate, must be obtained. Alternate means of receiving credit if a student chooses not to participate or chooses to withdraw during the course of the study should be provided.
To assure that students feel free to refuse to participate without concern that the evaluation of their classroom performance will be affected, the instructor should not be present during any research activities. Furthermore, the instructor should not be informed nor be aware of who participates.
When investigators wish to audio record or video record university classes, students have the right to refuse participation. At the same time, students should not be penalized by losing significant classroom instruction in the event they decide not to be recorded. The following procedures should be used:
Because research involves time that would otherwise be used for instructional activities, departments may wish to promulgate policies with regar