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Academics and Research – Research
|EWU Policy 302-02||Authority: EWU Board of Trustees|
|Effective: July 13, 2012||Proponent: Provost and Vice President for Academic Affairs|
Purpose: This policy prescribes standards for the use of human subjects in research activities at Eastern Washington University.
History: This policy was published on July 13, 2012 and supersedes UGS Policy 435-080, Human Research, et seq, as adopted by the EWU Board of Trustees in August, 1999. This policy includes reformatting and housekeeping changes only and does not constitute any material change in policy.
Chapter 1 – General
1-1. Policy for the Protection of Human Subjects
It is the policy of Eastern Washington University to adhere to the generally accepted ethical and professional standards for the protection of human subjects of research that are formulated in The Belmont Report and the Nuremberg Code. The three Belmont Principles have been summarized by the Office for Protection from Research Risks, National Institutes of Health, as follows:
a. “Respect for Persons involves a recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy. …Required by the moral principle of respect for persons, informed consent contains three elements: information, comprehension, and voluntariness…Institutional Review Boards should be especially sensitive to these factors when particularly vulnerable subjects are involved.”
b. “Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks or harm…The Report recommends the Institutional Review Board’s insistence upon precise answers to direct questions. The IRB should: (a) determine the ‘validity of the presuppositions of the research;’ (b) distinguish the ‘nature, probability, and magnitude of risk…with as much clarity as possible;’ and (c) ‘determine whether the investigator’s estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.’ ”
c. “Justice requires that the benefits and burdens of research be distributed fairly…The principles of justice mandate that the selection of research subjects must be the result of fair selection procedures and must also result in fair selection outcomes. The ‘justness’ of subject selection relates both to the subject as an individual and to the subject as a member of social, racial, sexual, or ethnic groups.”
1-2. Applicability of Policy
The following policy statements, definitions, and procedures are in accord with the federally mandated requirements of 45CFR46 and constitute the basis of the university’s Single Project Assurances filed as required with the office for protection from research risks (OPRR) of the department of health and human services (DHHS).
In compliance with federal regulations governing federally-funded research, and in consideration of the liability assumed by the university when faculty, students, and employees conduct research, all research involving human beings as subjects who are being investigated for any purpose other than solely for the benefit of the subject as an individual, shall be approved by the University Institutional Review Board (IRB) and reviewed at the appropriate level, following the established procedures presented in this subtopic (435-080).
1-3. Responsibility, Jurisdiction and the Institutional Review Board
a. University policies and procedures apply to any research activity which involves human subjects, whether such research is undertaken on a large or small scale, whether it is preliminarily or fully designed, whether it is student or faculty research, whether it is funded or non-funded, and whether it involves minimal risk or more than minimal risk.
b. Ultimately the responsibility for maintaining ethical standards and protecting human rights rests with the individual researcher (and, in the case of university students, their faculty research advisor). The IRB is required as an added measure of reassurance and as a local resource for the interpretation of ethical guidelines. Any research involving human subjects must have associated with it a responsible project investigator who is a qualified faculty member or a qualified staff member, and who will monitor and be liable for the conduct of the research.
c. Engaging in research with human subjects without IRB approval puts the researcher at risk and is a violation of university and federal policies. Regardless of investigator intent, unapproved research involving human subjects places those subjects at an unacceptable risk.
d. Written approval from the IRB must be received before initiation of subject recruitment or initiation of procedures that involve human subjects.
e. Human subjects approvals granted by the IRB are good for one year from the date of approval, unless substantial modification of the approved protocol has required a new review. Approval of exempt protocols is valid for five years from the date of approval.
f. “The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. Research that has been reviewed and approved by [the] IRB may be subject to review and disapproval by officials of the university. However, those officials may not approve research if it has been disapproved by the IRB.” (Federal Policy 45CFR46.112)
g. In addition to compliance with federal and university procedures contained herein, projects involving human subjects whose protection is the responsibility of an agency other than Eastern Washington University, will also be subject to that agency’s procedures.
Chapter 2 – Policy
2-1. Informed Consent
Informed consent includes three essential elements: voluntariness, disclosure, and comprehension.
a. Participation of human subjects in research governed by this policy must be voluntary. The consent of authorized representatives is usually required, in accordance with applicable statutes and regulations, for subjects who have diminished capacity to consent, as well as that of the subject if practicable. Such persons include minors, the mentally retarded, the mentally disabled, individuals with limited civil freedom, fetuses, or children.
The methods used for approaching subjects and securing their participation should be designed carefully to protect the privacy of the subjects and should be reasonable in terms of their condition or circumstances.
No coercion, explicit or implicit, should be used to obtain or maintain cooperation. Where the professional-client or faculty-student relationship is converted into an investigator-subject relationship, special care must be taken to ensure that the subject feels completely free to decline to participate. Where access to subjects is gained through cooperating institutions or individuals, care should be taken not to abridge prior commitments made to the subjects about the confidentiality or other terms of the primary relationship.
Any payment made to subjects should not be large enough to constitute excessive inducement for participation of the subjects.
Standards for the use of pregnant women and of fetuses in research exceed those of other categories of subjects. Pregnant women and fetuses may not be used as research subjects unless studies of animals and non-pregnant individuals have been completed, unless the study is to meet the health needs of the woman and fetus, and the risk to each is minimal. A fetus in utero may be used for research only if: (i) the purpose of the activity is to meet the health needs of the particular fetus and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or (ii) the risk to the fetus imposed by the research is minimal and the purpose of the activity is the development of important, biomedical knowledge which cannot be obtained by other means. No inducements, monetary or otherwise, may be offered to terminate pregnancy for purposes of the activity.
b. Disclosure generally includes: the research procedures; their general purposes, risks, and anticipated benefits; alternative procedures where therapy is involved; and a statement offering the subject the opportunity to ask questions and to withdraw without negative consequences at any time from the research. The extent and nature of information should be such that persons, knowing that the procedures are neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, subjects should understand clearly the range of risk and the voluntary nature of participation. For research involving more than minimal risk, it is necessary to provide an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
In some research, fully informing the subject would invalidate the research. In such cases, it may be necessary to withhold information from the subject. However, information should not be withheld if withholding it would affect a reasonable person’s decision to participate or damage his or her subsequent self-esteem. Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator.
c. Comprehension is the third element in informed consent. The manner and context in which information is conveyed is as important as the information itself. Consideration must be given to the subject’s ability to understand the language and terminology used as well as the subject’s physical and mental state. Investigators are responsible for ascertaining that the subject has comprehended the information.
2-2. Confidentiality of Data
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.
The university recognizes the rights of the subjects to be protected against injury or illegal invasions of their privacies and their interests as members of a free society in preserving their dignity. The more sensitive the material, the greater the care that must be exercised in obtaining, handling, and storing data. Ordinarily, the following requirements must be met, subject only to their applicability to the particular activity.
a. Questionnaires, inventories, interview schedules, and other data-gathering instruments and procedures should be carefully designed to limit the personal information to be acquired to that which is absolutely essential to the activity.
b. Data that include information which would reveal a subject’s identity should be stored in files accessible only to the project investigator and his or her authorized staff or representatives.
c. As early as feasible, the data should be handled in coded form; i.e., the subject’s name and information that would reveal his or her identity should be removed. Plans and a schedule for the ultimate disposition or indefinite retention of the data must be approved by the IRB.
d. The identity of subjects must not be released except with their express written permission.
e. Use of stored data or information, which were originally obtained for different purposes and which involves identifiable subjects, requires examination of the risk involved, a determination of whether the new use is within the scope of the original consent or whether obtaining additional consent is necessary and feasible, and provision for the preservation of anonymity of the subjects.
Data that are part of the public domain are not covered by the foregoing restrictions. (For research requiring prior review, the material submitted for review must specify the provisions for maintaining the confidentiality of data and/or preserving the anonymity of subjects.)
2-3. Classification of Risk and Required Safeguards
A subject is at risk if he or she may be exposed to the possibility of injury, including physical, psychological, or social injury as a consequence of participation as a subject in the research, development, or related activity. These potential injuries must depart from the established and accepted methods necessary to meet the subject’s needs or increase the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation or field of service. A subject may be at risk when an investigator uses stored data or information obtained for purposes other than the investigator’s research.
For the purposes of safeguarding the human subjects and ensuring that these safeguards are continuously provided, two classifications of risks are introduced.
a. Minimal Risk. 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.
b. More Than Minimal Risk. The anticipated risks in the proposed research exceed, either in probability or magnitude, those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
In classifying research involving human subjects, the investigator and those who review the proposed use of subjects should follow the principles and procedures of this document in arriving at a carefully reasoned decision.
Chapter 3 – Review
Research using human subjects can be divided into three review categories: Exempt, Expedited Review, and Full IRB Review.
3-1. Exempt Research
Based on applicable federal regulations and/or provisions of the university’s policy and procedures, investigators whose research involves human subjects will not make the final determination of exemption. Exemption requires the approval of the IRB.
The IRB reserves the right to require review of specific research activities or classes of research activities even though they qualify for exemption. Exercise of such oversight will rarely be necessary. Requirements of sponsoring agencies, unexpected problems, and the need to evaluate experiences with exemption categories might trigger such review.
Categories of exempt research are established by federal regulations and cannot be amended. Research may be exempt from review if it meets one or more of the following six federal grounds for exemption and does not include one of the 12 exceptions to the exemptions.
a. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
(1) research on regular and special education instructional strategies, or
(2) research on the effectiveness of or on the comparison among instructional techniques, curricula, or classroom management methods.
b. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
(1) information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; and
(2) any disclosure of the subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
c. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph (b) of this section, if:
(1) the human subjects are elected or appointed public officials or candidates for public office; or
(2) federal statute(s) requires without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
d. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
e. Research and demonstration projects which are conducted by or subject to the approval of the department or agency heads, and which are designed to study, evaluate, or otherwise examine:
(1) public benefit or service programs;
(2) procedures for obtaining benefits or services under those programs;
(3) possible changes in or alternatives to those programs or procedures; or
(4) possible changes in methods or levels of payment for benefits or services under those programs
f. Taste and food quality evaluation and consumer acceptance studies,
(1) if wholesome foods without additives are consumed or
(2) if a food is consumed that contains a food ingredient at or below the level of and for a use found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
3-2. Ineligibility for Exempt Status
Based on both federal policy and/or university policy, exempt status may not be granted for research in the preceding six [(a)-(f)] categories if any of the following conditions applies:
Any of the subjects are children as defined by state law.
Any of the subjects are confined in a correctional or detention facility.
Pregnancy is a prerequisite for serving as a subject.
Fetuses in utero are subjects in this research.
Any subjects are presumed not to be legally competent.
Personal records (medical, academic, etc.) are used without written consent.
Data from subjects (responses, information, specimens, etc.) are directly or indirectly identifiable.
Data are damaging to subjects’ financial standing, employability or reputation.
Material obtained at autopsy is to be used in the research.
Subjects are to be asked sensitive questions about personal feelings, behavior, interactions, or sexual experiences.
Alcohol or any other drugs will be ingested.
Blood or body fluids will be drawn.
3-3. Non-exempt Research
Non-exempt research is subject to one of two levels of review, either Expedited Review or Full IRB Review.
a. Expedited Review
The following list of research activities (carried out through standard methods) may be reviewed through expedited review procedures as long as the research contains minimal risk to the subjects, does not address sensitive issues, and does not use subjects who are not competent to give consent. This list is based on federal regulations so that additions to and extrapolation from the list by the IRB are not appropriate. If there is external funding, projects shall comply with the review requirements of the funding agency as well as complying with the minimum requirements set forth in this document. In the case of expedited review, the investigator will not begin the research until informed that the IRB will not conduct a full review of the project.
(1) Collection of hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
(2) Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
(3) Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject’s privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).
(4) Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
(5) Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
(6) Voice recordings made for research purposes such as investigations of speech defects.
(7) Moderate exercise by healthy volunteers.
(8) The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
(9) Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects.
(10) Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
b. Full IRB Review
All research not exempted or eligible for expedited review shall be reviewed by the full IRB; this includes all research that involves more than minimal risk to the subjects, addresses sensitive issues, uses subjects who are not competent to give consent, and/or is required by a funding source to undergo full IRB review.
Chapter 4 – Reviewing Bodies
There are three administrative units that may participate in the several levels of the review process: The Office of Grant and Research Development (OGRD), the Institutional Review Board (IRB), and the Departmental Review Committee.
4-1. The Office of Grant and Research Development
The OGRD is the administrative unit responsible for coordinating all reviews of research conducted with human subjects. It is also the office that maintains the records of all applications, proceedings and results appropriate to the various levels of review pursuant thereto. The administrative director of academic grants and contracts shall be a member of the Institutional Review Board and shall be the authorized institutional official whose responsibility is to ensure that the university will effectively fulfill its research-oversight function.
The OGRD must prepare and maintain adequate documentation of IRB activities. Such documentation must include copies of all research proposals reviewed, minutes of IRB meetings, records of continuing review activities, copies of all correspondence between the IRB and investigators, and statements of significant new findings provided to subjects.
4-2. The Institutional Review Board
The IRB will consist of a minimum of five members. Each department in the university that regularly conducts research that involves human subjects shall provide a member. In addition, departments that occasionally conduct or have the potential to conduct research that involves human subjects may be invited to provide a member as appropriate to their current interest. The chair will be chosen from the IRB members. In addition, the administrative director of academic grants and contracts shall be a voting member of the IRB. Further, in accordance with federal policy requirements, the IRB should include one or more individuals who are knowledgeable about and experienced in working with vulnerable categories of subjects; at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas; and must include at least one member who is not otherwise affiliated with the university and who is not part of the immediate family of a person who is affiliated with the university. The IRB may invite individuals with special expertise not available on the IRB to assist in the review of specific issues; these individuals may not vote. No IRB member may participate in the review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. A list of current IRB members must be submitted to OPRR and also kept with the IRB’s records. Any changes in IRB membership must be reported to the office for protection from research risks (OPRR).
The responsibilities of the IRB shall be to review all research involving human subjects that is not exempt, as defined above, either by a full Board review or as an expedited review.
a. In the case of exempt research, the IRB will be regularly notified of the approval of such exemptions by the OGRD.
b. In the case of expedited review, the chair of the IRB or the administrative director of Academic grants and contracts will review all applications along with one or more members as necessary from the IRB, each of whom in turn will serve in this reviewer capacity for a one month tenure. The expedited review procedure may result only in one of three decisions: approval, approval contingent upon minor changes, or referral to the full IRB for further consideration. Expedited procedure reviewers may not disapprove research.
c. In the case of full board review, the IRB will hold an open meeting at least once per quarter, and more frequently as needed, to review all research neither exempt nor expedited. At such meetings a majority of the members of the IRB must be present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting. The IRB may approve, disapprove, or ask for further modification/clarification of all research proposals. Acceptance by the IRB does not guarantee institutional or administrative approval of the project.
4-3. Departmental Review Committee
Departments that have a large volume of research involving human subjects, which is neither externally funded nor involves research above minimal risk, may have a prior review process for nonexempt research that is then submitted for IRB approval. Such departmental committees may also make the initial determination of exempt status for research, to be then submitted for IRB/OGRD approval. If a department has a departmental review committee, that body should provide the initial review of all student research: in the case of faculty or staff members, applications for review may be submitted directly to the IRB unless department policy requires preliminary department review. The departmental review committee must use IRB-approved guidelines consistent with the IRB policies and procedures contained in this document. The composition of a departmental review committee shall, at a minimum, consist of at least two members.
a. Disapproval of research by the departmental review committee may be appealed to the university IRB.
b. In the case of departmental review committee approval of research, that recommendation shall be conveyed to the OGRD. The administrative director of academic grants and contracts or the chair of the IRB will notify the Department of IRB concurrence with the approval of the research. Research that has been approved by an IRB-approved, departmental review process will be subject to appropriate review and approval or disapproval by the university IRB. If approved by the IRB, the research proposal may also be subject to review and approval or disapproval by officials of the university, in accordance with the policies and processes for university review of research proposals for reasons other than protection of human subjects.
Chapter 5 – Submission of Proposals
Written approval from the OGRD must be received by the investigator before the research is begun.
5-1. Exempt Research
The investigator should complete the application for exemption (available from the OGRD) and submit three copies to the appropriate review body, either the IRB (through the OGRD) or the departmental review committee. If a department has a Departmental Review Committee, that body should review the application in the case of all student research; in the case of faculty or staff applications for exemption these may be submitted directly to the IRB unless departmental policy requires departmental review. This should be done in a timely manner prior to the start of research. If the research is approved as exempt by a departmental review committee, the application will be signed by the Chair of the review committee and forwarded from the department to the OGRD for concurrence, recorded by the OGRD, and returned to the investigator. This must be done before initiation of subject recruitment or initiation of any procedures that involve human subjects. Approval of exempt protocols is valid for five years from the date of approval.
5-2. Non-exempt Research
The investigator must complete the application for IRB review (available from the OGRD) with relevant attachments and submit the required number of copies to the OGRD.
a. In the case of full IRB review, 18 copies of this completed form with relevant attachments should be submitted two weeks prior to the next scheduled open meeting of the university IRB, unless other arrangements are made with the OGRD. Principal investigators are encouraged to attend the IRB meeting to respond to questions raised by the board members.
b. In the case of request for IRB, expedited review, three copies of this completed form with relevant attachments should be submitted sufficiently in advance of the desired date to begin research so that the IRB reviewers have a reasonable length of time to respond to the proposal and, if deemed necessary, submit it to full IRB review.
c. If the research is to be reviewed by a Departmental Review committee, the investigator should check with his/her department to determine the number of copies to be submitted and how long approval is likely to take. Subsequent to departmental approval, three copies of this completed form with relevant attachments should be submitted sufficiently in advance of the desired date to begin research so that the OGRD/IRB has a reasonable length of time to respond to the proposal.
d. Human subjects approvals granted by the IRB and the department review committee are good for one year from the date of approval.
Both investigators and reviewing bodies will endeavor in good faith to submit and respond to proposals in a reasonably timely manner so that research that would otherwise be approved is not jeopardized by the administrative constraints of the process. Exempt and expedited reviews at the IRB/OGRD level should normally take less than a week. Full IRB reviews will take longer and are dependent on the meeting schedule of the IRB.
Chapter 6 – Changes in Protocols / Renewals
6-1. Minor Changes
If, subsequent to initial approval, a research protocol requires minor changes, the OGRD should be notified of those changes prior to their implementation.
6-2. Major Changes
Any major departures from the original proposal must be approved by the appropriate review process before the protocol may be altered. An application for change of protocol must be submitted to the IRB for any substantial change in the protocol. The administrative director of academic grants and contracts or the chair of the IRB will determine whether or not the research must then be resubmitted for approval.
6-3. Annual Renewals
If research is to continue, with no substantial changes, beyond the term for which it has been approved, an application for renewal of approval must be obtained prior to continuation of the project.