WSU Guidelines Manual
Human Subjects in Research
Section I. (Human Subjects in Research Committee)
Section II. (Application Process)
Section III. (Review Checklist for Protection of Human Subjects)
Section IV. (Submission of Application and Committee Action)
Section V. (Assurance and Responsibility)
- Investigator's Statement of Assurance
- Investigator's Responsibility After Committee Action
The Department of Health and Human Services and the administration of Weber State University require that all research involving human subjects conducted by faculty, staff, or students affiliated with the University be approved by the Human Subject in Research Committee prior to initiation.
The Department of Health and Human services defines research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge". Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Research requiring review by the committee
The federal regulations provide that certain kinds of research may be exempt from review. However, the administration of Weber State University requires that ALL RESEARCH INVOLVING THE USE OF HUMAN SUBJECTS MUST BE SUBMITTED FOR REVIEW. The Committee Chair may rule that a proposal is exempt if it fits in one of the following categories:
1. Research conducted in an established educational setting involving normal educational practices;
2. Research involving only educational tests, if the subjects cannot be identified;
3. Some research involving survey or interview procedures;
4. Some research involving observation of public behavior; and/or
5. Research involving the collection or study of existing data, documents, records, pathological specimens, if the sources are publicly available or the subjects cannot be identified.
Purpose of Committee To ensure Weber State University complies with the policy for the protection of human subjects used in clinical research and other scientific investigations as set forth by the Department of Health and Human Services and also the code for protecting the rights and welfare of human subjects as outlined in the declaration of Helsinki.
In fulfilling its purpose, the human subjects in research committee shall:
1. Review each research plan, recruitment procedures and subject consent forms in order to safeguard the rights and welfare of human subjects.
2. Study the background and methodology of each proposed project to determine possible benefits and/or risks, physical, psychological, social or legal.
3. Assess confidentiality, and adequacy of the method for securing informed consent from subjects.
4. Review the scientific design since a poorly designed study can expose the participants to unnecessary risk.
5. Report findings and actions to the investigator and the institution.
6. Review proposed changes in research activities to insure that changes in approved research during the period for which the committee approval has already been given, not be initiated without the review and approval of the committee.
7. Approve research only with the concurrence of the majority of the committee members in attendance.
8. Report to the appropriate administrative officer of Weber State University of continuing or serious non compliance by the investigators, with the requirements and determinations of the committee.
Criteria for Disapproval of Projects
The Human Subjects in Research Committee will disapprove a proposal if:
1. It violates any of the laws or regulations of the United States, Utah, or Weber State University;
2. The risks to human subjects outweigh the benefits, and/or unnecessary risks are created;
3. Selection of subjects is inequitable;
4. Procedures for obtaining and documenting informed consent are inadequate;
5. The committee judges that payments or other inducements to the participants are likely to influence the subjects unduly; and/or
6. The study is poorly or improperly designed as to make meaningful conclusions impossible.
Membership of the committee shall be appointed by the appropriate administrative officer of the University and shall meet the following guidelines:
1. At least five faculty members of diverse backgrounds who are able to ascertain the acceptability of research applications in terms of institutional commitments, applicable law, and professional standards;
2. Shall include members of both sexes;
3. Shall include at least one member whose primary concerns are in nonscientific areas;
4. Shall consist of members representing more that one discipline;
5. Shall include a member who is not affiliated with Weber State University;
6. Individuals with competence in an area not represented by the membership may be invited to assist in the review of complex issues.
Terms of Service 1. Members of the committee shall serve a term of two years beginning the calendar year each fall quarter following the appointment. Terms shall be staggered to assure returning membership to the committee each year.
2. Student member designee shall be appointed each Spring Quarter for the term of one calendar year effective with the commencement of fall quarter.
3. In the event of an unexpired term, the appropriate administrative officer will appoint a person to fulfill that term and the appointment shall commence immediately.
The Committee Chair shall be one of the faculty members appointed by the appropriate administrative officer for a designated term.
The committee shall meet each month of the designated calendar year with the time and place to be designated by the chair. Extra meetings may be called by the chair if deemed necessary to complete the functions of the committee. If no proposals are presented to the committee for review and there is no other business to discuss, the chair may cancel the scheduled meeting. A scheduled date of the meetings will be submitted to the appropriate administrative officers' secretary for faculty inquiries.
A quorum shall consist of a majority of the total voting members of the committee. If a quorum is present, a majority vote rules for the entire committee.
The chair shall appoint a secretary from the membership of the committee to take minutes and supply each member of the committee with copies of the minutes within one week following the meetings.
The chair, upon persistent lack of attendance of any member of the committee, may petition the responsible body to request that a new representative be appointed.
Committee Authority: Review of Research by the Committee
In conducting the review of research the Human Subjects in Research Committee shall:
1. Have authority to approve, require modifications in, or disapprove all research activities involving the use of human subjects associated with Weber State University;
2. Require that information given to subjects as part of informed consent be in accordance with the Department of Health and Human Subjects requirements;
3. Require documentation of informed consent or waive documentation in accordance with federal regulations;
4. Notify in writing the investigator and the institution of its decision to approve or disapprove the proposed research activity or of modifications required to secure the committee's approval. If the research is disapproved, the investigator shall be given a statement of the reasons for the decision and the opportunity to respond in person;
5. Conduct continuing review of research covered by the established regulations at intervals appropriate to the degree of risk, but not less than once a year, and have the authority to observe or have a third party observe the consent process and the research; and
6. Have the authority to suspend or terminate approval of research that is not in compliance with Weber State University guidelines or has been associated with unexpected serious harm to subjects. Any such action shall be reported promptly to the investigator, and appropriate institution officials, citing the reasons for the committee's actions.
In order to approve research, The Human Subjects in Research Committee shall ensure that:
1. Risks to subjects are minimized by using the safest procedures consistent with sound research design and whenever appropriate, by using procedures already being performed for diagnostic and treatment procedures;
2. Risks to subjects are reasonable in relation to anticipated benefits to subjects and the importance of the knowledge that may reasonably be expected to result. When assessing risk, the committee should not consider the possible long range effects of applying knowledge gained in research;
3. Selection of subjects is equitable, taking into account the purposes of the research;
4. Informed consent will be sought from each subject or the subjects legally authorized representative;
5. Informed consent will be appropriately documented;
6. Where appropriate, the research plan makes provision for monitoring the data collected to insure the safety of the subjects;
7. Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data; and
8. Additional safeguards are taken when vulnerable subjects are involved in the research, in order to protect against coercion or undue influence.
Under provisions for expedited review:
1. The Human Subjects in Research Committee may review some or all of the research through an expedited review procedure, if the research involves no more than minimal risk;
2. The Committee may also use the expedited review process to review minor changes in previously approved research during the period for which approval is authorized;
3. The review may be carried out by the chair or by one or more of the Committee members;
4. The reviewers may exercise all of the authority of the committee except they may not disapprove research;
5. The Committee shall adopt a method for keeping all members advised of research proposals which have been approved under the procedure; and
6. The Committee or Chair may restrict, suspend, or terminate the use of the expedited review when necessary to protect the rights or welfare of subjects.
The application consists of five parts: A) Application form; B) A brief description of the study and review procedures; C) Consent information; D) Experimental subjects Bill of Rights; E); Investigators statement and assurance, Application protocol and Committee action; F) IRB Certification.
A. APPLICATION FORM
The application form must be filled out completely so that committee members may have a clear understanding of the nature and human subject implications of the research proposal. A summary paragraph for each section is sufficient. A statement referring to attached materials is not sufficient and will not be accepted. Applications submitted with incomplete forms will be returned without consideration of the proposal.
Give the complete title as it appears on the grant proposal.
2. DESCRIPTION OF THE STUDY
Include the nature of the study and how human subjects will be used and indicate any special procedures.
3. DURATION OF THE STUDY
Estimate the length of time it will take to complete the entire project.
4. MULTICENTER STUDY
Indicate whether this is a multicenter study and give the number of institutions outside the University which will be participating.
5. NUMBER OF SUBJECTS
Identify the total number of subjects to be used in every center.
6. HEALTH STATUS OF THE SUBJECTS
Include the information regarding the health of the subjects.
7. SUBJECT GROUPS EXCLUDED
Describe any subject groups excluded for medical reasons or vulnerable subject groups. List the specific exclusion criteria for the study. If more explanation is needed, the committee has further information.
8. AGES OF SUBJECTS
Include the information regarding the age of the subjects.
9. DESIGN OF THE STUDY
Include a brief statement about the design that will be used.
10. RISKS TO SUBJECTS
Describe all the risks to which the study may expose the subjects, including those which are considered to be of low probability. If the risks to the subject are substantial, explain how the risks are justified by the expected benefits. Discuss how possible reactions or side effects will be managed.
ANY MODERATE OR HIGH RISK STUDY MUST GO THROUGH A SEPARATE REVIEW PROCEDURE WHICH INCLUDES THE APPROPRIATE ADMINISTRATIVE OFFICER AND THE UNIVERSITY ATTORNEY.
11. BENEFITS TO SUBJECTS AND OTHERS
Include all remuneration to the subjects including the amount given or prorated for those who do not complete the study. Subjects may not be offered compensation in order to induce them to participate in the study.
12. COSTS TO BE BORNE BY SUBJECTS
Specify the charges relating to the study for which the participant will be financially responsible.
13. IS CONFIDENTIALITY ASSURED
State how research subjects will be recruited or selected and how their participation will be solicited in the study. State specifically the procedures used to obtain informed consent from each one. Researchers must obtain and document informed consent from each participant or their representative before they participate in the study. See the section on informed consent.
Describe explicitly how the security and confidentiality of all information received and the privacy of all subjects will be maintained.
14. CONTRACT OR GRANT NUMBER
Include the contract or grant number, sponsoring agency, and/or granting agency.
15. NAME OF PRINCIPAL INVESTIGATOR AND DEPARTMENT
Include the names of all of the investigators, the principal investigator's name and signature, mailing address, telephone number, University Department, and Department Chair's signature.
B. DESCRIPTION OF THE STUDY
This should be brief (no longer than two pages) and should include:
1. Background information.
2. Experimental methods (including description of the study, population, research design, and interpretation of significant results).
3. Description of recruitment procedures (include all advertising methods).
4. If the proposal is deemed moderate or high risk, submit ten copies of the complete proposal as well as any other information that is appropriate to the review of the study.
C. INFORMED CONSENT
The human subjects in Research Committee in conformance with federal guidelines requires documentation of informed consent. The committee may, for some or all subjects, waive the requirement that the subject or the subjects legally authorized representative sign a written consent form if it finds that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context. In cases where the documentation requirement is waived, the committee may require the investigator to provide subjects with a written statement regarding the research.
No informed consent, whether oral or written, may include any exculpatory language through which the subject or representative is made to waive or appear to waive any of the subjects legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability from negligence.
The entire consent form must be written in the second person and in language totally intelligible to an average person who has no background in science or scientific technology.
Click here to find answers to common questions about Informed Consent.
BASIC ELEMENTS OF INFORMED CONSENT
In seeking informed consent, the following information shall be provided to each subject:
1. A statement that the study involves research, an explanation of the purposes of the research, and the expected duration of the studies expected participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
2. A description of any foreseeable risks or discomforts to the subject.
3. A description of any benefits to the subject or to others which may reasonably be expected from the research.
4. A disclosure of any alternative procedures or courses of treatment, if any, that might be advantages to the subject.
5. A statement describing the extent, if any to which confidentiality of records is maintained and that notes the possibility that the food and drug administration may inspect the records, if applicable.
6. For research involving more than minimal risk, 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.
7. An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of a research - related injury to the subject.
8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
ADDITIONAL ELEMENTS OF INFORMED CONSENT
When appropriate one or more of the following elements of information shall be provided to each subject:
1. A statement that the particular procedure may involve risks to the subject (or the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
2. Anticipated circumstances under which the subjects participation may be terminated by the investigator without regard to the subjects consent.
3. Any additional costs to the subject that may result from participation in the research.
4. The consequences of the subjects decision to withdraw from the research and procedure for orderly termination of participation by the subject.
5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
6. The approximate number of the subjects involved.
Except as previously stated, informed consent shall be documented by the use of a written consent form approved by the committee and signed by the subject or the subjects legally authorized representative. A copy shall be given to the person signing the form.
Except as previously stated, the consent form must be either of the following:
1. A written consent form that embodies the elements of informed consent. This form may be read to the subject or legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.
2. A short form written consent stating that the elements of consent have been presented orally to the subject or subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the committee shall approve a written summary of what is to be said to the subject or representative. Only the short form itself is to be signed by the subject or legal representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.
If the study requires only that subjects complete a questionnaire, ordinarily a consent form does not need to be completed. Instead, the questionnaire may begin with description of the study and its purpose. A statement that the person is not required to complete the questionnaire, (i.e. that participation is voluntary ) and that by completing the questionnaire, and turning it in, a subject has expressed his willingness to participate. A copy of the questionnaire, including this explanatory statement, must be submitted to the committee.
The committee may waive the requirement that an investigator document consent for some or all subjects if it finds and documents that the only record linking the subject to the research would be the consent document, or the only significant risk to the subject is potential harm resulting from breach of confidentiality. Each subject is asked whether he or she wants there to be a record linking the subject with the research. The subject's wishes on this will govern.
D. EXPERIMENTAL SUBJECT'S BILL OF RIGHTS
The rights below are the rights of every person who is asked to be in a research study.
As an experimental subject, I have the following rights:
1. To be told what the study is trying to find out.
2. To be told what will happen to me and whether any of the procedures, drugs, or devices are different from what would be used in standard practice.
3. To be told about the frequent and / or important risks, side effects or discomforts of the things that will happen to me for research purposes.
4. To be told if I can expect any benefit from participating and, if so, what that benefit might be.
5. To be told what other choices I might have and how they may be better or worse than being in the study.
6. To be allowed to ask any questions concerning the study both before agreeing to be involved and during the course of the study.
7. To be told what sort of medical treatment is available if any complications arise.
8. To refuse to participate at all or to change my mind about participating after the study is started.
9. To receive a copy of the signed and dated consent form.
10. To be free of any pressure when considering whether I wish to agree to be in the study.
E. INVESTIGATOR'S STATEMENT OF ASSURANCE
Include the investigator's statement of assurance and signature. If the investigation involves the use of human subjects, the investigator must understand the University's policy concerning the use of human subjects and must agree:
1. To obtain informed consent of subjects who are to participate in this project;
2. To report to the Human Subjects in Research Committee any unanticipated effects on subjects which become apparent during the course, as a result of experimentation, and the actions taken;
3. To cooperate with the members of the committee charged with the continuing review of the project;
4. To obtain prior approval from the Committee before altering or amending the scope of the project or implementing changes in the approved consent form; and
5. To maintain documentation of consent forms and progress reports as required by institutional policy.
F. National Institute of Health IRB Certification
WSU is asking that every professor submitting an IRB application for review must complete the IRB computer-based training course (CBT), and attach a copy of the training course certificate of completion to his/her IRB application. This course will help familiarize you as an investigator with the ethical principles and guidelines of using human subjects in research. You can access this computer-based training course from the the following link:
I. The rights and welfare of the subjects are adequately protected.
A. Are there any unnecessary or unacceptable hazards?
B. Are adequate safeguards provided?
1. Does the project cross disciplinary lines?
2. Does it involve new and untried procedures?
3. Does it involve procedures new to the personnel who will apply them?
4. Are proper precautions provided to deal with emergencies that may develop even in the course of seemingly routine activities?
C. Has provision been made for safeguarding information that could be traced to or identified with subjects?
1. Are data gathering instruments and procedures designed to limit the personal information to be acquired absolutely essential to the project or activity?
2. Will proper safeguards be used to secure codes and ciphers, tapes, discs, and printouts?
3. Have provisions been made for the destruction of all edited, obsolete, or depleted data, for future data, and stored data related to the activity?
D. Have legal rights and procedures been provided for in relation to:
1. Who may give consent?
2. Who may prescribe or proscribe the performance of certain medical and surgical procedures?
3. The protection of confidential communications.
4. The definition of negligence.
5. The invasion of privacy.
6. The requirement of disclosure of records pursuant to legal process.
7. The limits of charitable and governmental immunity.
II. The risks to an individual are outweighed by the potential benefits to him by the importance of the knowledge to be gained.
A. Is it probable that participation will confer substantial benefits on the subjects?
B. Will subjects be motivated to accept risks for unsuitable or inadequate reasons?
C. Is compensation to volunteers an undue inducement?
III. The informed consent of subjects will be obtained by methods that are adequate and appropriate.
A. Has provision been made for the basic elements of informal consent?
1. A fair explanation of the procedures to be followed including identification of those which are experimental.
2. A description of the attendant discomforts and risks.
3. A description of the benefits to be expected.
4. A disclosure of appropriate alternative procedures that would be advantageous for the subject.
5. An offer to answer any inquiries concerning the procedures.
6. An instruction that the subject is free to withdraw the consent and to discontinue participation in the project or activity at any time.
B. Does the agreement entered into by the subject exclude all exculpatory language through which the subject is made to waive or appear to waive any of his legal rights, or to release the University or its agents from liability for negligence?
C. Will informed consent be documented?
1. Will it be obtained from the subjects themselves?
2. If not, will the validity of the consent of guardians, next of kin, or other qualified third parties representative of the subjects' interests?
3. Are these third parties presumed to have the necessary depth of interest and concerns with the subjects' rights and welfare?
4. Are these third parties legally authorized to expose the subjects to the risks involved?
Application along with all appropriate forms should be sent to:
Dr. Matthew Donahue, Chair of the IRB Committee
The IRB requests should be in either Microsoft Word and/or PDF formats that are readily convertible to Word. These requests should have appropriate signatures, documentation, and all other pertinent information necessary to facilitate a thorough IRB review. Incomplete requests will not be reviewed until remedied. These files will be archived in Box or other comparable web-based storage platforms.
A. INVESTIGATOR'S STATEMENT OF ASSURANCE
1. To obtain informed consent of subjects who are to participate in this project;
2. To report to the Human Subjects in Research Committee any unanticipated effects on subjects which become apparent during the course, or as a result, of experimentation and the actions taken as the a result;
3. To cooperate with members of a committee charged with the continuing review of the project;
4. To obtain prior approval from the Committee before altering or amending the scope of the project or implementing changes in the approved consent form; and
5. To maintain documentation of consent forms and progress reports as requires by institutional policy.
B. INVESTIGATOR'S RESPONSIBILITY AFTER COMMITTEE ACTION
The federal regulations provide that after the committee has approved your study, you may not make any changes without prior committee approval except where necessary to eliminate apparent immediate hazards to the subjects. Further, you must report to the committee any changes that you make and any unanticipated problems involving risks to subjects or others that rise.