Policies and Procedures for the Protection of Human Subjects in Research

Human Subjects Research

Research for the purpose of the human subjects policy is defined as "A systematic investigation designed to develop or contribute to generalizable knowledge". Research includes questionnaires, interviews, tests, observations, surveys and other experiments.

Applicability

All faculty, staff and students conducting research involving human subjects under the auspices of Butler University.

Administration

The Provost and Vice President of Academic Affairs is responsible for the administration of the human subjects policy and procedures. The Provost and Vice President of Academic Affairs may disallow approvals of the IRB, but cannot change disapprovals or impose restrictions. The oversight of the policy and management of the procedures is delegated to the Director of the Institute for Research and Scholarship.

Institutional Review Board (IRB)

The IRB is the institutional body that approves the procedures to be used in research with humans. The IRB may suspend or terminate approvals. The IRB is appointed by the Provost and Vice President of Academic Affairs for three year staggered terms and is composed of at least five individuals, including at least four faculty members, one outside member and the Director of the Institute for Research and Scholarship who is ex-officio non-voting.

Researcher Responsibilities

The individual researcher is responsible for knowledge about the human subjects policy and procedures. The academic or thesis advisor of a student is responsible for familiarizing the student with the policy and procedures.

Application and Approval Process

Researchers complete the Application for Approval and submit it to the Director of the Institute for Research and Scholarship. The Director will ascertain if the application is complete and forward it to the appropriate reviewer. The IRB will decide if a human subjects protocol is approved, conditionally approved with required revisions or denied for those reviews where such review is required.

Continuing Review

The IRB must conduct a minimum of one review of approved research activities every 12 months. The IRB may request an update or periodic review from any investigator at any time. The IRB may, from time to time, conduct such additional reviews as may be necessary to assure that compliance with policies, guidelines, and pertinent law is satisfactory. Examples of studies that may require more frequent review include transplant protocols and gene therapy studies. The IRB may consider whether involvement of vulnerable populations merits more frequent review. In addition, if a protocol has a number of protocol-related adverse events which cause concern, or if there are compliance or other problems associated with the protocol, the approval interval may be reduced so that re-review frequency is increased.

Protocol reviews are monitored by the Institute for Research and Scholarship (BIRS). The BIRS forwards continuing review notices to the Principal Investigator 30-60 days in advance of the due date, and an overdue notice the day after the due date. This review is due each year in the same month the protocol was originally approved; if the review has not been completed and turned in to the BIRS by the due date, accrual on that protocol is suspended until the review is completed. The PI must complete and sign a continuing review form regarding protocol progress to date and addressing any adverse events, both expected and unexpected, any unanticipated problems involving risks to subjects or others, and a summary of any reports or complaints about the research since the last IRB review.

Continuing review forms remain in the same category in which the original protocol was approved (expedited or full), unless circumstances dictate a change in category.  Following approval of the continuing review form submitted by the PI, the PI will be notified of final approval through receipt of a letter from the BIRS. If there are stipulations and/or recommendations, the review will be returned to the PI for revisions. These revisions must be made within 10 days of notification of the IRB stipulations/recommendations in writing.

Informed Consent

Informed consent is required for most expedited and full review projects unless the investigator specifically requests a waiver from informed consent (45 CFR 46.116). Informed consent is recommended for exempt projects but is at the discretion of the investigator.

Special Populations

Research involving prisoners, children, people with disabilities, pregnant women and other vulnerable groups has special requirements.

Maintenance of Records

The University, the IRB and the Researcher must maintain appropriate records for three years after the termination of the study.

Protocol

A written description of the involvement of humans in the research project and the measures to protect them from risk.

Butler University recognizes the responsibility to protect the rights and welfare of individuals involved as subjects of research conducted under the auspices of the institution or under the direction of any employee or agent of the institution. The IRB's Policies and Procedures reflect the institutions commitment to the protection of human subjects in research. These policies and procedures are in compliance with the Department of Health and Human Services (DHHS) regulations for the Protection of Human Research Subjects (Title 45, Code of Federal Regulations, Part 46, Revised June 18, 1991). Butler University is also guided by the ethical principles regarding the use of human subjects in research as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled "Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Belmont Report)".

This policy applies to research under the auspices of the University involving the use of human subjects conducted by Butler University faculty, staff or students regardless of the source of funding. "Under the auspices of the University" is defined as: The research is funded externally by way of a grant, contract or similar agreement between the sponsor (public or private) and the University, the University by way of grant, contract or similar agreement funds the research internally, the research is conducted upon assignment by the University, or the research is actively assisted by the use of University facilities, resources, supplies, equipment or personnel. Any research involving human participants that is conducted by faculty, staff or students at Butler University must be submitted for review to the IRB. Similarly, any research conducted on the property of Butler University, regardless of the affiliation of the researcher, must be submitted for review. Review and approval by an IRB at another institution does not constitute an exemption from review by the Butler IRB, although the Butler IRB may elect to rely upon the review of another qualified IRB.

Butler University has adopted the following definitions included in the federal regulations to guide researchers and other interested parties in determining the necessity for review:

Research

"A systematic investigation designed to develop or contribute to generalizable knowledge." Research encompasses work that is conducted on or off campus and includes questionnaires, interviews, tests, observations, surveys, and other experiments, regardless of the content or routine nature of the research. The policy applies to research that is preliminary in nature as well as fully developed study. Research extends, but is not limited, to any systematic collection of data from human subjects that occurs in conjunction with classroom projects, "demonstration" and "service" programs.

Human Subject

"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).

Minimal Risk

Means that the risks or 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 examination or tests.

Assent

A subject's affirmative agreement, oral or written, to participate in research. Failure to object cannot be construed as assent.

Legally Authorized Representative

An individual, or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

Research Protocol

The procedures and rules for dealing with the subject and the records derived from the subject.

The Butler University official responsible for overseeing the Policy and Procedures for the Protection of Human Subjects in Research is the Provost and Vice President of Academic Affairs. The functions to be performed by the University include: the development of an institutional policy, the establishment of procedures to insure protection for human subjects in research, the continuing education of personnel with respect to the policy, the modification of the policy to maintain its conformity with laws and regulations, and the provisions of appropriate administrative support and legal assistance for the IRB. The Provost and Vice President of Academic Affairs has delegated the oversight of the policy and procedures, the management of support services required by the Institutional Review Board (IRB) and the maintenance of records to the Director of the Institute for Research and Scholarship.

The IRB is responsible for the review, approval or disapproval of all research subject to this policy.

Membership

• The IRB shall be composed of at least five individuals, including at least four faculty members and one member who is not otherwise affiliated with the University and who is not part of the immediate family of a person affiliated with the University. The University IRB shall include at least one faculty member whose primary concerns are in a non-scientific area. The Director of the Institute for Research and Scholarship will be an ex-officio non-voting member of the IRB.
• The Provost and Vice President of Academic Affairs will appoint all members for terms of three (3) years. Membership on the IRB shall be staggered so that the terms of no more than two members will expire in any given year. Members may be reappointed.
• The IRB shall elect two officers, a Chair and a Vice Chair, to serve two-year terms. Officers may be re-elected. The Director of the Institute for Research and Scholarship will be the Secretary to the IRB.
• No member who has a conflicting interest in a particular research project may participate in the IRB's initial or continuing review of that research except to provide information requested by the IRB.
• The IRB, at its discretion, may invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond, or in addition to that available on the IRB. These individuals may not vote with the IRB.

Responsibilities of the IRB

1. Be responsible for the review of proposed research projects involving human subjects and the approval, required modifications for approval or the disapproval of the proposed research.
2. Determine the most appropriate type of review (i.e. Exempt, expedited or full) for a proposed research project. In cases of an Exempt review, the IRB chairperson or one member of the IRB will evaluate the proposal. An Exemption Reviewer has the authority to approve a study, ask for clarification to ensure the procedures meet the Exempt criteria, or disapprove the research for exemption. The chairperson shall provide oversight to the Exemption review process to ensure compliance with the policies and procedures of this Board.
3. A proposed study that is disapproved for exemption is eligible for submission to the IRB as a Full or Expedited application. In cases of an Expedited review, the IRB chairperson or one or two members of the IRB designated by the IRB chairperson will evaluate the proposal. In cases of a Full Review, (1) the review must be conducted at a convened meeting (2) a majority of members must be present, (3) at least one member whose primary concerns are in nonscientific areas must be present at the meeting, and (4) the study must receive approval of a majority of the members present at the meeting.
4. Notify the investigator and the Provost and Vice President of Academic Affairs in writing, of its decision. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
5. Conduct continuing reviews of approved research in accordance with this policy and report all findings and actions to the Provost and Vice President of Academic Affairs.
6. Require that information given to subjects as part of informed consent is in accordance with this policy and applicable law. Require documentation of informed consent or waive documentation in accordance with this policy.
7. Establish written policies for conducting the initial review, monitoring and approving of continuing projects for annual review or any changes in procedure.
8. Require prompt reporting to the IRB of unanticipated problems involving risks to subjects or others.
9. Be responsible for reporting to the Provost and Vice President of Academic Affairs and the appropriate government agency any serious or continuing non-compliance by investigators.

Meetings

The IRB will meet on a monthly basis unless there is no business to be conducted.  At a minimum, the Board will meet once each semester.  The IRB will have other meetings as needed.  These meetings will be called by the Chair or at the request of a majority of the members on the IRB.  A quorum is a majority of the voting members.  A majority vote of the members present is required to approve research protocols.

It is the responsibility of the researcher to know and comply with the Butler University Policy and Procedures for the Protection of Human Subjects and the requirements of the IRB. Research investigators shall make a determination as to whether research will involve human subjects using the definitions on this website. When it is not clear whether the research involves human subjects, researchers should seek assistance from the Chair of the IRB or the Director of the Institute for Research and Scholarship.

Responsibilities

1. Comply with the policy and procedures to obtain approval for the project.
2. Complete the Application for Approval describing the research to ensure the protection of human subjects and submit it to the Director of the Institute for Research and Scholarship.
3. Ensure that required compliance with the policy on informed consent is followed.
4. Inform the IRB and the Director of the Institute for Research and Scholarship of any problems related to human subjects as part of the research.
5. Ensure that the IRB is informed and approval is obtained for any changes in the research involving human subjects.
6. Ensure that the IRB is informed and approval is obtained for projects continuing beyond the yearly anniversary date of approval.
7. Provide to the IRB and the Director of the Institute for Research and Scholarship a brief description of the results of the research and benefits to and problems for the subjects.
8. Maintain all appropriate records related to the research and the measures to protect human subjects.

All personnel involved in Human Subjects Research that is under the purview of the Butler University IRB must demonstrate completion of an education program on the use of human participants in research.  In the fall of 2010 the university began using an on-line education program through the Collaborative Institutional Training Initiative (CITI).   One advantage of this program is that it includes material for both social and behavioral researchers and biomedical researchers. 

As of October 1, 2011, anyone from Butler University who has not completed human subjects education and will be involved in human subjects research must complete a CITI course.  People who have previously completed the CITI education do not need to repeat the CITI course. 

To complete the required education go to CITI's website.  

• Select Butler University as your "participating institution" and create an account.
• When you have created an account you will be directed to a page titled "Select Curriculum" which displays a list of courses on Human Subjects Research: Biomedical Research Investigators; Social & Behavioral Investigators, and IRB Members. Choose the human subject research module most appropriate to the type of research you conduct.
• The course may take a few hours to complete but can be done over a period of time. When you complete the course, CITI will e-mail your completion record to the BIRS office.

If you have done CITI education for another organization, add Butler to your profile.  You will be given credit for your previous courses to the extent they overlap with Butler's requirements.

Student Research

Should the researcher be a student, the student's academic or thesis advisor assumes primary responsibility for the proposed activity. The advisor is to familiarize the student with his/her obligation for the protection of the subject from risks incurred as a result of participating in the research. Student researchers must abide by the above training requirements (CITI Training).

Any Butler employee or student planning to conduct research involving human subjects should proceed as follows:

Application Process

1. Read the Policy and Procedures for the Protection of Human Subjects in research as provided in 45 CFR 46.
2. Contact irb@butler.edu for any questions.
3. Complete and submit the application form to the Institute for Research and Scholarship in JH 109.

Guidelines for Completing Faculty Research Protocols

1. Describe the purpose of the study, and in non-technical terms, what will happen to your subjects.
2. Describe any potential risks to the subjects.
3. Give the ages, sex, and number of subjects, and explain how they will be recruited.
4. Describe the procedures for obtaining informed consent as provided for in the Code of Federal Regulation section 46.116.
5. Provide copies of questionnaires, letters, stories or other documents to be used in the investigation.
6. If minors are involved, describe the procedures for obtaining individual assent to participate from minors capable of giving assent, as well as the procedures to obtain parental or guardian consent.
7. Explain fully the knowledge to be gained and/or the benefits to the subjects from the proposed research. Justify the risks that the subjects may incur.
8. Explain what, if any, support services will be provided in the event of harm to a subject.

Exempt ~ determined by an Exempt IRB Reviewer designated by the IRB chairperson; View Details

Expedited Review ~ conducted by the chairperson or the chairperson and one reviewer designated by the chairperson, or two reviewers designated by the chairperson; View Details

Full Review ~ review by a quorum of IRB members at a convened meeting. Except as may otherwise be provided by law, the IRB has final authority to determine whether particular research is subject to this policy or exempt. Only the full IRB Board can disapprove a project.

When one other member of the IRB determines a research proposal involves more than a minimal risk to the subjects and it does not fall with in the expedited review category, the proposal is referred to the IRB for full review. In such cases, the researcher may be required to submit additional information necessary to perform the risk/benefit analysis outlined below. The full review conditions are:

Cooperative Research Review ~ As permitted and encouraged by applicable federal regulations to eliminate duplicative efforts the Butler IRB has approved a  Procedure for Accepting Approval of Another Institution's IRB. Read full text here.

Unless exempted or specifically waived by the IRB in accordance with federal regulations, it is the researcher's obligation to obtain the legally effective informed consent of the subject or the subject's legally authorized representative prior to the start of data collection. In addition, the researcher must solicit the assent of any minor subject capable of assenting. To be legally effective, informed consent should: be in language understandable to the subject or the representative; be obtained under circumstances that offer the subject or the representative sufficient opportunity to consider whether the subject should or should not participate; and not include exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the research investigator, the sponsor, the institution or its agents from liability for negligence.

Basic Elements of Informed Consent

1. Statement that study involves research; explanation of purposes of research and expected duration of subject's participation; description of procedures to be followed and identification of any experimental procedures.
2. Description of risks or discomforts to subject.
3. Description of benefit to subject or to others.
4. Disclosure of alternative procedures, if appropriate.
5. Description of the extent to which confidentiality will be maintained.
6. For research involving more than minimal risk, explanation as to whether compensation and medical treatments are available if injury occurs.
7. Explanation of whom to contact if questions arise about the research, the subject's rights or whom to contact if research-related injury occurs.
8. Statement that participation is voluntary, refusal to participate involves no penalty or loss of benefits, and the subject may discontinue at any time.
9. If minors are involved, a specific section for the parent/guardian to indicate refusal to allow participation.

Video/Audio Taping Procedures

Unless exemptible, projects involving the use of videotaping or audiotaping, must make specific mention of these practices in the consent documents. The subject must have the choice of whether to participate in the electronic recording procedures. This consent is separate and distinct from consent to participate in the project, therefore a separate signature and date line is required. Videotapes must be appropriately secured during a project and destroyed after the project to protect the anonymity of the subject.

Additional Consent Requirements

When called for by the IRB, the research investigator must provide additional elements of information to the subject, including the possibility of currently unforeseeable risks; any additional costs to the subject that may result from participation in the research; the consequences of a subject's decision to withdraw from the research; procedures; informing subjects of significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation and the approximate number of subjects involved in the study.

Documentation of Informed Consent

The researcher shall be responsible for insuring that informed consent is documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative, unless this requirement is specifically waived by the IRB. Each person signing the written consent form is given a copy of that form. A written consent form should include those standard elements listed above, and contain the subject's signature and date lines. This form may be read to the subject or the subject's legally authorized representative. In any event, the research investigator shall give either the subject or the representative adequate opportunity to read the form before signing it. A convenient way to document informed consent is to have a tear-off form at the bottom of a page describing the subject's participation in the project. The subject can read the description, sign the form and give it to the project director.

Short Form

A "short form" may also be used in which the elements of informed consent have been presented orally to the subject or the subject's legally authorized representative. When the "short form" is used, researchers should insure that a copy of the short form is given to the subject or the representative and that a written summary of what is to be said to the subject or the representative receives prior approval by the IRB. Furthermore, a witness should be present at the oral presentation, and the subject (or representative), the witness, and the researcher (or person obtaining consent) must sign the short form. Research investigators are responsible for placing the consent documents signed by human research subjects in a repository approved by the IRB chair.

Waiver of Informed Consent

In cases where the research would be jeopardized by full consent procedures, full or partial consent may be waived by the IRB if it is found that:

• the research involves no more than minimal risk to the subjects;
• the waiver or alteration will not adversely affect the rights and welfare of the subjects;
• the research could not practicably be carried out without the waiver or alteration; and
• whenever appropriate, the subjects will be provided with additional pertinent information after participation. Also, the IRB may waive the requirement for signed consent forms if the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. Requests for a full or partial waiver of informed consent procedures must be accompanied by sufficient justification. In cases where the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

The IRB, in compliance with federal regulations, gives special consideration to proposed research involving: prisoners, children, persons with physical or mental handicaps, fetuses, pregnant women, in-vitro fertilized human ova, and other potentially vulnerable groups. Of particular concern is research involving children as subjects. Parental consent (as well as IRB approval) must be obtained prior to any research project that alters a child's routine or behavior. This includes research conducted in classroom settings, such as educational tests, and surveys. Parental consent may be waived only when the child is legally designated an emancipated minor or when it is determined by the IRB that parental permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children). Furthermore, assent of the children must be obtained unless the IRB determines that the capability of the children is so limited that they cannot reasonably give assent. For research conducted in settings in which general blanket participation forms have been signed by guardians, (e.g., schools, classrooms), specific consent of the guardian and assent of the child must still be obtained for each project conducted with these subjects unless there will be no manipulation of the subject's behavior or disruption of the normal routine of the individuals in these settings.

The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, the Provost and Vice President of Academic Affairs, and if the research is externally funded, to the sponsor.

Institutional Review Board approvals, actions and recommendations are subject to review and to disapproval or further restrictions by the Provost and Vice President of Academic Affairs. Such disapprovals or further restrictions shall then be returned to the IRB and the investigator. However, IRB disapprovals, restrictions or conditions cannot be rescinded or removed except by further action of the IRB or in the case of federally funded research, by appeal to the Department of Health and Human Services or other federal agency with appropriate jurisdiction.

The IRB in cooperation with the Director of the Institute for Research and Scholarship shall prepare and maintain documentation of its activities.

Required Records

1. Copies of all research protocols reviewed, scientific evaluations, if any, that accompany the protocols, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
2. Minutes of IRB meetings shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controversial issues and their resolution.
3. Records of continuing review activities.
4. Copies of all correspondence between IRB and the investigators
5. A list of IRB members as required by the United States Department of Health and Human Services.
6. Written procedures for the IRB as required by this policy.
7. Statements of significant new findings provided to subjects.

Maintenance Time Limit

The records required by this policy shall be retained for three years after the termination of the study.