Policy Number: C5.0
Policy Name: POLICY FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH
The purpose of the review of research involving human subjects at RIT is to insure the protection of the human subjects in such research. This policy is compliant with federal regulations called the Common Rule: Part 46 of Title 45 of the Code of Federal Regulations (45 CFR 46), and in accordance with the RIT Federal-Wide Assurance for Protection of Human Research Participants, which certifies that RIT will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects.
It is the responsibility of the entire RIT community to insure this protection by using procedures for:
1. Review and approval of each research protocol prior to the beginning of that activity by the Institutional Review Board (IRB) to determine that:
a. the risks of injury to the subject, if present, are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks;
b. the rights and welfare of any such subjects will be adequately protected; and
c. informed consent, if required due to potential risk of injury to subjects, will be obtained by adequate and appropriate methods in accordance with the provision of the regulation.
2. Certification of such review and approval.
3. Continuing review of all research activities in keeping with the above.
1. Common Rule Definitions
The definitions underlying this policy are included in the Common Rule: Part 46 of Title 45 of the Code of Federal Regulations:
Cooperative Research projects are those projects which involve more than one institution.
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.
Informed consent is the knowing assent of an individual or legally authorized representative who has exercised free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion.
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, academic records). 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 means that 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.
Research means 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.
2. Categories of Research
a. Excluded: Any project that is (i) not research or (ii) not research with human subjects.
b. Exempt: For the purposes of protection of human subjects, research projects involving human subjects that are exempt must fit into one of the following six categories, which are defined more completely in the Code of Federal Regulations (45 CFR 46): The IRB shall determine what research is exempt. Investigators do not have the authority to make an independent determination that research involving human subjects is exempt.
Research is exempt from IRB review if it meets one of the following conditions:
(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
(i) research on regular and special education instructional strategies, or
(ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
(ii) any disclosure of the human 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.
(3) 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)(2) of this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or
(ii) Federal Statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
(4) 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.
(5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs;
(ii) procedures for obtaining benefits or services under those programs;
(iii) possible changes in or alternatives to those programs or procedures; or
(iv) possible changes in methods or levels of payment for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies,
(i) if wholesome foods without additives are consumed or
(ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level 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.
c. Research involving no greater than minimal risk to human subjects.
d. Research involving greater than minimal risk to human subjects.
Regarding research categories (c) and (d), see the definition of “minimal risk” in section B.1. A subject at risk is an individual who may be exposed to the possibility of injury, including physical, psychological, or social injury, as a consequence of participation as a subject in any research project.
C. INSTITUTIONAL REVIEW BOARD
All research initiated by Investigators or conducted at RIT must be approved by the RIT Institutional Review Board (IRB) if it involves human subjects. The RIT IRB will consist of separate branches, as needed, to accommodate review of human subjects research at RIT. New IRB branches will be created and approved by the Institutional Official of RIT as RIT research activity increases; all IRB branches collectively constitute the “RIT Institutional Review Board.” The establishment of IRB branches will be motivated by the need to focus on research activity within individual colleges of RIT, within specific discipline areas, within groupings of several discipline areas within or across colleges, or by the need for specialized attention to specific subject populations.
1. Composition of each branch of the IRB:
A board of five members or more to review research protocols involving human subjects will be appointed by the Institutional Official of RIT. Before appointing members, the Institutional Official of RIT will consult with the chief academic officer of specific colleges as appropriate. Membership will meet the following criteria:
a. Varying backgrounds: The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. Each branch of the IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
b. Representation to ensure acceptability of the board's conclusions in terms of: (i) acceptability of applications and protocols relative to institutional commitments and regulations, (ii) applicable law, (iii) standards of professional conduct and practice, and (iv) diversity of race, gender, and cultural background.
c. Representation of community: Each branch of the IRB will include at least one member who is not otherwise affiliated with RIT and who is not part of the immediate family of a person who is affiliated with RIT.
d. Conflict of interest: Voting members should be free of conflict. No members shall participate in review (either initial or continuing) where there is a potential or direct conflict of interest. They may, however, serve as a resource for objective information.
e. Invited experts: When appropriate, individuals with competencies in special areas may be invited to an IRB meeting to assist in the review of issues but may not vote.
Board members and the chair of each IRB branch will be appointed by the Institutional Official for a one three-year term, effective August of each year. Members may be reappointed. In order to assure an active and effective board, the Institutional Official will promptly replace members who resign or otherwise fail to meet their responsibilities.
The board will be responsible for:
a. implementing RIT’s policy for the protection of human subjects in a manner as facilitative as possible to research at RIT;
b. informing research investigators of RIT’s policies and procedures for the protection of human subjects;
c. reviewing research protocols and approving, requiring modifications of, or rejecting such protocols based on risk of injury to subjects. A majority of IRB members, including at least one non-scientific representative, must be present to vote on protocols. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
d. notifying the investigator in writing of action taken on the research protocol and the rationale;
e. maintaining on file a copy of the:
(i) description of the research protocol involving human subjects
(ii) completed but unsigned informed consent form to be used
(iii) record of board vote and minutes of formal deliberations
(iv) notification to the investigator of action taken by board
f. notifying the investigator within ten months of the board’s prior approval that the project must be re-reviewed by the board if human subjects continue to be involved;
g. reporting promptly to the cognizant federal agency responsible for the protection of human subjects of any unanticipated problem identified to the board involving injury to subjects or others, including adverse psychological or medical complications (Note: It is the responsibility of the investigator to report to the IRB promptly in writing any proposed changes in the research activity that increase risk of injury and unanticipated problems involving injury to subjects or others, and it is the board’s responsibility to re-evaluate the project for risk of injury and benefit of the research).
3. Board Meetings
The chair of the IRB will convene the board regularly to classify protocols, to approve or disapprove protocols, to defer decision based on inadequate information, and/or to defer decision based on specified conditions which must be met.
The IRB administrator shall be responsible for compiling research protocols and all associated documentation which under normal circumstances will be distributed to the IRB members at least three days in advance of the meeting.
In reviewing research protocols at IRB meetings members will respond in writing to each protocol indicating:
(1) classification of a proposed project as:
c. Involving no more than minimal risk
d. Involving greater than minimal risk
(2) approval or disapproval based on the RIT Policy for the Protection of Human Subjects
(3) deferral based on inadequate information
(4) deferral based on specified conditions which must be met and which must receive board approval prior to the initiation or continuation of the project.
The RIT IRB Administrator will notify the Investigator of the decision of the board.
In addition to its regular meetings, the IRB chair, in consultation with the IRB administrator, may convene the board:
(1) at the request of any member
(2) at the request of an investigator for a formal hearing following disapproval or suspension of a project by the Board
(3) for other board business.
4. Expedited Review
While there are categories of research that may be reviewed by the IRB through an expedited review process, it is anticipated that reviews will generally be handled at regularly scheduled meetings of the IRB. In the event that full board review is not possible in a timely fashion, a research protocol that is proposed as Exempt or involving no greater than minimal risk to the subjects may be reviewed in an expedited process. Under such circumstances, the chair or the chair’s designee from the membership of the IRB and the IRB administrator have the authority to expedite the proposal review process without the necessity of full committee review. They may also send out such research protocols electronically for full board review. Records of a request and its disposition should be maintained by the IRB regardless of whether the request has received full board or expedited review. The full IRB shall be informed of all decisions resulting from expedited review.
The following categories of research are eligible for expedited review (45 CFR 46):
(1) Clinical studies of drugs and medical devices under certain conditions.
(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture, under certain conditions.
(3) Prospective collection of biological specimens for research purposes by noninvasive means.
(4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non research purposes (such as medical treatment or diagnosis).
(6) Collection of data from voice, video, digital, or image recordings made for research purposes.
(7) Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
(8) Continuing review of research previously approved by the IRB as follows:
(i) the research is permanently closed to the enrollment of new subjects;
(ii) all subjects have completed all research-related interventions; and
(iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
(9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories (2) through (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
5. Determination of Risk
If a determination is made by the board that subjects will be placed at risk of injury, the board must determine, before approving a research protocol:
(a) that the risks of injury to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks;
(b) that the rights and welfare of the subject will be adequately protected; and
(c) that effective informed consent will be obtained in accordance with the methods prescribed in the Common Rule.
6. Board Action
a. Project Approval
In principle, board approval will be given to initiation or continuation of a research protocol which in the board’s judgment meets either of the following conditions:
(i) presents no risk of injury to subjects, or
(ii) if risk of injury is involved, such risk is outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained.
Board approval will be given to proceed for projects that have the approval of the majority of the members. The chair will have one vote. No members may vote on a project in which they are associated as an Investigator or project supervisor.
Board approval does not constitute full institutional authorization for a project to begin or continue, but only the board's judgment that appropriate attention is being given to the protection of human subjects.
b. Project Deferral
The board will defer its decision on approval or disapproval of a research protocol based on any of the following:
(i) inadequate information from the Investigator to permit a board decision;
(ii) absence of or unsatisfactory provisions for informed consent if required by this policy or the board; or
(iii) inadequate assurances of precautions to be taken to minimize risk and significance of injury if required by this policy or the board.
c. Project Disapproval
In principle, the board will disapprove the initiation or continuation of research which in its judgment involves risk of injury that outweighs the benefit to the subject and the importance of the knowledge to be gained. Disapproval of research results when less than a majority of board members present at a meeting cast a vote of approval.
Disapproval of a project by the board may not be overturned by any other body or person within or outside RIT. A hearing will be granted if requested by the Investigator, the investigator's supervisor, or an officer of RIT for the purpose of presenting additional information or project modifications which might lead the board to reverse its decision.
d. Project Suspension
The board may suspend a project, on the vote of the majority of the board, based on information that
(i) unanticipated problems increasing risk of injury to subjects have arisen,
(ii) the project has been modified with the potential for adding risk of injury to subjects,
(iii) the Investigator has withheld information from the board, deliberately or otherwise, which might lead to disapproval of the project,
(iv) failure to obtain or demonstrate to the board that informed consent has been obtained as required, or
(v) non-compliance with this policy by any party.
7. Continuing Review
For continuing review of a protocol, IRB members will receive a protocol summary and status report on the progress of the research, to include
(a) the number of subjects accrued;
(b) a summary of adverse events and any unanticipated problems involving risks to subjects or others and any withdrawal of subjects from the research or complaints about the research since the last IRB review;
(c) a summary of any relevant recent literature, interim findings, and amendments or modifications to the research since the last review; and
(d) any relevant multi-center trial reports. If the project has been modified, IRB members will also receive any other relevant information, especially information about risks associated with the research, and a copy of the current informed consent document and any newly proposed consent document.
Review of proposed protocol changes must be conducted by the IRB at convened meetings where there is a quorum. IRB members shall receive all materials as for an initial review, with the revision incorporated into the original written protocol.
D. INVESTIGATOR (FACULTY, STAFF, OR STUDENT)
RIT administrative or faculty approval of a research proposal does not substitute for review by the RIT Institutional Review Board. Before a research project involving human subjects is conducted, the protocol must be reviewed and approved by the IRB. An investigator is also required to complete online or on-campus training related to human subjects research before a protocol involving human subjects is reviewed for approval. Acceptable online and on-campus training options are listed through the RIT Human Subjects Research Office. The investigator receives a certificate of completion for this one-time training and submits it to the office of the IRB Administrator for filing.
Board approval of a research project does not bind the investigator to initiate or complete the project.
1. Investigator Responsibilities
a. The investigator is responsible for furnishing the board with full information necessary for the board to meet its responsibilities, including the classification of a protocol in a category of research. Copies or descriptions of proposed tests and questionnaires should be furnished to the board, along with a copy of proposal, including the proposal abstract. Incomplete protocols will be returned to the investigator without board review.
b. If the approved project is modified after board action in any way, it must be resubmitted to the board.
c. The investigator will promptly inform the board by memo of any unanticipated problems involving risks to subjects or others, steps taken to eliminate or reduce this effect, and efforts to assure the effect will not reoccur.
d. If for any reason an approved research project is not initiated within twelve months of the date of board approval, and there is an intent to involve human subjects, the Investigator will cease project activities and resubmit the project proposal for reclassification.
e. The investigator will resubmit requests for continuation of approved projects at least annually if the research remains in a phase where human subjects are directly participating.
f. The investigator will be responsible for collection and retention of all signed informed consents from subjects (guardians if subjects are under 18) for a period of three years following completion of the project (see Section E., Informed Consent).
2. Student-Initiated Research
RIT faculty supervising undergraduate or graduate students who are conducting research with human subjects are responsible for informing students of elements of the RIT policy that are relevant to the students’ research, including Informed Consent for research protocols when deemed appropriate and in cases involving children or other protected groups, such as prisoners or mentally ill persons.
Faculty supervisors who have filed a certificate of training with the IRB (Office of Human Research Protections training available online at their website) or who have completed on-campus IRB-related training are given the authority to approve student projects as excluded from IRB oversight. Upon receipt of a certificate of training, this authority will be confirmed in writing by the IRB.
Excluded projects are projects that are (1) not research or (2) not research with human subjects. A project is research if it follows a systematic investigation designed to develop or contribute to generalizable knowledge. Faculty supervisors are responsible for facilitating student applications to the IRB. Only the IRB can approve human subjects research protocols at RIT, as defined in Categories of Research (Section B.2.) For all human subjects research, students should be advised that protocols may require up to four weeks’ time for IRB review.
E. INFORMED CONSENT
Informed consent is the knowing assent of an individual or legally authorized representative who has exercised free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form os constraint or coercion.
Per Federal Guidelines at 45 CFR 46, no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.
Informed consent can be obtained by developing a consent form. Except as provided in paragraph (a) or (b) of this section, the form must include the following basic eight elements and must be submitted to the board for approval:
1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed and identification of any procedures which are experimental;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject or others which may reasonably be expected from the research;
4. A disclosure of any appropriate alternative procedures or courses of treatment, if any, that might be advantageous for the subject;
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
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 can be obtained;
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
When appropriate, one or more of the following elements of information shall also be provided to each subject:
1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
3. Any additional costs to the subject that may result from participation in the research;
4. The consequences of a subject's decision to withdraw from the research and procedures 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; and
6. The approximate number of subjects involved in the study.
(a) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:
(1) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
(i) public benefit or service programs;
(ii) procedures for obtaining benefits or services under those programs;
(iii) possible changes in or alternatives to those programs or procedures; or
(iv) possible changes in methods or levels of payment for benefits or services under those programs; and
(2) The research could not practicably be carried out without the waiver or alteration.
(b) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:
(1) The research involves no more than minimal risk to the subjects;
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
(3) The research could not practicably be carried out without the waiver or alteration; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
If the IRB determines that a research protocol is designed to study conditions in children or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects, it may waive the parental permission requirements provided that an appropriate mechanism is in place to protect the children, and provided that the waiver is not inconsistent with federal, state, or local law. Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
The choice of an appropriate substitute mechanism for protecting children participating in research would depend on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and the child’s age, maturity, status, and condition.
Signed informed consent forms must be retained by the Investigator for a period of not less than three years following the completion of the investigation.
Any proposed or continuing project which poses a potential risk to unborn children of subjects must be indicated to the board, and the informed consent form must include the following statement, "This project poses a potential risk to unborn children. Pregnant women are asked not to participate."
If the board determines that there is risk of physical injury to subjects, informed consent must include any provisions made for medical treatment or compensation in the event of injury.
Before a statement concerning provisions for medical treatment or compensation for physical injury is prepared for informed consent, the Investigator should meet with an appropriate RIT official to establish the level of RIT’s responsibility.
F. COOPERATIVE RESEARCH
1. RIT-Initiated Research in Other Institutions
RIT researchers seeking the cooperation of another institution in RIT-initiated research involving human subjects must submit their protocols to the RIT Institutional Review Board for approval regardless of approval by the other institution. While compliance of other participating institutions with applicable regulations is the responsibility of those institutions, research sponsored wholly or in part by RIT must comply with RIT’s policy.
If the cooperating institution has its own Institutional Review Board for the protection of human subjects, it will wish to conduct its own review. The RIT researcher is urged to submit the protocol first to the RIT Institutional Review Board since its decision and conditions are binding on RIT personnel. (The outside board may add conditions or decline the participation of its institution.) The decision and any conditions to be added by the outside board must be received in writing by the RIT Institutional Review Board before subjects become actively involved in the cooperating institution. The decision of the RIT Institutional Review Board and the RIT policy for the Protection of Human Subjects will be forwarded to the outside board on request.
If the cooperating institution does not have its own institutional Review Board for the protection of human subjects, the investigator should share with that institution the information presented to the RIT Institutional Review Board and the decision reached by the board. A letter should be prepared by the appropriate official of that institution, on the institution’s letterhead, which indicates that the protocol and the decision of the RIT Institutional Review Board have been reviewed and that the official believes the decision conforms to the DHHS guidelines for the protection of human subjects. If that institution adds any conditions for the protection of human subjects in that institution, these added conditions should be indicated in the letter. The letter should be addressed to the RIT Investigator who, upon receipt must forward a copy to the RIT IRB. Data collection in that institution may not begin until after this letter has been acknowledged as received by the RIT Institutional Review Board.
The RIT researcher must retain the original or a copy of all informed consent and comply with all other aspects of the RIT policy.
2. Third Party Research at RIT
RIT will entertain inquiries from outside institutions and Investigators who wish to conduct research and collect all or some of their data at RIT. Regardless of whether a project has been reviewed and approved by the Institutional Review Board of another institution, it must also be reviewed and approved by RIT’s Institutional Review Board before data are collected at RIT. If the applicant is affiliated with another institution with an Institutional Review Board, that board should first review the proposed research, and a copy of its findings and documentation must be forwarded to the RIT Institutional Review Board. RIT’s Board may not reduce the conditions for approval but may add conditions or disapprove the participation of RIT. Added conditions may include the designation of an RIT faculty member to serve as a liaison between RIT and the applicant.
Responsible Party: Human Subjects in Research Office
Effective Date: Approved February 6, 1985
Last Revised March 15, 2006
Edited June 2007
Edited October 2010