Human Subject Research: Guidelines
Approval of human participants research.
The criteria governing the approval of human participants research are contained in Table 2.
Table 2. Criteria for approval of human participants research
(Criteria adapted from §46.111 of 45 CFR 46).
(a) In order to approve research covered by this policy (i.e., deem that research ethical), the Committee shall determine that all of the following requirements are satisfied:
(1) Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. Potential risks to be evaluated include both physical risks and psychological risks (e.g., might the research demean or humiliate the participant?)
In evaluating risks and benefits, the Committee should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The Committee should not consider possible long range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
(3) Selection of subjects is equitable. In making this assessment the Committee should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons.
(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent provided by §46.116.
(5) Informed consent will be appropriately documented, in accordance with, and to the extent provided by §46.117.
(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Each participant prior to participation shall be provided with the following information:
- 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;
- a description of any reasonably foreseeable risks or discomforts to the subject;
- a description of any benefits to the subject or to others which may reasonably be expected from the research;
- a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
- 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;
- 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
- 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.
Informed consent shall be documented by use of a written consent form (including the pertinent information described above and, when applicable, a statement that this information has been provided orally) signed by the participant or the participant’s legally authorized representative (e.g., when children are the participants). Informed consent may be waived or altered only in situations specified in §46.116(d) of the Federal Regulations, as stated below.
§46.116(d) [A Research Ethics Committee] may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the Research Ethics Committee finds and documents 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.
Consequences for Non-Compliance with this Protocol
All North Central College employees who conduct or supervise research using human research participants or animal subjects are responsible for being familiar with and following this protocol. Faculty supervisors are responsible for ensuring that their students follow this protocol. Faculty researchers who do not follow this protocol will be referred in writing to the Dean of the Faculty for appropriate disciplinary action, and the Committee Chair will draft a letter to the Faculty Personnel Committee documenting this noncompliance. Non-complaint researchers who are not faculty members will be referred to their immediate supervisors for disciplinary action.
In order to ensure compliance; read the requirements at left and then complete a Human Subject: Application