Randolph-Macon guidelines for the conduct of research involving human subjects
The Randolph-Macon Institutional Review Board (IRB) evaluates all research projects involving
the use of human participants at Randolph-Macon. The focus of the evaluation is on the ethical treatment of
the individuals participating in the research process.
The Randolph-Macon guidelines for research with human subjects are based on the three principles
outlined in the 1979 Belmont report: Respect for Persons, Beneficence and Justice. The principle of
Respect for Persons acknowledges the dignity and autonomy of individuals. This principle requires that
subjects give informed consent to participation in research. The principle of Beneficence requires us to
protect individuals by maximizing anticipated benefits and minimizing possible harms. The principle of
Justice requires that we treat subjects fairly. These core principles have been translated into specific
guidelines by several organizations including the Department of Health and Human Services, the American
Psychological Association, and the American Sociological Association. The guidelines of these
organizations include the need for Informed Consent, Confidentiality, Debriefing, Limited Deception and
Protection from harm.
The process for approval by the IRB begins when a researcher submits an application to the
committee, using the attached form. For applications requiring full board review, applications will be
reviewed by all members of the IRB for their approval, denial, or conditional approval with necessary
changes indicated. Research studies that involve minimal risk to subjects may be reviewed using an
expedited process; in these cases, proposals will be reviewed by one or more members of the IRB. An
expedited review may result in approval, conditional approval with necessary changes indicated, or referral
to full board for review. Although the IRB is free to make suggestions on methodology and hypotheses, the
decision on the approval of a study is made solely on the basis of ethics and not the quality of the proposed
study. Similarly, it is not purview of the IRB to edit a submitted proposal.
Completed applications should be submitted electronically to Barb Wirth (bwirth@rmc.edu).
Additional questions or concerns can be directed to the IRB Chair, Amy Armenia (amyarmenia@rmc.edu).
Revised 10/2013
APPLICATION FOR APPROVAL OF RESEARCH
RANDOLPH-MACON COLLEGE IRB
Title of Project:
Date Submitted:
Date Response is needed by:
Principal Investigator: ______________________________________________________________
name
extension
email
Signature(s) of principal investigator(s): _________________________________________________
Co-investigator: __________________________________________________________________
name
extension
email
Co-investigator: __________________________________________________________________
name
extension
email
Co-investigator: __________________________________________________________________
name
extension
email
Co-investigator: __________________________________________________________________
name
extension
email
Faculty Sponsor: __________________________________________________________________
If project is meeting a course requirement, list course name and number: ______________________
If project is funded by any outside sources, please note this below:
1. Briefly explain the study, including purpose, participants and study procedures.
2. Will human subjects be recruited for this research? ___Yes ___No
If yes, please describe how subjects will be recruited, and what the research process will involve for
subjects.
3. Are any potential participants under age 18? ___Yes ___No
Note that if any subjects are under the age of 18, parental consent and subject assent will be
required.
4. Do the research activities involve more than “minimal risk” to subjects? ___Yes ___ No
As noted in the federal regulation 45 CFR 46.102(i), “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.”
5. Describe any potential risks (physical, psychological, social, legal or other) of participation for subjects.
6. Describe any procedures to minimize risk, including any debriefing procedures.
7. Describe how informed consent will be obtained, or provide justification for waiving informed consent.
See Appendix for guidelines on informed consent procedures. A copy of an informed consent
document (and subject assent, if necessary) following these guidelines should be attached, unless
investigators propose waiving informed consent.
8. How will the confidentiality or anonymity of subjects be protected?
Note that “anonymity” means that not even the researcher is able to determine the identity of a
subject. Interviews cannot be anonymous but the researcher can provide confidentiality. Detail how
anonymity or confidentiality will be provided, including protection of data once collected, or
justification if responses will not be kept confidential and/or anonymous.
9. Describe potential benefits of this research to the individual or society.
10. Describe any stipend or incentive given to the subjects for participation (e.g., money, extra credit).
If incentives involve extra credit, you, with the agreement of the instructor(s), must provide other
ways for students, who are unable or choose not to participate in your study, to earn the same extra
credit. If you are recruiting subjects by using a voluntary gift card drawing for research participants,
or other incentive(s) unrelated to any course grade, you need not do anything else.
11. Attach a copy of any tests, questionnaires or interview protocols that will be used. A BRIEF literature
review and justification may be included only in extraordinary circumstances when subjects are at risk.
Appendix: GUIDELINES FOR INFORMED CONSENT
Informed consent is typically documented by the use of a written consent form approved by the IRB, and
signed by the subject or their legally authorized representative. If subjects are under 18, informed consent
must be signed by a parent or legal guardian, and the subject should be given an opportunity to assent to
participation, in an age-appropriate format.
Written informed consent procedures may be waived in some situations, including when:
1. The only record linking the subject and the research would be the consent document, and the
principal risk would be potential harm resulting from a breach of confidentiality; or
2. 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. For example,
observation of public behavior need not involve a written consent document.
3. If the proposed study is minimal risk and truly anonymous, an implied consent model may be
used. An implied consent process provides subjects with the information below (on the first page
of an anonymous survey, for example), but the signature line is replaced with a statement
informing the participant that completion and return of the survey is considered implied consent.
Standard elements of an informed consent document:
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A statement that the study involves research
An explanation of the purposes of the research
The expected duration of the subject's participation
A description of the procedures to be followed
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 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 (usually the IRB chair and principal investigator), and whom to contact
in the event of a research-related injury to the subject
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
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A place for the subject (or their legally authorized representative) to sign and date the form.
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A copy of this form (without signatures) should be provided to the subject.