QUESTION: What is the Committee
for the Protection of Human Subjects (CPHS)?
ANSWER: The Committee serves as the University’s
Institutional Review Board (IRB). An IRB is a specially constituted review
body established or designated by an entity to protect the welfare of
human subjects recruited to participate in behavioral or biomedical research.
QUESTION: How do I know if I need
to submit an application to CPHS?
ANSWER: All research projects involving
the use of human subjects (including projects utilizing archival or existing
data) must be submitted to the CPHS for approval. Human subjects are individuals
whose physiologic or behavioral characteristics and responses are the
object of study in a research project. Under the federal regulations (45
CFR 46.102[f]), human subjects are defined as living individual(s) about
whom an investigator conducting research obtains: (1) data through intervention
or interaction with the individual; or (2) identifiable private information.
QUESTION: How often does the committee meet?
ANSWER: The committee meets once a month. The deadline
for submission of applications is 2 weeks prior to the next committee
QUESTION: What is exempt review and how do I know if
ANSWER: Based on DHHS regulations,
the University recognizes 6 categories of research as exempt from continuing
CPHS review. Only truly anonymous research is eligible for exempt status,
provided any additional requirements specified in each category are also
satisfied. The use of the term “exempt” refers only to the
requirement for annual review, not the general requirements for informed
consent and the protection of subjects. Either a full committee or a subcommittee
can review files that qualify for one of the exempt categories. Please
refer to the “Exemption Categories” portion of this website
for further information.
QUESTION: What is expedited review and how do I know
if I qualify?
ANSWER: Based on DHHS regulations, the University recognizes
9 categories of research for which review can be expedited because they
involve procedures posing no more than minimal risks to subjects, for
which clear standards can be set. Either a full committee or a subcommittee
can review files that qualify for expedited review. However, standard
requirements for informed consent and the protection of human subjects
apply regardless of the type of review. Please refer to the “Expedited
Review Categories” portion of this website for further information.
QUESTION: Why are so many copies required?
ANSWER: Each member of the committee or subcommittee
must have a copy of each application to read before the meeting, and your
signed original must be kept in our files.
QUESTION: What do I need to attach
to my application?
ANSWER: Adequate documentation
must be attached to the application to allow the CPHS to evaluate the
following factors: (1) that the rights and welfare of the subjects will
be adequately protected; (2) that the risks to the subjects are reasonable
in relation to anticipated benefits; and (3) that the informed consent
of subjects will be obtained by adequate and appropriate methods.
Documentation must include: all relevant informed consent documents;
copies of any and all questionnaires or research instruments (if appropriate);
a list of questions for interviews (if appropriate); copies of recruitment
ads; copies of approval from cooperating facilities or institutions (such
as a school district); and any other documentation that you feel might
facilitate the committee’s review.
QUESTION: How soon after the committee meeting will
I be notified of its decision?
ANSWER: Written correspondence is sent 7 to 10 working
days after the committee meets. Letters to graduate students are mailed
care of the faculty sponsor. Committee decisions are not given over the
QUESTION: How do I know if I need to prepare an informed
ANSWER: No subject may be involved in research without
the legally effective informed consent of the subject or the subject’s
legally authorized representative. This consent shall be sought under
circumstances that provide sufficient opportunities for the subject to
freely consider whether or not to participate. If the subject is a minor
(less than 18 years of age), written parental consent is required. In
addition to the parental consent, the investigator must also obtain the
assent of the child, unless the child is too young or incapable of giving
QUESTION: If I have the parents’ permission, why
do I need the child’s assent?
ANSWER: Out of respect for children as developing persons,
children should be asked whether or not they wish to participate in a
research project. In order to minimize undue influence, parental consent
and child assent should be obtained through separate procedures.
QUESTION: What is negative consent, and why is it not
ANSWER: Negative consent requires a subject to decline
participation, rather than actively agreeing to participate. It does not
adequately assure that subject participation is truly voluntary.
QUESTION: What type of information should be included
in an informed consent?
ANSWER: It is important to remember
that informed consent is a process, and that the written form serves to
document this process. The informed consent document must include sufficient
information to allow the potential subject to understand what he/she is
being asked to do and to weigh any risks against the potential benefit
before agreeing whether or not to participate. Federal regulations require
the inclusion of certain information, such as the number of potential
subjects, how much time will be required, risks, benefits, etc. University
policy requires the inclusion of other information, such as the name and
telephone number of the faculty advisor if the investigator is a student,
and a statement indicating that the project has been reviewed by the CPHS
which includes a contact number. Please refer to the “Sample Informed
Consent Documents” portion of this website for more information
and model forms.
QUESTION: What are the possible
decisions the CPHS can issue?
ANSWER: There are six possible decisions: (1) exempt
(no changes required; must be renewed every five years; (2) contingent
exempt (minor changes and /or additions required; must be renewed every
five years; (3) approval (no changes required; must be reviewed annually);
(4) contingent approval (minor changes and/or additions required; must
be reviewed annually); (5) table (significant problems and/or missing
documentation; must be reviewed by the full committee again after materials
are corrected and/or added); (6) disapprove (project does not comply with
human subjects’ regulations and the committee is convinced that
the problems cannot be corrected).