Frequently Asked Questions

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 meeting date.

QUESTION: What is exempt review and how do I know if I qualify?
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 telephone.

QUESTION: How do I know if I need to prepare an informed consent form?
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 assent.

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 acceptable practice?
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).

Last updated or reviewed on 7/7/09