Appendix C: HSC APPROVAL CHECK LIST
THE FOLLOWING CHECKLIST IS INCLUDED TO HELP GUIDE YOU IN THE COMPLETION OF THE HSC HUMAN RESEARCH APPROVAL FORM. PLEASE REFER TO IT AS NECESSARY. We realize that for some qualitative research in some disciplines, some of the items below may not be relevant or instructive. Please feel free to submit information that is relevant to your particular study as the case may be.
1. Administrative
a. Are the appropriate number of copies submitted?
b. Are copies of each informed consent form submitted?
c. Are copies of each questionnaire and/or example stimuli
submitted?
d. If this is a student project, do you have your faculty supervisor’s
signature (or has your supervisor submitted a letter or e-mail to the Office of Sponsored Programs) indicating approval to submit?
2. Scientific Aspects
a. Is the hypothesis stated?
b. Is the research design appropriate?
c. Does the information to be collected provide a means to answer
the hypothesis?
d. Is a sample size calculation performed? If not, is it necessary?
3. Human Subjects Issues
a. Is the study population defined?
b. Are there any anticipated problems from using this study
population? Is it appropriate for the hypothesis to be tested?
Are subject recruitment procedures documented? Will the study
be advertised? Is subject compensation addressed?
c. Are the risks1 adequately defined?
d. Are the potential benefits clearly defined to the subjects and
to society?
e. Do the benefits outweigh the risks?
f. How are subjects protected from risks?
4. Consent Form
a. Is the study title on each page with the investigator's name, telephone number and email address available? If this is a student project, do you provide your faculty supervisor contact information?
b. Are all the elements of informed consent listed on your form? (See the CCSU Human Studies Council policy for further details). These include:
1. An explanation of the purposes of the research
2. The expected duration of the participant's participation
3. The description of the procedures to be followed.
4. Identification of any procedures that are experimental.
5. A description of any reasonably foreseeable risks or discomforts to the participant.
6. A description of any benefits to the participant or to others which may reasonably be expected from the research.
7. If applicable, a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.
8. A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.
9. For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical (or other) treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained.
10. An explanation of whom to contact for answers to pertinent questions about the research and research participants' rights, and whom to contact in the event of a research-related injury to the patient.
11. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue at any time without penalty or loss of benefits, to which the participant is otherwise entitled.
c. These additional elements to your consent form should be added, if appropriate.
1. The approximate number of participants involved in the study
2. Anticipated circumstances under which the participant's participation may be terminated by the investigator without regard to the participant's consent.
3. Any additional costs to the participant that may result from participation in the research.
4. The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant.
5. A statement that significant new findings developed during the course of the research, which may relate to the participant's willingness to continue participation, will be provided to the participant.
6. A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant), which are currently unforeseeable.
d. Is the consent form readable? Is it appropriate for the age, language, ability and education of prospective participants or the participants' legally authorized representative? Is it written in easy to understand lay terms without jargon? Are there spelling, typographical or grammatical errors?
e. Have you provided additional protections for minors (<age 18 years) involved as participants in research? For example, have you made adequate provisions for soliciting the assent of children, as appropriate? Have you obtained parental permission? Current federal standards maintain that one parent's permission is acceptable for research not involving greater that minimal risk or for research involving greater that minimal risk but presenting the prospect of direct benefit to the individual participants. If research involves greater than minimal risk and has no prospect of direct benefit to individual participants, but is likely to yield generalizable knowledge about the participant's disorder or condition or research not otherwise approval which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children, both parents must give their permission. One parent's permission is acceptable in these circumstances if one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. [If the HSC determines that a research protocol is designed for conditions or for a participant population, for which parental or guardian permission is not a reasonable requirement to protect the participants (for example, neglected pr abused children), it may waive the consent requirements described above provided an appropriate mechanism for protecting the children who will participate as participants in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state or local law.
version 8.30.2001 for web