Sweet Briar College

Human Subjects Research Review Committee

Investigator Summary Description of Research Involving the use of Human Subjects

Submission Date: Proposed Start-up Date:

Investigator’s Name:

Co-Investigators:

Project Title:

Dept: Phone:

email:

This research is being conducted for:

________ Undergraduate Course

(Course name/number _______________________________)

(Faculty Advisor ____________________________________)

_______ Faculty Research

Granting Agencies:

I hereby certify that upon approval of this proposal by the human subjects committee, no changes will be made without approval of the HSRC, and that any problems, adverse reactions, or unforeseen conditions encountered in the use of Human subjects will be immediately reported to the chair of the HSRC. I further agree to supply the HSRC with all requested reports, and a certificate of compliance upon completion of this project.

P.I. Signature___________________________________ Date ___________
I. Project Description.

In the space below, briefly describe the objectives of your research, data collection procedures, the need for human subjects, and any special conditions or procedures for their involvement. You need not be lengthy, but provide enough information for the Review Board to assess the risks to which your subjects may be exposed and the benefits likely to result from you proposed experiment(s). Any questionnaires or interview protocols referred to in your proposal must be attached.

II. Characteristics of the Subject Group(s)

Describe the characteristics of the group(s) to be used. Specify particularly if human subjects are either children, mentally incompetent, or from a legally restricted group. For each statement, indicate the page number in the proposal where substantiating documentation can be found.

a) Gender, race or ethnic group, age range, etc.

b) Affiliation of subjects (e.g. college students, elementary school children, hospital patients, general public, etc.)

c) Subjects’ general state of health (mental or physical)

d) The necessity for using these particular groups.

e) Briefly explain how subjects will be recruited. Describe the procedure to the point of gaining consent.

f) Explicitly describe what the subjects will be asked to do.
III. Risks to Subjects

Describe in detail any physical, psychological, social, legal, economic, or other risks you can foresee both immediate and long range. For each statement, indicate the page number in the proposal where substantiating documentation is found.

a) Immediate Risk

b) Long Range Risk

c) Rationale for the necessity of such Risks

d) How will the risks be minimized

e) If the risks have been identified, briefly describe the importance of knowledge to be gained and explain why you feel that the value of the information to be gained outweighs the risks.
IV. Confidentiality of Data

What precautions will be taken to safeguard identifiable records of individuals? This question applies if you are using secondary sources of data. Be specific about the long range and immediate use of data by you and others.

V. Consent procedures

Federal regulations require precautionary measures to be taken to insure the protection of human subjects on physical, psychological, social and other issues. This includes the use of “informed consent” procedures as described in the institutional guidelines.

a) How will the subjects be informed of the nature of the investigation, the reasonably foreseeable risks, and the voluntary nature of his/her participation?

_____ (in writing) _____ (orally)

b) Once the above information has been presented, will you obtain written consent from the subjects (i.e. their signature) prior to their participation.

_____ Yes (attach a copy of the informed consent form)

_____ No (identify the reasons for requesting a waiver of the written consent requirements)

c) If the subjects are minors _____, or mentally incompetent _____. describe how and by whom permission will be granted.

_______________________________________ _______________

Signature of Primary Investigator Date
Addendum:

VI. The use of deception.

If deception is to be utilized in your project you must describe in detail the circumstances which you feel justifies the use of deception. In particular, specify the nature of the deception, how and when the subjects will find out about the deception and explain precisely the nature of your debriefing procedures.

a) If at any point in your procedure, will it be necessary for you use deception?

b) Briefly explain the rationale for using deception in this project.

c) Explicitly describe your debriefing procedure.

d) How long after the experimental session will subjects be debriefed?

e) If debriefing is not done immediately, at which point will subjects be made aware of the deception in the experimental session?