Guidelines for Submitting Proposals for IRB Review

Scripps College maintains an Institutional Review Board (IRB) in order to ensure (1) that researchers who are part of the College community protect the dignity, privacy, and safety of the participants they recruit for their research, and (2) that the dignity, privacy, and safety of members of the Scripps community are protected when they choose to participate in research. Scripps’ IRB deals only with research involving human participants; research involving nonhuman subjects must be reviewed elsewhere at The Claremont Colleges.

College policy requires that all research involving human participants and all information-gathering regarding individual human beings carried out by the students and faculty of Scripps or taking place on campus should follow the principles set forward in The Belmont Report and in Section 3.17 of the Scripps College Faculty Handbook and that all such research and information-gathering must be submitted for IRB review.

Guidelines for Using Deception in Human Subjects Research

  1. These guidelines clarify how the IRB abides by the Belmont Report to protect the integrity of informed consent, which is one of the most important aspects which the Report identifies as necessary for ethical human subjects research.
  2. As a general rule, deception is not acceptable when doing research with humans. Using deception jeopardizes the integrity of the informed consent process, since participants who are deceived give their consent under the condition of false information about the study they are consenting to. Deception can also potentially harm your participants. Occasionally, exploring your area of interest fully may scientifically require misleading your participants about the subject of your study. For example, if you want to learn about the susceptibility of persons to group pressure, you may need to form pre-arranged groups that make pre-arranged group decisions, without the knowledge of your participants. The IRB will review any proposal that suggests using deception or misrepresentation very carefully. They will require an in-depth justification of why the deception is necessary for the study and the steps you will take to safeguard your participants.
  3. Here is language taken from a research ethics course linked to the HHS website: “Deception is rarely acceptable in social science research and is never morally permitted when the results can be achieved with non-deceptive means. Deception is a problem in research, as in regular life, in that deception is possible only because those deceived trust that they are being told the truth. Deception eats at the trust that is necessary for social interaction. Deceiving when the same goal can be met without deception is never morally permitted.”
  4. Here is language taken from the HHS Guidelines to IRBs, Chapter 5: “However, some studies do present a risk of social harm (e.g., harm to a subject’s reputation, which is sometimes a danger if confidentiality is not maintained) or psychological harm, which may occur if the research involves deception or provides subjects with unwelcome and disturbing information about themselves. When deception is involved, the IRB needs to be satisfied that the deception is necessary and that, when appropriate, the subjects will be debriefed. (Debriefing may be inappropriate, for example, when the debriefing itself may present an unreasonable risk of harm without a counterveiling benefit.) The IRB should also make sure that the proposed subject population is suitable. [See Guidebook Chapter 3, Section A, "Risk/Benefit Analysis."]

Some studies involve the possibility of a moral wrong, which is what some commentators have labeled the ethical problems posed by deception of subjects or invasions of their privacy. Although some psychologists have overemphasized the value and necessity of using deception, deception or incomplete disclosure may be the only scientifically valid approach for certain research. An example of such research would be a study designed to determine the effect of group pressure (i.e., responses of others) on a subject’s estimate of the length of a series of lines. In some groups, pseudo-subjects would be told in advance to give incorrect answers to questions about the length of the lines to determine the effect of such misinformation on the real subjects’ responses. Obviously, if the subjects were told all about the research design and its purpose in advance, it would not be possible to do the research. IRBs need to determine whether any deception or invasion of privacy involved in a research protocol is justified.”

The Research Summary and Supporting Materials

The Research Summary should be a typed document written specifically for the review of the IRB. Grant applications and M.A. or Ph.D. proposals are not an appropriate substitute, because typically they are longer than suits the committee’s purposes, are not written entirely in language accessible to the lay person, and may not address the issues of risk and benefit. The Research Summary should include the following information:

  1. The title of the research and the name of the principal investigator;
  2. The research question or questions under investigation;
  3. The nature of the population to be studied and, in addition,
    1. how the participants will be recruited,
    2. whether or not participants will be personally identified,
    3. what they will be told regarding the research and the character of their participation,
    4. whether or not the project requires any deception;
  4. How consent will be obtained.
  5. The degree of sensitivity of the information to be gathered and, if participants are to be personally identified, the steps that will be taken to ensure confidentiality;
  6. The methods to be used, including a copy of any questionnaires or surveys that are to be administered;
  7. An assessment of the benefits of the project, including its contribution to scientific knowledge and any direct benefits it may offer to the participants;
  8. An assessment of the risks to participants and how they will be handled;
  9. Relevant supporting materials. Attach a copy of the surveys, questionnaires, consent forms, and any other documents or materials to which the participants will be exposed in the process of giving consent.

The IRB also requires that the principle investigator and faculty sponsor read The Belmont Report and take the Web training course for human subjects protection provided by the Office of Human Subjects Research, NIH. A copy of the “Completion Certificate for the IRB Members” training session must be attached to the Research Summary.

If the Principal Investigator is a student, the Application for Review must be signed by a faculty sponsor, and the name and contact information for the faculty sponsor should be included on the consent form.

The IRB Application, Research Summary, and supporting materials should be submitted to   https://www.formstack.com/forms/scrippscollege-irbnewproposalform
.

The Principal Investigator also can obtain the following documents from Amy Emmert, Scripps College:

  • Guidelines for Constructing Research Consent Forms;
  • Title 45, Part 46 of the Code of Federal Regulations;
  • The Belmont Report; and
  • the Section 3.17 of the Scripps College Faculty Handbook.