200 WORD RESPONSE

CHAPTER 4 ETHICS AND THE INSTITUTIONAL REVIEW BOARD (IRB) PROCESS

Chapter highlights

The need for ethical review: IRBs; purpose and history of ethical oversight

Nuts and bolts of IRBs: Revised Common Rule including definitions; IRB duties, membership, and types of reviews

Deception and its role in IRB review

Components of IRB proposal (especially, informed consent)

Research with children

The ethics of participant pool use and alternatives to participation

Incentives in research

IRB training modules: CITI and alternatives

OVERVIEW

When thinking about research, one question that arises fairly early is whether there are rules or regulations that govern what you can and cannot study and how you can study it. The answer is “yes.” Regulations, starting at the federal level, have been developed to protect people who participate in research (and animals used in research), the researchers themselves, and the institutions they represent. There are also specific definitions of what constitutes research and what a human subject is. Research is essentially a systematic investigation designed to contribute to generalizable knowledge. A human subject is a living individual from whom the researcher gathers information or biospecimens through interaction or intervention or about whom the researcher has access to identifiable private information or identifiable biospecimens. A biospecimen from humans is material such as blood, tissue, urine, cells, or protein. These definitions of research and human subjects come from the federal regulations known as the revised Common Rule (45 CFR Subpart A 46.102[l] and [e][1], respectively), which is discussed in more detail later in the chapter. Not every study rises to the level of research (e.g., a study on food preferences in a single residence hall might not be designed to contribute to generalizable knowledge), but the ethical treatment of people who participate in studies is an important aspect, whether or not the study is technically “research.”

After a lengthy review process that generated over 2,000 public comments in response to the proposed rule changes, the Common Rule has been substantially revised. The essential components of Subpart A of the revised Common Rule (also called the 2018 Requirements and the 2018 Rule), which went into effect on January 21, 2019, are presented in this chapter. Additional subparts (B–D) dealing with subjects in the revised Common Rule include Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research; Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects; and Subpart D: Additional Protections for Children Involved as Subjects in Research. While this chapter focuses on the material in Subpart A, additional information regarding the protections for children involved in research will also be highlighted.

Research: With respect to the federal definition (45 CFR 46), research involves a systematic collection of data with the goal of generalizable knowledge.

Human subject: A human subject is a living individual from whom the researcher gathers information or biospecimens through interaction or intervention or about whom the researcher has access to identifiable private information or identifiable biospecimens.

Revised Common Rule: Set of federal regulations that govern research with human subjects (also called the 2018 Requirements and the 2018 Rule).

Deception: In research, when participants are not fully informed of the purposes and/or procedures; receives close attention in institutional review board (IRB) review.

Many students have heard of Stanley Milgram’s (1963) research on obedience to authority, either in class or through the 2015 movie about the research (i.e., The Experimenter). In the research, participants are deceived, believing they are giving potentially lethal shocks to unseen “learners,” who are performing a word association task and are shocked for their incorrect answers. In fact, these learners are confederates, or collaborators of the experimenter, and no such shocks are being administered. Conducted after World War II, the Nazi war crimes were a clear motivation for Milgram’s studies; he mentioned them in the introduction to his paper about this research, published in 1963. Milgram questioned the extent to which ordinary people would potentially inflict harm on others when instructed to do so by someone in authority, in this case, an “experimenter.”

Milgram’s (1963) research raised a host of questions, many of them about deception and the extent to which we can ethically mislead people in research. The point of the research was determining the extent to which people follow authority, but concerns were raised about the immediate and long-term effects on the participants, who believed they were inflicting potentially harmful levels of shock. Institutions are sensitive to such issues and have established boards that evaluate the ethical issues raised by research. In considering ethical aspects of research, this chapter will explain why these boards exist and how they work.

This chapter will explain why we have ethical review boards (typically called institutional review boards or IRBs) and how to prepare a research proposal to undergo IRB review. Institutions that conduct research with humans and/or animals and receive federal funding to conduct or support that research are required to have IRBs and must comply with the revised Common Rule to determine that ethical guidelines are being followed. There are separate boards for humans and animals (i.e., infrahuman species). This chapter will concentrate on research with humans. Institutions where there is research on animals have a separate review committee for that research, often called the Institutional Animal Care and Use Committee (IACUC). Whether or not federal funding is involved, most institutions have IRBs for evaluating research with human subjects and/or with animals. Evaluating the ethical parameters of research protects all parties involved. In addition, if research is submitted for publication, most journals require certification that the research has undergone IRB review or its equivalent.

Try This Now 4.1

Have you ever been deceived by someone you trusted? What were your reactions? Ask your instructors about their experiences in research involving deception and their immediate and longer-term reactions.

Institutional Animal Care and Use Committee (IACUC): institutional committee that reviews research with animals and their care.

The parameters of the research (most importantly the kinds of participants and the degree of risk involved in the research) determine the level of review required. The level of review makes a practical difference for the researcher. Meetings for the highest level of review require all IRB committee members, and those meetings are held infrequently. By learning about the different levels of review, you will be able to gauge how long the review of your proposal is likely to take.

Materials included in appendices at the end of this book explain the information needed to submit a proposal for IRB review (Appendix B); Appendices C (Informed Consent) and D (Debriefing) provide you with sample documents that are required parts of research. Informed consent explains the nature of the research and states participants’ rights. By doing so, participants can make fully informed decisions about whether to participate. A debriefing or explanation of research document provided at the end of the study explains the specific hypotheses and aims of the study in more detail. If the study involves deception, the debriefing explains why that was necessary. Often, institutions provide templates for informed consent and debriefing documents on an institutional website along with other information about the IRB (e.g., committee meeting dates, timelines for review, and application materials).

Informed consent: Document given to potential research participants that outlines the nature of the research; participants must agree and sign or otherwise provide evidence of consent in order to take part in research.

Debriefing: Document given to participants at the conclusion of a research project that explains the hypotheses and rationale for the study.

WHAT IS THE IRB, AND WHY DOES IT EXIST?

Human subjects IRBs are charged with protecting the welfare of individuals who participate in research. An IRB has jurisdiction over the research proposed by any member of that institution.

Regulations to protect human subjects in research emerged in the mid-20th century (Frankl, cited in J. G. L. Williams & Ouren, 1976). Since 1950, several pieces of legislation have targeted protecting the welfare of human subjects (e.g., the National Research Act in 1974) and established commissions to monitor research. One important commission is the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Office for Protection from Research Risks [OPRR], 1993). Among other duties, this commission was charged with determining the risk–benefit criteria to evaluate research with human subjects (National Research Act, 1974, Section 202. B.2).