ORI Introduction to RCR: Chapter 3. The Protection of Human Subjects

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Federally funded research that uses human subjects must be reviewed and approved by an independent committee called an Institutional Review Board or IRB. The IRB provides an opportunity and place for individuals with different backgrounds to discuss and make judgments about the acceptability of projects, based on criteria set out in the Common Rule.
Under the Common Rule, IRBs must have at least five members and include at least one scientist, one non-scientist, and “one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution”(§ 46.107(d)). IRBs have authority to approve, require modification of (in order to secure approval), and disapprove all research activities covered by the Common Rule. They also are responsible for conducting continuing review of research at least once per year and for ensuring that proposed changes in approved research are not initiated without IRB review and approval, except when necessary to eliminate apparent immediate hazards to the subject.
IRBs weigh many factors before approving proposals. Their main concern is to determine whether (§ 46.111(a)):
  • risks to subjects are minimized;
  • risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result;
  • selection of subjects is equitable;
  • informed consent will be sought from each prospective subject or the subject’s legally authorized representative;
  • informed consent will be appropriately documented;
  • when appropriate, the research plan makes adequateprovision for monitoring the data collected to ensure the safety of subjects; and
  • when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
Researchers should consider each of these issues before completing their research plan and submitting it to an IRB for approval.
Making decisions about whether human subjects will be treated fairly and appropriately or given adequate information requires judgments about right and wrong (moral judgments). In the 1979 Belmont Report, the National Commission recommended three principles for making these judgments:
  • respect for persons and their right to make decisions for and about themselves without undue influence or coercion from someone else (the researcher in most cases);
  • beneficence or the obligation to maximize benefits and reduce risks to the subject; and
  • justice or the obligation to distribute benefits and risks equally without prejudice to particular individuals or groups, such as the mentally disadvantaged or members of a particular race or gender.
While this list does not exhaust the principles that can be used for judging the ethics of human subjects research, it has nonetheless been accepted as a common standard for most IRB deliberations. Knowing this, researchers should spend time considering whether their work does provide adequate respect for persons, appropriately balances risks and benefits, and is just.

Belmont Report


Source URL: https://ori.hhs.gov/content/chapter-3-The-Protection-of-Human-Subjects-IRBs