As researchers, we are bound by rules of ethics. For example, we usually cannot collect data from minors without parental or guardian permission. All subjects must give their permission to be part of a study and they must be given pertinent information to make an "informed" consent to participate. Researchers must obtain a subject's (and parents' if the subject is a minor) permission before interacting with the subject or if the subject is the focus of the study. Subjects have the right to refuse to participate without penalty if they wish. Each university that receives federal funds (and most do) must have an Institutional Review Board (IRB) that reviews all research conducted at the university. Therefore, anyone doing research associated with the university must file a IRB-1 prior to beginning research. Even if the research is except from a full review by the IRB, an Exemption Form must be filed and approved by the Department chair and submitted to the IRB. 

 Researchers are bound by a code of ethics that includes the following protections for subjects

1. Protected from physical or psychological harm (including loss of dignity, loss of autonomy, and loss of self-esteem)
2. Protection of privacy and confidentiality
3. Protection against unjustifiable deception
4. The subject must give voluntary informed consent to participate in research. Guardians must give consent for minors to participate. In addition to guardian consent, minors over age 7 must also give their consent to participate.

NOTE: Voluntary informed consent means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over reaching, or other ulterior form of constraints or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable her to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmation decision by the experimental subject there should be made known to her the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon her health or person which may possibly come from her participation in the experiments.

The consent form subject sign should cover the following main points:

1. It should tell the participants what they are being asked to do, by whom, and for what purpose. Participants must know the identity of the researcher, his or her affiliations if any, and whom to contact for information if they have problems with the research process. This not only includes contact information for the researcher, but also contact information for the university IRB.
2. It should inform the participants of any risks they might be taking by participating in the research.
3. It should inform the participants what rights they have in the process, particularly the right of review of material and the right to withdraw from the process.
4. It should indicate whether or not participants' names will be used in the study, whether any other names will be used, or whether pseudonyms will be substituted.
5. It should indicate how the results of the study will be disseminated and whether participants can expect to benefit in any way, monetarily or otherwise, from participating in the study.
6. It should indicate that participants are free to participate or not participate in the research without prejudice to them.
7. In the case of children, it must be signed by the child's legal guardian. Children cannot be expected to give total informed consent.
8. The consent form should be written in the second person (e.g., "You have the right to ...")

THE UNIVERSITY OF CONNECTICUT gives assurance that it will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects and has set up an Institutional Review Board to review all research associated with the University. Researchers (including student researchers) are required to file a IRB-1 prior to conducting research. Certain types of studies quality for exempt or expedited review. Research involving minors almost NEVER qualifies for exempt status. Even if a study qualifies for exempt status, the researcher must still file a IRB-1 with the Department Head and submit it to the IRB.

Human subjects forms are available on the web from the Office of Sponsored Programs at the University of Connecticut.

Note: If a research project extends beyond one year, the project must be reviewed each year by the institutional review board.

Informed consent must also be given for interviews.

Informed consent can be giving verbally, provided there is a witness.

Studies involving minors rarely quality for exempt filing

The following criteria are often considered by Institutional Review Boards for the Protection of Human Subjects:

1. Are risks greater than "minimal risk"*?
2. Are risks minimized?
3. Are risks reasonable in relation to the benefits?
4. Is subject selection equitable (e.g., subject population included or excluded; risk of coercion in recruitment, etc.)
5. Is the process for obtaining consent appropriate?
6. Is informed consent appropriately documented?
7. Is there adequate provision for monitoring the data collection to insure safety of the subjects?
8. Are the provisions for protecting privacy adequate?
9. Are the provisions for maintaining confidentiality adequate?
10. Have additional safeguards for subjects vulnerable to coercion or undue influence been included?
11. Is "annual" continuing review sufficient?
12. Do the research staff/investigators have appropriate expertise to perform their responsibilities in the study?

*"minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the research are no greater in and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.

I have included six mini case studies to test your knowledge about IRB issues.

Heightened Awareness of Problems with Unethical Research
In 1966 Dr. Henry Beecher, an anesthesiologist, wrote an article for the June 16, 1966 New England Journal of Medicine called "Ethics and Clinical Research". In it he described 22 examples of research studies with controversial ethics that had been conducted by reputable researchers and published in major journals. He noted that "unethical or questionable ethical procedures are not uncommon." Beecher's article played an important role in heightening the awareness of researchers, the public, and the press to the problem of unethical human subjects research.

Establishment of the National Research Act
The publicizing of the Public Health Service Syphilis Study at Tuskeegee (1932-1971) led to the establishment of the National Research Act of 1974 which created a national commission that ultimately issued the The Belmont Report (1979). The Belmont Report outlined three basic ethical principles.The TUSKEGEE SYPHILIS STUDY involved 399 African-American men with latent syphilis who were not told by researchers there was a cure for the disease.  This was done so the researchers could study the long-term effects of the disease. The Tuskegee syphilis study, coupled with abused reported in the NUREMBERG TRIALS indicated that researchers and research they conduct needed to be monitored.

Three Basic Ethical Principles Outlined in the Belmont Report

Respect for Persons (Treat individuals as autonomous human beings, capable of making their own decisions and choices, and do not use people as a means to an end)
Three Requirement Based on Respect for Persons

- obtain and document informed consent
- respect the privacy interests of research subjects
- consider additional protection when conducting research on individuals with limited autonomy

Beneficence (Minimize the risks of harm and maximize the potential benefits)
Five Requirements Based on Beneficence

- use procedures that present the least risk to subjects consistent with answering the scientific question
- gather data from procedures or activities that are already being performed for non-research reasons
- risks to subjects should be reasonable in relation to both the potential benefits to the subjects and the importance of the knowledge expected to result
- maintain promises of confidentiality
- monitor the data to ensure the safety of subjects

Justice (treat people fairly and design research so that its burdens and benefits are shared equitably)
Two Requirements Based on Justice

- select subjects equitably
- avoid exploitation of vulnerable populations or populations of convenience

Rationale for an Institutional Review Board (IRB)
The ethical principles and federal regulation generated by the Belmont Report provide a framework for IRBs to evaluate research involving human subjects. An objective review of research is necessary because

1. highly motivated people tend to focus on their goals and may unintentionally overlook other implications or aspects of their work and
2. no one can be totally objective about his or her work.

The IRB review system is designed to provide an independent, objective review of research involving human subjects so that the privilege of conducting human subjects research may be maintained.

Only activities that meet the definition of research with human subjects need review by an Institutuional Review Board (IRB).

Research is a

• systematic investigation (this might range from applying scientific methodology involving independent and dependent variables to an ethnographic study of a community)
• including research development, testing, and evaluation (this also includes pilot studies, feasibility studies, and other preliminary studies)
• designed to develop or contribute to generalizable knowledge (An essential consideration is whether it is the intention of the investigator to contribue to generalizable knowledge.

Some activities that involve interactions with humans and data gathering many not fit the definition of research with human subjects, since they are designed to accomplish somethign else, such as in-house quality improvement. For example, a survey of college students about their university's counseling services may be designed to improve the service delivery for students on campus. Publication of the results is sometimes used as a measure of whether research is generalizable, but this is too narrow a measure for two reasons. First, not every study will produce results worthy of publication. Second, there are other ways that results can be made available to others. They may be presented at a conference. They may be shared with colleagues through the Internet, appear in a dissertation, provided to Board members in a project report, or archived for future research).

A human subject is a
"living individual about whom an investigator (whether professional or student) conducting research obtains:

1. Data through intervention or interaction (does not need to be face-to-face, could be via email or a participant observation) with the individual or
   
2. Identifiable private information" (a) information about behaviors that occur in a context where the individual can reasonably expect that no observations or recording is taking place or b) information that is provided for a specific purpose and for which the individual can reasonably expect will not be made public).

Once the IRB approves a protocols, it must be reviewed at least annually (every 12 months), although IRBs may specify a shorter review period. Amendments and changes to approved protocols must be approved prior to their implementation. An exception could occur if a revision to approved procedures was in response to an unanticipated risk and had to be implemented immediately for the health or well-being of the subjects. Such revisions must be reported promptly to the IRB, not when the research in completed.

The federal regulations governing research with human subjects, which have been adopted by numerous federal departments and agencies, are often referred to as the Common Rule. They were first written by the Department of Health and Human Services (DHHS). The DHHS regulations are often referred to as 45 CFR 46. Pregnant women, fetuses, neonates, children, and prisoners are considered vulnerable populations and are provided additional protection in the DHHS regulations. The DHHS regulations do not have specific additional protections for the elderly, for mentally disabled persons, or for persons whose decision-making capabilities are impaired. Investigators may consider and the IRB may require additional safeguards for these populations. The Common Rule does not include requirements for formatting protocols for IRB review. Formatting requirements are institution specific. Most institutions decide to apply the Common Rule to all research with human subjects, regardless of the funding source.

Research is eligible for expedited review when it poses no more than minimal risk (minimal risk means that "the probability and magnitude of harm or discomfort anticipated in the research are not greater…than those ordinarily encountered in daily life…") to the participants and when all the activities fall within the categories identified as eligible.

Research is only eligible for exemption if all the activity associated with the research fall into one of six categories of activities described in federal regulations. Three of these are frequently used by social and behavioral scientists:

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices
2. Research involving survey procedures, interview procedures, or observations of public behavior providing that any disclosure of identifiable information outside the research setting would not place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation (Note: By institution choice, interviews with children and participant observation with children may not be exempt).
3. Research involving the collection or study of existing data (collected prior to the research for purposes other than the research) if the data is publicly available or recorded by the investigator in such a manner that the subjects cannot be identified.

The regulations do allow some research with children to be exempt (although institutional policy may not). The duration of the study and the experience of the investigator are not criteria for determining eligibility for exemption.

IRBs must either have sufficient expertise among their members or seek expertise through consultation if the members are not familiar with a methodology or population under consideration. They must have the expertise and professional competence to evaluate research activities commonly conducted by their institution. The primary purpose of the IRB is to protect the rights and welfare of research subjects. An IRB must exercise all of its authorities in order to do so, including monitoring research when appropriate. Although IRBs serve their institutions, they do not represent the interests of their institutions. According to federal regulations, institutional officials may not override an IRB disapproval of a protocol.

While physical risks are minimal in social and behavioral science research, risks associated with participation in social and behavioral science research are often more elusive and less predictable. Every interaction in a research context is a communication of some sort, and communications can go awry. For example, notification by mail to set up a follow-up appointment for a participant in a research study may result in an inadvertent breach of confidentiality.

Risks in social and behavioral sciences generally fall into three categories (in rare circumstances the risk may be physical such as a study of victims of domestic violence who may become the victims of retaliatory violence):

• Invasion of Privacy - This can occur if personal information is accessed or collected without the subjects' knowledge or consent. The subjects' participation may be revealed without their knowledge (e.g., e-mail communications with a subject about recovering from sexual assault might be read by family members).
• Breach of Confidentiality -- The primary source of risk in the social and behavioral sciences is that information obtained by researchers could harm subjects if disclosed outside the research setting. This could include unintended disclosure of subject's HIV status resulting in loss of health insurance coverage; revelation of sexual preferences that results in discrimination; disclosure of employee attitudes about their employer resulting in job lose; revealing information about illegal activities or status (drug use or immigrant status) resulting in legal consequences.
• Study Procedures -- In some cases, simply participating in the research can cause social or psychological harm. Subjects who experienced abuse as children may experience emotional or psychological distress by participating in a study.

When assessing risk associated with participation in a research study, there are two distinct elements of risk that need to be considered.

• The Probability of Harm -- The likelihood that a specific harm might occur
  
• The Magnitude of Such Harm

Risks in research participation are specific to time, situation, and culture. Thus, what may be a socially sensitive issue or topic at one time or place may not be so at another time or place. Risks in social and behavioral science research are mostly culturally determined. For example, asking women if they have had abortions would carry very different risk in cultures where abortion is a routine medical practice, a country where it is illegal, and a country where it is legal but fraught with religious and political controversy. Risks will differ according to the subject population. A survey about sexually transmitted disease would carry different risks for middle class suburban men, Catholic clergy, and gang members (who in one study claimed to have STD's when they did not). The risk of emotional distress cannot be managed by anonymizing data, but rather by developing a plan to respond to the distress should it occur.

Risks and Benefits -- Researchers tend to underestimate risks involved in activities with which they are familiar and to overestimate the benefits of things that are important to them. Thus, an independent assessment of risk is critical. One function of Institutional Review Boards is to provide this independent assessment. When potential outcomes are severe, people tend to over estimate their probability, regardless of the true probability. And when potential outcomes are less severe, such as embarrassment, people tend to underestimate their probability. Federal regulations, based on the ethical principle of beneficence, require that risks associated with research be reasonable in relation to the anticipated benefits. A great deal of research in the social and behavioral sciences offers little potential for direct benefits to the subjects themselves. The benefits of the research often lie in the importance of the knowledge to be gained. Most research in the social and behavioral sciences poses little or no risk to the subject.

A Certificate of Confidentiality protects sensitive information provided by research subjects from civil, criminal, or administrative subpoena. This protects identifyable research information from forced disclosure. The Certificates are issued by the National Institute of Health (NIH) and may be secured for any research (even non-NIH research), regardless of the source of funding or even for un-funded research. Certificates of Confidentiality may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. Substance abuse or other illegal behaviors; sexual attitudes, preferences, or practices; genetic information; and psychological well-being are kinds of information that can be protected.

If the only identifier collected in the course of a study would be the signature on the consent document and the principal source of harm would be a breach of confidentiality, a waiver of documentation of informed consent should be sought. A waiver of documentation of informed consent is helpful when the consent form is the only document that links the subject to the study.

Note: Some of the material provided here was adapted from material available in CITI (Course in The Protection of Human Research Subjects)

Del Siegle, Ph.D.
Neag School of Education - University of Connecticut
del.siegle@uconn.edu
www.delsiegle.info