Ethical Principles Underlying Protection of Human Participants

The Department of Health, Education, and Welfare published the ethical principles upon which the regulations concerning human participants research is based in 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Participants Research (National Commission for the Protection of Human Participants of Biomedical and Behavioral Research, www.ed.gov/offices/OCFO/humansub.html) provides an analytical framework, through the basic principles of respect for persons, beneficence, and justice, that guides resolution of ethical problems arising from research involving human participants.

Respect for Persons: Individuals must be respected as autonomous beings capable of deliberation regarding their actions and consequences of those actions. In the context of human participants research clear and complete information regarding the research and clear indications that the participant enters the research voluntarily. Respect for persons also implies protecting individuals with diminished autonomy. The extent of protection depends upon the risk of harm and the likelihood of benefit.
Beneficence: Research on human participants must be conducted with forethought to the maximization of benefits and the reduction of risk that might accompany the research investigation. If risk to the participant is involved, the benefits should so far outweigh the risk in long-term benefit to society that the research warrants exposing persons to possible harm.
Justice: All individuals must be treated equally with regard to their selection as human research participants. Care should be taken to make sure that vulnerable populations (e.g. welfare patients, children, particular racial and ethnic minorities, or persons confined to institutions) are not singled out as human participants. Justice also demands that benefits arising from the research are distributed fairly and equitably among all participants.

The IRBPHP is responsible in providing assurance of compliance for human participant research that the above ethical principles are maintained. The IRBPHP must ensure risks to participants are minimized, risks to participants are reasonable in relation to anticipated benefits, and the selection of participants is equitable http://www2.ed.gov/policy/fund/reg/humansub/part97-2.html#97.119 (34 Part 97). Researcher should examine their projects in light of these principles prior to seeking IRBPHP approval.

Dominican University of California expects students and faculty conducting research using human participants to conform to basic ethical responsibilities as outlined by the Belmont Report. The task of the IRBPHP is to insure that the researcher and his/her project meet these responsibilities.

The scientific researcher at Dominican University of California must exhibit the following basic ethical responsibilities:

1. scientific competences;

2. open and honest behavior with participants and loyalty to all promises and commitments made to them;

3. concern about the welfare, dignity, privacy and self-determination (i.e., right to refuse) of research decisions;

4. sensitivity to issues of ethics and values;

5. responsible behaviors relative to his/her decisions, actions, and their effects;

6. concerns about the future uses of the knowledge gained in research and accepting personal responsibility for decisions bearing on them;

7. high standard of scientific objectivity and confidentiality;

8. honesty and accuracy in reporting results without omissions that would seriously affect interpretation;

9. commitment to developing a methodology to advance knowledge and truth and not simply support a predetermined position.

Note on Confidentiality:

All researchers should be aware that the confidentiality of information collected from participants cannot always be guaranteed. In most cases, information obtained in confidence as part of a research study has constitutional protection. However, while the likelihood of a request for disclosure is generally remote, disclosure of some information may be mandated by statute or ordered by the court.

A more detailed discussion under various headings of these basic responsibilities and their corollaries is meant to serve as a reference document for the scientific researcher and members of the IRBPHP. (These guidelines are based upon a study by E. Diener and R. Crandall, Ethics in Social and Behavioral Research, U. of Chicago, Chicago & London, 1978, and upon the codes of ethics of the American Psychological and the American Sociological Associations.)

4.1 Objectivity and Competence

Complete scientific objectivity is an ideal that cannot be realized in practice, but the researcher should strive to be as objective as possible in conducting research. Biases should never be deliberately introduced into the design or reporting of studies. Since poor research based on faulty methodology and design does not advance knowledge and wastes valuable resources, all researchers have a responsibility to do the best research of which they are capable. Results should be reported accurately and honestly, without omissions that would seriously affect their interpretation. Although values may influence the topic of research, the methodology should be designed to advance truth and not simply support a predetermined position.

4.2. Sensitivity and Responsibility

The ethical researcher is concerned about the well-being of research participants and about the future uses of the knowledge, and s/he accepts personal responsibility for decisions bearing on them. The basic ethical imperatives are that the researcher be concerned about the welfare of participants, be knowledgeable about issues of ethics and values, and consider these when making research decisions and actions.

4.3. Precautions to Safeguard Participants

It is the researcher's responsibility to protect participants from physical or mental discomfort, harm, or danger. In research exposing participants to possible discomfort, harm or danger, safety must be insured by stringent safeguards, including carefully selecting participants and checking afterward for harmful effects. The investigator has a positive obligation to correct any harm that does befall a participant.

4.4. Informed Consent

The informed consent process is at the heart of the ethical principal for the respect for human participants. Human participants must voluntarily consent to the participation in any research project and evidence of that consent is absolutely essential.

The process of obtaining informed consent must comply with the federal requirements of 45CFR46.116 and the California Health and Safety Code The documentation must comply with 45CFR46.117 of the federal guidelines and Section 24173(a) for the State requirements. For further information please refer to the following documents: http://www.hhs.gov/ohrp/policy/consentckls.html

If researchers are conducting experiments in states other than California they are expected to adhere to the laws of the state in which the research is being conducted as well as those of California.

Voluntary consent requires that the person has the legal capacity to give consent and be free to exercise choice without pressure or coercion. Information must be presented in such a way that an individual can clearly understand the nature of the research and any risk/benefits they may incur as a result of participation so that they can make a decision on whether or not they wish to participate. Researchers should not use scientific terminology in describing the research and it is best to use language at approximately the 8th grade reading level to make sure that most people are able to understand the document. If changes occur during the research period that will affect the risk to the human participant, revised consent forms must be presented immediately to the research participants.

The consent document must include the following; the purpose of the research, nature of the experiment, duration of the experiment, procedures to be used, risks, potential inconveniences and/or hazards, and benefits of the study, confidentiality of records, and the participant’s rights in participating in research, and the freedom to decline to participate without consequences. All consent forms MUST provide the name, institutional affiliation, and address of the person or persons actually performing and primarily responsible for the conduct of the experiment as well as the name, address, and phone number of the faculty advisor or another impartial third party, not associated with the experiment, to whom the participant may address complaints about the experiment. Questions about the research are usually best answered by the researcher but questions concerning rights as a research participant should be referred to the research supervisor, if the researcher is a student. The IRBPHP may also be listed as a contact for questions posed by the participant and as the contact for reporting the event of a research-related injury to the participant. (See Appendices F and G for sample forms)

It is important that research participants be informed that they can withdraw from the research project at any time without penalty and that participation in the research is entirely voluntary. An informed consent checklist that can be used to develop the consent document can be found at: http://www.hhs.gov/ohrp/policy/consentckls.html

The signed informed consent form must be provided as part of the documentation when seeking approval of the IRBPHP. A copy of the signed form must be given to the person signing the form (participant or participant’s legal representative).

4.4.1 Waiver of Signed Consent

The IRBPHP may waive the requirement for a signed consent form if the only record linking the participant and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality, or where there is a possible risk to the participant entailed in signing the consent form (e.g. for immigrants who might be identified as being undocumented), or in a retrospective records review or analysis of previously collected data where the participants need not be contacted as part of the study and appropriate precautions to protect confidentiality of the data are described, or that the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.

Informed consent forms are not needed for survey research. This research poses minimal risk to participants and a returned questionnaire is considered as evidence of implied consent.

In cases where the signed consent is waived, the IRBPHP requires the researcher to provide participants with a written statement regarding the research. (Modeled after Appendix I)

4.4.2 Proxy Consent for Participants Unable to Give Consent for Themselves

For studies involving participants who cannot give signed or verbal consent for themselves (children under the age of 18, cognitively or emotionally impaired persons, unconscious patients, etc.) the IRBPHP may waive the consent requirement as stated above and require consent from a legally authorized representative, relative or participant advocate. (See Appendix H for sample Proxy Consent Form.).

4.4.3 Consent Document Standard Format

The standard format for the Consent Form has been developed to satisfy federal and California State informed consent requirements and to encourage construction of a consent document that presents all necessary information to the prospective human participant in as clear and easily understandable a manner as possible.

Understandable Reading Level: It is recommended that the consent form be written at an eighth-grade reading level using everyday vocabulary and simple sentence structure.

Lay Language: Technical and/or scientific terminology should be replaced by lay language unless participants are themselves professionals.

Non-legalistic Language: Use common language to ensure clear comprehension by the participant.

Grammatical Person: Form should be written in the first person (e.g. “I have been asked to participate.”). If the participant is less than 18 years of age the third person should be used (e.g. “My child has been asked to participate.”)

See sample Informed Consent Form in Appendix G. Additional sample information and consent forms are found in Appendices H, I, J, K.

4.5. The Less Powerful

Special care must be taken to protect the rights and interest of the less powerful participants in research such as children, the poor, minorities, prisoners, and patients.

4.5.1 Children in Research

Special regulations outlined in 45 CFR 46, Subpart D apply when research involves participants who are children. Children are described as inherently more vulnerable than adults and are covered by the additional protections in the federal regulations. In California, individuals under the age of 18 years qualify as a “child” or “minor” and cannot consent to participation in research (except in cases of emancipated or self-sufficient minors).

When planning a study that will involve children, the IRB needs to consider four main issues (adapted from UCSF Office of Ethics and Compliance):

Rationale for inclusion: What unique outcomes will come from studying children?
Risks and benefits: What is the risk level of the study? What benefits and risks will come from studying children?
Study procedure versus standard procedure: How are study procedures different from standard procedures for participants (such as an educational intervention in a classroom environment)?
Consent and Assent: What are consent (permission) and assent requirements for the study?

4.5.2 Children’s Assent

Federal regulations include requirements for both parental permission (consent) and assent from children.

Assent is a child's affirmative agreement to participate in research. Assent should be obtained from children capable of providing assent, "[taking] into account the ages, maturity, and psychological state of the children involved” [45 CFR 46.408]. Mere failure to object should not, absent affirmative agreement, be construed as assent. The IRB relies on the expertise of the primary investigators to aid in determining the capability of a particular child or groups of children to assent. In general, out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research.

Assent Guidelines (adapted from UCSF Office of Ethics and Compliance):

Age of Minor Participant Assent Form Recommended Separate Parental Permission Form

Infant-6 years old No* Yes

7-12 years old Yes Yes

13-17 years old Yes Yes**

* The investigator may deem a child in this age range (Infant-6 years old) capable of being involved in the assent process. If so, give the child a simple verbal explanation of what will happen to him/her, and then document on the parental permission form or in the study records that you obtained verbal assent (See Appendix K).

**Adding a line to the adolescent assent form for parent(s) to sign is an acceptable option.

4.5.3 Waiver of Children’s Assent

Assent may be unnecessary in certain circumstances. The IRB can consider waiving the requirement to obtain children’s assent, for example:

“The capability of some or all of the children is so limited that they cannot reasonably be consulted;” or
“The research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research” [45 CFR 46.408 21 CFR 50.55].
The parents’ right to make decisions for their child may come into conflict with the child’s right to give or withhold assent. In this situation, assent may not be mandatory, though it always should be sought.

In such cases, the PI may propose a waiver of child’s assent in the IRB application. The IRB’s decision about waiver of assent will depend on the specifics of the study.

Additional Parental Consent and Child Assent Guidelines (according to UCSF Office of Ethics and Compliance):

If the child is considered capable of providing assent, always provide a simple verbal explanation of what will happen to him/her and the opportunity for questions and discussion.
Even if the requirement for assent is waived, it is always preferable to seek the child’s assent, if possible.
Document on the parental permission form or in the study records that the child was appropriately informed about the study.

4.6. Privacy

Information about participants may be collected only with their consent. All research information on individuals should be strictly confidential and published only in summary form unless participants agree that they may be named in the report.

4.7. Deception

Research deceptions should never be practiced until an ethical analysis of the situation has been made. Are there other ways to obtain the knowledge? What will be the negative effects of the deception? Can safeguards such as forewarning and debriefing be used? Deceptions vary from mild to blatant, and though many mild deceptions may be justifiable, large deceptions often are not. In addition to the ethical questions, deception research often suffers from methodological problems.

4.8 Review By Others

If the investigator is unsure about the ethics of her/his research, s/he should seek the opinions of others, in this case especially the Institutional Review Board for the Protection of Human Participants. If participants are to be exposed to risks or if the research raises serious value questions, it is wise to solicit the opinions of several reviewers. Disinterested persons may have a sounder ethical perspective than the scientist who is deeply involved with the research. It is often important to gain input from participants as well as from professional colleagues.

4.9 Experiments In Change

The goal of research is to change individuals or a group, those who are the target of change should be consulted and their wishes and needs respected. Usually the target group can be involved in setting the goals of the change intervention. When various treatment groups are used in formal experiments, the researcher should carefully consider whether the various experimental manipulations are ethical. A group should not be placed at a serious disadvantage unless participants have accepted this possibility or resources are sufficient to offer the most desirable treatment to all persons.

4.10 Uses of Research Knowledge

The researcher should examine the possible applications of scientific findings and endeavor to make these uses constructive. Before conducting a study the researcher must consider how the information will affect the people being studied.

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