In this module, you will explore the following aspects of using human subjects in research:
The module consists of:
Click on the image below to read the case study.
The last century witnessed multiple cases of the unethical treatment of human subjects in research studies. These and other cases dramatized the need for a system to protect the rights and welfare of humans subjects in research.
The Nuremberg Code was developed after World War II in response to Nazi atrocities. Building on these principles, the World Medical Association adopted the Declaration of Helsinki in 1964 to further protect human subjects in biomedical research.
Public outrage over the Tuskegee Syphilis Study prompted Congress to pass the National Research Act in 1974. This initiated a set of federal regulations to protect human subjects in research. These regulations have been revised and amended several times.
Other famous cases involving the unethical treatment of human subjects in research projects in the United States, include the following:
The current Federal Policy (Common Rule) for the Protection of Human Subjects has been codified by 17 government departments and agencies.
Some departments and agencies have additional regulations governing research involving special populations or specific issues over which they have jurisdiction. For instance, the Department of Health and Human Services has regulations governing the use of prisoners and children in research.
The regulations require institutions accepting federal funds for research involving human subjects to institutionalize mechanisms for protecting subjects from harm.
The administrative body in each institution for ensuring the protection of human research subjects is the Institutional Review Board (IRB). The IRB’s mission is to protect the rights and welfare of human subjects who participate in research studies.
IRBs have the authority to:
Federal regulations stipulate that an IRB must consist of at least five properly qualified, but otherwise diverse, members of whom at least one must be:
In 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued the Belmont Report. The Belmont Report was important primarily because it linked desired ethical standards and practices, and existing concerns about them to fundamental ethical principles.
The report identified three fundamental ethical principles for the protection of human subjects in research:
Respect for persons recognizes the personal dignity and autonomy of individuals, and requires special protection of those with diminished autonomy (vulnerable populations), such as:
Respect for persons requires these practices:
Beneficence obliges researchers to protect persons from harm by maximizing the research’s anticipated benefits and minimizing its possible risks. Beneficence requires:
Justice necessitates that the benefits and burdens of research be distributed fairly and equitably. It requires these practices:
The Belmont Report raises the following key issues in research involving human subjects:
Another key issue is:
The IRB reviews risks that are reasonably foreseeable, even if unlikely, and determines if there are safeguards in place against them.
Participation in a research study must be purely voluntary. Subjects should agree to participate without the researcher (or others) exerting any undue influence or coercion on them.
Subject selection criteria must avoid discriminating against classes of humans (e.g., sex, age, or ethnicity) except as required for scientific reasons.
Recruitment methods must not violate individuals’ privacy. For example, when using a snowball sampling technique, a researcher should provide individuals she contacts with information about the study for them to forward to other people instead of individuals giving the researcher names of and contact information for other people without the latter's permission.
The IRB must review and propose any proposed recruitment materials for a study before they are used.
Incentives for participation must not create undue influence, such as assignment of grades or comparatively large sums of money. If incentives are extended to some members of a group, these must not disadvantage other, non-selected members.
If a researcher is also the instructor of a course from where students will be recruited, the researcher needs to assure that students understand that the research opportunity is not a class assignment, and that refusal to participate will not impact their participation in the class nor their grade or class standing. In such cases, individuals (e.g., a graduate assistant, another faculty member) other than researcher should present research opportunities to students in courses that they teach to avoid undue influence.
If students receive extra credit in a course for participation in a research study, the instructor must also offer equivalent, non-research extra credit options.
At UNH, each study available through the psychology department subject pool has an alternative non-research assignment for students to earn equivalent subject pool credit without participating in the study.
If a researcher proposes to use a raffle as an incentive, the researcher needs to provide to the IRB in the application materials information about the raffle, including the prizes, how subjects will enter the raffle, how raffle contact information will stored in relation to subjects’ responses, when the raffle will be drawn in the timeframe of the study, and what will happen to raffle entry information at the end of the study.
Informed consent is a process of information exchange between a subject and researcher throughout the study. Informed consent should be an ongoing process, not simply the one-time reading and signing of a form. The consent form is merely a tool to assist the researcher and inform the subject.
Only legally competent adults may give consent. Provisions must be made for soliciting assent from children or adults who are not legally competent AFTER obtaining consent from the individual's legal representative (parent or guardian).
All subjects must give consent voluntarily to participate in a study. Potential subjects must be given sufficient information to make informed choices about either beginning or continuing participation in a study. In order for consent to be fully informed, the subject must:
Usually, consent is given by signing a consent form indicating understanding of the:
By signing a consent form, subjects do not give up any legal rights.
Oral consent may be appropriate for some types of research (e.g., a telephone interview).
Further, the IRB may waive the requirement for subjects to sign consent forms (called a waiver of documentation of consent) in various types of studies, such as:
In survey research, providing consent information in the form of the cover letter is generally adequate. In Web-based research, the researcher should provide consent information on the study website prior to the first screen of study activities/questions.
Where the IRB has waived documentation of consent for interviews, researchers should record in their field notes provision of consent information to each subject and the confirmation of each subject to participate in the study. This is because a researcher will not have signed consent forms as evidence of the provision of consent information and confirmation of a subject's decision to participate.
Subjects must be able to withdraw from a study at any time. If subjects need to complete certain study activities in order to receive compensation or receive an incentive (e.g., enter a raffle), criteria for receiving the compensation/incentive need to be explained clearly in the consent document.
For example, a researcher is offering $15.00 per interview for completion of each of three interviews. If a subject completes only two interviews and then withdraws from the study, she will receive $30.00 for the completion of the two interviews; the penalty for withdrawal should be explained as being paid $15.00 only for completion of each interview.
Deception is the withholding of information about a study from subjects. It is often used where the provision of that information about the study to subjects could alter their behavior. Any deception must be justified by scientific necessity and benefit, and is assumed to be necessary only rarely. Where deception is allowed, subjects must be thoroughly debriefed after the intervention.
Providing subjects with debriefing information is also appropriate in Web-based surveys and in some other types of studies, such as those involving interviews. Often, researchers can also provide referral resources in debriefing information for subjects to consult in the event that participation in a study raises issues for them.
Vulnerable populations are those who may not be capable of self-determination, due to age, illness, or circumstances restricting liberty. Examples of vulnerable populations are:
Researchers planning to involve children/minors as subjects in a research study need to take into account special considerations. The UNH IRB has developed Guidelines for Research Involving Children/Minors.
Studies involving prisoners raise special issues and are subject to additional safeguards. All research at UNH involving prisoners must be reviewed by the IRB at a convened meeting (i.e., requires Full Board review). In addition, an IRB member or consultant who is a prisoner advocate must be present at the review.
Involvement in studies of individuals with diminished capacity to consent, whether through mental illness or developmental disability, requires additional protections (e.g., consent of legal guardians). All research involving these individuals must be reviewed by the IRB at convened meeting (i.e., requires Full Board review).
Privacy is an individual’s control over the extent, timing, and circumstances of sharing him/herself (physically, behaviorally, or intellectually) with others (Amdur & Bankert, 2001). Researchers must respect subjects’ privacy. Researchers must safeguard subjects' privacy during recruitment for the study and during data collection. Data must be stored securely and in a form that prevents, where possible, the identification of individuals.
Confidentiality is the treatment of information disclosed in a trust relationship and with the expectation that it will not be divulged to others in ways inconsistent with the understanding of the original disclosure without permission (Amdur & Bankert, 2001).
Confidentiality is an agreement between parties made via the consent process. Researchers must keep subjects' contributions to the research confidential unless subjects have agreed otherwise (preferrably in writing). Researchers, however, cannot guarantee absolute/complete confidentiality and must inform subjects of this. For example, in the case of a complaint, the IRB may have to review data. Further, researchers have to comply with applicable mandatory reporting laws (see IRB guidance, Information Indivdiuals in New Hampshire are Legally Required to Report), court orders, or other legal actions. Finally, transmission of information via the internet presents a risk of breach of confidentaility. This may be minimized by encrypting transmission of data.
Privacy pertains to individuals whereas confidentiality pertains to data; privacy is a right that can be violated whereas confidentiality is an agreement that can be broken.
Data should be stored securely and accessed only by those individuals identified in the IRB application. Researchers should not store data on portable memory devices (e.g., thumb drives/memory sticks) as such media are not secure and are easily lost. The IRB strongly encourages researchers to store data on UNH Box; alternatively, researchers should store data on password-protected computers that are regularly backed-up, and when necessary, transported via portable memory devices from which they should be erased.
The IRB encourages researchers not to destroy data at the end of a study, but rather to deidentify them and store them securely. Researchers need to comply with the UNH policy on Ownership, Management, and Sharing of Research Data vis-à-vis the retention of research data.
Data must be stored securely and when possible in a form that prevents identification of individuals.
Anonymity means that no identifiers can link the information/records/samples to the individual from whom they were obtained. The presence of a list of codes and associated identifiers (e.g., names) means that data are NOT anonymous. Further, when collecting data via Web-based survey software, the IRB considers computer IP addresses identifiers.
When reporting data from small, bounded populations, researchers need to be careful that demographic information does not lead to the identification of unique individuals. One way to minimize this risk is to not report on variables with less than ten responses with demographics.
Although subjects’ contributions to the research, in general, must be kept confidential, researchers should not guarantee absolute confidentiality to subjects. In the consent document, researchers should inform subjects of any exceptions to confidentiality, such as:
Further, in consent documents researchers should inform subjects that, in rare instances (e.g., during an investigation of a complaint), information from the study may be shared with:
While subjects’ identities, in general, must be kept confidential, subjects also should be informed that researchers will report this information in certain situations required by law (e.g., child abuse, threatened violence against self or others).
Researchers may want to consider applying for a federal Certificate of Confidentiality to protect them from forced disclosure (e.g., under subpoena) of private identifiable information of subjects collected as a part of a study.
More information about best practices for researchers regarding privacy and confidentiality is available from the UNH IRB.
An institution commits to oversee and perform human subjects research according to federal regulations and the ethical principles identified in the Belmont Report via a Federalwide Assurance (FWA). The FWA is a legal contract that defines the role and responsibilities of the institution, its IRB, and its researchers.
At UNH, the IRB has five functions:
At UNH, research involving human subjects requires prior review by the IRB and receipt of written, unconditional approval from the IRB, regardless of discipline or whether the project is funded. Projects conducted as part of coursework that are not disseminated beyond the classroom are not considered research.
Federal regulations define research and human subjects as follows:
Using this definition of human subjects, all research activities involving the prospective collection of information about individuals via intervention/interaction are considered using human subjects and thus require UNH IRB approval before commencing.
When studies involve the use of secondary/existing data (data/information that exist(s) at the time the research project begins [e.g., previously collected survey data, school records, medical records]), UNH IRB approval is NOT needed to use such data for research purposes if the secondary/existing data do not contain private information.
Some common examples of secondary/existing data that are not considered private information include, but are not limited to:
Researchers should be aware that not all information on the Internet is considered publicly available and not all datasets that are characterized as anonymous actually are. Examples include, but are not limited to:
As the UNH IRB does not give post-hoc approval, researchers must be certain that the secondary/existing data do not contain private information before use.
Further, some journals require proof of IRB approval for research projects that the UNH IRB may not consider to involve human subjects (e.g., use of anonymous datasets). Researchers should check journal requirements before conducting the project and contact the IRB with any questions.
Use of human subjects in research without IRB approval is a violation of UNH policy. Appropriate sanctions are administered by the Institutional Official (Senior Vice Provost for Research).
Federal regulations define levels of IRB review and the categories of research they encompass. At UNH, the IRB uses three levels of review:
At UNH, the IRB, not the researcher, decides which review level the research must undergo.
At UNH, “Exempt” does not mean exempt from IRB review and approval.
Full Board review is required for studies involving special populations and/or presenting greater than minimal risk, such as those involving:
To approve the use of human subjects in a study, federal regulations require the IRB to determine that eight criteria are met. Researchers must:
At UNH, ongoing IRB approval carries the following five conditions:
At UNH, ongoing IRB approval carries the following five conditions (cont.):
Researchers conducting studies involving human subjects have, but are not limited to, ten primary responsibilities. They must:
Researchers conducting studies involving human subjects have, but are not limited to, ten primary responsibilities (cont.):
1. The graduate student does not need permission from the principal as the supervising teacher has approved the project.
2. The graduate student does not need to obtain parental consent and student assent to use students’ coursework in her research.
3. The graduate student needs to obtain parental consent and student assent to videorecord students during classtime, as well as to interview students outside classtime.
4. The graduate student does not need to get parental consent from any students who are over 18 years of age.
5. If parents refuse to allow their child to participate in the study but these students want to participate, the graduate student can involve the students in the study.
6. If a student refuses to participate in the interview, the graduate student can take that into account when as an intern, she is assigning a grade for the class.
1. The student needs to obtain IRB approval for the pilot data if she plans to use them in her dissertation
2. The proposed recruitment methods do not pose any privacy issues.
3. The UNH IRB would not approve a waiver of documentation of consent in this study.
4. Because of her friend’s experience, it is reasonable for the IRB to ask the researcher to provide referral resources to participants in the event that the interview raises issues or questions for them.
5. Use of pseudonyms is appropriate in order to mask participants’ identity.
Click on the images below to see the case study that was presented at the beginning of this module.
Once you have finished all of the review questions click ’Certify Completion’.