In this module, you will explore the following aspects of using human subjects in research:
The module consists of:
After completing this module, you will be able to:
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. This timeline shows key events in the history of human subject protections.
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 the United States 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 most 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:
Persons who have not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted.
Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute or individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives.
Persons with diminished capacity are individuals who may not be capable of self-determination due to a lack of cognitive capacity, either temporary or permanent, or developmental disability.
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 probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
to subjects consistent with justifiable scientific necessity. All risks must be fully and comprehensibly disclosed to subjects prior to participation. In this context, risk is the probability of harm occurring as a result of participation in study. Risks may be:Does the study involve sensitive issues (e.g., sexuality, victimization, alcohol, or drug use) that may create emotional upset, anxiety, distress, precipitate a behavioral disorder, or raise questions for subjects? Is there a referral path readily available for subjects who need it (e.g., free mental health counseling)?
Could participation or a breach in confidentiality create embarrassment, ostracism, stigmatization, loss of status, or precipitate personal conflict for the subject?
Could participation or a breach in confidentiality cause the subject to lose their job, be passed over for advancement, or lose income, existing resources, or benefits? Could a business be negatively impacted?
Does the study involve blood draws, the placement of electrodes, or maximal exercise? Could physical harm requiring treatment, initial or recurrent, be caused by participation in the study? How likely is it that discomfort, illness, injury, or death may occur?
Is the information gathered subject to subpoena? Are subjects asked to report illegal behaviors? Could a breach in confidentiality put subjects at risk of arrest, prosecution, civil or criminal liability, or punishment?
The IRB reviews risks that are reasonably foreseeable, even if unlikely, and determines if there are adequate safeguards in place to minimize them.
Participation in a research study must be purely voluntary. Subjects should agree to participate without the researcher (or others) exerting any undue influence on them or by coercing them (threats of harm).
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 private 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 college 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 drawing as an incentive, the researcher needs to provide to the IRB in the application materials information about the drawing, including the prizes, how subjects will enter the drawing, how drawing contact information will stored in relation to subjects’ responses, when the drawing will take place in the timeframe of the study, and what will happen to drawing 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 survey 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 delivery 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 stop participating in 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 drawing), 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 stops participating in the study, she will receive $30.00 for the completion of the two interviews; the penalty for stopping participation should be explained as being paid $15.00 only for completion of each interview.
Incomplete disclosure or deception may interfere with the ability of research subjects to make a fully informed decision about whether to participate in a study. They are often used where the provision of that information about the study to subjects could alter their behavior.
Incomplete disclosure involves withholding some information about the real purpose of the study, or the nature of the research procedures.
Deception is when a researcher gives false information to subjects or intentionally misleads them about some key aspect of the research. 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:
Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives.
Persons with diminished capacity are individuals who may not be capable of self-determination due to a lack of cognitive capacity, either temporary or permanent, or developmental disability.
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. Further, UNH researchers who conduct research involving children/minors need to comply with the UNH Policy and Procedures for the Protecton of Minors as applicable.
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 themselves (physically, behaviorally, or intellectually) with others (Amdur & Bankert, 2001). Researchers must respect subjects’ privacy. Researchers must safeguard subjects' privacy during recruitment for a study and during data collection. Data must be stored securely and in a form that prevents, where possible, the identification of individuals.
Federal privacy laws that may impact a research study include the Family Educational Rights & Privacy Act (FERPA), which applies to students in K-12 and higher education settings, and the Health Insurance Portability and Accountability Act (HIPAA).
To help protect subjects' privacy, researchers should gather only the data necessary to answer the research question(s) and the minimum amount of identifying information.
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 informed 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 USNH IT secure cloud storage (i.e., OneDrive or SharePoint). If for some reason, this is not possible, researchers should store data on password-protected computers that are regularly backed-up, and when necessary, transport data via portable memory devices from which they should be erased immediately after being copied onto a computer.
Increasingly sponsors, journals and professional associations require researchers to share data (normally deidentified) as a condition of funding or publication. Researchers should anticipate and plan for sharing data; they should include this information as part of the IRB application, and disclose information to subjects about such sharing as part of informed consent process.
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, limited/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 (unless subjects agree in writing otherwise), 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:
In addition, where applicable, subjects also should be informed that researchers will report relevant information in certain situations required by law (e.g., suspected 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 if the study involves collecting sensitive information that is not anonymous..
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 as follows:
Includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for researc
Includes communication or interpersonal contact
“Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human
Federal regulations define human subject as follows:
Includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
or interactionIncludes communication or interpersonal contact between researcher and subject.
with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information“Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information” (45 CFR 46.102(e)(5)).
or identifiable biospecimens.” [45 CFR 46.102(e)(1)].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]) and if the secondary/existing data do not contain private information, UNH IRB approval is NOT needed to use such data for research purposes.
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 (Associate Vice President and Chief Research Administration Official).
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.
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
, including those that involve:At UNH, “Exempt” does not mean exempt from IRB review and approval.
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
, such as:Full Board review is required for studies involving special populations and/or presenting greater than minimal risk, such as those involving:
UNH faculty, staff, or students who plan to conduct research involving human subjects must submit an application to, and receive written, unconditional approval from, the IRB prior to starting a study, including recruitment of participants. Researchers need to submit completed applications to the IRB for via Cayuse IRB/Human Ethics. Research Integrity Services (RIS) staff provide administrative support to the IRB and assist researchers with IRB applications.
Applications to the UNH IRB must include for every listed UNH faculty, staff, or student documentation of completion of the UNH web-based training on human subjects protections (this training). The training expires three years from the date of completion. Researchers should submit documentation of completion of IRB training from the home institution for each non-UNH individual listed on an application.
Studies qualifying for Exempt or Expedited level review are reviewed by the IRB as they are received. Studies qualifying for Exempt or Expedited level are forwarded upon receipt to IRB members for review. Initial Exempt or Expedited level review generally takes 10 working days during the semester and 15 working days during the winter break and summer.
The IRB meets twice a month during the academic year and once each month during the summer to review studies qualifying for Full Board review. Studies requiring Full Board level review must be submitted according to the posted schedule. Upon receipt by RIS staff, applications are placed on the agenda for the next scheduled IRB meeting. Applications are reviewed on a first come, first served basis; if too many applications are received for review at a specific IRB meeting, the review of those received latest may be postponed until the following IRB meeting. Researchers who plan to conduct studies requiring Full Board review should submit applications to the IRB at least 4 weeks prior to the anticipated start date (allow 8 weeks in the summer).
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 class time, as well as to interview students outside class time.
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’.
