Human Subjects

The Ethical Use and Treatment of Human Subjects in Research

Introduction

In this module, you will explore the following aspects of using human subjects in research:

  1. The current regulatory framework and its historical context
  2. Basic ethical principles for protecting human subjects in research, and key issues in research involving human subjects
  3. Functions of the Institutional Review Board (IRB) at the University of New Hampshire (UNH), its review and approval processes, and a researcher’s primary responsibilities

Introduction (cont.)

The module consists of:

Case Study

Click on the image below to read the case study.


Historical Context

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.

Historical Context (cont.)

Other famous cases involving the unethical treatment of human subjects in research projects in the United States, include the following:

Regulations

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.

Regulations (cont.)

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:

Regulations (cont.)

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:

Ethical Principles & Key Issues

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:

Ethical Principles (cont.)

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:

Ethical Principles (cont.)

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:

Key Issues

The Belmont Report raises the following key issues in research involving human subjects:

Another key issue is:

Key Issues: Minimizing Risks

Research procedures must result in minimal risk

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:


The IRB reviews risks that are reasonably foreseeable, even if unlikely, and determines if there are safeguards in place against them.

Key Issues: Recruitment

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.

Key Issues: Recruitment (cont.)

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.

Key Issues: Recruitment (cont.)

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.

Key Issues: Informed Consent

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).

Key Issues: Informed Consent (cont.)

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:

Key Issues: Informed Consent (cont.)

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.

Key Issues: Informed Consent (cont.)

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:

Key Issues: Informed Consent (cont.)

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.

Key Issues: Informed Consent (cont.)

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.

Key Issues: Informed Consent (cont.)

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.

Key Issues: Vulnerable Populations

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:

Key Issues: Vulnerable Populations (cont.)

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).

Key Issues: Privacy & Confidentiality

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.

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).

Privacy is a right that can be violated whereas confidentiality is an agreement that can be broken.

Key Issues: Privacy & Confidentiality (cont.)

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. Data should be stored 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.

Key Issues: Privacy & Confidentiality (cont.)

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.

Key Issues: Privacy & Confidentiality (cont.)

Although subjects’ contributions to the research 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:

Key Issues: Privacy & Confidentiality (cont.)

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).

Some studies may require a federal Certificate of Confidentiality to protect a researcher from forced disclosure (e.g., under subpoena) of private identifiable information of subjects collected as a part of a study.

The Institutional Review Board at UNH

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:

  1. Review all research studies involving human subjects
  2. Address concerns involving the use of human subjects in research
  3. Advise faculty, staff, and students on the ethical conduct of research involving people
  4. Conduct appropriate reviews of the UNH’s human subjects protections program and develop guidelines to ensure compliance with federal and state regulations
  5. Serve in an advisory capacity to the Senior Vice Provost for Research

The IRB at UNH (cont.)

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:

The IRB at UNH (cont.)

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.

The IRB at UNH (cont.)

Some common examples of secondary/existing data that are not considered private information include, but are not limited to:

The IRB at UNH (cont.)

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.

The IRB at UNH (cont.)

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.

The IRB at UNH (cont.)

Exempt level review may be used for studies presenting no greater than minimal risk

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 IRB at UNH (cont.)

Expedited review may be used for specific kinds of research also presenting no greater than minimal risk

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:

The IRB at UNH (cont.)

To approve the use of human subjects in a study, federal regulations require the IRB to determine that eight criteria are met. Researchers must:

  1. Minimize risks to subjects
  2. Balance risks with anticipated benefits
  3. Select subjects equitably
  4. Seek informed consent, where appropriate
  5. Document informed consent, where applicable
  6. Make adequate provisions for monitoring data
  7. Make adequate provisions to protect subjects' privacy and maintain confidentiality of data
  8. Ensure protections for vulnerable populations

The IRB at UNH (cont.)

At UNH, ongoing IRB approval carries the following five conditions:

  1. IRB approval must be kept active until data collection is finished and while identifiable data are being analyzed and/or interpreted. Once data are deidentified, researchers may close their study vis-à-vis IRB approval.
  2. Researchers whose studies are approved initially at the Expedited or Full Board review levels must renew IRB approval annually, until data are deidentified or the study is complete.
  3. Researchers must submit any modifications of approved studies to the IRB for review prior to implementation. Modifications must not be initiated until approved by the IRB in writing without contingencies. The only exception is a deviation necessary to eliminate an immediate hazard to a subject.

The IRB at UNH (cont.)

At UNH, ongoing IRB approval carries the following five conditions (cont.):

  1. Any injuries or other unanticipated problems involving risks to subjects or others must be reported promptly to the IRB by the researcher within one working day of occurrence. Reports should be made to Research Integrity Services.
  2. Researchers must report deviations from approved studies involving human subjects to the IRB promptly. Reports should be made to Research Integrity Services.

The IRB at UNH - Researchers’ Responsibilities

Researchers conducting studies involving human subjects have, but are not limited to, ten primary responsibilities. They must:

  1. Acknowledge and accept responsibility for protecting the rights and welfare of human subjects in their studies
  2. Comply with applicable institutional policies and government regulations
  3. Not involve human subjects in a study until they have received from the IRB written approval without contingencies
  4. Possess adequate skills and adhere to high ethical standards
  5. Ensure that research personnel under their supervision are adequately trained and act in an ethical manner

The IRB at UNH - Responsibilities (cont.)

Researchers conducting studies involving human subjects have, but are not limited to, ten primary responsibilities (cont.):

  1. Provide a copy of the IRB-approved, signed informed consent document to each subject at the time of consent (unless the IRB has specifically waived this requirement)
  2. Forward to the IRB any proposed modification(s) prior to initiation; changes must not be initiated prior to receipt of written approval without contingencies from the IRB
  3. Report progress of approved research to the IRB as often as, and in the manner, prescribed by the approving IRB, but not less than once a year for Expedited and Full Board studies
  4. Report to the IRB any injuries or other unanticipated problems involving risks to subjects or others within one working day of occurrence
  5. Decline to obtain research credit for, or use data from, patient interventions that constitute the provision of emergency medical care without prior IRB approval

Review Scenario 1

Scenario: An undergraduate student plans to write an honors thesis using data from the U.S. Census Bureau and from her faculty advisor’s longitudinal study of inner-city residents for which he has just finished data collection. The census data is available on the U.S. Census Bureau website, and the student’s faculty advisor will provide the student with a copy of the whole dataset now it is deidentified (anonymous). The faculty advisor tells the student that UNH IRB approval is not needed because the data are existing. The student discusses her project with a graduate student in the research group who tells the student that she needs to get IRB approval because the data from the advisor are not publically-available. Which one of the following statements is correct?
Incorrect. UNH IRB approval is not needed for use of either dataset. This is because neither dataset contains private identifiable information; the census data are publically-available and the faculty advisor’s dataset is anonymous (no identifying information is contained in it).
Incorrect. UNH IRB approval is not needed for use of either dataset. This is because neither dataset contains private identifiable information; the census data are publically-available and the faculty advisor’s dataset is anonymous (no identifying information is contained in it).
Incorrect. UNH IRB approval is not needed for use of either dataset. This is because neither dataset contains private identifiable information; the census data are publically-available and the faculty advisor’s dataset is anonymous (no identifying information is contained in it).
Correct. UNH IRB approval is not needed for use of either dataset. This is because neither dataset contains private identifiable information; the census data are publically-available and the faculty advisor’s dataset is anonymous (no identifying information is contained in it).

Review Scenario 2 - Questions 1 & 2

Scenario: A graduate student is interning in a New Hampshire high school. For her master’s thesis, the student wants to evaluate the novel method to teach students critical analysis skills she has introduced in her 12th grade class. She proposes to her supervising teacher to use in her study writing samples that students create for class. In addition, she will videorecord (which does not occur currently) class discussions and she will interview some high performing students outside class time. The teacher gives the graduate student permission to conduct the study. While preparing the UNH IRB application materials, the graduate student decides that she does not need permission from the school principal because the classroom teacher has approved the project. Further, she writes in her application that she will get parental consent and student assent only for students she interviews because the other information she will use for her study is part of their classwork. Which of the following statements are true?

1. The graduate student does not need permission from the principal as the supervising teacher has approved the project.

Incorrect. The UNH IRB requires in a K-12 school setting that permission for research to take place in the site must come from the principal. Some school districts require permission at the superintendent or school board level.
Correct. The UNH IRB requires in a K-12 school setting that permission for research to take place in the site must come from the principal. Some school districts require permission at the superintendent or school board level.

2. The graduate student does not need to obtain parental consent and student assent to use students’ coursework in her research.

Incorrect. Generally (and in this scenario), the UNH IRB requires in a K-12 school setting that parents and students must give permission in order for a student’s coursework be used for research purposes.
Correct. Generally (and in this scenario), the UNH IRB requires in a K-12 school setting that parents and students must give permission in order for a student’s coursework be used for research purposes.

Review Scenario 2 - Questions 3 & 4

Scenario: A graduate student is interning in a New Hampshire high school. For her master’s thesis, the student wants to evaluate the novel method to teach students critical analysis skills she has introduced in her 12th grade class. She proposes to her supervising teacher to use in her study writing samples that students create for class. In addition, she will videorecord (which does not occur currently) class discussions and she will interview some high performing students outside class time. The teacher gives the graduate student permission to conduct the study. While preparing the UNH IRB application materials, the graduate student decides that she does not need permission from the school principal because the classroom teacher has approved the project. Further, she writes in her application that she will get parental consent and student assent only for students she interviews because the other information she will use for her study is part of their classwork. Which of the following statements are true?

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.

Correct. Generally (and in this scenario), the UNH IRB requires in a K-12 school setting that parents and students must give permission in order for a student to be involved in a research study.
Incorrect. Generally (and in this scenario), the UNH IRB requires in a K-12 school setting that parents and students must give permission in order for a student to be involved in a research study.

4. The graduate student does not need to get parental consent from any students who are over 18 years of age.

Correct. Any students 18 years of age or older (or in other jurisdictions are the age of majority) can consent (or refuse) to participate in the study themselves, without parental consent.
Incorrect. Any students 18 years of age or older (or in other jurisdictions are the age of majority) can consent (or refuse) to participate in the study themselves, without parental consent.

Review Scenario 2 - Questions 5 & 6

Scenario: A graduate student is interning in a New Hampshire high school. For her master’s thesis, the student wants to evaluate the novel method to teach students critical analysis skills she has introduced in her 12th grade class. She proposes to her supervising teacher to use in her study writing samples that students create for class. In addition, she will videorecord (which does not occur currently) class discussions and she will interview some high performing students outside class time. The teacher gives the graduate student permission to conduct the study. While preparing the UNH IRB application materials, the graduate student decides that she does not need permission from the school principal because the classroom teacher has approved the project. Further, she writes in her application that she will get parental consent and student assent only for students she interviews because the other information she will use for her study is part of their classwork. Which of the following statements are true?

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.

Incorrect. Parents must give consent before the graduate student may approach a student about participating in the study. If parents refuse to give consent for their children to participate, the graduate student may not ask students to participate, let alone involve them in the study.
Correct. Parents must give consent before the graduate student may approach a student about participating in the study. If parents refuse to give consent for their children to participate, the graduate student may not ask students to participate, let alone involve them 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.

Incorrect. Participation in research must be voluntary, and refusal to participate should not incur any negative consequence or penalties. The graduate student must not and with no for refusal Parents must give consent before the graduate student may approach a student about participating in the study. If parents refuse to give consent for their children to participate, the graduate student may not ask students to participate, let alone involve them in the study.
Correct. Parents must give consent before the graduate student may approach a student about participating in the study. If parents refuse to give consent for their children to participate, the graduate student may not ask students to participate, let alone involve them in the study.

Review Scenario 3

Scenario: A UNH faculty member wants to conduct a study to see if there is any difference among majors in the way undergraduate students perform in his writing intensive course. He hypothesizes that liberal arts majors perform better on the writing assignments than science or engineering majors. In addition to using some of their class assignments as data in his study, he is considering surveying students during the class, and interviewing a cross-section of students outside class. He thinks he will get better participation if he offers extra credit for the survey and a $10 giftcard for the 30 minute interview. Which of the following statements are correct (check all that apply)?
Correct but there is another answer. Because the researcher is also the instructor of the course, students may feel that they have to participate in the study. To avoid this issue, an individual other than the course instructor (e.g., a graduate assistant, another faculty member) should present the research opportunity to the students in the course.
Correct but there is another answer. Because the researcher is also the instructor of the course, students may feel that they will get a better grade if they participate. The instructor needs to ensure 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.
Incorrect. Students under the age of 18 of age cannot give consent to participate in research as they are minors in New Hampshire. The researcher can elect to: (1) not include these students in the study; (2) obtain parental consent for these students to participate in the study and for those students whose parents give consent, obtain student assent; or (3) ask the IRB to waiver parental consent for the inclusion in the study and if granted, invite these students to participate in the study.
Correct but there is another answer. To avoid pressuring students to participate in the study in order to receive the extra credit, possibly because they are doing poorly in the course, the instructor must also offer equivalent, non-research extra credit options to students. This way, students can earn extra credit without participating the study.
You have selected all of the correct statements.

Review Scenario 4 - Questions 1 & 2

Scenario: A doctoral student is planning her dissertation research wherein she proposes to interview transgender individuals in the local (rural) area about their experiences with the health care system. She became interested in this topic because of a transgender friend’s very traumatic experience with health care. This friend is willing to participate in a pilot study where the student can refine her interview questions and protocol. This friend will provide her with contact information for other transgender people in the area so she can invite them to be in her study. She also plans to post information on her study on a listerv as well as on Facebook. When writing her application for the study to the UNH IRB, she plans to ask for a waiver of documentation of consent to help protect subjects’ identity as the signed consent forms would be the only record of their name in the study materials. Further, she plans to use pseudonyms in the dissertation and subsequent publications so they cannot be identified. Which of the following statements are true?

1. The student needs to obtain IRB approval for the pilot data if she plans to use them in her dissertation

Correct.
Incorrect. The student may only use the pilot data in her dissertation if she includes its collection in her IRB application.

2. The proposed recruitment methods do not pose any privacy issues.

Incorrect. Having the student’s friend provide her with contact information for transgendered individuals violates their privacy. When using a snowball sampling technique in her study, the student should provide to her friend information about the study for that individual to forward to other people instead of her friend giving to her contact information for other people.
Correct. Having the student’s friend provide her with contact information for transgendered individuals violates their privacy. When using a snowball sampling technique in her study, the student should provide to her friend information about the study for that individual to forward to other people instead of her friend giving to her contact information for other people.

Review Scenario 4 - Questions 3 & 4

Scenario: A doctoral student is planning her dissertation research wherein she proposes to interview transgender individuals in the local (rural) area about their experiences with the health care system. She became interested in this topic because of a transgender friend’s very traumatic experience with health care. This friend is willing to participate in a pilot study where the student can refine her interview questions and protocol. This friend will provide her with contact information for other transgender people in the area so she can invite them to be in her study. She also plans to post information on her study on a listerv as well as on Facebook. When writing her application for the study to the UNH IRB, she plans to ask for a waiver of documentation of consent to help protect subjects’ identity as the signed consent forms would be the only record of their name in the study materials. Further, she plans to use pseudonyms in the dissertation and subsequent publications so they cannot be identified. Which of the following statements are true?

3. The UNH IRB would not approve a waiver of documentation of consent in this study.

Incorrect. Based on the student’s rationale ~ signed consent forms would be the only record of participants’ name in the study materials ~ it is very likely that the UNH IRB would approve a waiver of documentation of consent for this study, particularly if the primary risk is anticipated to be potential harm resulting from a breach of confidentiality
Correct. Based on the student’s rationale ~ signed consent forms would be the only record of participants’ name in the study materials ~ it is very likely that the UNH IRB would approve a waiver of documentation of consent for this study, particularly if the primary risk is anticipated to be potential harm resulting from a breach of confidentiality

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.

Correct.
Incorrect. 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; particularly because she knows of one individual for whom this topic raises issues and because in relation to this topic, these individuals may be considered vulnerable.

Review Scenario 4 - Questions 5

Scenario: A doctoral student is planning her dissertation research wherein she proposes to interview transgender individuals in the local (rural) area about their experiences with the health care system. She became interested in this topic because of a transgender friend’s very traumatic experience with health care. This friend is willing to participate in a pilot study where the student can refine her interview questions and protocol. This friend will provide her with contact information for other transgender people in the area so she can invite them to be in her study. She also plans to post information on her study on a listerv as well as on Facebook. When writing her application for the study to the UNH IRB, she plans to ask for a waiver of documentation of consent to help protect subjects’ identity as the signed consent forms would be the only record of their name in the study materials. Further, she plans to use pseudonyms in the dissertation and subsequent publications so they cannot be identified. Is the following statement true?

5. Use of pseudonyms is appropriate in order to mask participants’ identity.

Correct. The study, however, is taking place in a rural setting where there may not be many transgendered individuals living, and where they may be visible or known, particularly to their health care providers. Because of this, the researcher should make it very clear in the consent document that she will use pseudonyms and not include identifying information in the write up of her study, but that others may recognize participants from descriptions provided and/or due to the topic of the study.
Incorrect. The study is taking place in a rural setting where there may not be many transgendered individuals living, and where they may be visible or known, particularly to their health care providers. Because of this, the researcher should make it very clear in the consent document that she will use pseudonyms and not include identifying information in the write up of her study, but that others may recognize participants from descriptions provided and/or due to the topic of the study.

Case Study Review

Click on the images below to see the case study that was presented at the beginning of this module.

Case Study Review

Congratulations!

Once you have finished all of the review questions click ’Certify Completion’.

Certify Completion