Chapter 13. Social and Behavioral Research

Social and behavioral research often involves surveys, observational studies, personal interviews, or experimental designs involving exposure to some type of stimulus or intervention.

A. Social and Psychological Harms. When evaluating social and behavioral science research, IRBs should carefully examine the research to determine the probability of risk of harm to subjects.

i. The IRB will consider the potential for participants to experience stress, anxiety, guilt, or trauma that can result in genuine psychological harm.

ii. The IRB will also consider the risks of criminal or civil liability or other risks that can result in serious social harms, such as damage to financial standing, employability, insurability, or reputation; stigmatization; and damage to social relationships.

iii. Collecting any identifiable, private information about any living individual constitutes human subject research. If information is being collected on living individuals in addition to the primary “target” subjects, the IRB will consider the risk of harm to those “non-target” individuals, as well. The IRB may require additional protections, study redesign, or the informed consent of “nontarget” individuals (unless the requirement for informed consent can be waived).

In order to mitigate such harms, the IRB will review the proposal for appropriate preventive protections and debriefings, adequate disclosure of risks in the informed consent information, and mechanisms to protect the confidentiality and privacy of persons participating in the research.

B. Privacy and Confidentiality Concerns. The use of confidential information is an essential element of much social and behavioral research.

i. It is important that the methods used to identify potential research subjects or to gather information about subjects not invade the privacy of the individual. In general, identifiable information may not be obtained from private (non-public) records without the approval of the IRB and the informed consent of the subject. Such is the case even for activities intended to identify potential subjects who will later be approached to participate in research. However, there are circumstances that will allow an exemption from the regulations to be granted, and circumstances in which the IRB may approve a waiver of the usual informed consent requirements.

ii. It is also important to protect individually identifiable private information once it has been collected in order to prevent a breach of confidentiality that potentially could harm subjects.

C. Safeguarding Confidentiality. When information linked to individuals will be recorded as part of the research design, the IRB requires that adequate precautions be taken to safeguard the confidentiality of the information. The more sensitive the data being collected, the more important are the confidentiality procedures.

i. When reviewing survey and interview research, the IRB should be aware of the regulatory provision at 45 CFR 46.117(c)(1) for waiving documentation of consent when a signed consent form would itself constitute a risk to the subjects.

ii. Among the available methods for safeguarding confidentiality are coding of records, statistical techniques, and physical or computerized methods for maintaining the security of stored data.

iii. Regulations at 45 CFR 46.116(a)(5) require that subjects be informed of the extent to which confidentiality of research records will be maintained (or not maintained).

iv. Federal officials have the right to inspect research records, including consent forms and relevant clinical records of individual subjects, to ascertain compliance with the rules and standards of their programs. FDA requires that information regarding this authority be included in the consent information for all research that it regulates. Identifiable information obtained by Federal officials during such inspections is protected by the provisions of the Privacy Act of 1974.

v. IRBs may require that an investigator obtain a DHHS Certificate of Confidentiality (CoC). The CoC protects against the involuntary release of sensitive information about individual subjects for use in Federal, State, or local civil, criminal, administrative, legislative, or other legal proceedings.

D. Exempt Research. Much social and behavioral research is exempt from the requirements of the Federal regulations (45 CFR 46.101(b)). However, appropriate application of these exemptions requires a relatively sophisticated level of expertise, and is not left to individual investigators. In reviewing exemption request, the IRB must elicit enough information from the investigator to ascertain whether the claimed exemption really applies.

All exemptions claimed for research conducted at the University of Notre Dame or by its employees or agents must be verified by the IRB. The following exemptions are particularly applicable to social and behavioral research.

E. Exempt Research in Educational Settings. Research conducted in established or commonly accepted educational settings that involves normal educational practices is exempt from Federal regulations in accordance with 45 CFR 46.101(b)(1).

i. This exemption does not apply if the setting is not commonly recognized as an educational one, or if other than normal educational practices are employed.

ii. Even if the research is exempt, the investigator has an ethical obligation to respect and safeguard students’ rights and welfare.

F. Exempt Research Using Educational Tests, Survey Procedures, Interview Procedures, and Observational Public Behavior. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or the observation of public behavior is ordinarily exempt under Federal regulations at 45 CFR 46.101(b)(2).

i. When the subjects are adults, this exemption applies UNLESS: (a) information is recorded in an identifiable manner (either directly or indirectly using codes or other identifying links); AND (b) disclosure of the information would place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation. NOTE: The research is exempt unless both (a) and (b) apply; i.e., the research is exempt unless the information collected is both identifiable and sensitive, except in the case of children as follows.

ii. This exemption applies to research involving children, EXCEPT that: (a) research involving survey or interview procedures with children is NOT EXEMPT; and (b) research involving observation of the public behavior of children is NOT EXEMPT if the investigator participates in the actions being observed.

iii. If not exempt under the conditions described above, research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or the observation of public behavior is exempt where: (a) the subjects are elected or appointed public officials or candidates for public office; or (b) federal statutes require confidentiality without exception. NOTE: Condition (b) regarding federal statutes rarely applies. The IRB should consult with OHRP if it receives an exemption request based on absolute confidentiality under a federal statue.

iv. If not exempt under the conditions described above, the IRB may often utilize expedited procedures for review and approval of research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or the observation of public behavior.

G. Exempt Research using Existing Data and Documents. Social and behavioral research often relies on analysis of existing data or documents. Such research, which may be exempt, will be discussed further in Chapter 17.

H. Expedited IRB Review of Social and Behavioral Research. Social and behavioral research that presents no greater than minimal risk to subjects and fits one (or more) of the nine categories specified in the November 9, 1998 Federal Register notice on expedited review may be reviewed by the IRB utilizing expedited procedures.

The categories discussed below are particularly applicable to social and behavioral research, and include research involving children as well as adult subjects. However, these categories do NOT apply to research involving prisoners, or to research specifically directed toward pregnant women.

I. Expedited Review of Research Involving Existing Data and Documents. Research involving materials (including data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes, may be reviewed using expedited procedures. NOTE: The intent of the drafters was to define two categories here, each appropriate for expedited review.

i. Non-exempt research involving materials that have already been collected (for any previous research or non-research purpose) at the time when the research is proposed.

ii. Non-exempt research involving materials that will be collected in the future for a non-research purpose.

J. Expedited Review of Research Involving Data from Voice, Video, Digital, or Image Recordings Made for Research Purposes. The IRB may utilize expedited procedures to review research that involves the collection of data from voice, video, digital, or image recordings made for research purposes.

K. Expedited Review of Research Involving Individual or Group Characteristics or Behavior or Research Employing Survey, Interview, Oral History, Focus Group, Program Evaluation, Human Factors Evaluation, or Quality Assurance Methodologies. The IRB may utilize expedited procedures to review of the following:

i. research on individual or group characteristics or behavior; or

ii. research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

This category covers a wide range of non-exempt social and behavioral research activities when they present no greater than minimal risk to subjects. Examples include, but are not limited to, research on perception, cognition, motivation, identify, language, communication, cultural beliefs or practices.

L. Research Involving Deception. IRBs reviewing research involving incomplete disclosure or outright deception must apply both common sense and sensitivity to the review.

Where deception is involved, the IRB needs to be satisfied that the deception is necessary and that, when appropriate, the subjects will be debriefed. (Debriefing may be inappropriate, for example, when the debriefing itself would present an unreasonable risk of harm without a countervailing benefit.

Deception can only be permitted where the IRB documents that waiver of the usual informed consent requirements is justified under the criteria present in Federal regulations at 45 CFR 46.116(d). Specifically, the IRB must find and document that all four of the following criteria have been satisfied:

i. The research presents no more than minimal risk to subjects.

ii. The waiver or alteration will not adversely affect the rights and welfare of the subjects.

iii. The research could not practicably be carried out without the waiver or alteration.

iv. Where appropriate, the subjects will be provided with additional pertinent information after participation.

Note that the regulations make no provision for the use of deception in research that poses greater than minimal risks to subjects.

Chapter 14. Student Research and Class Projects

Research, as defined in Federal Regulations 45 CFR 46 and conducted by undergraduate and graduate students, is subject to federal regulations that require that all research protocols involving human subjects be reviewed by the IRB. Some student projects will be classified as research and are subject to IRB review while others are not research and are not subject to IRB review.

A number of courses require students to undertake projects in which other people are interviewed, observed, or otherwise serve as participants. The purpose of these course projects is to train students and to provide them with an opportunity to practice various research and clinical methods. These projects do not generally result in the creation of generalizable knowledge or publications beyond class assignments and are not undertaken with these goals in mind. Therefore, federal guidelines do not consider them to be research and IRB review is not required. Such projects are considered “classroom exercises” and are typically quite limited in scope.

It is the responsibility of the faculty to determine, prior to assigning a project, whether the project is classified as a classroom project or research. Faculty members are encouraged to consult with the Director of Research Compliance in making such a determination. Should a class project be conducted that meets the definition of research but does not receive IRB review and approval, the faculty member will be considered to have engaged in IRB noncompliance and may be personally liable. No data collected as a course assignment that has not been subject to IRB review can be used for research purposes.

• IRB approval cannot be granted retroactively. Any data collected without IRB approval cannot be used for future theses, publications, or outside of classroom presentations. It will need to be recollected if it is subsequently determined that the work is appropriate for a research project. Recollection of the data may delay a student’s completion of course assignments or theses and dissertations.
• It is the responsibility of the faculty to assure that all students planning to conduct research involving human participants submit an application to the IRB in a timely manner and to thoroughly review the application before it is submitted. The IRB often requests additional information, or requires changes to the application, before projects can be approved. This can result in additional time required to gain approval from the IRB
• If a faculty member is planning to use data from class assignments for disseminated research, IRB approval must be obtained.
• It is the responsibility of the faculty member to monitor student projects from beginning to end for impact on human participants. Special attention should be paid to maintaining confidentiality and minimal levels of risks for participants, assuring freedom to withdraw without penalty, and providing informed consent to participants. All participants should be made aware of this activity as a class project.
• It is the responsibility of the faculty member to report unexpected adverse events, unanticipated problems, or complaints involving human participants to the Director of Compliance promptly.
• All class research projects that involve protected groups as defined in Title 45 Code of Federal Regulations Part 46 (such as, but not limited to pregnant women, children, prisoners, institutionalized mentally ill patients) require IRB review even if there is no intention to publish results.
• When a study involves deception, a debriefing is mandatory following the study.

Chapter 15. Guidance for Working with Students

Care should be taken to eliminate or reduce the risk that undue influence of faculty or coercion affects student participation in research. The following guidelines are offered to assist the IRB in evaluating research involving students.

A. K-12 Students as Research Subjects

• Principal investigators must acquire a letter of support to conduct research from the
• Principal(s) of the school(s) where the research is to be done. Such letters of support MUST be submitted to the IRB for review.
• Research involving minors (under 18 years of age) as subjects requires a signed parental permission in most instances as well as assent from the student (age 6‐12 verbal, age 13‐17 written). Some types of research may qualify for Waiver of Parental permission. If a parental permission form is sent home with a potential student subject, an investigator contact telephone number should be provided on the form to enable parents to ask any questions that they may have for the investigator.
• Parental permission and assent procedures should be clear as to the activities that are part of the research.
• FERPA is a federal law that protects the privacy of personally identifiable information contained within a student’s educational record. FERPA applies to all (K‐12 including postsecondary institutions) that receive funds under various programs from the U.S. Department of Education. Generally investigators may not access classroom performance evaluation, grades, or information in a student’s records without prior written permission from a parent or authorized legal representative, regardless of the access an investigator may have in his/her academic role.
• An investigator may not invite participation of potential subjects by a letter that requires the subject to send back a postcard (or telephone) only if he or she does not wish to participate. Subjects may become unwitting participants if, for example, they never receive the letter, don’t read English, or are simply confused by the instructions.
• When research activities to be done by the students are not part of the required class activities, the investigator should arrange to have the data collected by an independent third party, so that the investigator does not know who participated and does not have access to the identifiable data or identity of participants for any purpose until grades have been assigned and entered.
• When course credit or extra credit is given to students who participate in research as part of a course requirement, students are to be given other options for fulfilling the research component, for example; short papers, special projects, book reports, and brief quizzes on additional readings, research seminars, or completing a similar project. These projects should be comparable in terms of time, effort and educational benefit to participation as a research subject to ensure that students are not being coerced into becoming subjects. Alternatives offered to subjects need prior IRB approval.
• Solicitation of volunteer student subjects for research must be done in a non‐coercive manner. To avoid undue influence, subjects should be recruited by a general announcement, central posting or announcement mechanism and should include a clearly written description of the project and a statement of the proposed student participation.
• Whenever possible, researchers should avoid data collection during regular class meetings.
• Students must be allowed to withdraw from the study at any time. The informed consent statement should make clear the consequences of withdrawing from a project prior to completion. In general it is favorable to give credit if the subject withdraws, unless the student withdraws immediately or there is evidence of bad faith on the part of the student.
• If the research is one where data are collected from a group project or perhaps a videotape of the group interaction, each student’s consent is necessary for the use of the data in the instructor’s research. If one student does not consent, the data may be used only if the non‐consenting student’s data can be effectively excluded.
• Students have the right to full disclosure as soon as possible. Whenever possible a teaching opportunity in the form of an “educational debriefing” should be employed. Students should know something about the rationale for the study, the process of data collection, and intent of the researcher.

B. University Students as Research Subjects

• Students should be of the age of majority in Indiana (18 years old). Research involving minors (under 18 years of age) as subjects, (even 17 year old college students) in most instances requires a signed parental consent, as well as that of the student. Some types of research may qualify for a Waiver of Parental permission.
• Generally researchers may not access classroom performance evaluations, grades, and information in a student’s records without prior written permission from the student, regardless of the access an investigator may have in his/her academic role.
• When course credit or extra credit is given to students who participate in research as part of a course requirement, students are to be given other options for fulfilling the research component, for example; short papers, special projects, book reports, and brief quizzes on additional readings, research seminars, or completing a similar project. These projects should be comparable in terms of time, effort and educational benefit to participation as a research subject to ensure that students are not being coerced into becoming subjects. Alternatives offered to subjects need prior IRB approval.
• Solicitation of volunteer student subjects for research must be done in a non‐coercive manner. To avoid undue influence, subjects should be recruited by a general announcement, central posting or announcement mechanism and should include a clearly written description of the project and a statement of the proposed student participation.
• Whenever possible, researchers should avoid data collection during regular class meetings. When study participation consumes a significant portion of a class section, loss of instructional time for both participants and non‐participants may be considered a loss of benefits. Also when research participation is expected during the same session at which participation is invited students may be unduly influenced to take part due to peer pressure, perceived stigmatization from nonparticipation, or a sense of having otherwise wasted time by attending the day’s class.
• Students must be allowed to withdraw from the study at any time. The informed consent statement should make clear the consequences of withdrawing from a project prior to completion. In general it is favorable to give credit if the subject withdraws, unless the student withdraws immediately or there is evidence of bad faith on the part of the student.
• If the research is one where data are collected from a group project or perhaps a videotape of the group interaction, each student’s consent is necessary for the use of the data in the instructor’s research. If one student does not consent, the data may be used only if the non‐consenting student’s data can be effectively excluded.
• Students have the right to full disclosure as soon as possible. Whenever possible a teaching opportunity in the form of an “educational debriefing” should be employed. Students should know something about the rationale for the study, the process of data collection, and intent of the researcher. In exceptional circumstances, the full or true purpose of the research may not be revealed to the subjects until the completion of data collection. In such cases, students must not be subjected to undue stress or embarrassment and must have the right to full disclosure of the purpose of the study as soon as possible after the data have been collected. During the debrief students should be given an opportunity to decide whether the researcher(s) can use the data collected.
• Research conducted by graduate students in a class in which the researcher teaches, assists in the class or does any grading should be subject to the same restraints describe above.

Chapter 16. Research Using the Internet

Ethical guidelines for research studies in which interactions with subjects occur via the internet or e-mail are the same as for studies involving other modes of interaction. Internet-based studies must incorporate the principles of The Belmont Report and Title 45 CFR 46. Subjects’ identities must be protected to the extent the researcher is able such as using a secure, password protected study Web site and installing security software on the researcher’s computer. Studies must include an informed consent process. With appropriate preparation of the informed consent form, obtaining electronic agreement to voluntarily participate is possible. Research involving minors requires obtaining consent from parents, a legal guardian, or legal representative. Written consent (signatures) may be obtained by mailing or faxing an informed consent form or consent statement to the researcher. Telephone consent may be obtained for low risk studies. A face-to-face interview should be conducted to obtain parental consent for studies with minors that involve more than minimal risk.

When reviewing a proposed Internet-based study, the IRB will want to know how the researcher will

• Include an informed consent process;
• Ensure that a participant is in the desired age group and that he/she is not a minor—to the extent possible;
• Provide opportunities for potential participants to ask questions and fully understand what they will be doing in the study;
• Provide processes for subjects to withdraw from the study and to decline to answer any question(s);
• Secure all data collected;
• Provide assistance or treatment if subjects are harmed by their participation in a study;
• Ensure that intruders (hackers) will not be able to enter the study, intentionally or inadvertently;
• Provide a link to the online survey, questionnaire, focus group, or interview questions for review.

Researchers may, for example, design an online informed consent form with buttons for selecting “I Agree” and “I Do Not Agree,” followed by a “Submit” button. Potential participants who click “I Agree” and “Submit” will be directed to the survey, questionnaire, focus group, or interview questions. If a potential participant clicks “I Do Not Agree,” he/she should be returned to the study’s home page or directed to a “Thank you for considering participation in my study” page. Other methods for obtaining consent may also be used. A link to “Exit This Study” should be provided to allow participants to withdraw at any point in the study.

Unless a convincing case can be made, no Internet Protocol (IP) addresses may be retained or collected.

The CITI program offers an optional module addressing Internet research. Researchers submitting an application to the IRB for an Internet-based study are encouraged to complete this module.

A. Research Conducted in Online Communities

Conducting research in online communities, such as chatrooms, blogs, social sites, and gaming sites, requires researchers to respect members of the communities, their privacy, and their right to grant permission to conduct research within their communities. Researchers should take care to conduct research in online communities in such a way as to avoid damaging the reputation of researchers that would result in fewer opportunities for conducting research in online communities. Joining an online community for the purpose of lurking in the background while collecting information and quotes for a research study is unethical and would not be approved by the IRB.

A researcher may set up his/her own chatroom, for example, for a research study. Each person who joins the chatroom may be greeted with a statement about the research study. For a low risk study, the statement may be sufficient. For higher risk studies, obtaining informed consent from participants is needed.

Conducting Internet research involving sensitive topics, such as sexual orientation and activities or illegal activities, requires extreme caution to avoid the loss of confidentiality and release of a participant’s personally identifiable information. The use of pseudonyms and other coding methods may be used and employed with protection of the link between the real names and the pseudonyms or codes.

Researchers need to determine from whom to obtain consent in online communities—the site owner, a group’s gatekeeper, an online personality, and/or individual participants. Sometimes consent is necessary from more than one party.

Chapter 17. Bio-Social and Bio-Behavioral Research

Many studies combine characteristics of behavioral and social research with characteristics of biomedical research. Such studies may be referred to as bio-social and bio-behavioral research.

A. Prospective Use of “Existing” Materials. Prospective studies are designed to observe outcomes or events (e.g., diseases, behavioral outcomes, or physiological responses) that occur subsequent to identifying the targeted group of subjects, proposing the study, and initiating the research. Prospective studies using materials (data, documents, records or specimens) that will “exist” in the future because they will be collected for some purpose unrelated to the research (e.g., routine clinical care) do not qualify for exemption under DHHS regulations at 45 CFR 46.101(b)(4) and the Common Rule because the materials in these studies are not in existence at the time the study is proposed and initiated.

B. Retrospective Use of Existing Materials. Retrospective studies are research studies that involve the review of materials (including data, documents, records, or specimens) collected in the past (e.g., medical records, school records, or employment records) and existing at the time the research is proposed and initiated. Such research may be exempt under DHHS regulations at 45 CFR 46.101(b)(4) if the information is publicly available or if the information is recorded in such a manner that subjects cannot be identified, either directly or through identifiers linked to the subjects. If not exempt, the IRB may review such research utilizing expedited procedures, provided that the research involves no more than minimal risk to subjects.

However, retrospective studies using existing materials occasionally entail significant, greater than minimal risks and require review by the convened IRB (e.g., where the research reveals previously undisclosed illegal drug use and the expedited reviewer indicated concerns about invasion of subjects’ privacy and/or the adequacy of confidentiality protections proposed by the investigators).

C. Research Utilizing Large Existing Data Sets. Social and Bio-behavioral research often involves the use of large, existing data sets.

However, many of these data sets, though public, may contain restricted and confidential information (e.g., place of residence) that is not part of the public release files. IRB review is required when public datasets contain identifiable private information about living individuals. In such cases, the IRB must determine whether the information can be used without additional informed consent from the subjects.

i. In making this determination, the IRB should first examine the conditions of informed consent under which the data were originally obtained. It may be that the proposed research is permissible under the original terms of consent.

ii. If this is not the case, then the IRB should consider whether it is permissible to waive the usual informed consent requirements in accordance with 45 CFR 46.116(d). Many times, a waiver of consent will be appropriate.

iii. In other cases, the IRB may determine that the research can proceed only if the investigator obtains and uses “anonymized” data. Under this scenario, codes and other identifiers are permanently removed from the data set before the data are sent to the investigator, and the removal is accomplished in such a manner that neither the investigator nor the source maintaining the data set can re-establish subjects’ identities.

iv. An alternative to anonymizing data is to maintain the data set as a data repository under the guidelines established by OHRP (see below and refer to Guidance on this topic on the OHRP Website).

D. Research Utilizing Data or Tissue Repositories. Human data repositories collect, store, and distribute identifiable information about individual persons for research purposes.

Repository activities involve three components: (i) the collectors of data or tissue samples; (ii) the repository storage and data management center; and (iii) the recipient investigators. Under a repository arrangement, an IRB formally oversees all elements of repository activity, setting the conditions for collection, storage, secure maintenance, and sharing of the data and/or tissues with external investigators. Specifically, the IRB determines the parameters for sharing data and/or tissues (which are identifiable within the repository) in a manner such that additional informed consent of subjects is not required. (Refer to Guidance on this topic on the OHRP Website.) Typically, these parameters involve formal, written agreements stipulating these conditions:

i. The repository will not release any identifiers to the investigator.

ii. The investigator will not attempt to recreate identifiers, identify subjects, or contact subjects.

iii. The investigator will use the data only for the purposes and research specified.

iv. The investigator will comply with any conditions determined by the repository IRB to be appropriate for the protection of subjects.

E. Epidemiology Research. Epidemiology research often makes use of sensitive, individually identifiable, private information (usually obtained from medical or other private records), and links this information with additional information obtained from other public or private records, such as employment, insurance, or police records. Epidemiology research may also combine historical research with survey and interview research.

Epidemiology studies often present significant problems regarding both privacy and confidentiality.

i. The IRB must first consider privacy issues, and must satisfy itself that the research does not constitute an unwarranted invasion of the subjects’ privacy. The IRB will seek to establish that the investigator has legitimate access to any identifiable information that is to be utilized. For example, if State disease registry information is to be utilized, the IRB will need to examine State law relative to the legitimate release of such information for research.

ii. Once the IRB’s privacy concerns have been resolved, the IRB will examine mechanisms for maintaining the confidentiality of data collected. The IRB will seek to establish that confidentiality protections are appropriate to the nature and sensitivity of the information that has been obtained.

iii. Because epidemiology research typically requires very large numbers of subjects, epidemiology investigators almost always request that the IRB waive the usual requirements for informed consent. In order to approve such a waiver in epidemiology research, the IRB must find and document that the criteria at 45 CFR 46.116(d) for a waiver of informed consent have been met; specifically that (a) the research presents no more than minimal risk to subjects; (b) the waiver will not adversely affect the rights and welfare of the subjects; and (c) the research could not practicably be carried out without the waiver. The fourth requirement (“whenever appropriate, the subjects will be provided with additional pertinent information after participation”) usually does not apply.

F. Issues in Genetic Research. The protection of private information gathered for and resulting from genetic research is a major concern. The IRB will expect the investigator to describe in detail how individual privacy will be protected and how the confidentiality of obtained information will be maintained.

Information obtained through genetic research may have serious repercussions for the subject or the subject’s family members. Genetic information can adversely affect an individual’s insurability and employability.

The IRB is particularly careful about approving research that appears to involve only a simple, minimal risk blood draw, but then goes on to include or add a component involving genetic analysis. The addition of the genetic analysis can radically alter the level of risk.

Chapter 18. Potentially Vulnerable Subject Groups

DHHS regulations at 45 CFR 46.111(b), FDA regulations at 21 CFR 56.111(b), and the Common Rule require IRBs to give special consideration to protecting the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

The IRB is required to include adequate representation on the Board to consider specific kinds of research involving these vulnerable populations in a satisfactory manner.

A. Elements to Consider. IRBs must pay special attention to specific elements of the research plan when reviewing research involving vulnerable subjects.

i. Strategic issues include inclusion and exclusion criteria for selecting and recruiting participants; informed consent and voluntarism; coercion and undue influence; and confidentiality of data.

ii. The IRB should carefully consider group characteristics, such as economic, social, physical, and environmental conditions, so that the research incorporates additional safeguards for vulnerable subjects.

iii. Investigators should not over-select or exclude certain groups based on perceived limitations or complexities associated with those groups. For example, it is not appropriate to target prisoners as research subjects merely because they are a readily available “captive” population.

iv. Investigators must be knowledgeable about applicable laws that bear on the decision-making abilities of potentially vulnerable populations.

v. Research studies that plan to involve any potentially vulnerable populations must have adequate procedures in place for assessing subjects’ capacity, understanding, and informed consent or assent. When weighing the decision whether to approve or disapprove research involving vulnerable subjects, the IRB will look to see that such procedures are a part of the research plan.

vi. In certain instances, it may be possible for researchers to enhance understanding for potentially vulnerable subjects. Examples include the inclusion of a consent monitor, a subject advocate, interpreter for hearing-impaired subjects, translation of informed consent forms into languages the subjects understand, and reading the consent form to subjects slowly to gauge their understanding paragraph by paragraph.

vii. The IRB may require additional safeguards to protect potentially vulnerable populations. For instance, the IRB may require that the investigator submit each signed informed consent form to the IRB, that someone from the IRB oversee the consent process, or that a waiting period be established between initial contact and enrollment to allow time for family discussion and questions.

B. Pregnant Women, Human Fetuses and Neonates. DHHS regulations at 45 CFR Part 46, Subpart B detail special protections for research involving pregnant women, human fetuses and neonates. Under these regulations, the IRB is required to document specific findings to minimize the potential for risk or harm to the fetus, and additional attention must be given to the conditions for obtaining informed consent.

Unilateral exclusion of non-pregnant women of reproductive potential from research, in order to avoid a risk, will not be permitted by the IRB. Exclusion requires compelling scientific justification. Where such justification exists, it may also be appropriate to exclude men of reproductive potential.

Four separate categories, each with their own requirements and IRB determinations, apply to research with pregnant women, human fetuses and neonates, as outlined below. IRB determinations regarding the applicable category and protocol-specific findings relative to the specific requirements of the relevant category should be clearly documented in IRB records. DHHS Regulations at 45 CFR 46 provide the following in pertinent part:

46.204 Research involving pregnant women or fetuses prior to delivery.

Pregnant women or fetuses prior to delivery may be involved in research if all of the following conditions are met:

(a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;

(b) The risk to the fetus is not greater than minimal, or any risk to the fetus which is greater than minimal is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus;

(c) Any risk is the least possible for achieving the objectives of the research;

(d) The woman’s consent or the consent of her legally authorized representative is obtained in accord with the informed consent provisions of subpart A of this part, unless altered or waived in accord with §46.101(i) or §46.116(c) or (d);

(e) The woman or her legally authorized representative, as appropriate, is fully informed regarding the reasonably foreseeable impact of the research on the fetus or resultant child;

(f) For children as defined in 45 CFR 46.402(a) who are pregnant, assent and permission are obtained in accord, with the provisions of subpart D of this part;

(g) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;

(h) Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and

(i) Individuals engaged in the research will have no part in determining the viability of a fetus.

46.205 Research involving fetuses after delivery.

(a) After delivery, fetuses may be involved in research if all of the following conditions are met:

(1) Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to fetuses.

(2) The individual(s) providing consent under paragraph (b)(2) or (c)(5) of this section is fully informed regarding the reasonably foreseeable impact of the research on the fetus or resultant child.

(3) No inducements, monetary or otherwise, will be offered to terminate a pregnancy.

(4) Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy.

(5) Individuals engaged in the research will have no part in determining the viability of a fetus.

(6) The requirements of paragraph (b) or (c) of this section have been met as applicable.

46.206 Research involving, after delivery, the placenta, the dead fetus, or fetal material.

(a) Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local laws and regulations regarding such activities.

(b) If information associated with material described in paragraph (a) of this section is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.

c. Research Involving Prisoners. DHHS regulations at 45 CFR Part 46, Subpart C detail special protections for research involving prisoners, who, due to their incarceration, may have a limited ability to make truly voluntary and uncoerced decisions about whether or not to participate as subjects in research. A prisoner is defined as any individual involuntarily confined or detained in a penal institution. In order to consider research involving prisoners, the IRB must:

i. Have a majority of its members not otherwise associated with the prison.

ii. Include a prisoner or a prisoner advocate, who can adequately represent the interests of the prisoners, unless the research has already been reviewed by an IRB that included a prisoner advocate.

Approval of research involving prisoners must

i. Make the seven additional findings set forth in 45 CFR 46.305 that are listed below.

ii. Determine which category in 45 CFR 46.306 permits the research to go forward.

iii. If the research is DHHS-supported, certify these findings to OHRP. Certification to OHRP is not required for research not supported by DHHS. However, OHRP recommends that the IRB apply the standards of Subpart C to all prisoner research. Should non-DHHS research fall outside the category stipulations under 45 CFR 46.306, OHRP recommends that the IRB consult with appropriate experts before approving the research.

Under DHHS regulations, prisoners may participate in the following categories of research:

i. Studies (involving no more than minimal risk or inconvenience) of the possible causes, effects, and processes of incarceration and criminal behavior.

ii. Studies (involving no more than minimal risk or inconvenience) of prisons as institutional structures or of prisoners as incarcerated persons.

iii. Research on particular conditions affecting prisoners as a class (providing the Secretary of HHS has consulted with appropriate experts and published the intent to support such research in the Federal Register).

iv. Research involving practices that have the intent and reasonable probability of benefiting the prisoner subject. If the research involves possible assignment to a control group that may not benefit from the research, the Secretary of HHS must also consult with appropriate experts and publish the intent to support the research in the Federal Register (45 CFR 46.306).

The following additional determinations must be made by the IRB before research involving prisoners goes forward (45 CFR 46.305):

i. The research under review is limited to one of the categories of research listed above.

ii. Any possible advantages accruing to the prisoner through his or her participation in the research, when compared with the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired.

iii. The risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers.

iv. Procedures for selecting subjects within the prison are fair to all prisoners, and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the IRB justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project.

v. The information is presented in language that is understandable to the subject population.

vi. Adequate assurance exists that parole boards will not take into account a prisoner’s participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole.

vii. Where the board finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoner’s sentences, and for informing participants of this fact.

D. Research Involving Children. DHHS regulations at 45 CFR Part 46, Subpart D and FDA Regulations at 21 CFR 50 Subpart D require special protections for research involving children. Under the regulations, children are persons who have not attained the legal age for consent to treatments or procedures involved in the research under the applicable jurisdiction in which the research will be conducted.

The IRB will consider three main issues when reviewing research involving children: (1) risk-benefit analysis; (2) parental permission; and (3) assent of the child.

i. The IRB must make certain findings and determinations when reviewing research involving children. IRB records must reflect the IRB’s understanding and justification for the risks and benefits posed by approved research involving children. Proposed research must fall within one of the following four categories:

(a) Research not involving greater than minimal risk.

(b) Research involving greater than minimal risk, but presenting the prospect of direct benefit to the individual subjects.

(c) Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition.

(d) Research not otherwise approvable, which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

ii. Each category stipulates specific conditions that must be met before the proposed research can be approved. These conditions are summarized in the Table at the end of this Chapter.

iii. The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining when children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in 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, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement where (a) the research involves no more than minimal risk; (b) the waiver will not adversely affect subjects’ rights and welfare; (c) the research could not practicably be carried out without the waiver; and (d) when appropriate, the subjects will be provided with pertinent information after participation.

iv. The IRB should take great care in approving research where the child is suffering from a life-threatening illness with little real chance of therapeutic benefit from the research. IRBs should also take great care in allowing the parents to overrule the child’s dissent where experimental therapy has little or no reasonable expectation of benefit.

v. If it is deemed appropriate that the child’s assent should be solicited, the assent form should be tailored for the child, with respect to his or her level of understanding. For young children, the assent form should be a relatively brief document, with simple, age-appropriate language, presented in a manner understandable to the child.

E. Research Involving Decisionally Impaired Subjects. Decisionally impaired persons are individuals who have or may develop a diminished capacity for judgment and reasoning due to a psychiatric, organic, developmental, or other disorder that affects cognitive or emotional functions. Other individuals who may be considered decisionally impaired, with limited decision-making ability, are individuals under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps.

In cases where research involving cognitively impaired individuals is approved, IRBs may require additional safeguards (e.g., involvement of subject advocates, independent monitoring, formal capacity assessment, waiting periods) as part of the research plan to protect participants.

F. Research Involving Other Potentially Vulnerable Adult Subjects. Employees, students, and trainees at ND should also be considered vulnerable subjects. Thus, the IRB should uphold the same standards in approving research involving these groups as other research with vulnerable subjects.

The context of the research is an important consideration for the IRB to consider when reviewing research that involves other potentially vulnerable subjects. Research involving homeless persons, members of particular minority groups, or the economically or educationally disadvantaged pose significant challenges. Research involving significant follow-up procedures or offering significant monetary compensation may unduly influence certain types of subjects, and the IRB must take such considerations into account.

G. Fetal Tissue Transplantation Research. Human fetal transplantation research supported by DHHS is governed by Public Law 103-43.

The University of Notre Dame follows the Ethical and Religious Directives for Catholic Health Care Services, which specifically addresses the topic of fetal tissue for research purposes. For guidance on this issue, please contact the IRB Office.

H. Research Involving Deceased Persons. Research involving deceased persons is not covered by the FDA or DHHS human subject regulations.

Chapter 19. Qualitative Studies

For qualitative studies involving interaction with participants, the questions to be asked should be provided.

Researchers using participant observation or anthropological field work methods should be specific regarding where and among whom observations will be recorded and how subjects will identify themselves.

The IRB discourages covert participant observation in which the investigator conceals his or her identity as a researcher and will require a clear justification for this approach. The investigator must demonstrate that the research could not be conducted overtly and that participants will not be harmed or exposed to undue risk.

Procedures for obtaining informed consent in participant observation studies must be explicitly described in the Methods section of the application. Participant observation conducted in public settings ordinarily do not require formal consent. However, if observers interact with people, they must explain how they will introduce themselves and assure that people are aware that they are researchers. Participant observation conducted in private settings (e.g., homes, private clubs) requires informed consent by central participants.

Between public and private settings are quasi-public settings in which general members of the public do not normally have access, but in which persons do not have a reasonable expectation that their behavior will not be observed by a large number of others. Examples include schools, hospitals, and factories. The IRB will determine whether or not formal informed consent is required in quasi-public settings on a case-by-case basis according to the feasibility of obtaining consent and the potential risks to participants. Formal, scheduled interviews with people in quasi-public settings ordinarily will require formal consent; casual interviews will not as long as the person is aware of the researcher’s identity and has the opportunity to decline to talk (e.g., the investigator should ask, “Do you mind speaking with me about your work?”).

For minors, parental consent and children’s oral assent for participant observation among children in quasi-public settings will not be required if the investigator does not interact with children (for this purpose, interaction is defined as any conversation or questioning beyond normal civil behavior; e.g., “Good Morning,” “Excuse me,” “You dropped your pencil”), none of the individual children is a focus of the research, and information is not recorded about children in a manner in which they could be identified by anyone outside of the setting.

Chapter 20. Statement On Oral Histories

The U.S. Office for Human Research Protection (OHRP), part of the Department of Health and Human Services (HHS), working in conjunction with the American Historical Association and the Oral History Association, has determined that oral history interviewing projects in general do not involve the type of research defined by HHS regulations and are, therefore, excluded from Institutional Review Board oversight.

A decision whether oral history is subject to the policies and regulations outlined in an institution’s FWA and HHS regulations for the protection of human research subjects is based on the prospective intent of the investigator and the definition of “research” under HHS regulations at 45 CFR 46.102(d), i.e., “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

i. Oral history activities, in general, are designed to create a record of specific historical events and, as such, are not intended to contribute to generalizable knowledge. Only those oral history projects that conform to that regulatory definition of research need to submit their research protocols for IRB review.

ii. Researchers are urged to contact the IRB if in doubt about whether a project requires review.

iii. Some oral history interviewing projects may meet the definition of research. Other activities involving open-ended interview that have similar characteristics can involve research as defined by the HHS regulations when the activities are part of a systematic investigation designed to develop or contribute to generalizable knowledge.

iv. The evaluation of whether oral history activities require IRB review hinges upon whether the person is engaged in the creation of “generalizable knowledge.” In other words, does the activity represent a systematic investigation in which the historian intends to develop or contribute to generalizable knowledge?

Chapter 21. Preparation and Time for IRB Review

A properly prepared application that meets all IRB criteria for approval is the best assurance of timely IRB approval. Submitting an application at ten (10) business days before the IRB meets is strongly recommended. IRB meetings for the semester are posted on the OVPR website. Researchers should be aware that IRB approval is not guaranteed on first review and the possibility exists that researchers may encounter delays in beginning their projects. Thus, researchers are strongly encouraged to submit their protocols in advance of their start dates to allow for possible delays.

A possible delay in the expected project start date is not considered sufficient reason to expedite IRB consideration of a study outside the normal meeting agenda. Researchers may need IRB approval before they can make arrangements and/or obtain approval from individuals responsible for the physical location of their studies such as a school, a homeless shelter, or a treatment center. Assuring that appropriate location officials, such as owners, administrators, and/or supervisors, have been contacted and have granted permission to conduct research in a specific location/room/building is an essential element of ethical research. Approval letters or e-mails from the appropriate officials or supervisors should be included with the application or submitted as soon as received. Researchers may not begin recruiting study participants until their IRB applications have been formally approved, and they have received the official approval letter from the IRB.

Studies are expected to begin within six months of the date that IRB approval is granted. Under special circumstances, the IRB will consider applications for which the start date is more than six months in the future. However, if a researcher makes any substantive changes to his/her study in the interval between IRB approval and the start date, the researcher must submit an application for approval of those changes.

Chapter 22. Managing Conflicts of Interest

A. Federal Regulations and the Common Rule. The Federal human subject regulations and the Federal Policy (Common Rule) prohibit IRB members, chairs, or staff who have a conflicting interest from participating in the IRB’s initial or continuing review of research. The IRB meeting agenda includes a statement reminding the board members that no member of the IRB may participate in the review of any project in which the IRB member is an investigator, has a financial conflict of interest, or has any other interest which has an adverse impact on the IRB member’s ability to exercise independent judgment.

i. Such conflicts must be disclosed, and the IRB member, chairperson, or staff member must not take part in the discussion or voting of such research, except to answer questions from the IRB.

ii. IRBs may consider any matter that raises the possibility of coercion or undue influence in the consent process. The existence of an investigator conflict of interest would fall within this category.

iii. As a matter of policy, this institution requires disclosure of any potential conflicts of interest to appropriate institutional officials or committees established for this purpose. Adherence to this disclosure requirement is a routine condition for IRB approval of research.

Chapter 23. Protecting Research Data

In social and behavioral research, breach of confidentiality is a serious risk posed to research subjects. Rigorous data security is a key element of protecting subject data from an accidental or malicious breach. Data security includes a plan to manage the physical documentation associated with the project, such as paper surveys, signed consent forms or documents that contain contact information for subjects, to insure that those materials are not lost or accessed inadvertently by an unauthorized person. Increasingly important is the management of electronic data on desktops or servers as well as on mobile devices such as laptops and flash-drives.

The University of Notre Dame has issued guidelines for all researchers to ensure that research data are appropriately protected. Protecting this important data requires a commonsense approach to managing your computer systems. All university researchers need to be aware of common vulnerabilities and then take necessary steps to shield those vulnerable areas.

An important component in the IRB approval process is whether adequate provisions exist for the security of research data. When conducting research, investigators are entrusted with confidential and privileged human subject information, whether in paper or electronic form and must take measures to protect the security of this information. For IRB approval, PIs are required to:

1. Describe procedures (including safeguards for collecting, storing, processing subject data and data destruction) for minimizing potential risks to subject’s confidentiality.

2. Specify where and under what conditions individuals will have access to the data, what will be available and to whom.

Please consider the following when preparing your IRB application:

1. The IRB expects researchers to access only data that are necessary to conduct the study. Collect only minimum necessary information. Social security numbers and full birth date (mo/day/year) are protected information that generally should not be collected.

2. In the informed consent document, PIs must describe protection and confidentiality of records.

3. Keep data at a secure location. A secure location is a place to which only the PI and authorized research staff have access.

4. Limit electronic access to any computer that contains subject identifiers by password protection. Avoid storing data on portable devices, as these devices are susceptible to loss of theft. If the PI needs to use these devices, remove identifiers from data files and associate them with codes kept in a separate location. The data should be encrypted.

5. Avoid storing subject identifiable data on portable devices (such as laptop computers, cell phones, digital cameras, portable hard drives including flash drives, USB memory sticks, iPods or similar storage devices), as these devices are particularly susceptible to loss or theft. If there is a necessity to use portable devices for initial collection of subject identifiers, the data files must be encrypted, and subject identifiers transferred to a secure system as soon as possible.

6. If subject identifiers will be retained in the data files because of the specific needs of the research study, additional justification must be provided by the Investigator to justify retention. Again, if the data are stored electronically the files must be encrypted.

7. Use only secure modes of transmission of data; data submitted over a public network should be encrypted

8. If there is an unanticipated breach of confidentiality of the research data, the PI must report this to the IRB within 5 business days of becoming aware of the event.