Institutional Review Board

Frequently Asked Questions1

1. Q: What is the Institutional Review Board (IRB)?

2. Q: What are the historical origins of IRBs?

3. Q: How is Pitzer College’s IRB administered?

4. Q: Who is on the Pitzer IRB?

5. Q. How do I submit an application to the Pitzer IRB for review?

6. Q: When will I find out about the status of my application?

7. Q: Is my project research?  Is it human subjects research?

8. Q: If I am conducting research involving animals, is there a parallel approval process?

9. Q: What is considered minimal risk?

10. Q: Are there special provisions for “vulnerable populations?”

11. Q: Are any human research activities exempt from IRB review?

12. Q: Do course-related projects involving human subjects require IRB review?

13. Q: Do students carrying out senior theses, senior projects, or independent studies involving human research need to submit applications for IRB approval?

14. Q: Does the IRB/human subject protection guidance also apply to pilot studies and questionnaire development?

15. Q: I'm not asking anything about the respondent. I want to know only about the place where she works. Does my survey still need to be reviewed by the IRB?

16. Q: I'm not asking any sensitive questions. Does my survey still need to be reviewed by the IRB?

17. Q: Do I need IRB approval to put a survey online?

18. Q: If I am doing research involving human subjects and I wish to recruit students, faculty, or staff at the other Claremont Colleges either in person or electronically (via email or web), will the Pitzer IRB approval be sufficient?

19. Q: How do I contact the IRBs at the other Claremont Colleges?

20. Q: What types of actions does an IRB take?

21. Q: What types of research projects are exempt from full IRB review?

22. Q: What is the difference between an expedited and a full review?

23. Q: Do I always have to get informed consent?

24. Q: What are the elements of consent that must be provided to subjects?

25. Q. I want to do a survey of high school students or children, do I need parental consent? What is assent?

26. Q: What is the difference between 'anonymous' and 'confidential'? How can confidentiality be maintained?

27. Q: Is it OK to pay respondents for their participation?

28. Q: When conducting data collection through email or web surveys, what unique features of internet communication and data storage must be addressed?


1. Q: What is the Institutional Review Board (IRB)?

A: Institutional Review Boards (IRBs) are committees designated by an institution to review research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of people involved in research.

The Pitzer College Institutional Review Board (IRB) is required by federal regulations to review all human subjects research activities conducted for which: (1) the conduct or recruitment of the research involves Pitzer College resources (property, facility or funding, including extramural funds administered by Pitzer College); (2) the research is conducted by or under the direction of any employee, student or agent of Pitzer College in connection with his or her institutional responsibilities; (3) the research is conducted by or under the direction of any employee, student or agent of Pitzer College using any property or facility of Pitzer College; or (4) the research involves the use of Pitzer College's non-public information to identify or contact human research subjects or prospective subjects.

Pitzer files a Federalwide Assurance (FWA) with the Department of Health and Human Services/Office of Human Research Protections (DHHS/OHRP).  Pitzer College’s FWA assures the government and the public that it will comply with federal regulations for the protection of human research subjects.

The function of the IRBs is to ensure adherence to all federal, state, local, and institutional regulations concerning the protection of the rights and welfare of human subjects participating in research. Pitzer College’s IRB review is required for both funded and non-funded human subjects research.

The IRB's role at Pitzer extends to all research involving human subjects whether conducted by faculty, staff, or students. The purpose of the IRB is to inform and protect human subjects used in research. The IRB acts as an advocate for the research subject. This means that the IRB, during its review of a research project and the informed consent, has the right and responsibility to ensure that the research subject is fully informed of the procedures involved in the study as well as the risks.

2. Q: What are the historical origins of IRBs?

A: IRBs have been implemented to prevent unethical treatment of human subjects. The history of contemporary human subjects protections began in 1947 with the Nuremberg Code, developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the Nazis. The Code captures many of what are now taken to be the basic principles governing the ethical conduct of research involving human subjects. Similar recommendations were made by the World Medical Association in its Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects, first adopted in 1964 and subsequently revised many times. Basic regulations governing the protection of human subjects in research supported or conducted by HHS (then the Department of Health, Education and Welfare) were first published in 1974.

In the United States, there were a series of highly publicized abuses in research. Perhaps the best known of these is the Tuskegee Study. The Tuskegee Study was a federally funded study. The purpose of the research project was to determine the progression of untreated syphilis over several decades. The research subjects included a large number of working-class, African-American men with syphilis. The men in the study were NOT informed they were subjects in a research study. And, the men in the study were NOT offered treatment with penicillin even after it became available. Many men in the study died from complications related to syphilis. When this breach of ethics became publicly known in the middle of the 1970s, the federal government created legal requirements for an external process for review and approval of research done using federal funds.

This and other abuses led to the enactment of the 1974 National Research Act (Public Law 93-348), which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the National Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines to assure that such research is conducted in accordance with those principles. In 1978, the Commission published “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” also known as the Belmont Report, named after the Belmont Conference Center where the Commission met when drafting the report. The Belmont Report identifies three fundamental ethical principles for all human subjects research: respect for persons, beneficence, and justice.

Based on the Belmont Report and other work of the National Commission, HHS revised and expanded its regulations for the protection of human subjects in the late 1970s and early 1980s. The HHS regulations are codified at 45 CFR part 46, subparts A through D. The statutory authority for the HHS regulations derives from 5 U.S.C. 301; 42 U.S.C. 300v-1(b); and 42 U.S.C. 289. The regulations found at 45 CFR part 46 are based in large part on the Belmont Report and were written to offer basic protections to human subjects involved in both biomedical and behavioral research conducted or supported by HHS.

In 1991, 14 other Federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46 of the HHS regulations. This uniform set of regulations is the Federal Policy for the Protection of Human Subjects, informally known as the “Common Rule.” In 1995 the Central Intelligence Agency was required by Executive Order to comply with all subparts of the HHS regulations.

Review of research involving human subjects is required by federal law. Federal laws and regulations regarding research on human subjects have specific requirements for IRB and study administration. The federal requirement for review of research by human subjects committee stems from experiences in the Tuskegee Study.

3. Q: How is Pitzer College’s IRB administered?

A: The college established the IRB as a standing committee with committee membership compliant with the Office for Human Research Protections (OHRP), a subsidiary of the US Department of Health and human Services. In order to be compliant with federal laws governing the protection of human research subjects, the college officially registers its IRB with the OHRP every two years. In addition, the college submits a Federal Wide Assurance (FWA) with the OHRP every second year.

4. Q: Who is on the Pitzer IRB?

A: Pitzer’s Institutional Review Board is not part of the College's standing committee structure. Its composition is governed by 45 CFR part 46.107.

The membership must represent diverse academic and personal backgrounds including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition, the IRB includes at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (§46.107).

The Dean of Faculty and Chair of Faculty Executive Committee (FEC) in consultation with the Associate Dean of Research recommends IRB members and the FEC approves the members.

Please refer to the irb homepage at www.pitzer.edu/irb for current membership and contact information.

5. Q. How do I submit an application to the Pitzer IRB for review?

A: Submission instructions, applications, and sample forms can be found at: www.pitzer/irb.

Only complete applications will be reviewed.  To avoid delays in securing IRB approval, please refer to the appropriate checklist to ensure that all necessary documents are included with your application.

Completed documents should be submitted to irb@sakai.claremont.edu

6. Q: When will I find out about the status of my application?

A: Please allow a minimum of two weeks for your application to be processed and reviewed.

7. Q: Is my project research?  Is it human subjects research?

A: In defining human subjects research activities, two separate determinations must be made:

The first determination is whether or not the activity can be considered research.  According to 45 CFR 46.102 (a-j), research is "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes."

If the answer is "yes" to the first question, investigators must follow up with a second determination: Does the research involve human subjects?

According to 45 CFR 46.102 (f), “Human subject” means a living individual about whom an investigator (whether professional or student) conducting research obtains

(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Investigators unsure of whether an activity constitutes human subjects research should contact the IRB.

8. Q: If I am conducting research involving animals, is there a parallel approval process?

Yes. Please refer to the JSD protocol on animal research.

9. Q: What is considered minimal risk?

A: Minimal risk means that the probability and magnitude of harm or discomfort anticipated 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 (45 CFR 46.102(i)).

10. Q: Are there special provisions for “vulnerable populations?”

A: The federal regulations require that IRBs 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 [Federal Policy §___.111].  Federal regulations set forth specific provisions on research involving fetuses, pregnant women, and human in vitro fertilization [45 CFR 46 Subpart B]; prisoners [45 CFR 46 Subpart C]; and children [45 CFR 46 Subpart D].

11. Q: Are any human research activities exempt from IRB review?

A: If research is done for a class project, does not include vulnerable populations, involves no more than minimal risk, and will not be presented or published (e.g., as a thesis, scholarly paper, or community forum), then this research does not require formal review. However, the IRB requests that the investigator complete the NIH training.

If an investigator begins a non-research project and later finds that the private identifiable data about living individuals gathered could develop or contribute to generalizable knowledge, the investigator must submit a proposal to the IRB for review and approval or certification of exemption from IRB review for the analysis of the data for research purposes prior to publication or presentation of the data (e.g., journal article, poster session, public speech or presentation, or project report).  Investigators who determine during the conduct of a non-research project that non-research project data derived from private identifiable information about living individuals could develop or contribute to generalizable knowledge must seek IRB approval at that time, prior to the collection or analysis of additional data which s/he intends to analyze for research purposes.

12. Q: Do course-related projects involving human subjects require IRB review?

A: Some projects assigned to students in graduate and undergraduate research methodology classes are designed to teach students skills and provide the opportunity to practice methods such as observation, interview, or survey techniques, data analysis, etc. and may have a research component.  Such classroom projects that are exclusively intended for instructional purposes and are not intended to develop or contribute to general knowledge or literature in the field need not undergo review by the IRB. However, instructors and students are expected to follow federal guidelines and College policy when designing and conducting class projects with human volunteers.  In addition, the IRB strongly recommends that the instructor and his/her class complete the NIH training.

When course-related projects are intended to develop or contribute to generalizable knowledge, they are subject to federal guidelines and are required to undergo IRB review and approval, prior to the initiation of the research activities, including contact or recruitment of subjects.

Pitzer College IRB encourages faculty members who anticipate that course-related projects may develop or contribute to generalizable knowledge to consult with the IRB early in the semester in which data will be collected.

13. Q: Do students carrying out senior theses, senior projects, or independent studies involving human research need to submit applications for IRB approval?

A: Yes.

14. Q: Does the IRB/human subject protection guidance also apply to pilot studies and questionnaire development?

A: Yes. The definition of research in the federal regulations includes research development, testing, and evaluation (45 CFR 46.102(d)). Some IRBs might not consider such studies research if they are not systematic but, overall, pilot studies and feasibility studies, including those involving only one human subject, require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in applications to the IRB. Ordinarily the data collected from subjects in a pilot or feasibility study are not used for study findings.

15. Q: I'm not asking anything about the respondent. I want to know only about the place where she works. Does my survey still need to be reviewed by the IRB?

A: Yes. The project may not meet the definition of human subject if the questions are not about any individual (attributes, attitudes, or private knowledge). However, this determination is sometimes difficult to make and the decision rests with the IRB, not with the investigator.

16. Q: I'm not asking any sensitive questions. Does my survey still need to be reviewed by the IRB?

A: Yes. All research must be reviewed by the IRB. If the project is minimal risk, then it may be handled in an expedited review by the IRB. The specific decision rests with the IRB, not with the investigator.

17. Q: Do I need IRB approval to put a survey online? (e.g., Survey Monkey)

A: Yes. Computer- and internet-based research protocols must address fundamentally the same risks (e.g., violation of privacy, legal risks, psychosocial stress) and provide the same level of protection as any other types of research involving human subjects. All studies, including those using computer and internet technologies, must

(a) ensure that the procedures fulfill the principles of voluntary participation and informed consent,

(b) maintain the confidentiality of information obtained from or about human subjects, and

(c) adequately address possible risks to subjects including psychosocial stress.

18. Q: If I am doing research involving human subjects and I wish to recruit students, faculty, or staff at the other Claremont Colleges either in person or electronically (via email or web), will the Pitzer IRB approval be sufficient?

A: No. Principal investigators affiliated with Pitzer College who wish to collect data at other institutions must gain initial IRB approval at Pitzer College and then seek IRB approval at the other institutions concerned.

19. Q: How do I contact the IRBs at the other Claremont Colleges?

A: Scripps College; Pomona College; Claremont McKenna College; Claremont Graduate University; Harvey Mudd College; (please note; HMC uses the CGU IRB).

20. Q: What types of actions does an IRB take?

A: All projects involving human research must be submitted to the IRB for review.  The chair makes an initial determination of whether the review will be expedited, and hence be carried out by one member of the IRB or a small subset of IRB members, or needs to be considered by the IRB as a whole (full IRB review). Federal regulations permit the exemption of some types of research from full IRB review and allow other research to be reviewed in an expedited process.

The determination of the type of review or exempt status rests with the IRB. The determination does NOT rest with the investigator.

21. Q: What types of research projects are exempt from full IRB review?

A: During the initial review, the IRB may give exempt status to an application. Note that this designation rests with the IRB and not with the individual investigator. The language in the federal regulation is somewhat confusing. The term “exempt” as it is used here does not mean that the project does not need IRB review.

Projects granted exempt status must meet one or more of the following criteria listed in 45 CFR 46.101(b):

Category 1 - Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (a) research on regular and special education instructional strategies; or (b) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods.

Category 2 - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: (a) information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects' responses outside the research could reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation. (Note: Exemption for survey and interview procedures does not apply to research involving children. Exemption for observation of public behavior does not apply to research involving children except when the investigator does not participate in the activities being observed.)

Category 3 - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under Category 2 above if: (a) the subjects are elected or appointed public officials or candidates for public office; or (b) federal statues(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Category 4 - Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to them.

Category 5 - Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to these programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.

Category 6 - Taste and food quality evaluation and consumer acceptance studies: (a) if wholesome foods without additives are consumed; or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

NOTE: Exemption categories cannot be applied to research involving fetuses, pregnant women, children, human in vitro fertilization, or prisoners.

22. Q: What is the difference between an expedited and a full review?

A: Expedited review is an option when the research activity will expose participants to no more than minimal risk and when the proposed study meets one or more of the specific criteria listed below. The IRB chair or his/her designee reviews protocols and may either approve them by expedited review or refer the protocol to the full IRB for review at the next meeting. The criteria for expedited review are as follows (45 CFR 46.110(a)):

An IRB may use the expedited review procedure to review either or both of the following:

(1) some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk,

(2) minor changes in previously approved research during the period (of one year or less) for which approval is authorized.

Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in §46.108(b).

Category 1 - Clinical studies of drugs and medical devices only when (a) the research is on drugs for which an investigational new drug application (21 CFR 312) is not required or (b) the research is on medical devices for which (i) an investigational device exemption application (21 CFR 812) is not required or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Category 2 - Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from (a) healthy, non-pregnant adults who weigh at least 110 pounds for whom (i) the amounts drawn do not exceed 550 ml in an 8 week period and (ii) collection does not occur more frequently than 2 times per week or (b) other adults and children, for whom, considering the age, weight, and health of the subjects, and the collection procedures, (i) the amount of blood to be collected does not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and (ii) collection does not occur more frequently than 2 times per week. (Note: Children are defined as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.")

Category 3 - Prospective collection of biological specimens for research purposes by noninvasive means, including, but not limited to: (a) hair and nail clippings, in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; and (j) sputum collected after saline mist nebulization.

Category 4 - Collection of data through non-invasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Such procedures include, but are not limited to: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; and (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. (Note: Where medical devices are employed, they must be cleared/approved for marketing.)

Category 5 - Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis).

Category 6 - Collection of data from voice, video, digital, or image recordings made for research purposes.

Category 7 - Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. According to the federal regulations and Category 7, most survey research that is not otherwise exempt is eligible for expedited review.

Note that the expedited review procedure may not be used "where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal." (63 FR 60364, November 9, 1998)

23. Q: Do I always have to get informed consent?

A: Yes. The informed consent process is a basic ethical obligation for researchers. It consists of providing adequate information to the subject about the study, giving the subject the opportunity to consider options, responding to questions the subject may have and ensuring that the subject or the legal representative (parent or guardian) understands the information (see 45 CFR 46.116). Consent must be obtained from the research subjects or their legally authorized representatives (parents or guardians) before participation in research begins. The regulations refer to a signed consent statement (45 CFR 26.117(a)).

However, the regulations also provide for some flexibility. If requested by the investigator, the IRB may waive the signature requirement for certain types of minimal risk research, such as surveys. This is referred to as a waiver of documentation of consent. Even when documentation is waived, the informed consent process must still occur. For example, IRBs have approved waivers of documentation when an introductory letter or introductory paragraph includes the elements of consent required. According to 45 CFR 46 Section 46.117 (c), an IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: the research presents no more than minimal risk and the research involves no procedures for which written consent is normally required outside of the research context or the principal risks are those associated with a breach of confidentiality concerning the subject's participation in the research and the consent document is the only record linking the subject with the research.

24. Q: What are the elements of consent that must be provided to subjects?

A: The following elements of consent are required by the federal regulations (45 CFR 46.116(a)). The first set (elements 1-8) lists the requirements for all research. Additional elements may be required by the IRB (see below).

(1) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

(2) a description of any reasonably foreseeable risks or discomforts to the subject;

(3) a description of any benefits to the subject or to others which may reasonably be expected from the research;

(4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(6) for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

(7) an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and

(8) a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Additional elements to be added as deemed appropriate by the IRB may include:

(1) a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;

(2) anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;

(3) any additional costs to the subject that may result from participation in the research;

(4) the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

(5) a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and

(6) the approximate number of subjects involved in the study.

25. Q. If I want to do a survey of high school students or children, do I need parental consent? What is assent?

A: Yes, you need parental consent. Because children have not yet attained legal age (18 years), the parent or legal guardian is asked to give permission for participation whenever a child is asked to take part in research (45 CFR 46.408(b)). Federal regulations require, however, that children be asked to provide assent, or agreement to participate in the research, whenever they are capable of doing so. Age, maturity and psychological state need to be taken into account when determining whether to ask for assent (45 CFR 46.408(a)). Out of respect for developing persons, it is important to involve children in the decision-making process whenever possible. Though they may not be able to give legal consent, they have the ability to assent or to dissent. It is important to keep in mind that a child's failure to object to participation should not automatically be construed as assent. Assent implies the affirmative, explicit agreement of the child. Usually children who are age seven and older are asked to provide verbal assent or, in some cases, sign an assent form, which is stated or written in language appropriate to the ages and conditions of study subjects. The assent should include a description of the study and describe any inconveniences and discomforts subjects may experience.

26. Q: What is the difference between 'anonymous' and 'confidential'? How can confidentiality be maintained?

A: The term “anonymous” means that the identities of the participants cannot be determined from materials gathered as part of the research. No one, including the investigator, can link an individual person to the responses of that person. For this reason, face-to-face interviews are never anonymous. If phone numbers are not stored, then random digit dialing (RDD) telephone interviews could be considered anonymous. Mailback questionnaires are considered anonymous only if no tracking codes are utilized.

The term “confidential” means that the investigator can (or could) identify individuals who participated in a study, perhaps through a code, put the identities of participants will not be revealed to third parties.

Although the identities of participants may be recorded, data can be kept confidential if they are carefully coded, if face sheets and consent documents are separated from survey instruments, if computer sheets and other papers are properly disposed, if access to identifiable data is limited, if research staff are educated about the importance of protecting confidentiality, and if records are stored in secured locations. More elaborate procedures may be appropriate for research involving sensitive data that may involve a greater risk should confidentiality be breached, and investigators may want to seek Certificates of Confidentiality to protect such data from subpoena. However, unless federal statutes mandate this confidentiality (e.g., statutes surrounding the decennial census), confidential surveys that are not anonymous are not eligible for exemption using these criteria. Confidential surveys may, however, still be eligible for exempt status if any disclosure of the human subjects' responses outside the research could not possibly place them at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation.

27. Q: Is it OK to pay respondents for their participation?

A: The regulations do not directly address payment of subjects. Whether or not individuals are paid for participating in research can depend on a number of factors, including availability of funds and the extent of effort on the part of study subjects. When subjects are reimbursed for direct expenses incurred due to research participation (e.g., parking and transportation), there is no ethical debate. However, the IRB will pay particular attention to inducement payments (e.g., payments for participation) to determine the effect that undue inducement could have on a prospective subject's ability to make an informed, voluntary choice about taking part in research. This is especially important when participation may include more than minimal risk. If compensation or the use of incentives is to be part of your study, it is important to include specific information in the IRB application and to provide detailed information about payment (including terms) in the informed consent information.

28. Q: When conducting data collection through email or web surveys, what unique features of internet communication and data storage must be addressed?

A: Electronic recruiting and data collection pose some additional challenges to human protections primarily in the area of confidentiality. The key challenges can be broken down into 4 areas:

RECRUITMENT: Computer- and internet-based procedures for advertising and recruiting potential study subjects (e.g., internet advertising, e-mail solicitation, banner ads) should follow the IRB guidelines for recruitment that apply to any traditional media, such as letters, telephone scripts, newspapers and bulletin boards. Authentication - that is, proper qualification and/or identification of respondents - is a major challenge in computer- and internet-based research and one that threatens the integrity of research samples and the validity of research results. Researchers should take steps to authenticate respondents. For example, investigators can provide each study subject (in person or by letter) with a Personal Identification Number (PIN) to be used for authentication in subsequent computer- and internet- based data collection.

DATA COLLECTION: It is often recommended that any data collected from human subjects over computer networks be transmitted in encrypted format. This helps insure that any data intercepted during transmission cannot be decoded and that individual responses cannot be traced back to an individual respondent. In addition, if the content of the responses would pose risk to the respondents if the information were shared, it is recommended that the highest level of data encryption be used, within the limits of availability and feasibility. This may require that the study subjects be encouraged or required to use a specific type or version of browser software. It should also be noted that encryption standards vary from country to country and that there are legal restrictions regarding the export of certain encryption software outside the US.

SERVER ADMINISTRATION: It is recommended that for online data collection a professionally administered survey server be used or that a) The server is administered by a professionally trained person with expertise in computer and internet security, b) Access to the server is limited to key project personnel and is configured with firewalls to minimize the possibility of external access to the server data, c) There are frequent, regularly scheduled security audits of the server, and d) The server is subject to the periodic security scans.

DATA STORAGE/DISPOSAL: If a server is used for data storage, personal identifying information and IP addresses should be kept separate from the data, and data should be stored in encrypted format. Data backups should be stored in a safe location, such as a secure data room that is environmentally controlled and has limited access. Competent data destruction services should be used to ensure that no data can be recovered from obsolete or discarded electronic media. For projects that are minimal risk, if these data security safeguards cannot be put in place, then language in the consent information should be added indicating that complete confidentiality cannot be guaranteed and/or that encryption of responses is not provided.

1Many of the questions and answers were adapted from http://www.aapor.org/irbfaqsforsurveyresearchers