Q. Is my survey project really human
A. Most surveys do meet the federal definition of research. 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. If the answer is "yes," investigators must follow up with a second determination: Does the research involve human subjects? Both determinations must be made using the definitions of the terms "research" and "human subjects" in 45 CFR 46.102 (a-j):
Research-"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." Investigators unsure of whether an activity constitutes human research should contact their IRB.
Human subjects-"living individual(s) 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." Activities in which a researcher collects private, identifiable information about third parties would meet the definition of "human subjects."
Examples of activities that do not meet these definitions would be (1) ad hoc evaluations of a workshop or symposium (not a systematic investigation), (2) sample surveys on employee satisfaction within one company if the goal is to identify areas for improvement within that company (not designed to contribute to generalizable knowledge) or (3) an analysis of 1880 census records (not information about living individuals).
Q. I think my project is exempt and should
not have to be submitted. Are all research projects involving human
subjects required to undergo full IRB Committee review?
A. No. 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 exemption status rests with the IRB or with an administration official named by your institution. The determination does not rest with the investigator. Therefore, all projects must be submitted to the IRB for initial review. Some IRBs have special forms for requests for exemptions while others use the same application materials for all projects.
Exempted projects 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.NOTE: Exemption categories cannot be applied to research involving fetuses, pregnant women, children, human in vitro fertilization, or prisoners. In the case of studies where pregnant women might be part of the subject pool (e.g., RDD or other surveys) but are not a target population, some IRBs may deem the study as eligible for exemption while others may not.
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.
Q. My survey doesn't meet the requirements
for exemption. Does that mean it has to be reviewed by the full IRB
A. Not necessarily. Federal regulations allow expedited review if the protocol meets one or more of the specific criteria listed below. The process varies from institution to institution but typically, the IRB chair or his/her designee reviews protocols and may either approve them or refer the protocol to the full Board for review at the next meeting. The categories for expedited review are as follows (45 CFR 46.110(a)):
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.According to the Federal regulations and Category 7, most survey research that is not otherwise exempt is eligible for expedited review. However, 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 subjects= 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)
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.
Q. Do I always have to get informed
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 andMost survey research meets the requirements for waivers of signed consent, because surveys conducted outside of a research context rarely require written consent. However, it is important to note that it is the investigator's responsibility to request waivers of documentation of consent, and the investigator's rationale for a waiver may or may not be compelling to the IRB.
the research involves no procedures for which written consent is normally required outside of the research context
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.
The following elements of consent are required by the Federal regulations (45 CFR 46.116(a)). The first set lists the requirements for all research. The second set is required only if deemed appropriate or applicable by the IRB.
(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.
(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.
Q. Can any of the required elements be
waived by the IRB?
A. Yes. If there is a compelling reason to waive one or more elements, then the IRB may do so (45 CFR 46.116(d)). In the context of minimal risk survey research on mundane topics, where potential subjects might refuse to participate rather than listen to a lengthy informed consent process, an investigator might wish to minimize respondent time burden by requesting a waiver of one or more elements in the oral consent process and offering instead to provide the information in response to a subject's question. For example, some IRBs have agreed to waive the required "explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights" if it is available to any subject requesting it. Importantly, it is the investigator's responsibility to request waivers of consent or any specific elements of consent, and the investigator's rationale for a waiver may or may not be compelling to the IRB.
The Federal regulations (45 CFR 46.116(d)) state that IRBs may approve a waiver of consent or any specific elements of consent if the IRB determines:
Q. What is considered minimal
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)). Most, but not all, surveys meet this definition.
Q. What is the difference between
'anonymous' and 'confidential'? How can confidentiality be
A. According to the Federal regulations (45 CFR 46.101(b)), survey research may be exempt from the regulations unless "the information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects" or if "federal statues(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter." The former refers to anonymous research. Anonymous means entirely without name or identifier, so the individual cannot be discerned in any way by anyone. No one can link an individual person to the responses of that person, including the investigator. For this reason, face-to-face interviews are never anonymous. If phone numbers are not stored, then RDD telephone interviews could be considered anonymous. Mailback questionnaires are considered anonymous only if no tracking codes are utilized.
Confidential means that the investigator can (or could) identify individuals who participated in a study, perhaps through a code. Although the identities 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 exemption 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.
Q. 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, 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. IRB requirements may vary regarding the age at which a signed form is required.
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.
Q. I'm not asking any sensitive
questions. Does my survey still need to be reviewed by the
A. Yes. All research must be reviewed by the IRB. If the project is minimal risk, then it may qualify for exemption from review or be handled in an expedited review by the IRB. The specific decision rests with the IRB or with an administration official named by your institution, not with the investigator.
Q. May I ask a respondent to tell me
personal details about other family members?
A. It depends. This question deals with an issue known as third party consent. Although the Federal regulations do not deal with this issue explicitly, the question has received increasing discussion over the last several years. Many IRBs would conclude that, when an investigator conducting research obtains identifiable private information about a living individual, that individual becomes a research subject, regardless of whether that person is the individual with whom the investigator is having an interaction. For example, if the research involves asking the primary subject to provide identifiable private information about a third party (also known as a secondary subject), that third party then becomes a subject in the research. As such, all of the regulatory requirements for protecting that individual obtain.
IRBs may differ in their interpretations of "identifiable private information." To better understand the issues of interpretation, consider two examples: (1) an unemployed person provides household income information for a two-person household in which only one household member is employed; (2) a mother provides health information about the father of her child. In the first example, the information is identifiable, but may not be considered private. In the second example, the information is private, but may not be considered identifiable if no identifying information was gathered about the father. However, if an IRB determines that these examples represent "identifiable private information" (as it may reasonably do), then the Federal regulations require informed consent from the employed person or the father before such questions are asked of the unemployed person or the mother.
The IRB can determine whether informed consent needs to be sought from third party subjects. The IRB can also determine whether this consent may be waived. The Federal regulations (45 CFR 46.116(d)) state that IRBs may approve a waiver of consent if the IRB determines that the research poses no more than minimal risk to the secondary subject, that the rights or welfare of the secondary survey would not be adversely affected, that the research could not be practicably conducted if consent from the secondary subject were required, and that, if appropriate, there be a plan to provide the waived consent information to the secondary subject after the conclusion of the study.
Investigators whose research may involve secondary subjects are encouraged to contact the IRB to discuss how to best protect the rights and welfare of these subjects in a given project. Other information on the issue of third party information is available at:
Q. My IRB does not have any survey
experts among its members. What right do they have telling me how to
improve my survey and why are they questioning the science rather than
the subject protections?
A. During their review of research, IRBs are expected to make a determination about whether any risks to subjects are reasonable relative to the expected benefits. When determining whether the risks to subjects are outweighed by the benefits of the research, the IRB may take into account the merits of the scientific design (45 CFR 46.111(a)(2)). If the scientific merit is deemed marginal, then the IRB may determine that there will be no benefit and that any risk is therefore unwarranted.
Rather than reject marginal research outright, some IRBs will tell investigators how to improve the scientific merit of the research. The regulations specify that the IRB must include persons knowledgeable in the specific research areas being reviewed (see 45 CFR 46.107a), with sufficient "experience and expertiseâ€¦to promote respect for its advice and counsel." . Although many issues are common across social science methods, some are not. In cases where expertise is lacking on an IRB, the IRB should seek consultation from experts outside the IRB for assistance in a review. Investigators should consider asking about expertise and suggesting colleagues that might be knowledgeable about the specific research areas being reviewed. Investigators can also direct the IRB to the AAPOR website for additional information and assistance regarding issues related to human subject protections when utilizing survey methods.
Q. Is it OK to pay respondents for their
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, IRBs 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.
Q. If the respondent completes my survey,
she must have agreed to participate. Why do I need a separate consent
A. In many cases, documentation of consent (the signature on a physical consent form) may be waived for questionnaires or interviews. Unless there is more than minimal risk, many IRBs will waive the documentation and allow the investigator to provide the relevant consent information in the form of a cover letter, introductory statement (in an interview), or introductory screen display (in a web survey). In cases where there is greater than minimal risk, a waiver of documentation may still be appropriate if the survey is anonymous because the signed consent form would be the only part of the study that identifies a subject. In other cases (e.g., surveys of minors), many IRBs will require documented permission granted by the parent or guardian.
Q. If I have approval for my survey from
one IRB, why would I need approval from other IRBs?
A. Under the current system, IRBs have local control and review protocols in the context of the local and community attitudes. Hence, approval from an IRB in another place or institution is not considered sufficient if there is also a local IRB in place. Therefore, protocols require review at the investigator's institution even if they have been reviewed and received approval from a co-investigator's IRB. IRBs do, however, have the option of relying on another qualified IRB in order to avoid duplication of effort (45 CFR 46.114). Don't expect your IRB to defer jurisdiction if you have direct contact with the subjects. But if you are only acting in an advisory role, only adding a few questions to an omnibus survey, or only engaged in analysis issues, then your limited role in the research may convince your IRB to rely on the qualified IRB at another place or institution. The regulations permit, but do not encourage, such actions for cooperative research projects.
Q. Do I need IRB approval to put a survey
A. 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.
Q. When conducting data collection
through email or web surveys, what unique features of internet
communication and data storage must be addressed?
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.
Q. My IRB wants me to state the possible
harms that might come from a survey that does not include any highly
sensitive questions. What should I tell them?
A. In some cases, the IRB may want only an explicit statement in the consent information indicating that risks are minimal and are no greater than those encountered in day-to-day life. In other cases, even demographic items might be viewed as "potentially harmful" by some IRBs if, for example, knowledge of income, religious affiliation, or educational attainment might pose a social risk in some contexts if the data were made public. In these cases, the introductory consent information might include disclosure that general items about income and education will be included in the interview. For other surveys of more sensitive topics, possible harms include embarrassment, psychological distress, or discomfort as a result of question content (e.g., surveys of private behaviors, abuse, or crime victimization). Some IRBs may require investigators to include the explicit statement that respondents may skip any item that they do not wish to answer. Additionally, mere contact may put a potential subject at risk depending on the survey and its target population. For example, the act of contacting individuals who have completed rehabilitation programs could be damaging if their families did not have knowledge about their treatment. All of these potential risks will be important to the IRB and will need to be anticipated and addressed by the investigator in order to provide adequate subject protections.
Q. I want to access administrative
records to develop a sample frame for a health survey. What are the key
issues related to consent for this and other studies?
A. Investigators sometimes want access to existing records in order to identify potential subjects or in order to conduct research. If the investigator will record subjects' names (either for further record review or for personal contact), this activity requires IRB review. The IRB will determine whether the consent of subjects should be sought before the researcher gains access to the records; in some cases, a waiver can be granted. When determining whether it is appropriate to waive the requirement to obtain consent from these subjects, the IRB considers the sensitivity of the information being recorded, the vulnerability of the subject population, and other risks to the subject. The IRB also considers whether the rights or welfare of the subjects would be adversely affected by the waiver, the purpose for which the investigator wants access to the information, and the practicability of conducting the research without the waiver. In some cases, consent cannot be waived. For example, the Buckley Amendment [the General Education Provisions Act (20 USC 1232), also known as FERPA] requires written parental permission for release of records or identifiable information about children in public schools. It is also important to note that recent HIPAA (Health Insurance Portability and Accountability Act) regulations are applicable to most medical records and may impact access and/or the ability of IRBs to grant consent waivers.
Q. Does the IRB/human subject protection
guidance also apply to pilot studies, questionnaire development, and
testing efforts conducted with members of the population?
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.