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Institutional Review Board (IRB) FAQs

  1. What is the IRB?
  2. Why have an IRB?
  3. What is the Belmont Report?
  4. What is the Common Rule?
  5. What is the authority of the IRB?
  6. What is research?
  7. What is a human participant?
  8. What is research involving human participants?
  9. How do I know if I should request review of my research project by the IRB?
  10. I am working with a student on a research project. Does this require IRB review?
  11. What if my project involves photography, video or audio recordings as art rather than research characterized by systematic study and generalizable knowledge?
  12. Are oral histories subject to IRB oversight?
  13. What is the difference between scholarship being "excluded" and "exempt"?
  14. Is my research exempt?
  15. Why do I need to submit a protocol for a project that in my own judgment meets the exemption criteria?
  16. What are some common items that may move research from the "Exempt" category to "Expedited" or "Full" review?
  17. Is my research expedited?
  18. What is minimal risk?
  19. What is informed consent?
  20. What should I include in my informed consent form?
  21. Under what conditions can some part of consent be waived?
  22. Can informed consent ever be obtained orally?
  23. How can I obtain informed consent from a non-English speaker or What if written informed consent is not culturally appropriate?
  24. Does the IRB really want me to follow the consent form template? I have my own ways of expressing things.
  25. What should I consider as I contemplate the benefits of my research to participants?
  26. I am not sure how to maintain the confidentiality of my participants. What are some ways to maintain confidentiality?
  27. What are the main areas of concern to Bridgewater's IRB when reviewing protocols?
  28. It is possible to know who reviewed my project?
  29. What are the submission deadlines?
  30. When will I find out about approval of my project?
  31. What happens if my project is not approved?
  32. Can I make changes to my proposal once it has been approved?
  33. I already have IRB approval from another institution. Do I need to obtain IRB approval through Bridgewater College as well?
  34. What is deception in research and when can I use it?
  35. Can I get approval of a project after the data are collected?
  36. Can I offer course credit to students participating in my study?

 

1. What is the IRB?
The acronym IRB stands for "Institutional Review Board.” The mission of an IRB is to ensure the safety, dignity, and fair treatment of human research participants as stipulated by the Belmont Report, and to assist researchers in maintaining compliance with Title 45 Code of Federal Regulations, Part 46 Protection of Human Subjects.

At Bridgewater, the IRB is composed of six faculty members selected to reflect the demographics and range of academic disciplines (e.g., natural sciences, social sciences, arts, and humanities) of the campus. The board also includes one community member who is not affiliated with the institution and an administrator whose role is to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice (45 CFR 46.107).

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2. Why have an IRB?
The goal of IRB review at Bridgewater is to help researchers examine their research design so that 1) human participants are recruited and treated ethically, and; 2) participants feel their consent to participate is fully informed by an accurate consideration of the risks and benefits of participating.

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3. What is the Belmont Report?
The Belmont Report summarizes the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Research. Three basic principles identified by the Belmont report are particularly relevant to the ethics of research involving human subjects and guide the IRB’s review of research: the principles of respect for persons, beneficence, and justice.

The principle of respect for persons asserts that individuals should be treated as autonomous agents, and that persons with diminished autonomy are entitled to protections.

The principle of beneficence requires researchers to maximize the possible benefits and minimize the possible harms of participation in research.

The principle of justice requires that these benefits and risks be fairly or equitably distributed among participants of research.

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4. What is the Common Rule?
In 1991, the U.S. Department of Health and Human Services (HHS) issued a set of revised regulations for protecting the rights and welfare of human research subjects delineated in Title 45 Code of Federal Regulations, Part 46 Protection of Human Subjects. These regulations, known as the Common Rule, constitute the core regulatory structure for federally-funded research involving human participants, and is subscribed to by at least sixteen federal departments and agencies, among them the National Science Foundation, the Department of Agriculture, the Department of Education, and the Department of Defense.

For a thorough review of the common rule see Pritchard, I.A. (2001). "Searching for "˜Research Involving Human Subjects': What is Examined? What is Exempt? What is Exasperating?" IRB: Ethics & Human Research, 23, no. 3, pg 5-12.

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5. What is the authority of the IRB?
Both federal regulations and state law as delineated in Title 45 Code of Federal Regulations, Part 46 Protection of Human Subjects, and Virginia Code 32.1-162.16-20, define the authority of an IRB to approve, require modifications in, or disapprove all research activities outlined in these laws.

The Bridgewater College IRB is authorized to review student, faculty, and staff research involving human participants, and to refer ethical or other violations to appropriate institutional authorities for sanction.

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6. What is research?
The Bridgewater College IRB does not seek to define what constitutes research within any discipline. These decisions are rightfully left to each discipline. To determine the research activities for which IRB review may be applicable, the IRB assesses whether (1) the research is systematic (i.e., having a formal protocol); (2) is designed with the intention to test a hypothesis or explore a research question, and; (3) whether it will develop or contribute to generalizable knowledge (i.e., the researcher draws generalizable conclusions that inform policy, promote theory development, or contribute to revision of current knowledge, theories or principles.).

As cited in Pritchard, I.A. (2001). "Searching for "˜Research Involving Human Subjects': What is Examined? What is Exempt? What is Exasperating?" IRB: Ethics & Human Research, 23, no. 3, pg 5-12.

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7. What is a human participant?
"Human participant" refers to a living individual about whom an investigator (whether professional or student) obtains data (46.102). Under federal definition, human participants are referred to as "human subjects." Other terms used by various disciplines to describe human participants include "participant," "consultant," and "collaborator."

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8. What is research involving human participants?
Research that involves an:
a. intervention with human participant(s) in which data is collected from the participant(s);
b. interaction between the researcher and the human participant(s) (i.e., communication or interpersonal contact) or observation by the researcher in which data is collected from the participant(s); or
c. information collected about a human participant(s), which is private (i.e., individual can reasonably expect that no observation or recording is taking place) and readily identifiable.

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9. How do I know if I should request review of my research project by the IRB?
If your scholarly activity constitutes research with the intent to generalize and involving human participants, as outlined in FAQ #6 - 8, then it falls under the purview of the IRB. If a research project qualifies for IRB review an application should be submitted and approved prior to data collection. (See IRB Decision Table.)

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10. I am working with a student on a research project. Does this require IRB review?
The IRB delegates to instructors the responsibility for ensuring that the rights and welfare of human participants are adequately protected when student research involves only a minimal risk to participants and is conducted as part of standard educational practice. Therefore, class projects involving human participants would be excluded from IRB oversight unless the students or professors intend to generate generalizable research (i.e., it constitutes research involving human participants, see FAQ #9).

Students conducting honors or independent projects that are applicable to IRB review should seek IRB approval. When a student is listed as a principal investigator, a faculty member must provide assurance and advise the project.

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11. What if my project involves photography, video or audio recordings as art rather than research characterized by systematic study and generalizable knowledge?
There are many types of scholarship and only a small number of these fall under the auspices of the IRB. Although this project represents one of many types of scholarly activity, it does not require IRB review because it does not constitute research involving human participants as dictated by the Federal Regulation. Yet it should be noted that there might be scholarly activities, like artwork, that still need to be cognizant of the welfare of human participants. Therefore, all scholars are encouraged to look at discipline-specific protocols for protecting the welfare of participants (e.g., model consent documents).

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12. Are oral histories subject to IRB oversight?
Oral histories present a particularly complicated and ambiguous category in relation to IRB oversight. Oral histories may be used in a wide variety of different ways in a research project.

Whether or not oral histories are subject to IRB oversight may be determined to a large degree by understanding whether the research project incorporating oral histories falls within the federal definition of research (systematic study; generalizable knowledge). Some research involving oral histories incorporates systematic study leading to generalizable knowledge according to federal definitions and is, therefore, subject to IRB oversight. An example might include an ethnographic study undertaken by an anthropologist or sociologist that will or has the potential to contribute to the knowledge base of the field (i.e., developing or contributing to theories and principles or informing policy). Some oral histories are incorporated into projects that are not defined as research under federal regulation. Examples might include folklore research or artistic creations such as documentaries, which may contain a definable point of view but do not attempt to draw conclusions and, therefore, do not contribute to generalizable knowledge.

Whether or not oral histories are subject to IRB may also be determined by the disciplinary context in which they are used. For example, the American Historical Association and Oral History Association recently requested and were granted by OHRP exclusion from IRB oversight for most oral history research. In other words, oral histories in this context were deemed not to represent research as federally defined and are thus not subject to IRB oversight but rather were subject only to discipline-specific standards. Other disciplines, such as the American Folklore Society and the American Anthropological Association advocate that researchers conducting ethnographic or folklore research, in which oral history is a method, work with their institution's IRB to ensure the welfare of participants are appropriately protected.

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13. What is the difference between scholarship being "excluded" and "exempt?"
The committee recognizes that the difference between these two terms may be confusing. "Excluded" describes scholarship that does not fall into the purview of IRB review. Examples of scholarship activities that would typically be deemed excluded include: works of a creative nature (novel, poetry), research taking place in a laboratory without any human participation, studies that are not generalizable (“How Bridgewater students feel about the alcohol policy”), etc. The term "exempt" is used to describe research that qualifies as research involving human participants, but the federal regulations deem as exempt from the policy. It may be better to think of this research as "exempt from further review."  IRB applications are submitted for exempt scholarship, but not for scholarship that is excluded. 

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14. Is my research exempt?
Not all research with human participants needs IRB review according to federal code 46.101 b (1-6). However, since the federal regulations can be subject to interpretation, institutions including Bridgewater College believe that an IRB must determine if a particular research project is exempt from further review. The main advantage to having exempt status is to remove the need for annual review by the IRB, but exempt status does not eliminate the need for ethical treatment of human participants.

The Bridgewater College IRB will provide exempt review for proposed research that is considered exempt from federal regulation guidelines as stated in 45 CFR 46, Protection of Human Subjects (46.101). Exemption is appropriate for research activities that fall under one or more of the categories listed below:

  • Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricular or classroom management methods. This category may include children.
  • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants; and (ii) any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employment or reputation. Research that deals with sensitive aspects of the participant's own behavior such as illegal conduct, drug use, sexual behavior or use of alcohol cannot be exempt from review due to issues of confidentiality.
  • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) for which participants cannot be identified or release of the information would not be harmful to the subject. This category may include children.
  • Research involving the use of survey procedures or interview procedures or observation of public behavior for which participants cannot be identified or release of the information would not be harmful to the subject. This category may not include children.
  • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior if the human participants are elected or appointed public officials or candidates for public office (regardless of personal identifiable information). Research that deals with sensitive aspects of the participant's own behavior such as illegal conduct, drug use, sexual behavior or use of alcohol cannot be exempt from review due to issues of confidentiality.
  • 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 participants cannot be identified, directly or through identifiers linked to the participants. This category may include children.
  • Research and demonstration projects that are conducted by or subject to the approval of federal department or agency heads and that are designed to study, evaluate or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. This category may include children.
  • Taste and food quality evaluation and consumer acceptance studies (i) if wholesome foods without additives are consumed or (ii) 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 U.S. Food and Drug Administration or approved by the Environmental Protection Agency or the Food and Safety and Inspection Service of the U.S. Department of Agriculture. This category may include children.
  • Research projects that have undergone IRB approval at another institution.

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15. Why do I need to submit a protocol for a project that in my own judgment meets the exemption criteria?
Not all research with human participants needs IRB review according to federal code 46.101 b (1-6). However, since the federal regulations can be subject to interpretation, institutions including Bridgewater College believe that an IRB must determine if a particular research project is exempt from further review.

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16. What are some common items that may move research from the "exempt" category to "expedited" or "full" review?

  • Collecting blood from research participants.
  • Collecting other biological samples (urine, hair, DNA) from research participants.
  • Making recordings, voice and/or video, of the research participants.
  • Collecting data with identifiers such as name, SSN, college ID.
  • Asking survey questions about sensitive aspects of the participant's own behavior such as illegal conduct, drug use, sexual behavior or use of alcohol cannot be exempt from review due to issues of confidentiality.
  • Research involves vulnerable populations not limited to pregnant women, prisoners, the cognitively impaired and children in some cases.

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17. Does my research qualify for expedited review?
Research can qualify for expedited review if the project poses no more than minimal risk to participants and meets other requirements, or if minor changes are made to previously approved protocols. The activities listed below may be considered for expedited review (45 CFR 46.110) if they also pose only minimal risk to participants (see FAQ #18):

  • Research on individual or group characteristics or behavior (including, but not limited to, experimental 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.
  • Collection of data from voice, video, digital or image recordings made for research purposes.
  • Research involving materials (data, documents, records or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
  • Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 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.
  • Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows: from healthy, nonpregnant adults who weigh at least 110 pounds. For these participants, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than two times per week or from other adults and children (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), considering the age, weight and health of the participants, the collection procedure, the amount of blood to be collected and the frequency with which it will be collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than two times per week.
  • Prospective collection of biological specimens for research purposes by noninvasive means. Examples: hair and nail clippings in a nondisfiguring manner, excreta and external secretions (including sweat), 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, mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washing, sputum collected after saline mist nebulization.
  • Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Examples: 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, weighing or testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography, moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight and health of the individual.

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18. What is "minimal risk"?
To meet the federal recommended definition for minimal risk, any risks in the research should be defined as equal to or less than the risks normally encountered in the daily lives or the routine medical and psychological examination of healthy subjects. Determining if a research project has more than minimal risk should include evaluation of potential physical, psychological and social harms. The research director and IRB committee should carefully evaluate whether the proposed participants would be more sensitive or vulnerable to the risks posed by the research as a result of their general condition or disabilities. If so, the procedures would constitute more than minimal risk for those subjects. These concerns are equally applicable to other subjects. Here are some examples of more than minimal risk:

  • Physical: taking a blood sample or pulling a tooth may represent significant risk to a hemophiliac; outdoor exercises might be dangerous to persons with asthma if the air is polluted or saturated with allergens; modest changes in diet might be dangerous to diabetics
  • Psychological: will a survey of 9-11 survivors cause strong feelings of depression or guilt; staging a fake heart attack would cause significant stress to participants
  • Sociological: would a breach of confidentiality cause a loss of employment or criminal prosecution; would the information cause "stigmatization" of the research participant

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19. What is informed consent?
The process of informed consent is based on the principle of respect for the rights of others to make informed decisions concerning participation. Researchers must provide research participants with sufficient knowledge about the purpose of the research and the type of involvement in the study and the potential risks and benefits of participation. Based on this knowledge, participants can then make an informed decision as to whether they would like to engage in the research project or not. All investigators are requested to secure written informed consent of the participant or the participant's legally authorized representative, unless a waiver is granted (see FAQ #21 for waivers to informed consent).

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20. What should I include in my informed consent form?
An informed consent form (hereafter ICF) will contain a number of statements written in clear language appropriate for the intended participants. According to federal regulation, the following represent standard elements for informed consent:

  • 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 basic description of the procedures to be followed, and identification of any procedures that are experimental;
  • a description of any reasonably foreseeable risks or discomforts to the subject;
  • a description of any benefits to the subject or to others that may reasonably be expected from the research;
  • a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  • a statement describing the extent to which confidentiality of records identifying the subject will be maintained;
  • 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;
  • an explanation of whom to contact for answers to pertinent questions about the research and research participants' rights and whom to contact in the event of a research-related injury to the subject; and
  • 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 (45 CFR 46.116a).

Please refer to the following documents for further elaboration of these basic components and other necessary items not mentioned above.

Federal Regulations on Informed Consent Documents

Bridgewater College Consent Form Templates

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21. Under what conditions can some part of consent be waived?
There are circumstances where the Bridgewater IRB will consider waiving requirements for a signed consent form from each participant. To receive a waiver of consent, studies must pose no more than minimal risk to non-vulnerable participants. A waiver may also be granted if the signed document actually increases risks or is culturally inappropriate (see below).

The federal regulations do not allow a waiver of informed consent simply because the conditions of informed consent are difficult to carry out or because the conditions make it difficult to enroll subjects into the research. However, the IRB may grant a waiver of some portion of informed consent under the following conditions:

  • the research involves no more than minimal risk to the participants;
  • the waiver or alteration will not adversely affect the rights and welfare of the participants;
  • the research could not practicably be carried out without the waiver or alteration;
  • signed consent increases risk (e.g. informed consent form would be the only way to identify subjects in a minimal risk study such as on-line survey)
  • whenever appropriate, the participants will be provided with additional pertinent information after participation.

Following 45 CFR 46.117, "An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context." Following 45 CFR 46.116, "In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research."

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22. Can informed consent ever be obtained orally?
In short, yes, but only under specific conditions. Informed consent does not always take the form of a document stipulating all the elements specified in the templates (see above). The Federal Regulations allow the consent process to occur orally. Regulations concerning oral consent and use of the short-form for written consent can be found in the federal regulations 45 CFR 46.116 & 45 CFR 46.117.

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23a. How can I obtain informed consent from a non-English speaker?
The Federal Regulations require that "The information that is given to the subject or the representative shall be in language understandable to the subject or the representative."

Thus, you should have a version of your informed consent document prepared in the language of your intended participants, whether that is English, Spanish, Chinese, etc. Furthermore, the document should be in language that is readable by the general public. You should avoid scientific jargon wherever possible and try not to write in "legal-ese."

Alternatively, you might seek oral consent (following the guidelines above) in the participant's native language (through a translator/witness) and ensure that the short-form consent document and the summary are both in language intelligible to the translator/witness.

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23b. What if written informed consent is not culturally appropriate or understandable to the intended subject or representative?
The Federal Regulations require that "The information that is given to the subject or the representative shall be in language understandable to the subject or the representative."

If written informed consent is not culturally appropriate (e.g. if the participants do not have a standardized written form of language or if the participant is illiterate), then you should follow the guidelines for oral consent as specified above.

Alternatively, you might request a waiver of some portion or all of the consent process, though such waivers do require increased review to ensure the safety of the participants. See the discussion of waiver of the consent process above. Furthermore, depending on the nature of the research, illiterate participants may be considered members of a vulnerable population.

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24. Does the IRB really want me to follow the consent form template? I have my own ways of expressing things.
The IRB does NOT require that you copy the template verbatim, changing only the necessary portions to suit your research, you are welcome to use your own wording and style. However, the eight (8) basic elements required by 45 CFR 46.116 must be present in some form (see FAQ #20). If you wish to alter or omit one or more of these items you will have to make sure that your application is sufficiently detailed so that the IRB can establish whether a waiver of the specified portion(s) of consent are appropriate for your research (see above).

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25. What should I consider as I contemplate the benefits of my research to participants?
It is important to carefully plan the ethical aspects of your study from the very beginning. The Belmont Report provides a useful and accessible framework for thinking ethically about both risks and benefits of research to human participants. Risks and benefits to participants are specifically addressed in Part 2, Assessment of Risks and Benefits. Benefits, according to the Belmont Report, are "something of positive value related to health and welfare." Risks and benefits may affect individual subjects, their families and the larger society.

Benefits of research to individual participants are most important and most straightforward. Much more complicated are situations in which the relationship between risks to participants and benefits of broader knowledge resulting from the research must be weighed. In all situations, the researcher's first priority is to minimize risk and to protect the rights of the participant.

While risks and benefits to participants must both be considered, benefits must go beyond the potential absence of harm to research participants. Specific benefits of the research study to participants should be identified and, to the extent possible, quantified. In designing a study, one should overestimate risks and underestimate benefits.

Finally, a useful rule of thumb in considering benefits to research participants is to ask yourself: Would I honestly want someone I love to participate in this study?

Practically speaking, the IRB will weigh the risks and benefits when considering a proposal. Where there is little risk there does not need to be great benefit so don’t be afraid to say that there are no direct benefits to the participant. Section II of the IRB application is requesting information about direct benefit to the patients (e.g. extra credit, a monetary incentive, learning about their health status, free medications, etc.)

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26. I am not sure how to maintain the confidentiality of my participants. What are some ways to maintain confidentiality?
Maintaining confidentiality of participants, both during the project and after the research is complete, is essential to ethical research but can be complicated depending on the nature of the research study. IRB Guidebook, Chapter 3, Part D, "Privacy and Confidentiality" provides an overview of basic methods that may be used to protect confidentiality, and outlines a variety of problems and complicating circumstances related to maintaining confidentiality.

In most cases, maintaining confidentiality involves routine practices that many researchers will be familiar with such as: substituting numeric codes or pseudonyms for identifiers (e.g. names), removing face sheets (containing such items as names and addresses) from survey instruments containing data, conducting interviews in private locations and transcribing them with headphones on, limiting access to identified data, training research staff about the importance of confidentiality, and storing records (e.g. code sheets, surveys, interview transcripts) in separate locked cabinets. Additional measures thus include storing data on password protected computer systems or encrypting confidential identifying information and the avoidance of emailing or otherwise sharing unencrypted data. When appropriate, a waiver of documentation of consent may be the best way to ensure confidentiality of an on-line survey or interview where there is no other identifying data collected. See guidelines for when it is appropriate to request a waiver of consent.

In some studies, more complex methods may be needed in order to create a situation in which participants are willing to participate fully and honestly in the study or to be able to strongly and honestly assure participants that confidentiality will be maintained, especially in studies involving collection of sensitive data related to sexual behavior or criminal studied, for example. Please see the IRB Guidebook for further discussion.

It should also be noted that there are certain types of research projects in which the degree of confidentiality may vary. For example, the American Folklore Society states that most participants in folklore research want to be acknowledged for their contributions and expertise in books, articles and displays. In such cases, researchers inform participants of identifiable information as part of the consent process and maintain confidentiality when requested by participants, or when information is collected that might place a participant at risk. (See the AFS Position Statement on Human Subjects and Ethnographic Research, http://www.afsnet.org/?page=HumanSubjects)

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27. What are the main areas of concern to Bridgewater's IRB when reviewing protocols?
The IRB is concerned with respect for persons, beneficence and justice, as outline in the Belmont Report. All IRB applications are individually reviewed with these major principles guiding decisions. When reviewing a protocol the IRB will use the following criteria to determine the approval of the project. (45 CFR 46.111) (Note: Some of these criteria may not apply to certain research designs or review types):

  • Minimal risk to participants.
  • Risks are reasonable in relation to benefits to participants and information gained from the project.
  • Selection of participants is equitable and appropriate considerations have been made for vulnerable populations.
  • Informed consent procedures are adequate and in accordance with federal regulations.
  • Researchers make adequate provisions for monitoring the data collection to ensure the safety of participants.
  • Provisions are in place to protect the privacy and confidentiality of the participant.

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28. It is possible to know who reviewed my project?
Yes. The names of current IRB committee members can be found on the IRB website. The type of review application submitted determines who will review the proposed research project. For Exempt Review applications two members will review the proposed project. Expedited review applications will be reviewed by three IRB members, including an IRB officer. Full review applications will be reviewed by the entire IRB committee. The reviewer’s names will be recorded on the IRB decision letter.

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29. What are the submission deadlines?
Exempt and Expedited applications can be submitted any time and during the academic school year they will be reviewed within 10 business days, as outlined in the IRB policies and procedures documents. Full review applications must be submitted 1 week prior to an IRB meeting to be considered that month; meeting dates are posted each semester on the IRB website. Occasionally the committee will determine that applications submitted as exempt or expedited need to be reviewed by the full committee, this would happen at the next regularly scheduled meeting, therefore in order to avoid a month long delay it is advisable to have all applications submitted at least 1 week prior to the scheduled meeting for that month.

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30. When will I find out about approval of my project?
Typically, IRB exempt and expedited review will take no more than 10 business days and you will receive a decision letter from the IRB Chairperson within 3 business days of a decision being made. Once the application is submitted the process of review will begin by the committee almost immediately. In some circumstances, review may take longer than 10 business days or require full committee review which happens once per month (dates are posted on the IRB website). If your application is being reviewed by the full committee you will receive a decision within 3 business days after the monthly IRB meeting. Review will take longer during summer months. Investigators are encouraged to submit applications as early as possible.

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31. What happens if my project is not approved?
When a proposal is not approved the IRB committee will offer a detailed written explanation as to why. The committee may also suggest changes to the study. The researcher will be encouraged to resubmit the application to the IRB committee once changes are made. If you choose to appeal a decision you can do so, the process is outlined in the IRB Policies and Procedures.

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32. Can I make a change to my proposal once it has been approved?
If changes need to be made to the research protocol previously approved by the IRB, the investigator should submit an Application for Amendments to Research Projects. A member of the IRB will review the proposed changes and provide a prompt decision regarding approval (no more than 10 working days). Note that project changes may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to participants.

Researchers who have received IRB project approvals should also advise the IRB promptly of any unanticipated problems involving risks to participants.

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33. I already have IRB approval from another institution. Do I need to obtain IRB approval through Bridgewater College as well?
Yes, if you are collecting data on the Bridgewater Campus or if your research participants will be Bridgewater students, staff, or faculty. If a research project has undergone IRB review at another institution, an IRB approval letter from the cooperating institution may be submitted with the Bridgewater application form to the Bridgewater IRB with a request for exempt review. If you are not affiliated with Bridgewater College then you must also have a campus contact and approval from the Dean of Academic Affairs to conduct research at Bridgewater.

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34. What is deception in research and when can I use it?
Deception in research involves withholding information from or deliberately giving false information to human participants about the hypothesis or methods of a research project. Deception cannot be used in order to obtain consent from human participants. From the APA guide to ethics (http://www.apa.org/ethics/):

  • Researchers do not conduct a study involving deception unless they have determined that the use of deceptive techniques is justified by the study's significant prospective scientific, educational, or applied value and that effective nondeceptive alternative procedures are not feasible.
  • Researchers do not deceive prospective participants about research that is reasonably expected to cause physical pain or severe emotional distress.
  • Researchers explain any deception that is an integral feature of the design and conduct of an experiment to participants as early as is feasible, preferably at the conclusion of their participation, but no later than at the conclusion of the data collection, and permit participants to withdraw their data.

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35. Can I get approval of a project after the data are collected?
No. All projects involving the active participation of human participants require approval from the IRB prior to data collection. Retroactive or post-hoc IRB approval is prohibited by the federal regulations.

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36. Can I offer course credit to students participating in my study?
Yes you can, but there are some issues that require consideration to ensure that the credit provided is reasonable and non-coercive. In particular, the Bridgewater IRB requires that any awarded credit satisfy the following four elements: (1) the credit may not exceed a reasonable amount and may not be coercive; (2) any faculty member awarding credit for participation must give fair access to alternative means of earning equivalent credit; (3) the amount of credit awarded for participation in a study must be equitable among faculty members awarding such credit; and (4) faculty members awarding such credit must sign IRB's Course Credit Acknowledgment Form agreeing to award credit consistent with the requirements of the study (see the Application and Forms Section on the side menu). The principal investigator is responsible for insuring compliance with the aforementioned elements and retaining the forms as documentation. For more information on these issues see the Federal IRB Guidebook, Chapter 6.