These are areas the IRB has questions about from time to time. Investigators whose protocols will involve research in these areas will find the information under each area useful.Research with children
Guidelines for Reporting Sensitive Information
Online or Internet research
Advertisements and recruitment materials
Payments to Participants
Use of Pre-Existing Data
Use of Restricted Data
Human Tissues and Samples
Disclosure of Financial Conflicts of Interest
Children are considered a vulnerable research population because their intellectual and emotional capacities are limited and they are legally incompetent to give valid consent. Special procedures and considerations are, therefore, required by the Federal regulations for the review of research involving children. In reviewing protocols, the IRB will consider the degree of risk inherent in the proposed research and the methods for obtaining the assent of the children and the permission of parents or legal guardians.
Who is a child according to federal regulations?
"Children" or “minors” are 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 ( http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartd ). In most cases, these are individuals under the age of 21 years. However, in the state of Maryland, individuals are adults and of legal age (released from parental authority), when one attains the age of 18 years. Minors are those individuals who have not attained the age of eighteen years (source: http://mlis.state.md.us/asp/statutes_respond.asp?article=g1§ion=24&Extension=HTML).
Federal regulations state the IRB has the authority to review and approve, require modifications in (to secure approval), or disapprove all research activities. At the same time, the IRB must review degree of risk associated with the research. Risks to subjects are to be reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research.
When the IRB is assessing risk to children participating in research and evaluating a protocol application proposing to involve children, the IRB will consider the following issues:
- Is the participation of children as research participants justified in this particular instance?
- Has every effort been made to ensure that a parent is present when the research intervention is conducted? This will not only comfort the child but will enable the parent to exercise the right to end the child's participation in the research project at any time. Investigators should note that in some cases (e.g. research into sensitive personal matters, physical examinations of adolescents, research into abuse, etc.) it may not be appropriate to have a parent present. If a parent will not be present during the course of the project, has the investigator clearly stated why in the protocol?
- Are the personnel involved in the research, and the facility in which the research will be conducted, knowledgeable about and sensitive to the physical and psychological needs of the children and their families?
- Have the investigators taken into account the child-participant's previous experience with illness and medical interventions? Some children may be able to cope with stresses of research better than others as a result of previous experiences with medicine. Younger, "less experienced" children may be unprepared for participation in a research study.
- How the investigator determined the number of children to be enrolled for the study. Investigators should justify the number of subjects they propose to study.
- Whether the proposed techniques are the least invasive (physically and psychologically) in order to obtain the information for the study.
- Have the investigators clearly defined how the assent of the child-participants will be obtained?
- If this research question can be addressed initially in adults, has this work been conducted? If so, have results from this adult research benefit, or at least, not be harmful to children?
Obtaining consent and assent for participation
In almost all cases, written consent from a parent or legal guardian must be obtained if the research involves children under the age of 18. In cases where child abuse is an issue, the requirement for parental consent can be waived.
Documentation of assent is required for participants between the ages 7 and 18 years of age unless the participant is incapable, either mentally or emotionally, of being reasonably consulted about participating. The assent form, submitted to the IRB for review, should include a simplified version of the elements of informed consent, such as an explanation, at a level appropriate to the child's age, maturity and condition, of the procedure(s) to be used, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research.
(NOTE: Participants under the age of 18 will need to complete an Assent form; a separate parental consent form is required for these participants providing parental permission to participate).
In almost all cases, written consent from a parent or legal guardian must be obtained if the research involves children under the age of 18. Investigators need to consider how they will handle confidentiality if such situations should they arise. The permission and/or assent form should describe plans for disclosure—or non-disclosure—of such information to parents, legal authorities, and the subjects themselves.
Documentation of assent is required for participants between the ages 7 and 18 years of age unless the participant is incapable, either mentally or emotionally, of being reasonably consulted about participating. The assent form, submitted to the IRB for review, should include a simplified version of the elements of informed consent, such as an explanation, at a level appropriate to the child's age, maturity and condition, of the procedure(s) to be used, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research.
The sample assent and consent templates onthe below link has recommended wording for minors who are recruited to be participants in a study.
Click to download the consent and assent templates
Exempt research with minor children (under age of 18)
Research with children is eligible for exemption from IRB review involving these situations: 1) normal educational practices in commonly accepted educational institutions, 2) educational testing, and 3) observation in public settings. These activities fall under exemption categories (1) and (2), with the following provisions:
46.101(b)(1): Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. All data collected must be compiled as “groups of students” with no possible way to identify individuals, or compromise privacy or confidentiality.
46.101(b)(2): Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) also applies to children. Information must be obtained and recorded in such a way, that subjects cannot be identified.
Research and procedure involving surveys (such as longitudinal studies), interview procedures (of ethnographic nature) or observations of public behavior where the investigators participate in the activities being observed does NOT meet exemption classification. In these cases, investigators are involved in an intervention and/or interaction where privacy may be compromised.
Waiver of Parental/Guardian Permission
By regulatory definition, “children” are persons who have not attained the legal age for consent to treatments, procedures, or other activities involved in research. Since children are considered a vulnerable population, the IRB imposes additional protections on research involving children, in accordance with the 45 CFR Part 46, Subpart D. This includes the investigator obtaining the permission of parents or guardian through the consent process and of the assent of the child, and the IRB being able to make certain findings based on the level of risk and benefit of the research. Consent from a parent or guardian must always be an affirmative agreement to participate or to give permission for one's child to participate in research.
The IRB may waive parental or guardian permission if:
- the regular conditions for waiver of consent are met (see 45 CFR 46.116(c) or 46.117(d)); or
- the study focuses on a condition for which parental or guardian permission is not a reasonable requirement to protect the children and an appropriate mechanism is substituted, e.g. is of such private and sensitive nature that it is not reasonable to require permission, (for example, adolescents in studies concerning treatment of sexually transmitted disease); or
- a subject population for which parental or guardian permission is not a reasonable requirement to protect the children and an appropriate mechanism is substituted, e.g. is such that parental permission is not a reasonable requirement to protect the participants, (for example abused or neglected children). (45 CFR 46.408)
Click to download the sample waiver of parental permission
Research that does not pose greater the minimal risk
A waiver of the requirement for parental or guardian permission may be requested by the researcher in studies that do not pose greater than minimal risks to the subjects. In such research, prior parental notification could then be used as one mechanism for meeting the requirement in 46.408(c) that an "appropriate mechanism for protecting the children who participate as subjects in research is substituted." Researchers will be required to provide a detailed plan for fully informing parents/guardians about the potential study and document that the research meets the criteria found in 46.116(d). A letter or packet of information sent home to parents or guardians with information about the study (for example, with students as part of regular school mailings) would satisfy parental notification. The IRB may accept an alternative mechanism to protect the child participants (i.e., appoint a qualified child advocate). In accordance with the federal regulations, the IRB requires that the investigator obtain the assent of the children, if the children are capable of providing assent, and it is not waived. The IRB also needs to know how the affirmative assent of the child will be documented, e.g., signature on assent forms, documented by the investigator, or other.
In certain situations, studies that may have a risk/benefit ratio where the benefit is high and will make a positive impact on the life and welfare of the children population involved. In these cases, researchers may be interacting with subject groups where parents or guardians have a lower response rate and do not send in consent forms, even after repeated attempts. In other extreme cases, a parent or guardian may not have the capability or knowledge to decide what is in a child's best interests.
Classroom or school based research
Research is ordinarily NOT suitable for a waiver of permission if it involves any of the following issues:
· parental political affiliations or beliefs
· mental or psychological problems
· sexual behavior or attitudes
· illegal, antisocial, or self-incriminating behavior
· appraisals of other individuals with whom the minor has a familial relationship
· relationships legally recognized as privileged (lawyers, doctors, clergy), or
· religious affiliations or beliefs.
More than minimal risk research
One cannot obtain a waiver of parental consent for research that involves more than minimal risk unless the research involves issues of child abuse or neglect or other situations where obtaining parental permission might increase the risks to the child participants. In such cases parental consent may be waived. However, the investigator must supply an appropriate mechanism and justification for obtaining consent from someone serving as an advocate for the child.
In situations where the protocol involves more than minimal risk, parental consent alone may NOT be sufficient. A recent ruling by the Maryland state appeals court (downloadable in .pdf format, Grimes v. Kennedy Krieger - 366 Md. 29) affects how researchers in Maryland may conduct research with children that involves more than minimal risk. Although this ruling pertained to medical research, UMBC investigators, who plan to involve children in more than minimal risk studies, must carefully design protocols that will sufficiently provide protections from potential research harms. That is, investigators cannot use a placebo control group if a more effective intervention is available. Protocol submissions will require full board review.
In the course of certain types of research, investigators may discover sensitive information about subjects that is not related to the study itself which would be reported the appropriate authorities. Examples of such information include sexual activity, STDs, use of illegal substances, or suspected child abuse. It is important for investigators to be aware of the signs of child abuse, reporting responsibilities, and where to report any suspicion. Investigators who work with at-risk minors, for example, will need to demonstrate their qualifications and capability of working with this population, as the IRB views these children as particularly vulnerable.
UMBC Investigator Responsibilities
Investigators have ethical and legal obligations whenever child abuse is discovered. Investigators should be aware that, in most cases, the same reporting expectations pertain in research settings as those acting in a professional capacity (e.g. health practitioner, police officer social workers, etc.).
Any researcher working with children must be familiar with Maryland law requiring reports of suspected child abuse or neglect. According the USM Board of Regents (BOR) Policy on the Reporting of Suspected Child Abuse and Neglect (VI-1.50), University researchers who, when acting in a professional capacity have reason to believe that a child has been abused or neglected, have the obligation to report this suspicion. The Frequently Asked Questions on the UMBC Office of Human Relations provide specifics on what has to be reported, who is required to report, when a report should be made and to whom this report must be made. In essence, if UMBC researchers have reason to believe abuse is occurring or has OCCURRED IN THE PAST, they must make a report to the local police department or the local department of social services and to UMBC’s President’s Designee for USM Policy on the Reporting of Suspected Child Abuse and Neglect.
Review the Research with Children link for specific information on what to include when submitting applications and consent/assent documents for IRB review.
In some cases, it may be appropriate for the PI to seek an NIH Certificate of Confidentiality.This certificate is issued by the National Institutes of Health (NIH) to protect the privacy of research subjects by protecting investigators and institutions from being compelled to release information that could be used to identify subjects with a research project. However, researchers are not prevented from the voluntary disclosure of matters such as child abuse, reportable communicable diseases, or subject's threatened violence to self or others. See http://grants.nih.gov/grants/policy/coc/ for information as to whether this is applicable for a particular study.
The incidence of on-line or Internet research has increased exponentially over the years, rapidly advancing ahead of efforts to create effective compliance guidelines. Internet communities (such as mailing lists, chat rooms, newsgroups, or discussion boards on websites) are rich sources of qualitative data for researchers. The IRB believes that online and Internet-based research protocols must address potential risks (e.g., violation of privacy, legal risks, and psychosocial stress) and provide the same level of protection as any other types of research involving human participants.
All studies, including those using computer and Internet technologies, must ensure that the procedures fulfill the principles of voluntary participation and informed consent, maintain the confidentiality of information obtained from or about human participants, and adequately address possible risks to participants including psychosocial stress and related risks. Participation by minors must be addressed in the protocol application.
The following guidelines are offered to help researchers plan, propose, and implement on-line or Internet research:
Online and internet-based procedures for advertising and recruiting study participants (e.g., internet advertising, e-mail solicitation) must follow the IRB guidelines for recruitment that apply to any traditional media, such as newspapers and bulletin boards.
It is strongly recommended that data collected from human participants 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. The highest level of data encryption should be employed, within the limits of availability and feasibility. Participants may be required to use a specific type or version of browser software.
All personal identifying information should be kept separate from the data, and data should be stored in encrypted format. Researchers are advised to use pseudonyms when reporting results.
Observation of Internet activity:
This usually involves such activities as gathering information about the use of the Internet, recording user information or users’ comments. Examples include: participant observation of an on-line discussion group, using "cookies" to track web sites visited, or asking visitors to a web site to provide demographic information. The human subjects issues involved in this type of research generally involve consent/disclosure issues. Investigators need to indicate to the IRB how they intend to obtain the subjects' consent to use this information for research. As with other types of participant observation, investigators generally must disclose their role as researchers to the group participants.
For anonymous web-based surveys, participants would still need to be presented with the consent information and level of potential risk as a result of participating in the research, but would be informed that their consent is implied by submitting the completed survey. Other web-based surveys must include "I agree" or "I do not agree" buttons on the website for participants to click their choice of whether or not they consent to participate. A cover letter/consent page should indicate that by clicking on a "I agree" link, subjects are consenting to participate. This page should also include an e-mail address in addition to a telephone number to withdraw consent and remove data, to the extent possible, upon request of the respondent.
Click to download a sample web-based survey cover page
E-mail solicitations requesting participation in a study should contain a version of the approved cover letter and consent forms. Participants must be informed that by replying to the e-mail and completing the requested task(s) constitutes consent. With all of the above cases, researchers must request a Waiver of Written Informed Consent from the IRB, documenting how and why written consent would not be appropriate, and what format will be used to provide consent information to participants.
Confidentiality or Anonymity:
Researchers conducting web-based research should be careful not to make guarantees of confidentiality or anonymity, as the security of online transmissions is in question. Investigators need to address how they intend to assure confidentiality, keeping in mind that the degree of concern over confidentiality is directly related to the sensitivity of the data. Data transmitted via e-mail cannot be anonymous without the use of additional steps. Because respondents' electronic addresses are typically provided when they return such surveys by e-mail, PIs should devise a plan for stripping such information to maintain the confidentiality and anonymity of respondents' names.
The researcher should also state how the confidentiality of the data will be maintained, for instance, when a survey will be posted online through a third party like Survey Monkey or Zoomerang, so that email addresses or web URLs will not be noted by the researcher.
Data submitted over the web can only be anonymous if software is used to store the information directly in a database without identifiers; otherwise identifiers are attached to the data. Web servers automatically store a great deal of personal information about visitors to a web site and that information can be accessed by others.
Association for the Advancement of Science, Ethical and Legal Aspects of Human Subjects Research on the Internet (.pdf)
Association of Internet Researchers, Ethical decision-making and Internet research
American Psychological Association, Psychological Research Online: Report of Board of Scientific Affairs' Advisory Group on the Conduct of Research on the Internet
All oral history interviews should conform to the principles and standards of the practice, such as those proposed by the Oral History Association. These interviews may, in their design and/or implementation, contribute to generalizable knowledge which would constitute “research” as defined by DHHS regulations at 45 CFR part 46.
These general principles do apply to how UMBC researchers conduct oral history research. Specifically, two of these principles* reflect the IRB's ethical review mission to confirm that participants are allowed to review the material prior to public archive and decide if they do not wish any or all of the oral history archived as well as ensuring researchers make provisions for obtaining informed consent from all participants and document the process. These are:
Oral historians inform narrators about the nature and purpose of oral history interviewing in general and of their interview specifically.
Oral historians insure that narrators voluntarily give their consent to be interviewed and understand that they can withdraw from the interview or refuse to answer a question at any time. Narrators may give this consent by signing a consent form or by recording an oral statement of consent prior to the interview.
UMBC uses an Oral History consent form to document the conversation. A template of this form is found here.
Interviewees hold the copyright to their interviews until and unless they transfer those rights to an individual or institution.
This is done by the interviewee signing a release form or in exceptional circumstances recording an oral statement to the same effect. UMBC uses a Deed of Gift which grants to the interviewer authorization to make any use of the content of recordings and the permission to deposit the recordings into one or more publicly accessible archives. The interviewee has the right to restrict access to all or portions of this interview or to place other access restrictions. The interviewee also has the option to remain anonymous in any interview transcript. The Deed of Gift may be obtained from the Martha Ross Center for Oral History.
At present, to meet its oversight responsibility, the UMBC IRB does require oral history researchers to submit an Exempt Application for review prior to initiating the study. Projects that may not fall within this classification may review expedited or full board review. Please contact the ORPC at firstname.lastname@example.org with any questions.
Investigators wishing to conduct oral histories may want to contact Dr. Joseph Tatarewicz, Department of History or Dr. Barry Lanman, Director of the Martha Ross Center for Oral History to discuss strategies in developing projects, interview and surveys.
The purpose of a pilot study is to evaluate the feasibility of a more exhaustive study and to serve as a model for the larger, more exhaustive scope of the research. In other words, pilot data is used to determine if a proposed study has the sufficient power to produce scientifically valid results. Some of the purposes for using a pilot study include the testing of a survey or questionnaire (to identify issues with wording or confusion with terms), identify potential issues with subject recruitment and participation, or to estimate statistical variations for the ultimate use and calculation of data.
IRB's need to review requests for such studies to determine if the risk/benefit ratio is acceptable. This will provide the Board an opportunity to comment on the ethical considerations of the design. Pilot studies must be reviewed by the IRB using the protocol submission process before they are initiated. Such studies will be approved on a six month continuing review basis.
Note that pilot studies:
- are limited to questionnaire and/or measure development to measure non-sensitive topics
- must include specific information about the measures, question use, interventions planned
- are limited to a range of participants (number to be decided based on population)
- consent documents must include wording that data collected from any phases of the measure development would be used in the publication or presentation of results.
Results from pilot studies may be used, and pooled, with the larger sample, provided the population remains the same and survey methods and instruments do not substantively change.
Additional information about the design of pilot studies and the difference between pilot and exploratory studies may be found on Steve Simon's web site, via Children's Mercy Hospital, Office of Medical Research, at http://www.childrens-mercy.org/stats/plan/pilot.asp.
Advertisements and recruitment material are considered the first step of the informed consent
process and are used to meet a project’s recruitment need for research participants. The IRB must
approve all advertisement materials and recruitment methods and material during the initial
protocol submission as well as for review and re-approval at the time of continuing review.
Advertising and recruiting procedures must protect potential participants' confidentiality. The content of recruitment materials and the method for communicating it cannot create undue influence or contain misleading or exculpatory language. Additionally, advertisements must clearly state that volunteers are being recruited for research purposes.
Examples of direct advertisement include posted notices, paid and unpaid newspaper solicitations or magazine advertisements (which may include public service announcements), websites, bulletin board announcements, recruitment posters, flyers Internet/website postings and solicitations by electronic mail.
Advertisements should contain information that provides enough detail to allow the prospective
participant to determine his/her eligibility and interest. Advertisements must:
- not appear as coercive
- include name and phone number of the investigator
- describe the general purpose of the research and include a summary of the eligibility criteria that will be used to admit subjects into the study
- provide a straightforward and truthful description of the benefits not state or imply a certainty of favorable outcome or other benefit beyond what is in the informed consent form
- indicate the location of the research and the person to contact for further information
Advertisements must display the UMBC IRB approval stamp or at a minimum have the essentials of
the validation stamp: "UMBC IRB, Approval On (date), Approved until (date)."
Recruitment methods may include:
- Verbal recruitment (via telephone or in-person): investigators must provide the IRB with a script of the verbal recruitment process, detailing the intended “contents” of the delivery.
- Electronic recruitment (via e-mail, web sites, or listservs): investigators must provide the IRB with a version of the e-mail script or web site view detailing the recruitment process and how consent will be obtained. An investigator may be required to provide the IRB with access to the proposed web address.
- Recruitment by mail: Investigators must provide the IRB with the materials that would be used for the mailing campaign
- Recruitment by advertisements: Investigators must provide the IRB with the intended proposed advertisements, flyers, and ads to recruit participants for research purposes.
A sample flyer for recruitment is found here.
Requesting approval of advertisements and recruiting materials
1. Follow the submission instructions for an initial application or continuation review.
2. Identify and describe the method(s) of advertisement for research participants in the protocol document.
3. Attach a copy of the text or a printed copy of any website, newspaper, or other media advertisements for use initial application or continuation review submission for IRB review and approval.
“Pre-screening,” for IRB purposes, is the term used to describe activities before obtaining informed consent (i.e., before enrollment) to determine initial eligibility for and interest in a study. Pre-screening may be performed over the telephone, in-person or on-line and may not include any research procedures.
“Screening” is the term used to describe activities performed after obtaining consent to ensure participants are qualified for the study. Screening activities include any interaction or intervention with potential participants to determine further eligibility that would not otherwise have been performed if not for the study, or collecting data directly from subjects through written screening tools or oral responses to questionnaire
Regardless of the strategy used, investigators must protect the privacy of the potential participant and the confidentiality of information collected about him/her.
Questions appropriate for pre-screening address the specific inclusion/exclusion criteria for the study and other issues of suitability, for example, an individual's ability to come to the research site multiple times. It is not appropriate to gather information that is not directly related to assessing eligibility and suitability. Administering eligibility tests is considered a research activity and may not be conducted during a pre-screening but rather only after the participant has been deemed eligible, agreed to participate, and has signed a consent form. Regardless of the setting, only information pertaining to the participant’s eligibility should be gathered during pre-screen. It may be acceptable to perform very limited protocol procedures as part of a pre-screen if they directly relate to eligibility determinations and an individual verbally consents to have them performed.
How should pre-screening over the telephone be done?
To begin a phone pre-screening conversation, a study team member should identify himself or herself as such. Then, potential participants should be:
- Informed of the nature and sensitivity of the questions,
- Told how long the phone call is expected to take,
- Asked whether there might be a better time for them to answer these questions, and
- Offered the option of completing the pre-screening in person, if possible.
Next, the study team member should explain that a set of questions will be asked to determine eligibility.
Whenever possible, the potential participant should be asked to indicate if s/he appears to be eligible only after all questions have been asked. Sometimes this is not possible, for example, when pre-screening for specific levels of activity. The investigator should consider this carefully when designing pre-screening procedures.
In the interest of confidentiality, only the potential participant's first name or initials should be recorded at the beginning of the pre-screening conversation. After the screening conversation, if s/he appears to be eligible and is interested in pursuing the study, contact/identifying information can be recorded - e.g., last name, address, birth date, and Social Security number.
How should pre-screening in person be done?
Pre-screening is done in person usually when potential participants are finding out about research during routine, non-research activities. The guidelines for the conduct of pre-screening in person are the same as those for conducting prescreening over the telephone.
Can pre-screening online be conducted on-line?
Can information be retained from individuals who are pre-screened but not enrolled?
Yes, non-identifying information may be retained about individuals who are pre-screened for a study, but do not actually pursue the study or enroll.
Pre-screening sheets from individuals who did not provide identifying information can be retained with no further action.
Pre-screening sheets with identifying information may also be retained in research files. Fields containing identifiable information must be blacked out or cut off as soon as it is clear that the individual will not be enrolled.
What needs to be included in the application for IRB review?
Protocol: All pre-screening activities are considered part of the participant selection and recruitment process and must be reviewed and approved by the IRB prior to initiation. Pre-screening procedures should be described in the protocol document. In addition, the specific inclusion/exclusion criteria for the study should be stated. The IRB will compare the screening tools with these inclusion/exclusion criteria, to ensure that the questions asked during pre-screening are not beyond the scope of the criteria.
Screening tools: The questionnaires, checklists, or other screening tools that will be used must be submitted for IRB review. If pre-screening is to be done over the telephone, investigators should provide a script for IRB review. The script should follow the points outlined above (How should pre-screening over the telephone be done? section).
Consent form: Pre-screening does not need to be described in the consent form because it is done before the consent discussion and documentation of consent takes place.
Screening activities include any interaction or intervention with potential subjects to determine eligibility that is performed following a participant’s consent to continue with the research. The IRB protocol application should describe activities in the recruitment process including:
- The screening instruments to be used and script followed to perform the procedures
- How subjects will respond - e.g., calling in response to advertisements, referrals from other participants, etc.
- A description of the data, if any, that will be collected..
- How the data collected during the screening procedures will be stored.
- Whether the investigator intends to retain or destroy data collected from subjects who are deemed ineligible upon completion of the screening process.
The script must include an introductory statement that informs participants of the purpose of the questions and that they do not have to answer any questions they do not want to answer and must be in language understandable to the population under study.
When appropriate, the script must include an introductory statement warning the subjects of the sensitive nature of the questions that might make the subject uncomfortable, and preferably include an example (for instance, “We are going to ask you about drug or alcohol use.”) The script must not describe the type of questions that will be asked as “confidential;” i.e., rather than saying “we would like to ask you some confidential questions,” say “we would like to ask you some questions.” It is acceptable to say “personal questions” or “sensitive questions.” The purpose of this policy is to prevent any possible misunderstanding that the answers will be held in complete confidence.
The body of the screening script should the actual questions that will be asked, not just a general statement such as “inclusion/exclusion criteria addressed.” The script must include a closing statement informing participants of whether or not they have met the preliminary screening requirements. If they do, the closing statement whether the information received from the subject will be destroyed immediately, or whether it will be stored, and if so for how long and where.
Note: the IRB realizes that the script may not be followed verbatim, as subjects may ask additional questions or stray from the topic. This is acceptable, but it is expected that the interviewer will keep as closely as possible to the spirit and letter of the script. If a participant refuses to participate in the proposed research, it is recommended that the script detail what information will be obtained and retained. Informed consent may still be required.
Research participants may be reimbursed for travel or be offered in-kind compensation (including course credit) for their participation in research. While these payments in money or in kind to research subjects are generally allowable with appropriate informed consent, incentives should not be so large to persuade participants to take undue risks or volunteer against their better judgment. Payments or rewards that undermine a person's capacity to exercise free choice invalidate consent.
Direct payments or other forms of remuneration offered as an incentive or reward for participation should not be considered a "benefit" to be gained from research.
Review of participant costs in the protocol application
The IRB will consider whether paid participants in research are recruited fairly, informed adequately, and paid appropriately. Additionally, the IRB must determine whether the rewards offered for participation in research constitute undue inducement, when a participants' medical, employment, educational, financial, emotional status is considered. The IRB will attempt to make sure that prospective subjects realize that their participation is voluntary, and that choosing not to participate will not adversely affect their relationship with the institution or its staff in any way. To make this determination, IRBs should know who the subjects will be, what incentives are being offered, and the conditions under which the offer will be made. Therefore, the purpose of incentives as well as the schedules of payment, the use of class course credits, etc. must be clearly stated in the protocol application and referenced, as appropriate, in recruitments/advertisements and the informed consent document.
Additional information and guidance regarding payments to research participants may be found in Grady C, Dickert N, Jawetz T, Gensler G, Emanuel E., An analysis of U.S. practices of paying research participants. Contemp Clin Trials 2005 Jun;26(3):365-75. A link to this article is available from PubMed Central (National Library of Medicine)
Tracking of participant costs
UMBC investigators are required, when using funds obtained from the campus Working Fund, to account for monies disbursed during the course of a project. This is a necessary component of financial auditing. However, this accounting must be done in a way that participant confidentiality is not compromised. Using any type of identifier will void confidentiality protection mechanisms and possibly contradict what the participant was informed about in the consent document.
For this purpose, investigators should maintain a log of expenses, tracking each expense by subject ID, the amount paid (e.g. cash, gift cards, etc.) and when payment occurred. Payments of cash are the preferred method for remuneration from state of Maryland funds, including sponsored awards made to UMBC, in order to meet state and university auditing requirements. Gift cards may only be used if the cost of such items is identified as a line item in the approved and final budget of a sponsored award made to UMBC. This documentation is kept in the protocol file. UMBC Accounting has a process to obtain funds from Working Fund and has created a "Receipt for Funds Disbursed to a Study Participant" that will serve as an audit back-up support document. This form does not track individual participant identifiers, but will require the investigator certify payment was made and for what purpose.
In many areas of the social sciences, one of the most commonly used methods of research is the secondary analysis of publicly available files of data. The federal government as well as large data consolidation bureaus and consortiums provide public access to many data sets. Additionally, many federal funding programs as well as social science professional organizations and journals now require that researchers make the data they collect publicly available to encourage scholarly replication of research. Data may also available from previously IRB approved protocols where the data sets do not contain information that could be used to identify individual research participants.
Publicly available, de-identified sources
- as long as the data come from sources that are publicly available
- and the data is deidentified and uncoded and stripped of identifiers.
The IRB has created a list of pre-approved data holders whose archives include publicly available, de-identified data. Review this list and follow the respective links below to learn more about the access and download procedures each data source. Investigators who plan to use these publicly available, de-identified sources do not require prior IRB review - no application is required.
Caution: If you are designing a research project that merges more than one public data set and you recognize that this may increase the risk of identification of individual research participants, please contact the ORPC.
To obtain pre-approval of other eligible data sets and archives, investigators must submit the following information to the IRB:
- The name of data set or data archive; and
- The URL for the data set/archive or other specific information on how to obtain the data set; and
- An abstract that describes the content and potential uses of the data set/archive.
If the IRB endorses the submission, the data set will be added to the list.
Data holders whose archives or sources are available on a restricted basis have certain conditions for use and possession of their data. In these cases, a Data Use Agreement (DUA) is required to address issues such as limitations on use of the data, liability for harm arising from the use of the data, publication, and privacy rights that are associated with transfers of confidential or protected data. A DUA is contractual document between a “Data Users” (the UMBC investigator requesting access to information) and the "Data Set Source" (the organization or institution providing the data) describing the provisions used to transfer confidential or protected data that may be used for the purpose of conducting human subjects research.
DUAs are commonly used when a researcher (the Data User) wishes to access archives or restricted data sets that may contain identifiable information about individuals for the purpose of conducting research. Examples of such data include:
- Restricted use records from institutions or governmental agencies (e.g. the Inter-University Consortium for Political and Social Research, the National Center for Health Statistics, the U.S. Department of Education) that require a formal agreement to gain access to data held by them
- Disclosure of existing human research subject data for research purposes and
- individual authorization for disclosure to the Data User is not/has not been obtained (from human subject, as through use of a subject-signed informed consent authorization) and
- disclosure is permitted under an IRB-approved protocol (for human subject research) or
- the researcher is disclosing or receiving a “limited data set” of personal health information, as defined under HIPAA.
Data Users who wish to use this data from these sources are required to submit to the IRB an application for Expedited or full board review; a draft version of the Data Use Agreement must be attached to the protocol application. The IRB may provide conditional approval of a protocol if it is needed in order to get a DUA signed, but final approval will not be granted until a copy of the signed Data Use Agreement is received from the Office of Sponsored Programs.
A DUA is not typically required for human subjects data when:
- Data is publically available in public domain, or
- Data is shared that is not subject to a legal or other restriction on its use, or
- A research subject signs a consent authorization form that authorizes the sharing of data with the Data User
- Another Agreement (Research Agreement, Sub-award, etc) is in place since data transfer requirements are often addressed in the language of the agreement.
For more information about the Office of Sponsored Programs Data Use Agreement review process, please click here.
UMBC investigators may propose research that involves the use of previously collected data and/or specimens. Certain secondary uses of previously collected data and/or specimens may be defined as “research involving human subjects” and will require IRB review or exemption, may require HIPAA authorization if the data contains protected health information and participant informed consent. Consent from participants is required prior to the release and/or use such data in a research study.
In other cases, secondary research uses of previously collected data and/or biological specimens do not meet the definition of “research involving human subjects” and IRB review or exemption is not required before initiating research activities.
Use of secondary data and specimens that require IRB review or exemption ((§46.101(b)4) )
- Prospective collection of data and/or specimens for research purposes (e.g., additional questions added to routine surveys being performed for non-research purposes, an extra tube of blood taken at the time of clinical blood drawing, etc.).
- Collection and storage of data and/or specimens for future research uses and/or distribution (i.e., rather than using data/specimens only for pre-defined analyses as described in a specific IRB-approved protocol).
- Use of previously collected data and/or biological specimens, unless only anonymous [unidentified and cannot be linked directly or indirectly by anyone to their source(s)] or coded (direct personal identifiers have been removed) data/specimens are used.
- Use of non-research collections of data/specimens for research purposes (e.g., archived pathology specimens) if the collections have not been established as repositories (held by a single investigator in his/her office or laboratory to large networks with central coordinating centers) with IRB approved procedures for releasing materials
- Use of existing data and/or specimens will be considered exempt from IRB review when all of the following conditions are met:
- All data and/or specimens are available or “on the shelf” at the time or before the research is submitted for an exempt determination
- The sources of the data and/or specimens are publicly available or the information is recorded by the investigator in a way that participants cannot be identified, directly or through identifiers linked to the participants
Use of secondary data and specimens that do not require IRB review or exemption
- Laboratory research with commercially available tissue specimens, cell lines, or other human cells
- Research with autopsy specimens
- Research with previously collected anonymous data and/or specimens only when the data/specimens to be studied were not collected specifically for the current research. An investigator may not de-identify data and/or specimens under his or her control (e.g., data collected by the investigator for another study) for future research uses without IRB review.
- Research with previously collected coded data and/or specimens only when all of the following conditions are met:
- The data and/or specimens to be studied were not collected specifically for the current research
- Investigator(s) cannot “readily ascertain” the identity of the source(s) of the coded data or specimens because at least one of the conditions below is met:
- The investigators and the holder of the “key” enter into an agreement prohibiting the release of the key to the investigators under any circumstances (until the source individuals are deceased)
- IRB-approved written policies and procedures for the repository or data coordinating center prohibit the release of the key to the investigators under any circumstances (until the source individuals are deceased).
Researcher’s are advised to review the following guidance from The Office for Human Research Protections coded private information or specimens “ Guidance on Research Involving Coded Private Information or Biological Specimens athttp://www.hhs.gov/ohrp/policy/cdebiol.html .”
Additional information and regulatory guidance and proper biohazardous materials waste disposal procedures may be found on the UMBC Biosafety Program web site, http://www.umbc.edu/ibc/
Please contact the ORPC at email@example.com with any questions or further guidance.
The IRB recognizes that graduate and undergraduate research methodology courses are designed by instructors to teach students research skills through a combination of readings, lectures and research activities or projects. Such research projects allow the student to apply what is taught in the classroom rather than to contribute to existing research literature in a field. Other activities do present the opportunity to apply skills learned in the class setting with the public in general. It is these activities that may place the proposed activity under the regulatory definition of “research” (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102).
Instructors do have the responsibility of ensuring that the student is educated on the general principles of research ethics, human subject protection, and that the students receive human subjects training. Please use the below definitions to determine if a project requires IRB review.
Participants enrolled in a class setting
In general, classroom educational activities that instruct students in research methodologies and techniques usually do not fall within the federal definition of research as described in 45 CFR 46.102(d). As such, activities that involve data gathered (surveys/ questionnaires/ interviews/ observations of public behavior) solely as part of a classroom project that will not go outside the classroom setting will not require review by the IRB. Presentations of class research results at the end of a semester are acceptable.
Participants not enrolled in a class setting
Classroom projects (i.e. research methodology courses) are designed to teach students research. As above, such activities involve gathering data via surveys, questionnaires, interviews and/or observations of public behavior. The design of these projects will involve some type of interaction with individuals outside of the classroom setting. The IRB has developed special guidelines (http://www.umbc.edu/research/ORPC/IRB_researchmethods.html) to advise course instructors on what are acceptable topics, the use of the consent process and their responsibilities for student IRB education training and application forms. Students may use data collected in these projects to support their own independent projects (URCAD, masters, and dissertation). They must, however, submit a separate application ( http://www.umbc.edu/research/ORPC/IRBprotdevelop.html) to the IRB for review.
HIPAA stands for the Health Insurance Portability & Accountability Act of 1996 (Public Law 104-191), which amends the Internal Revenue Service Code of 1986. It is also known as the Kennedy-Kassebaum Act. The Department of Health of Human Services issued the Privacy Rule, resulting from HIPAA regulations, and became effective April 14, 2001. Compliance is required of all covered entities for the Privacy Rule on April 14, 2003.
In the course of conducting research, researchers may obtain, create, use, and/or disclose individually identifiable health information. Under the Privacy Rule, covered entities are permitted to use and disclose protected health information for research provided an individual gives written authorization to use or disclosure PHI unless such authorization is waived or excepted by an IRBs or Privacy Board. The use of decedent’s information is protected by the Rule but authorization is not required. In other words, a covered entity will make good faith effort to tell individuals how PHI will be used & disclosed and will not share a patient’s PHI without their express permission (authorization). The Privacy Rule does not replace or modify the human research protection regulations found in 45 CFR 46. The Privacy Rule exceeds privacy provisions found in 45 CFR 46 as it extends to decedents, applies to all research, regardless of funding or activity and extends the definition of “identifiable information”.
Examples of identifiable information include:
- Social Security Numbers
- City or state
- Zip codes
- Medical record numbers
- Web URLs
- Street address
- Health plan numbers
- IP address numbers
- Phone numbers
- Account numbers
- Biometric identifiers*
- Fax numbers
- License/Certificate numbers
- Facial Photos/Images
- E-mail address
- Vehicle ID numbers
- Birth date
* - Note that biometric Identifiers are observable biological characteristics which could be used to identify an individual, e.g., fingerprints, iris/retina patterns, and facial patterns.
The Privacy Rule defines the means by which individuals will be informed of uses and disclosures of their medical information for research purposes, and their rights to access information about them held by covered entities. The Privacy Rule protects the privacy of individually identifiable health information, while at the same time setting conditions for researchers to have access to medical information when necessary to conduct vital research.
Health information is “information that relates to the past, present, or future physical or mental health or condition of the individual, or that relates to the provision of health care in the past, present or future.” Identifiable means information “that identifies the individual; or with respect to which there is a reasonable basis to believe the information can be used to identify the individual”. Examples of identifiable health or protected health information, as defined by the regulations, include names, telephone numbers, fax numbers, electronic mail addresses, social security numbers, Internet protocol (IP) address numbers, finger and voice prints and full face photographic images and any comparable images.
The HIPAA Privacy Rule only applies if investigators use, receive and/or disclose protected health information (PHI) from a covered entity in the course of doing research with human subjects or human subject data. Remember, researchers who are not employed or are involved with research falling under the jurisdiction of the University Health Center are not covered by HIPAA; therefore, HIPAA regulations do not apply.
In some situations, the IRB can waive the requirement that research subjects sign a HIPAA Authorization Form. A waiver may be requested, similar to a waiver of informed consent, by the IRB particularly for use retrospective records review where the data are already collected. A waiver of authorization does not mean research is exempt from HIPAA’s privacy regulations; it only means a researcher does not need signed authorization from each research subject.
The Privacy Rule requires researcher performing retrospective records review to have both an IRB approved Waiver of Informed Consent and a Waiver of Authorization.
To qualify for Waiver of Authorization, investigators should indicate that:
- The research use of the health information does not represent more than a minimal risk to privacy
- That the research could not be done without the requested health information
- That it would not be practical to obtain signed authorizations from the research subjects
- That the specific elements of health information that are requested are not more than the minimum necessary to accomplish the goals of the study.
Researchers who have questions about how HIPAA applies to their research may contact the Office for Research Protections and Compliance at 5-2737 or firstname.lastname@example.org.
Public Health Service (PHS) guidelines (42 C.F.R. Part 50.604) promote the objectivity in research and require institutions to assure there are no financial conflicts of interest in research projects.
A conflict of interest arises in a situation in which an actual, potential or perceived conflict exists that cause undue influence over judgment associated with institutional responsibilities such as performing research, reporting research results, or mentoring students. Examples of conflicts of interest may include receiving income from equity interests in a publicly traded corporation or a non-publicly traded corporation or entity (such as stocks, stock options or other ownership interests), property rights (such as patents or copyrights), consulting fees, or reimbursements of travel from third party entities that appears to relate to university responsibilities (except from U.S. institution of higher education, federal, state or local government agencies).
UMBC researchers have regulatory and ethical obligations to protect the rights and safety of individuals who participate in research. Conflicts of interest related to research involving human research subjects pose special concerns. Investigators conducting human subjects research can have conflicts of interests, including financial conflicts of interest if they or their family stand to benefit as a result of their human subjects research. Financial interests held by those conducting or sponsoring the research may compromise or appear to compromise the fulfillment of those ethical obligations and the well-being of the research subjects, as well as the integrity of the related research.