Investigator Manual: 5. Conducting Human Participant Research

In consideration of Respect for Persons, as detailed in the Belmont Report, investigators should ensure individuals have the necessary information to make a fully informed decision to participate in a study. Respect also means honoring an individual’s privacy and maintaining confidentiality when appropriate. When determining an appropriate consent process, certain considerations must be taken into account. For example, the age of participants, competency, understanding of the English language, etc.

Consent for participation in research is a process that involves an exchange of information and ongoing communication that takes places between an investigator and a potential research participant. An effective informed consent process involves the following elements:

• Conducting the process in a manner and location that ensures participant privacy.
• Providing adequate information about the study in a language understandable to the potential participant.
• Providing adequate opportunities for the potential participant to consider all options.
• Responding to the potential participant’s questions and/or concerns.
• Ensuring the potential participant comprehends the information provided.
• Obtaining the prospective participant’s voluntary agreement to participate.
• Documenting the consent appropriately
• Providing copies of the consent documents to the participants and continuing to provide information as the participant or research requires.

There are some basic elements of informed consent so a participant can make a fully informed decision to participate.

• Key elements section, to include the following:
  • A statement that the study involves research.
  • An explanation of the purposes of the research.
  • The expected duration of the subject’s participation.
• A description of the procedures and duration for each.
• A description of any reasonably foreseeable risks or discomforts to the subject.
• A description of any benefits to the participant or to others that may reasonably be expected from the research.
• A disclosure of alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
• A statement of who, outside the research team, may have access to research data; e.g., University auditors; Institutional Review Board and OHRSP: OHRP, federal agencies, and other parties funding the research (if applicable).
• Details regarding remuneration made to participants, how payments will be prorated, and when they will be provided to participants.
• One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
  • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
  • A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
• An explanation of whom to contact:
  • For answers to pertinent questions about the research (researcher’s name and phone/address, and that of faculty advisor if the investigator is a student);
  • Regarding research subjects’ rights (OHRSP); and
  • In the event of a research-related injury to the subject.
• A statement that:
  • Participation is voluntary;
  • Refusal to participate will involve no penalty or loss of benefits to which the individual is otherwise entitled; and
  • The individual may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
• An indication that the subject may keep a copy of the consent form.

Timing: Informed consent from the subject and/or their legally authorized representative must be obtained before initiating any research activities or data collection. Consent requirements for screening vary based on different regulations a given research study may fall under.

Ongoing communication: While the initial verbal explanation and dialogue with the subject are critical so that subjects know what they are agreeing to before they consent, ideally the consent process should be an ongoing conversation throughout the study. Throughout the study, make yourself available to answer questions and encourage subjects to ask questions or voice concerns, tell subjects about changes in the study procedures or risks or alternatives, and allow subjects to withdraw from the study for any reason at any time.

Additional approaches: With prior IRB approval, other methods of communicating information about a study may be used to supplement the consent process, or in rarer cases, substitute for a consent document. These approaches include the use of audio-visual materials, brochures, drawings, and information posted on a specific website.

Qualifications of the person obtaining consent: Principal investigators are responsible for assuring that all investigators obtaining consent are qualified and appropriately trained to explain the research and assess participant comprehension as described below. Any person who may obtain consent in a study should be listed in the IRB application as key personnel, though the person need not be listed as an investigator in the consent document itself.

Decision-making capacity: Participants should be able to understand the nature and consequences of the study. If they cannot, a surrogate consent may be required.

Voluntariness: Participants should be free from coercion when deciding to participate. This requires that researchers carefully evaluate, plan, and implement the recruitment, consent documents, and consent process. If the participant indicates “No” through words or body language, further attempts at obtaining consent should not be pursued.

Assent is defined as “a child’s affirmative agreement to participate in research.” Passive resignation to submit to an intervention or procedure is not considered assent. Federal regulations do not specify any of the elements of informed assent and do not provide an age at which assent ought to be possible.

In determining whether children are capable of assenting, the IRB takes into account;

• The ages, maturity, and psychological state of the children involved;
• Whether all or some of the children are capable of assenting;
• If written documentation of assent is required; and,
• When parental permission is required, whether by one or both parents.

In general, all adults regardless of their diagnosis or condition, are presumed competent to consent to participate in research unless there is evidence to the contrary. When investigators propose to include individuals with questionable capacity, you must provide a plan for assessing the participants’ decision-making capacity. Assessment is done on an individual basis and should determine the potential participants’ ability to understand and express a reasoned choice based on:

• The voluntary nature of research participation and the information relevant to their participation (research procedures);
• Consequences of participation for the participant’s situation, especially about the participant’s health condition;
• Consequences of the alternatives to participation;
• Potential risks and benefits involved in the study; and
• Procedures to follow if the participant experiences discomfort or wishes to withdraw.

If the assessment shows evidence that the participant is competent to consent, you must obtain valid informed consent directly from the participant. If the assessment determines that the potential participant does not have sufficient capacity to consent, you must do the following:

• Document the participant is incapable of understanding the information presented regarding the research in the participant’s research record;
• Document how the legally authorized representative was determined in a manner consistent with state law;
• Document the information provided to the participant’s legally authorized representative regarding the cognitive and health status of the participant, the risks and benefits of the research, and the role of the legally authorized representative in the research record;
• Obtain the consent and signature of the participant’s legally authorized representative;
• If it is expected that participants will regain their ability to consent, a plan for re-consenting the participants after study activities need to be implemented.

Any method of obtaining informed consent other than face-to-face consent must allow for an adequate exchange of information and documentation. This method must also ensure that the signer of the consent form is the person who plans to enroll as a subject in the study or is the legally authorized representative of the subject. Research records should document what method was used to conduct the consent process and document that informed consent was obtained before beginning study procedures.

“Digital signatures” may be acceptable forms of documentation of written informed consent. Electronic, computer, or tablet-based consent documents may facilitate record keeping even when an individual is present and could sign a paper form. Digital signatures may be considered for face-to-face and remote consent, but the technologies and processes used must be described in the protocol or application.

For FDA-regulated research, the digital signature platform and process must be 21 CFR part 11 compliant. In addition, the research team must verify the participant’s identity.

An investigator may request the IRB waive the requirement to obtain a signed informed consent form for some or all subjects. For the IRB to waive this requirement, at least one of the following criteria must be met:

• The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern;
• 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; or
• If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

Persons with limited English proficiency are individuals who do not speak English as their primary language and/or who have a limited ability to read, speak, write, or understand English. Subjects who have limited English proficiency should be presented with informed consent information in a language understandable to them that includes all the required and additional elements for disclosure.

For consent document translations, the investigator may wish to delay translating until IRB approval is granted for the English version to avoid extra translation costs. The IRB must have all versions of the research materials (e.g., recruitment informed consent form(s), instruments) in both English and non-English on file. When submitting non-English consent documents and other research material, please complete and submit a Certificate of Translation form.

If the subject/representative has limited English proficiency, you must obtain the services of an interpreter fluent in both English and the language understood by the subject/representative. The interpreter may be a member of the research team, a family member, or a friend of the subject/representative. If the research involves medical care and/or is more than minimal risk, the use of family or friends to interpret is discouraged.

The IRB reviews study recruitment methods (including advertisements and payments) to evaluate whether they will affect the equitable selection of participants and to ensure that the proposed methods adequately protect the rights and welfare of participants. All recruitment material requires IRB approval before implementation.

The protocol application must include a description of the following:

• the source of subjects for all study groups (intervention/case and control);
• when, where, how, and by whom these potential subjects will be recruited;
• the methods employed to identify potential subjects;
• the materials used to recruit subjects, including the use of email and text messaging; and,
• the number of times a study team can attempt to contact participants is study-dependent and the IRB will assess accordingly.

All communication methods and the protections in place to minimize privacy and confidentiality risks associated with programed must be described to the IRB as part of the review process.

The IRB is responsible for ensuring that any payment or remuneration offered to participants in human subject research is fair and not an undue inducement to participate. Remuneration for participation in research should be reasonable and the amount paid should be comparable to other research projects involving similar time, effort, and inconvenience. Payment amounts should not be large enough to constitute an undue inducement to participate in a risky or uncomfortable procedure. Additional guidelines for specific situations:

Short research studies involving one visit: Participants may be provided payment contingent upon completion of the study. Participants who are disqualified through no fault of their own must be paid for the time and effort they expended before their termination from the study.

Research studies involving multiple visits or lengthy or repeated participation: Partial payment should be provided to participants who withdraw, are discharged early from the study by the investigator, or otherwise fail to complete the study as agreed. The amount of partial payment should relate to the amount of time, effort, or discomfort involved. Payment schedules may be designed on a per-day, per-visit, or per-procedure rate, or some combination thereof. The terms for partial payment must be described in the application and the consent form.

Completion bonuses: Such remuneration may be acceptable to encourage the completion of all study procedures/visits. The amount of such incentives depends on the risk and duration of the study interventions.

The regulations identify prisoners and minors as vulnerable populations. Other groups of individuals may be vulnerable based on the nature of the research and data collection methods.

Prisoners: Department of Health & Human Services (DHHS), Subpart C of Part 46 provides additional protections for biomedical and behavioral research involving prisoners as subjects. These additional protections, or provisions, of the federal regulations, are intended to assure that 1) prisoners provide voluntary consent to participate in research; 2) prisoners’ confidentiality is rigorously protected; 3) prisoners are not used as subjects in studies for which non-incarcerated subjects are suitable. These provisions apply whether the research involves individuals who are prisoners at the time of enrollment in the research or who become prisoners after they become enrolled in the research.

DHHS also requires that the IRB have among its members:

1. One or more individuals knowledgeable about and experienced in working with prisoners when research, involving prisoners, is to be reviewed;
2. A majority of the Board, exclusive of the prisoner member(s), can have no association with the prison(s) involved apart from their membership on the IRB.

Children: If your research involves children under the age of 18, your protocol should include sufficient information in your protocol or application to justify the enrollment of children. Consider whether parental permission and assent should be obtained and incorporate this information in your application.

Participants with impaired decision-making: Your protocol or application should specify the method that will be used for assessing capacity to consent. For more information, refer to the Can I obtain consent from a decisional impaired individual? section of this document.

Other special populations: Examples of vulnerable populations include undocumented individuals; those who struggle with substance use and abuse; non-English speakers, students, employees of the researcher(s)/those with a status relationship with the researcher(s), and active-duty military members.

Additional protections may be required if recruiting vulnerable populations; for example: include having someone outside the study team observe the informed consent process, exclusion of the population if not required to achieve study objectives, and independent assessment to address consent capacity.

Snowball sampling (or chain sampling, chain-referral sampling, referral sampling) is a non-probability sampling technique where existing study subjects recruit or refer future subjects from among their acquaintances.

This recruitment approach may be approved by the IRB with justification for its use and how it relates to the study and subject population. The protocol should address how the risk of violating an individual’s privacy will be minimized and how snowball sampling may impact other study risks. Investigators are to provide this justification in the recruitment section of the protocol application form.

You are required to ensure human research includes adequate provisions to protect the privacy of participants and the confidentiality of data, as required by federal regulations.

• Privacy refers to a person’s desire to control the access of others to themselves. For example, research participants may not want to be seen entering a place that might stigmatize them, such as a pregnancy counseling center that is identified as such by signs on the front of the building.
• Confidentiality refers to the researcher’s agreement with the participant about how the research participant’s identifiable private information will be handled, managed, and disseminated.

For the IRB to assess privacy and confidentiality protections, the protocol should describe how participant privacy will be protected and how data kept confidential. The IRB will assess whether the participants’ privacy interests and confidentiality of data are protected in ways commensurate with the benefits to participants and the risks of everyday life.

Issued by NIH, the CoC protects the privacy of research participants by prohibiting forced disclosure of their individually identifiable, sensitive research information to anyone not associated with the research, except when the participant consents to such disclosures or in other limited specific situations.

All ongoing or new research with NIH funding and collects or uses identifiable, sensitive information is automatically issued a CoC as a term and condition of the NIH grant award. The Notice of Award and the NIH Grants Policy Statement will serve as documentation of the Certificate protection [a separate certificate document is no longer issued]. This automatic issuance of CoC protections also applies to research that receives re-distributed NIH funds. Studies that have been issued a CoC are required to inform the participants about the CoC protections and any exceptions to the CoC protections as part of the informed consent process.

Federally funded studies that meet the NIH definition of a clinical trial and any study (regardless of funding) that meets the FDA definition of an applicable clinical trial must be registered and study consent forms must include the required language.

NIH definition: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

FDA definition: Any experiment that involves a test article[1] and one or more human subjects and is subject to requirements for submission to the Food and Drug Administration. Clinical investigations must not be initiated unless that investigation has been reviewed and approved by an IRB.

Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical trial or designee Studies are registered on the website before commencing and updated throughout the study. On occasion, results of the study are submitted after the study ends. This Web site and database of clinical studies is commonly referred to as a “registry and results database.”

NU-RES can assist Pis with account setup and registration, but it is the PI’s responsibility to ensure their applicable study is registered on ClinicalTrials.gov.

Federal law requires the following exact statement to be included in the informed consent documents of applicable clinical trials:

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

[1] FDA defines a test article as: any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act:

The European Union has additional requirements regarding data privacy, referred to as the GDPR. Where Northeastern is working with personal data collected in, or transferred from, any European Economic Area country, GDPR will be relevant. This includes data collected, obtained, or used for research projects. Failure to follow GDPR if it applies puts the University at risk of noncompliance, monetary fines, and reputational harm so it is critical to understand and assess whether GDPR applies to your study.

GDPR requires a legal basis to collect and process (e.g., analyze) personal data. To use personal data for research, the legal basis that generally will apply is consent from the data subject. Consent must be freely given, specific, informed, and unambiguous as to the data subject’s wishes by a statement or by clear affirmative action.

 Note that other privacy laws may exist that need to be considered.

When conducting research in international sites, protocols are to comply with not only the regulations and laws of the United States but the international site, as well. These may be the result of differences in language, culture, social history, and societal norms. Where the two sets of standards present a conflict, the research must meet the higher standard. While we do not impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct of research or for a meaningful consent and/or assent process, including ensuring additional protections for vulnerable participant populations (e.g., children, prisoners).

Researchers are to be cognizant of relevant national policies and take special consideration in cases such as the availability of national health insurance, different philosophical legal systems, and social policies that may make U.S. research forms and procedures inappropriate. In addition to obtaining approval from the Northeastern IRB, investigators are to obtain approval from international IRBs or local ethics committees. The Office for Human Research Protection retains a current list of International Compilation of Research Standards. This document provides contact information for bio-medical and social/behavioral science IRBs or equivalent ethics committees.

Documentation of permission or approval must be submitted with the IRB application materials. In the absence of these laws or guidance, the researcher is required to obtain approval from the local government or community leaders or provide information as to the absence of the local review. Examples of local reviews may include the following:

• Ethics committees
• Drug approval agencies
• Local ministries
• Local governance

What it means for data to be coded, de-identified, or anonymous is important when it comes to understanding the identifiability of data. The identifiability of data under the Common Rule (45 CFR 46) and the Health Insurance Portability and Accountability Act (HIPAA) differs.

Coded data refers to data that have been stripped of all direct subject identifiers, but in this case, each record has its study ID or code, which is linked to identifiable information such as name or medical record number. The linking file must be separate from the coded data set. This linking file may be held by someone on the study team (e.g. the PI) or it could be held by someone outside of the study team (e.g. a researcher at another institution). A coded data set may include limited identifiers under HIPAA. Of note, the code itself may not contain identifiers such as subject initials or medical record numbers.

 De-identified data refers to data that have been stripped of all subject identifiers, including all 18 HIPAA identifiers. This means that there can be no data points that are considered limited identifiers under HIPAA, i.e. geographic area smaller than a state, elements of dates (date of birth, date of death, dates of clinical service), and age over age 89. If the data set contains any limited identifiers, it is considered a limited data set under HIPAA. If the data includes an indirect link to subject identifiers (e.g. via coded ID numbers), then the data is considered by the IRB to be coded, not de-identified.

Anonymous data are essentially the same thing as de-identified data, this refers to data that have been stripped of all subject identifiers and which have no indirect links to subject identifiers. There should be no limited identifiers in an anonymous data set.

Identifiability under the Common Rule

• The Common Rule defines “individually identifiable” to mean that the identity of the subject is, or maybe, readily ascertained by the investigator or associated with the information.
• A data set may be identifiable under the Common Rule if it contains: initials, address, zip code, phone number, gender, age, birth date, occupation, employer, racial or ethnic group, dates of events, names of individuals related to the participant such as teacher or physician names, and genealogy.
• Age, ethnicity/race, and gender may be identifiers under the Common Rule if fewer than 5 individuals possess a particular cluster of traits.
• Data may be identifiable if any combination of variables could potentially identify a subject.
• Some of the identifiers listed above become less problematic if the sample size is large enough so that the potential identifiers could describe several individuals and thus cannot be linked to only one person. Conversely, if the sample size is small, the potential to identify an individual may increase, even in the absence of direct identifiers.

Identifiability under HIPAA

The HIPAA Privacy Rule regulation specifies 18 identifiers, most of which are demographic. The inclusion of even one of the following identifiers makes a data set identifiable. However, there are levels of identifiability. The following are considered limited identifiers under HIPAA: geographic area smaller than a state, elements of dates (date of birth, date of death, dates of clinical service), and age over age 89. The remaining identifiers in the bullet list are considered to be direct identifiers. If the data set contains any limited identifiers, but none of the direct identifiers, it is considered a limited data set under HIPAA.

Data Safety Monitoring Plan (DSMP) or Data Safety Monitoring Board (DSMB)

Any study that presents more than minimal risk to subjects must describe a data and safety monitoring plan. Studies utilizing IRB protocol templates will be prompted to provide this information. Most studies can utilize a DSMP, but some clinical trials or multi-site research may opt to utilize a DSMB instead. Please see NIH Guidance on Data and Safety Monitoring.

In the case of minimal risk research, the IRB may require a DSMP or DSMB if the committee deems that monitoring of the study is needed to ensure the protection of the rights and welfare of subjects or data integrity, which could affect the welfare of future subjects.

Deception: The IRB accepts the need for certain types of studies to employ strategies that include deception. However, the employment of such strategies must be justified. In general, deception is not acceptable if, in the judgment of the IRB, the participant may have declined to participate had they been fully informed of the true purpose of the research.

Radiation: If your study interventions involve the use/administration of radiation, additional state law requirements apply that are outside IRB purview. For information and assistance with these requirements, please refer to the NU Radiation Safety website.

If you are planning on conducting research in K-12 schools, additional requirements will apply to your research. These schools are autonomous institutions that retain the right to approve/reject any human research to be conducted on their site, in their facilities, or with their teachers, staff, or students. The IRB therefore requires documentation from an appropriate authority at each school or district granting permission to conduct human research.

Researchers are responsible for contacting each school or district to obtain this permission and meet the requirements each site may have for conducting human research (e.g., review by its research review committee). If review by a separate committee is required, you will need to plan additional time for this approval process as well as IRB review.

Other important items to keep in mind:

• Often K-12 school sites will require proof of IRB review before their approval.
• If teachers/school staff are members of the research team for non-exempt studies, they are to comply with training requirements.
• Some schools require research personnel to undergo background checks.
• Many school districts will not allow research activities to take place during normal class time.
• Many schools place limitations on the use of video or audio recordings in classrooms.
• Parental consent is required for minors to be included as research subjects.
• Minor assent is also required before including minors as research subjects.

Additional steps and protections are often needed when conducting research in collaboration with American Indian or Alaska Native (AI/AN) communities and populations. The Common Rule affirms that each tribe may have its definition of research and its own set of research protections and laws that may have more restrictions than the Common Rule. Research teams are responsible for ensuring any research on tribal land, using tribal resources, or focusing on individuals from a tribe is conducted in a manner that is respectful of tribal autonomy, sovereignty, and rights. While the IRB does not require approval/permission from the tribe to grant final approval, a researcher must receive appropriate review and approval from the tribe of their research.

The IRB uses the terms recruitment registry, data repository, and biospecimen repository for these various research tools/resources, although terminology can vary widely across institutions. Generally, the creation and maintenance of a research registry or repository requires IRB review and approval.

Recruitment Registry: a tool used to identify and track a group of individuals that have similar characteristics. The characteristics can vary widely (e.g., disease, genetic make-up, health behaviors, surgical procedures), but the registry intends to track and classify these groups of individuals. The IRB prefers the use of the word “registry” to be used to describe lists of people along with limited personal and, when applicable, medical information. The primary use of these lists is to provide investigators with pools of potential study volunteers, as in recruitment registries. Recruitment registries generally require IRB approval, both for the creation and maintenance of the registry itself, as well as for future projects that wish to use a registry as a recruitment method.

Data Repository: a tool used to compile a set of individual subject/patient data that will be used for analysis purposes. A data repository generally has data added to it in an ongoing manner that is stored long-term. Data in the repository are intended to be distributed to multiple users and subsequently used for ongoing analysis purposes. The IRB prefers the use of the term ‘data repository’ over terms such as ‘databases’ and ‘registries.’ If the primary intent of the repository is for use in future research projects, IRB review and approval are required and may be required for the subsequent use of the data from the repository.

Biospecimen/tissue repositories: Also known as a tissue bank, a mechanism for maintaining tissue, blood, and other biological specimens for unspecified future use. These repositories typically involve the collection and long-term storage of tissue and often corresponding data to be used primarily for future research projects. Tissue to be stored in the repository can be collected retrospectively, prospectively, or both. Tissue repositories can include tissue collected from other research protocols or clinical procedures. IRB review and approval are required for the banking of biospecimens and may be required for the subsequent use of the specimens from the repository.

The IRB review requirements for research involving decedents vary depending on whether the study involves ONLY decedents or decedents and living individuals.

The Common Rule (45 CFR 46.102I(1)) defines a human subject as “a living individual about whom an investigator (whether profession or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, analyzes, or generates identifiable private information or identifiable biospecimens.”

The FDA does not explicitly state that regulations apply only to “living individuals.” The regulations, however, imply that the subject is alive. FDA regulations (21 CFR 56.102I) define a “human subject” as “an individual who is or becomes a participant in research, either as a recipient of a test article or as a control.” That section goes on to state that a subject may be “either a healthy individual or a patient.” And, at 21 CFR 812.3(p), “subject” means “a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.”

Based on the above, the IRB Office has determined that Common Rule and FDA Regulations do NOT apply to studies ONLY using information or biospecimens from deceased individuals. In these cases, researchers do not need to submit an IRB application for review of decedent ONLY research.

Online research sources such as Facebook, Twitter, blogs, chat rooms, discussion forums, and other social networking sites will be treated as publicly available data by the IRB in a very broad sense, and with several limitations.

Privacy Statements & Terms of Use: You are responsible for checking the privacy statement and terms of use of any site being used for research purposes. You must adhere to the written policies of any site used for research. The IRB expects that researchers will either: 1) obtain consent to use data from an individual’s social media page or 2) make an appropriate argument as part of the application process as to why the IRB should waive consent for the project.

Publicly available: The IRB does not consider sites that require the user to create an account, and then provide a login and password, to be publicly available data. Therefore, participants must be consented before an investigator can observe or interact with participants in these online environments. Members of sites that require a login expect privacy and do not expect that anything they post will be used for research purposes. In some circumstances, researchers can petition the IRB for a waiver of consent. In these situations, researchers will need to provide an appropriate argument/justification as to why a waiver of consent is appropriate.

Data mining: Facebook, Twitter, and others may provide data mining services where their developers will mine data from the site, for a fee, at the researcher’s request. Depending on the scope, the IRB may treat the data differently because data collection would be done by the media site and (likely) provided to the researcher without direct identifiers. The IRB deals with this type of research activity on a case-by-case basis.