What is Human Subjects (Participants) Research?
Research is a systematic investigation designed to develop or contribute to generalizable knowledge. This typically involves the collection and analysis of data that the researcher intends to publish or present at a professional meeting. Human subjects' research is research where the researcher/investigator acquires the following from a living human being
i. data through intervention or interaction with the individual; or
ii. identifiable private information.
Please see this link http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102 for OHRP definitions.
What is the "Common Rule"(the Federal Policy for the Protection of Human Subjects)?
Please see this link http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html for OHRP definitions.
What is "generalizable knowledge?"
"Generalizable knowledge" means that the intent of the research is to add information to the field of study; the results can be applied beyond the subject population to other settings. It doesn't matter if the results will be published or not. If the research activities are designed in a way that will discover information that can be used in other settings, it can be considered research.
What does "intervention or interaction with the individual" mean?
If you perform physical procedures on a person, manipulate the person, manipulate the person's environment, communicate with a person, or have interpersonal contact with a person, you are engaged in an intervention or interaction with that person.
What is "identifiable private information"?
For information to be considered "identifiable private information" two criteria must be true. First, the information must be private, meaning it is either about behavior that occurs in a context where the individual reasonably expects no observation is taking place or the individual has provided the information for a specific purpose and reasonably expects the information will not be made public. Second, the information must be individually identifiable, meaning the identity of the person is or may be readily ascertained by the investigator or the identity of the person is or may readily be associated with the information.
Does oral history constitute research that requires review by the CPHPR?
Oral history that is conducted according to the guidelines of the national body, the Oral History Association, adheres to its own explicit research protocols. Completed in this specific way, oral history is not research.
In 2003 and 2004, the federal government deemed that oral histories conducted under the guidelines set forth by the Oral History Association was not "generalizable knowledge" and thus was not subject to oversight by the institutional review boards of higher education institutions.
It is imperative that researchers conducting oral history at Emmanuel College follow the standards of the Oral History Association in a rigorous way. Those unfamiliar with the standards or unwilling to utilize them fully after review must seek review of their projects via the CPHPR. The Oral History Association's guidelines are here: http://www.oralhistory.org/about/principles-and-practices/.
What is the timeline for submitting protocols and obtaining approval from the CPHPR?
Investigators are responsible for allowing a minimum of 3 weeks for the review process regardless of the level of review. Please carefully edit and proofread all application materials before submission to CPHPR as incomplete and missing information will cause delays in the protocol application review process.
The Emmanuel College CPHPR meets regularly to review protocols. Depending upon the nature of the research, some studies may be reviewed and approved independently by a smaller subgroup or by the Chair of the CPHPR. Other studies may require review by the full committee.
Protocol reviews are always prospective and never retrospective. Performing research with human subjects without prior CPHPR approval is unethical, illegal, and may jeopardize the rights and welfare of participants in research. A project that is conducted without CPHPR approval is subject to termination or other action by Emmanuel College.
What criteria determine if a project is classified as human subjects research?
The following projects do not require oversight by the CPHPR:
- a "non-research" project
- a research project that DOES NOT involve identifiable human subjects
In order to determine whether the project falls into either of these two categories, please complete the Request for classification of Human Subjects Research form (link).
What research requires review by the Emmanuel College CPHPR?
All research involving human subjects, as described above, that is conducted by faculty, staff or students on-campus or off-campus, or investigators from other institutions/organizations requires review. Research that uses Emmanuel property or non-public information to identify or contact prospective subjects must also be reviewed and approved prior to recruiting participants or collecting data. Approval by the Emmanuel CPHPR is required in addition to approval from the affiliated institution.
The CPHPR must determine that all of the following requirements are satisfied:
- Risks to participants are minimized;
- Risks to participants are reasonable in relation to anticipated benefits, if any, to participants and to the importance of the knowledge that may reasonably be expected to result;
- Selection of participants is equitable, Informed consent will be sought from each prospective participant or the participant's legally authorized representative, as required by DHHS regulations;
- Adequate provisions are in place for monitoring the data collected to ensure the safety of participants;
- Adequate provisions are in place to protect the privacy of participants and to maintain the confidentiality of any identifiable data; and
- When some or all of the participants are defined as vulnerable populations, additional safeguards are included in the study to protect the rights and welfare of these participants.
What training is required for Investigators conducting research with human subjects?
Investigators and student research assistants must comply with the federally-mandated educational training requirements. This may be accomplished by taking an online course offered by the Collaborative Institutional Training Initiative (CITI), titled "Course in the Protection of Human Research Human Subjects," which is found at www.citiprogram.org. The CITI program includes courses in the protection of human research participants for biomedical researchers, social/behavior/educational researchers, and student researchers and their research advisors. Investigators are required to submit evidence of course completion with their project proposals.
If you are applying for federal funding from a Public Health Service (PHS) agency such as the National Institute of Health (NIH), you will need to complete Responsible Conduct of Research (RCR) training also in CITI in order to satisfy the Financial Conflict of Interest (FCOI) training requirement. If you have completed any training through NIH or other agencies that cover the protection of human research participants, please contact the CPHPR to ensure that the training meets the necessary requirements. All trainings are good for 2 years and certificates of completion must be provided.
My research is not federally funded. Do the federal regulations for research still apply?
Yes. Emmanuel College applies the protections of the federal regulations 45 CFR 46 to all human subject research regardless of the source of support or funding.
If my students are doing research projects assigned through my course, what do I need to do?
Professors who assign a research project to be conducted by students within the time frame of an academic course should consult with the CPHPR to determine whether the project falls into either of these two categories:
- a "non-research" project
- a research project that DOES NOT involve identifiable human subjects
Please complete the Request for Classification of Human Subjects Research form.
If projects are classified as human subjects research, CPHPR review is required. To the greatest extent possible, please begin the CPHPR review process before the start of class to allow sufficient timing depending on the level of review.
How do I get approval for my research?
Please read the Policies and Procedures document and appropriate forms to better understand the role of an Investigator.
What are the different levels of review and how is the level determined?
All research activities must be reviewed by the CPHPR even when categorized as "exempt". Additionally, please note that the category called "expedited" does not mean a "faster" review. It only refers to the federal categories of research that do not require a full committee review.
Determination of the category of review is ultimately made by the CPHPR, not the Investigator.
Exempt Review - review process to determine if the research protocol qualifies for exemption from further institutional review by meeting one or more of the six exempt categories listed at 45 CFR 46 101 (b).
Expedited Review - initial review process for research protocols that involve no more than minimal risk to subjects and include activities listed in one or more of nine categories published by the U.S. Department of Health and Human Services. Expedited review also includes review of minor changes to previously approved research during the period (of one year or less) for which approval is granted 45 CFR 46 110 (b). Any proposed modification to previously approved research resulting in greater than minimal risk or having a negative impact on the balance between the risks and benefits of the research will be referred to the full CPHPR for review.
Full Committee Review - review process for research protocols that do not fall under the "exempt" or "expedited" categories, include vulnerable populations, and/or are determined by the IRB to involve greater than minimal risk to subjects 45 CFR 46 111.
NOTE: For protocols that are reviewed by the full CPHPR, the Investigator is expected to be present at the convened committee meeting to discuss their protocol and answer questions. (Link to CPHPR Meeting Schedule)
Continuing Review - federal regulations 45 CFR 46.109(e) mandate that ongoing Expedited or Full Review research studies be reviewed at intervals appropriate to the degree of risk, but not less than once per year from the previous date of approval.
How is "minimal risk" defined by OHRP?
"Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." 46.102(i)
How does the CPHPR assess risk to participants?
To determine whether a human participant will be harmed in any way as a result of his or her participation in a research project, the CPHPR will make a decision based on sound professional judgment and common sense as to whether or not the proposed research places the human participant "at risk."
What constitutes "Risk?"
A human participant is considered to be "at risk" if s/he may be exposed to the possibility of harm or discomfort (whether physical, psychological, sociological, or other) that is greater than the possibility of harm or discomfort encountered in daily life. The CPHPR will consider the fact that certain human participant populations (e.g., minors, pregnant women, prisoners, mentally disabled, culturally or socioeconomically disadvantaged individuals) may be vulnerable and thus at greater risk than others. See also Section IX.A (Research with Vulnerable Populations) for specific regulatory requirements for children, pregnant women, and prisoners.
Certain risks are inherent in life itself, but the CPHPR process does not address the ordinary risks of public or private living. Risks that are subject to DHHS regulation and CPHPR review are most evident in medical and behavioral science research projects involving procedures that may induce a potentially harmful altered physical state or psychological condition. Obvious examples include surgical procedures, the administration of drugs or radiation, strenuous physical exertion, and interventions that precipitate an emotional disturbance. There is also a wide range of medical, social and behavioral research which may not include physical risk but may subject the individuals to discomfort, anxiety, harassment, invasion of privacy, or constitute a threat to the human participant's dignity.
The CPHPR also will assess the risks involved in those studies that are dependent upon existing information or stored data that have been obtained for quite different purposes but that, when used in a research context, may present risk to the human participant. For example, there are medical and biomedical research projects concerned solely with organs, tissues, body fluids and other materials previously obtained in the routine performance of medical services that have been stored or banked. If an investigator desires to use any of these stored materials for research purposes and, in the process, would have access to identifiable, private information about the individual donors, then such research would meet the definition of human participants' research and would be subject to DHHS regulation and the College's CPHPR policies and procedures. Although the use of these materials for certain research purposes introduces no new element of physical risk to the human participant, their use for these purposes may present psychological, sociological, or legal risks to the human participant or his or her authorized representatives.
When Is Risk Acceptable?
If the CPHPR concludes that a proposed research project will expose a human participant to risk, then the CPHPR must assure itself that each of the following requirements is satisfied before approving a project proposal: (a) the rights and welfare of the human participant are adequately protected by the introduction of appropriate safeguards, (b) the methods used to obtain informed consent are adequate and appropriate, (c) the risks to the human participant are reasonable in relation to the potential benefits to the human participant and to the importance of the knowledge that is reasonably expected to be gained, and (d) the risks to human participants are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose human participants to risk. Any study carrying more than minimal risk will be considered by the full CPHPR, and decisions recorded in the minutes regarding calculations of acceptable level of risk.
Can I amend a study that has been closed?
No, you must submit a new protocol.
I am working with student researchers and other collaborators. Do they need training?
Yes. As the Investigator, it is your responsibility to ensure that all student researchers or collaborators have the required training to participate in your research activities.
I have an approved protocol but need to make some changes, what process should I follow?
Amendments/revisions to an approved protocol can be requested by completing an Amendment form (link to form). All changes must be approved before you implement the change(s).
Amendments that require approval include, but are not limited to, changing the Investigator, inclusion/exclusion criteria for subjects, sites of study, recruitment methods, consent and authorization processes, informed consent form, questions on survey/interview/focus groups, testing procedures, confidentiality measures, or safeguards for participants.
Note: Minimal changes are approved by expedited means and will likely involve little time. However, if changes are significant, they will be reviewed by the full CPHPR.
I am in the middle of a research study that was approved by the CPHPR and certain aspects of the study are not going as planned. How should I proceed?
Any adverse events involving human subjects must be promptly reported in writing to the CPHPR and the Chair will decide how best to deal with the situation in order to ensure the highest ethical standards for human subjects research protections.
I have an approved protocol that is expiring after one year but would like to continue the research study, how can I extend the approval?
A continuing review of research is required annually. Depending on the level of risk, the CPHPR may require more frequent intervals for continuing review 45 CFR 46.109(e).
For each approved study that has been reviewed under expedited or full committee status, the CPHPR assigns a continuing review interval and expiration date. The investigator must complete the Continuing Review Form (CRF) and return it at least one week before the designated date. Regardless of whether or not the study has begun, is still open to enrollment, is closed to new enrollment with follow-up and/or ongoing analysis of data or has concluded, the Continuing Review Form must be completed for our records.
Projects that do not receive written notice of renewed approval from the CPHPR may not continue past the expiration date.