University of New Mexico Health Sciences Center
Federal regulations dictate the criteria the HRRCs must follow to approve a protocol. The criteria required to be met are set forth below:
(45 C.F.R. 46.111(a)(1) and (2); 21 C.F.R. 56.111(a)(1) and (2)): One of the HRRCs’ major responsibilities in reviewing research is to ensure that risks* to subjects are minimized, and that the risks are reasonable in relation to the anticipated benefits**, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.
*Risk: *Risk: Means the probability of harm, including: physical (for example, in biomedical studies, the risks of adverse events or the risk of randomization and not receiving the treatment that turns out to be more efficacious), psychological (for example, depression, confusion, fear, stress, loss of self-esteem), social or economic (for example, breaches of confidentiality and privacy in research involving drug or alcohol use, sexual behavior, mental illness, or illegal activities, or in genetic research, could lead to embarrassment in a social group, prosecution, or loss of employment, insurability concerns, etc.). Both the probability and magnitude of possible harm may vary from minimal to significant. Risks include immediate risks of study participation as well as risks of long term effects.
**Benefit: A benefit is a valued or desired outcome--an advantage. Anticipated benefits may express the probability that subjects and society may benefit from the research procedures. Research may benefit the individual, for example, by alleviating a condition or providing a better understanding of his or her disease. Research that has no therapeutic intent may still benefit society as a whole. If research will not benefit individuals, it is required to provide a reasonable likelihood of resulting in benefits to society, e.g., the advancement of important knowledge.
In reviewing the risks to ensure that they are minimized, IRBs may consider whether previous animal and human studies have been done, whether the investigators serve a dual physician/investigator role to the subject and if so, whether any safeguards are necessary, whether the research is designed to yield useful data, whether there are any monitoring mechanisms if necessary, and whether follow-up counseling or other care will be provided (for instance, with genetic research), as applicable. Thus, the HRRCs may consider the study design in reviewing investigators’ studies, since putting subjects at any risk or even inconveniencing them with a study that is methodologically flawed such that little or no reliable information will be obtained would be unethical.
[45 C.F.R. 46.111(a)(3); 21 C.F.R. 56.111(3); 38 CFR 16.111(b); 38 CFR 17.45, 17.92] In making this determination, the purpose of the study, as well as the setting of the study, are relevant.
Proposed uses of vulnerable populations such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons (Section 6.2) are more closely scrutinized. The principles in FDA’s Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs, 58 Fed. Reg. 39,406 (July 22,1993), are considered to ensure that women of child bearing age are not inappropriately restricted from entering Phase 1 and 2 trials, but that there are sufficient methods proposed to monitor for pregnancy.
For VA research, the following groups of subjects cannot be enrolled unless identified requirements are met:
The HRRCs address issues of patient and subject privacy and confidentiality. Privacy is about persons and their sense of being in control of the access of others to themselves. In research, privacy typically refers to whether the subject considers it the researcher’s business to delve into the subject’s life concerning whatever matter is the topic of the research. In short, privacy refers to persons and to their interest in controlling the access of others to themselves. For example, a young child would want a parent present at a session with a researcher. A teenager has different issues of personal privacy and perhaps would want the parent absent. When designing research, investigators should consider steps that will be taken to protect subject privacy during the consenting process as well as during research procedures and followup procedures and address these issues of privacy under the applicable section of their HRRC application.
Confidentiality is an extension of the concept of privacy; it refers to (a) identifiable data[1] and (b) agreements about how those data are to be handled in keeping with respondents’ interest in controlling the access of others to information about themselves. This definition indicates the critical role of the informed consent, which states how the researcher will control access to the data and secures the participant’s agreement to participate under these conditions. Confidentiality issues are of particular concern in requests to review databases and medical records without patient consent, and research that will elicit potentially sensitive or damaging information (for instance, interview or genetic research) about the subject or a group to which the subject belongs. Factors that may be considered include the importance of the research, the sensitivity of the information sought to be obtained and to which the investigator will have access, whether links to identifiers will be maintained, the procedures the investigator has devised for protecting the information, and, if the review is for the purpose of identifying potential subjects, whether there are other feasible methods for recruiting subjects. Investigators should address these issues of confidentiality under the applicable section of their HRRC application.
Investigators may consider applying for a "Certificate of Confidentiality" for certain types of biomedical, behavioral, clinical, or other research where the disclosure of information learned about a subject could be particularly damaging. 42 U.S.C. Section 241(d). The Certificate protects against compulsory disclosure (such as a subpoena or court order) of research data that identifies a specific individual (not information in the aggregate), although review by federal agencies, such as FDA, is still permitted. Certificates are issued only "when the research is of a sensitive nature where the protection is judged necessary to achieve the research objectives." The categories of research explicitly covered include:
In addition, Certificates may be issued for other categories of research considered sensitive because of specific cultural or other factors, upon justification.
Various agencies within HHS provide these certificates. NIH Contacts
[1] Some information about a person that would permit others to identify the specific person, such as an identifiable survey, notes or a videotape of the person.
(45 C.F.R. 46.111(a)(4-5); 21 C.F.R. 56.111(4-5)): The HRRCs carefully review the proposed informed consent method and form to ensure that human subjects will be adequately informed regarding the proposed research. See Section 7 for more detailed information on informed consent requirements.
(45 C.F.R. 46.103 (b)(4) and 111(a)(6); 21 C.F.R. 56.108(a)(2) and 56.111(a)(6)): The HRRCs may decide in a review of a protocol that it requires more than annual review (see Section 8.4, Continuing Review) or that it needs verification from other sources that no material changes have been made since the previous review, and/or that the project needs additional monitoring or safeguard procedures to ensure the safety of the subjects in their reviews. Both of these determinations generally will be based on the degree of risk in the study, taking into account any vulnerability of the subject population.
Certain groups of human subjects are considered to be particularly vulnerable to coercion or undue influence in a research setting. Vulnerable populations include children (also indirectly an infant, if a nursing mother is a subject of research), mentally disabled (cognitively or decisionally impaired) persons, prisoners, pregnant women, and economically or educationally disadvantaged persons. 45 C.F.R. 46.111(b); 21 C.F.R. 56.111(b). In addition, terminally ill persons may be vulnerable as well since they may be willing to "try anything." The regulations identify and the HRRC follows additional requirements for review and approval of research involving fetuses, pregnant women, and human in vitro fertilization, 45 C.F.R. 46 Subpart B, prisoners, 45 C.F.R. 46 Subpart C, and children, 45 C.F.R. 46 Subpart D. In reviewing research projects involving all categories of vulnerable subjects, the HRRCs ascertain that their use is adequately justified and that additional safeguards are implemented to minimize risks unique to each group, as appropriate. A summary of the additional requirements for review and approval of research involving children, prisoners, and pregnant women and fetuses is presented below:
Under federal law, “children” are defined as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction, in which the research will be conducted (45 C.F.R. 46.402(a)). In New Mexico all individuals under the age of 18 are considered to be children for purposes of research unless the individual:
New Mexico law allows some minors to consent to health care procedures in limited circumstances, such as psychotropic medications, HIV/AIDS testing, termination of pregnancy, treatment for sexually transmitted disease, family planning services, pregnancy services, and drug and alcohol abuse counseling. However, these individuals are still considered children for the purposes of research even if the research procedures are limited to these treatments.
Parents under the age of 18 may provide permission for their children to take part in research. However, parents under the age of 18 are still considered children when they take part in research.
Even though the minor is authorized by law to consent to the treatment, and by parallel application, to treatment involved in research, the law may require reporting to another authority such as Public Health Division of Department of Health or Child Protective Services of the Children Youth & Families Department. For instance, HIV/AIDS, sexually transmitted diseases, and certain wounds must be reported to the Public Health Division. Moreover, if HIV/AIDS, sexually transmitted diseases, or pregnancy is the result of a relationship with an adult in a position of authority over the child (a parent, teacher, coach, babysitter, etc.), a report of abuse or neglect must be made to Child Protective Services and the minor should be informed that such reporting will be or may be reported. See New Mexico Department of Health, Public Health Division web-site for reportable injuries, illnesses and diseases.
45 C.F.R. 46, Subpart D, classifies research involving children into one of four categories depending upon the risks and benefits of the proposed research, which can be approved as follows:
Assent and Permission Required. The federal regulations require both "assent" of a child and "permission" by a parent or legal guardian for research. See Section 7.4.3 on informed consent requirements for studies involving children for more information.
Wards of State. Where children are wards of the state or another agency or institution, additional restrictions apply, and they may only be included in research that is related to their status as wards, or which is conducted in schools or other institutions in which a majority of children are not wards. If the HRRC approves research under this provision (45 C.F.R. 46.409), it must appoint an advocate for each child that is a ward.
No Exemption for Research involving Surveys or Interviews. Unlike research involving adults, the exemption at 45 C.F.R. 46.101(b)(2) for research involving survey procedures, interviews, educational tests, or public observations (except where the investigator does not participate in the activities being observed) does not apply to research involving children. 45 C.F.R. 46.401(b).
Child Abuse Reporting. The State of New Mexico has a law (Section 32A-4-3 NMSA 1978) that requires the reporting of suspected child abuse or neglect. Investigators are not exempt from that law. If the protocol involves interviewing children about topics that might lead to a suspicion or to knowledge on the part of the investigator of child abuse or neglect, the HRRC may require that the child (and parent or guardian) be informed of the reporting requirement as part of the informed consent process. In accordance with the HIPAA Privacy Regulation, 164.520(b)(1)(ii)(B), UNMHSC informs patients in the Notice of Privacy Practices that information related to child abuse may be disclosed without their permission.
NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects. Investigators submitting proposals to the NIH for human subject research must include children in the study unless there are scientific or ethical reasons not to include them. The proposals must specifically include a description of plans for including children. And, if children will be excluded, the application must present an acceptable justification for the exclusion. Investigators should review the NIH policy and guidelines before submitting their proposals.
Considerations for research involving children. What follows are some questions that may be appropriate, depending upon the study, for investigators and IRBs to consider in conducting or reviewing research-involving children:
* Has the research been addressed first in adults if possible (NIH guidelines provide that "while children usually should not be the initial group to be involved in research studies, in some instances, the nature and seriousness of the illness may warrant their participation earlier based on careful risk and benefit analysis")? Will older children rather than younger be used?
Investigators must disclose if they anticipate enrollment of subjects who meet the definition of a ”prisoner” during the course of the study. This would include any follow-up activity where data is being collected. It is not an HRRC requirement to obtain initial approval (IRB and OHRP) to include prisoners in research if the research is not targeting this population. It is, however, strongly encouraged if the investigator’s subject population is at increased risk for becoming a “prisoner” that approval be requested at the time of initial submission for enrollment of prisoners. Once the study has HRRC approval and OHRP certification under 45CFR46 Subpart C to include “prisoners” (if applicable), all amendments and continuing reviews will be reviewed under Subpart C criteria as well.
If a research subject is subsequently incarcerated (and thus considered a prisoner) and the research was not initially reviewed under subpart C, the investigator must complete a reportable event form and either:
*All DHHS conducted or supported research is subject to DHHS certification under subpart C if research involves prisoners.
** Note: OHRP has allowed one important exception. In special circumstances in which the principal investigator asserts that it is in the best interests of the subject to remain in the research study while incarcerated, the IRB chairperson may determine that the subject may continue to participate in the research until the requirements of Subpart C are satisfied.
45 C.F.R. 46, Subpart C, provides additional safeguards for prisoners since "Prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects of research.” This directly relates to the principle set forth in the Belmont report of respect for persons in that a prisoner may have markedly restricted liberty and autonomy.
Research involving prisoners at the VA must also be granted a waiver by the Chief Research and Development Officer at the Central VA office.
Per Federal Regulations, ‘Prisoner’ is defined as follows: “Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.”
A further interpretation of the definition of ‘prisoner’ includes people (children and adults) who are:
The following do not meet the Subpart C definition of “prisoner”
Individuals who do not meet any of the above and who are:
Research involving prisoners does not qualify for an exemption (Section 5.1).
Research involving prisoners is approvable only if it falls into one of the following four categories (45 C.F.R. 46.306(a)):
In addition to the general requirements for review (Section 6.1), in reviewing prisoner research, IRBs are required by 45 C.F.R. 46.304 to:
45 CFR 46.305 requires the IRB to do the following prior to approving research involving prisoners:
45 C.F.R. 46, Subpart B, provides addition protections for research involving fetuses, pregnant women, and in vitro fertilization.
In addition to the general requirements for review (Section 6.1), the HRRCs are required to:
* Determine that adequate consideration has been given to the manner in which potential subjects will be selected, and adequate provision has been made by the applicant for monitoring the actual informed consent process, including, where appropriate, involvement of the IRB or subject advocates in such oversight.
With regard to fetuses in utero (for research aimed at the mother or the fetus), the regulations prohibit any research unless:
With regard to research involving fetuses ex utero:
Research involving dead fetuses, fetal material, and the placenta has been permitted since a Presidential memorandum lifting the moratorium was issued in February, 1993. Such research must be conducted in accordance with state and local laws. Currently, New Mexico has no laws that specifically govern research involving dead fetuses, fetal material, or the placenta. Where fetal tissue transplantation research is conducted or supported by HHS, 42 U.S.C. 289g-1 governs the research and its provisions must be followed. This law requires, among other things, written informed consent of the woman (to include disclosure of the physicians interest, if any, in the research), which consent may only be obtained after the decision to abort, no alteration in the timing or methods of the procedure, informed consent of the donee and a statement by the researcher to include that the tissue may have been obtained from a spontaneous or induced abortion, and that the researcher had no part in the timing, method, or procedures used to terminate the pregnancy.
In addition, the purchase or sale of fetal tissue is prohibited, as is the directed solicitation or donation or solicitation of such tissue obtained from an induced abortion. 42 U.S.C. 289g-2.
When the research objectives can be met by enrolling subjects capable of consent, individuals who are unable to consent should not be used. If decisionally impaired subjects are to be used, and there is no benefit to the subjects, the risks to the subjects must be no more than minimal.
Drugs that have not been approved for marketing by FDA under an approved new drug application ("NDA") may only be studied pursuant to an investigational new drug application ("IND") in effect for a particular use (unless an exemption applies). This requirement applies regardless of the phase of study. A "drug" includes not only products listed in the USP, but also any substance that is intended for use in the diagnosis, mitigation, or cure of disease, or that is intended to affect the structure of function of the body of man. Thus, research involving the administration of naturally occurring substances or dietary supplements (products not typically thought to be "drugs") generally require submission of an IND to FDA.
Typically, a drug company will be the holder of the IND and will contract with the UNMHSC to conduct research using the investigational drug. In these cases, the investigator does not submit the IND application to the FDA. Occasionally, however, an investigator may seek to initiate studies him/herself, using an investigational drug, or a marketed product that requires an IND (section 6.3.2). In such cases, the investigator is responsible for preparing the FDA Form-1571 (the IND application) according to the requirements set forth in 21 C.F.R. 312.23, but should list UNMHSC as the "sponsor" of the study and forward the form and attached documentation to the HSC Controller’s Officer for review and signature.
Requirements of Investigator-Sponors:
Investigator-Sponsors who submit protocols to the HRRC involving an FDA investigational drug must include all supporting FDA documentation for their IND or provide evidence that the investigational drug meets IND exemption criteria.
Additionally, if the IND product will be manufactured at UNMHSC, the Principal Investigator must submit documentation that:
The IND product must be stored, secured, dispensed, and documented in accordance with documented policies and procedures.
An investigator-sponsor for an IND protocol must follow the FDA regulations in 21 CFR 312 applicable to sponsor responsibilities, particularly Subpart D. This includes:
A qualified auditor must site visit the investigator-sponsor before initiation of the research to determine compliance with these FDA regulatory requirements. If compliance has been demonstrated, the investigator-sponsor may begin the research. The audit must be repeated at the time of, and prior to the renewal, of the protocol by the HRRC.
Note: The Investigator can assign responsibility of compliance with some FDA regulatory requirements to a Contract Research Organization and can obtain an audit from a Contract Research Organization to ensure that procedures are in place so that all other FDA regulatory requirements of sponsors will be met.
The principal investigator will become responsible for fulfilling the additional requirements of a sponsor as set forth in FDA regulations at 21 C.F.R. 312.50-312.59, and must familiarize him/herself with these requirements. Investigators may not begin these studies until 30 days have passed since the submission of the IND application. Within this period, FDA will have provided the IND number and communicated with the investigator regarding any necessary changes/additions.
Investigators should inform the HRRC in their application that their study is investigator initiated, and attaches the IND application and the FDA’s IND response letter. If investigators have any questions regarding these regulatory matters and whether an IND is required, they should contact the HRRC Support Office.
Additional Veterans Affairs (VA Requirements)
VA policy requires that all research comply with the VA human subjects regulations, as well as with all applicable regulations and requirements regarding storage and security procedures for investigational agents.
Investigators shall provide a signed copy of Form 10-1086 to Pharmacy Service and monitored by the Research and Development (R&D) Committee.
Upon Approval of the research by the HRRC and the VA R&D Committee, a Report of Subcommittee on Human Studies (VA Form 10-1223) must be forwarded to the PI and the Chief of Pharmacy Services.
Investigator shall inform the Chief of Pharmacy Service, and the R&D Committee when a study involving investigational drugs has been terminated.
Research involving FDA-regulated test articles will be approved only after the HRRC:
Questions sometimes arise regarding whether research involving an approved drug (for instance, marketed drugs for different uses) requires the submission of an IND. FDA does regulate studies involving marketed drugs, and an IND is required for such a study unless all of the following are met:
21 C.F.R. 312.2(b). If an investigator is uncertain whether FDA would require an IND (e.g., it is not clear whether FDA may consider the proposed use to significantly alter the risks), he/she should contact FDA. Investigators should address these criteria in their HRRC submission and, if they have submitted an IND application, attach it and the FDA IND response letter (if received).
Certain research designed only to study the basic metabolism of a radioactive drug or to gather basic information about human physiology, pathophysiology, or biochemistry, but not intended for immediate therapeutic, diagnostic or similar purposes, or to determine the safety and effectiveness of the drug in humans for such purposes, is exempt from the IND requirement provided that the radiation dose falls within the limits prescribed by FDA, the study design meets certain criteria, and the protocol is approved by a Radioactive Drug Research Committee that has been approved by FDA. See 21 C.F.R. 361.1 for specific information. These studies still require HRRC approval. Investigators should note if they believe this exemption applies in their HRRC application, and call the HRRC Support Office with any questions.
Medical devices are subject to FDA regulation 21 CFR 812. A "device" includes any instrument, machine, implement, or other product that does not achieve its primary intended purpose by chemical action or by being metabolized and which is intended for use in the treatment, cure, diagnosis, or mitigation of disease or other conditions in man.
With limited exceptions, devices that have not been approved by FDA under the pre-market approval process ("PMA") or cleared for marketing under the 510(k) process (or an exemption) cannot be used on humans except pursuant to an approved investigational device exemption application ("IDE"). The approved IDE permits a new device to be studied for its safety and/or effectiveness. In addition, a device that is sought to be studied for a different indication from its approval may also be subject to this requirement.
Typically, a biotech company will be the holder of the IDE (Sponsor) and will contract with the UNMHSC to conduct research using the investigational device. In these cases, the Sponsor is responsible for the FDA IDE application and required reporting set forth in FDA regulations at 21 CFR 812. The investigator must meet the requirements set forth in Subpart E of 21 CFR 812.
The investigator should provide all relevant documents at the time of HRRC submission. (i.e. NSR claim or IDE number, the data safety monitoring plan, device accountability and storage procedures, labeling information, etc.). The HRRC will evaluate the appropriateness of the data safety monitoring plan and device accountability procedures to ensure subject safety as well as protection against accidental use of the controlled device.
The FDA Information Sheet on Investigational Devices provides a list of devices which FDA believes may be SR and NSR. Because the NSR determination includes the proposed use of the device in the study, the list may not be conclusive.
The Investigation Device Exemption regulations (21 CFR 812) describe two types of device studies, significant risk (SR) and non-significant risk (NSR).
The SR/NSR determination is important to research sponsors and investigators. SR device studies are governed by the IDE regulations 21CFR812. NSR device studies have fewer regulatory controls than SR studies and are governed by the abbreviated requirements set forth in 21 C.F.R. 812.2(b). The major differences are the approval process and reporting requirements.
A NSR claim is generally initially made by the sponsor. In such cases, the HRRC makes the following two separate determinations (unless it concludes that the study is exempt under 21 C.F.R. 812.2(c)):
Investigators must meet the requirements set forth in Subpart E of 21 CFR 812. Investigators are required to report each use of an investigational device on a subject, among other device-specific study requirements, even for NSR device studies. Investigators should familiarize themselves with the requirements set forth in 21 CFR 812, Subpart E.
Occasionally a UNMHSC/VA investigator may seek to initiate studies using an investigational device. In this instance, the investigator would be working with the FDA to determine if the device would be NSR or SR. The investigator is responsible for preparing the device application according to the requirements set forth in 21 CFR. 812. The principal investigator should list UNMHSC as the "sponsor" of the study and forward the application and attached documentation to the UNMHSC Controller’s Office for review and signature.
Investigator-Sponsors who submit protocols to the HRRC involving an FDA test article must include all supporting FDA documentation for their IDE or provide evidence that the test article meets IDE exemption criteria.
Additionally, if the IDE product will be manufactured at UNMHSC, the Principal Investigator must submit documentation that:
The IDE product must be stored, secured, dispensed, and documented in accordance with documented policies and procedures.
An investigator-sponsor for an IDE protocol must follow the FDA regulations in 21 CFR 812 applicable to sponsor responsibilities, particularly Subpart C. This includes:
The principal investigator will become responsible for fulfilling the additional requirements of a sponsor as set forth in FDA 21 CFR. 812 regulations, subpart B and C as well as Subpart E (investigators responsibilities) and must review these requirements with a designated person within the HRRC. The HRRC encourages the investigator to contact the HRRC during the FDA pre-application process to discuss the elements of 21CFR812 and the required reporting and monitoring plans expected from an investigator acting as “sponsor” for investigational device research studies.
Investigators must inform the HRRC in their HRRC application that their device study is investigator initiated, and attach relevant documents (the IDE application, FDA response letter, etc).
Research involving FDA-regulated test articles will be approved only after the HRRC:
The amount of compensation offered should not appear to be coercive - it should be commensurate with the amount of subject involvement. If the research involves an overnight stay(s), multiple procedures, multiple visits, or an extensive time commitment this would help to justify larger compensation amounts. Any amount of compensation that is paid as a bonus for completion of the study must be reasonable and not so large as to unduly induce participants to stay in the study when they might otherwise withdraw.
All consent forms include a "Payment for Participation" section. If the study involves subject compensation, the consent should include:
See section 11.2 for guidelines when developing advertisement materials for your study.
Note: for FDA-regulated research, compensation is not allowed in the form of a coupon good for a discount on the purchase price of the product once it has been approved for marketing.
(From VHA HANDBOOK 1200.5 - July 15, 2003)
VA policy prohibits paying human subjects to participate in research when the research is integrated with a patient's medical care and when it makes no special demands on the patient beyond those of usual medical care. Payment may be permitted, with IRB approval, in the following circumstances:
VA Investigators who wish to pay research subjects must in their application:
University students and particularly health professional students (as future physicians and possibly researchers) may be in a position to participate in some research because of their ability to comprehend the procedures and evaluate the risks involved, which may not be as easily achieved with other normal volunteers. Offering course credit is controversial, though common in the social and behavioral sciences (particularly in Psychology departments). Educational benefit to be gained by the individual is widely cited as supporting student participation in research. Likewise, participation of students is seen by faculty-investigators as necessary to the conduct of their research. Grant budgets often do not allow investigators to pay subjects and therefore giving course credit or extra credit is a means of obtaining sufficient participation rates.
The HRRC feels that prohibiting all student participation in research is over protective. However, the HRRC’s stance is that offering credit for student research participation to partially fulfill a course requirement should be restricted to only research involving no more than minimal risk (including physical, psychological, social, and privacy risks) and care must be taken to protect student autonomy and confidentiality. Students are in a position where there is the risk of them being coerced into participating in studies and in these circumstances it may be difficult to determine whether consent to participate is freely given. Therefore care should be taken to eliminate or reduce the risk that undue influence of faculty or coercion affects student participation in research. This is particularly important when course credit is offered for student research participation. Therefore the HRRC is offering the following guidelines for research projects in which students will be asked to be subjects:
In reviewing research being offered for student credit, the HRRC will give additional consideration to the following: